{"paper_id":"f25c7ae8-a26c-498a-95ac-c5b5d14a2aca","body_text":"Supporting Health, Improving Employee Life and Duty (SHIELD): Protocol for a cluster randomised controlled feasibility trial of dedicated time at work for Emergency Medical Service worker mental health | Research Square window.SnipcartSettings = { analytics: { enabled: false } }; (function() { var accessVector = localStorage.getItem('access_vector') || ''; window.dataLayer = window.dataLayer || []; if (accessVector) { window.dataLayer.push({ user: { profile: { profileInfo: { snid: accessVector } } } }); } })(); (function(w,d,s,l,i){w[l]=w[l]||[];w[l].push({'gtm.start':new Date().getTime(),event:'gtm.js'});var f=d.getElementsByTagName(s)[0],j=d.createElement(s),dl=l!='dataLayer'?'&l='+l:'';j.async=true;j.src='https://www.googletagmanager.com/gtm.js?id='+i+dl;f.parentNode.insertBefore(j,f);})(window,document,'script','dataLayer','GTM-K279D39R'); Browse Preprints In Review Journals COVID-19 Preprints AJE Video Bytes Research Tools Research Promotion AJE Professional Editing AJE Rubriq About Preprint Platform In Review Editorial Policies Our Team Advisory Board Help Center Sign In Submit a Preprint Cite Share Download PDF Research Article Supporting Health, Improving Employee Life and Duty (SHIELD): Protocol for a cluster randomised controlled feasibility trial of dedicated time at work for Emergency Medical Service worker mental health Sasha Johnston, Polly Waite, Mara Violato, Sarah Black, Jennifer Wild This is a preprint; it has not been peer reviewed by a journal. https://doi.org/ 10.21203/rs.3.rs-9542409/v1 This work is licensed under a CC BY 4.0 License Status: Posted Version 1 posted You are reading this latest preprint version Abstract Introduction Emergency Medical Service (EMS) personnel experience elevated levels of psychological distress, trauma exposure, and mental ill health than the general population and other NHS staff groups. Despite the availability of support services, uptake remains poor due to stigma, fear of negative career consequences, workplace culture, and a lack of time at work. EMS-SHIELD (Supporting Health, Improving Employee Life and Duty), is a structured peer-led 1-hour session, scheduled during work hours to promote reflection, well-being check-ins, and signposting to support resources. Preparatory studies suggest this approach aligns with EMS professional identity, organisational culture, and employee norms favouring peer support. Methods A two-arm, cluster randomised controlled feasibility trial will assess recruitment, retention, intervention delivery, and trial procedures in one UK NHS ambulance service in Southwest England. Approximately 128 paramedics working across four ambulance stations will be invited to participate, targeting a recruitment rate of at least 50%. The four stations (two urban, two suburban) will then be randomised (1:1 by station) to EMS-SHIELD (intervention: dedicated time at work with signposting to relevant support resources) or usual practice (no dedicated time at work; unchanged access to standard support services). Trained peers will deliver EMS-SHIELD with fidelity monitored using standardised checklists. Questionnaires will be collected at baseline (pre-randomisation), 4–6 week post-randomisation, and 3-months post-randomisation. Primary outcomes include feasibility metrics (recruitment, retention rates, fidelity, questionnaire completeness), alongside acceptability metrics (session attendance and qualitative interviews exploring experiences). Secondary outcomes provide preliminary estimates of well-being, post-traumatic stress disorder symptoms, perceptions of organisational support, attitudes towards help-seeking, trauma exposure, health-related quality of life, and resource utilisation. Analyses will be descriptive with confidence intervals for feasibility metrics, and qualitative data will be examined using reflexive thematic analysis informed by behaviour change frameworks. Discussion This study will determine whether dedicated time for structured peer reflection in work hours is feasible and acceptable in a live EMS setting and whether trial procedures and health economic data collection are practicable. Findings will inform progression to a larger definitive trial to examine effectiveness for improving employee mental health and perception of organisational support at work, alongside cost-effectiveness evaluation. Trial registration The protocol for this study has been registered with the ISRCTN register: https://doi.org/10.1186/ISRCTN12172690 ; date of registration: 6th November 2025. Psychology Health Economics and Outcomes Research Critical Care & Emergency Medicine Health Policy Leadership and Ethics Feasibility trial Cluster randomised trial Paramedic mental health Peer support Behaviour change frameworks Health economics Organisational well-being Figures Figure 1 Background The World Economic Forum projected that over half the global economic burden due to non-communicable diseases will be caused by mental ill health by 2030 [ 1 ]. Emergency Medical Service (EMS) workers are routinely exposed to trauma, long working hours, fatigue, and organisational stressors leading to rates of post-traumatic stress disorder and suicide that exceed those in other UK National Health Service (NHS) professions and the community samples [ 2 – 7 ]. Investigations commissioned by UK ambulance Trusts have raised concerns about the rate of suicide deaths among EMS staff, prompting calls for targeted prevention strategies [ 8 , 9 ]. Furthermore, UK EMS employees are stark outliers among NHS staff groups for mental ill health related sickness absence and employee dismissal for misconduct, which raises broader questions about culture and employee support [ 10 , 11 ]. However, employees often avoid disclosing mental health issues due to perceived stigma, fear of career repercussions, and a broader sense of feeling unsupported by their employer [ 12 , 13 ]. These conditions have led to EMS employees reporting the highest harassment, burnout, and bullying rates among NHS staff groups and being the least likely group to report feeling safe to speak up, undermining workplace psychological safety and compromising patient outcomes [ 14 – 17 ]. Several studies link these factors with medical errors, suboptimal patient care, increased motor vehicle accidents, depression, absenteeism, staff turnover, and low organisational commitment [ 18 , 19 ]. Despite growing recognition of these challenges and acknowledgement of the need for proactive approaches to staff well-being within EMS, many employees report multiple barriers to help-seeking, including stigma, perceived weakness, and a lack of time during work hours, alongside feeling too exhausted to engage with services outside of work [ 20 , 21 ]. Prior work identified that EMS culture, which emphasises stoicism and self-reliance, discourages openness. To address these issues and the gaps in the evidence-base, this study was underpinned by three preparatory studies and systematic Patient and Public Involvement and Engagement (PPIE). Early preparatory work included a systematic review [ 22 ] and qualitative exploration with EMS employees [ 23 ] of the barriers and facilitators to seeking and accessing organisational support, both of which identified the need for interventions congruent with professional identify and operational norms. Staff reported a preference for structured opportunities for reflection facilitated within work hours by trained peers. Despite evidence of mistrust and indiscretion among colleagues, EMS staff want to talk with peers who understand their work context rather than with people who do not. This was a critical factor in enabling staff to speak candidly about work-related issues. Evidence suggests that self-reflective practice may be a promising tool for high-risk occupations [ 24 ]. However, not all reflection is adaptive. Rumination, the repetitive, passive focus on the meaning of distressing events and their implications, is common among EMS staff who often replay critical incidents in ways that can intensify stress [ 25 , 26 ]. Unlike constructive reflection, rumination is a robust maintenance factor for depression and predicts the development of PTSD in paramedics [ 27 ]. Therefore, simply providing time at work to reflect may not be enough, as rumination predicts poor mental health [ 27 ] and may hinder reflective practice and help-seeking [ 28 ]. Grounded in these findings, EMS-SHIELD is a behaviourally informed, peer-facilitated one-hour session providing dedicated space for reflection, structured check-ins, and signposting to support. It draws on clinical supervision principles [ 29 ] and the Theoretical Domains and COM-B (Capability-Opportunity-Motivation-Behaviour) behaviour change frameworks [ 30 – 33 ], to embed reflection as a normative organisational behaviour rather than a remedial activity. The final content and format of the intervention were agreed through an eDelphi consensus study with experts in mental health, psychology, and EMS [ 34 ]. Through PPIE work, this intervention was named EMS-SHIELD - Supporting Health, Improving Employee Life and Duty. EMS-SHIELD aims to normalise discussion about mental health at work, reduce stigma, and establish clear expectations for participation in self-care, mirroring the success of mandatory workplace safety procedures [ 35 ]. The aim of this cluster randomised feasibility trial will be to evaluate the EMS-SHIELD intervention within a UK NHS ambulance service. The primary objectives are to determine feasibility, in terms of paramedic recruitment, scheduling and delivery of the intervention, and data completeness, and acceptability based on session attendance rates and participant experience. Secondary objectives include estimating statistical parameters needed to power a definitive trial for well-being, attitudinal, and symptom outcomes in each arm, and evaluating the feasibility of collecting health economic data. A pre-specified progression criterion, together with any identified barriers and facilitators to implementation, will guide the design of a future definitive trial. Methods Design This feasibility study will adopt a parallel-group, two-arm, pragmatic exploratory cluster randomised controlled design. The study design adheres to the Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT) guidelines [ 36 ] and the CONSORT statement extension to randomised pilot and feasibility trials [ 37 ]. Using a 1:1 allocation ratio, four ambulance stations (clusters) within one UK ambulance service will be randomised to usual practice (no dedicated time at work and individuals contact organisational support services unprompted) or to EMS-SHIELD (1-hour dedicated, structured wellbeing session at work with signposting to support resources as indicated), with a nested qualitative process evaluation. Usual practice was chosen as the comparator because it reflects the current standard approach to paramedic well-being support, allowing assessment of whether adding EMS-SHIELD offers a feasible and acceptable enhancement to existing care. Recruitment will begin in April 2026, and the trial is planned to continue for 6 months. A CONSORT-style study flow diagram is in Fig. 1 . Patient and public involvement and engagement (PPIE) The study design was co-produced with a dedicated group of EMS staff and PPIE contributors, who played key roles in shaping the recruitment strategy and advocating for the inclusion of qualitative interviews to enhance data richness and reduce survey fatigue during the process evaluation stage. A recruitment video co-created by PPIE members, felt to be useful for highlighting the link between employee care and patient care, will be used to encourage paramedic participation. PPIE will include a data analysis workshop to interpret study findings collaboratively, co-production of lay summaries for ambulance service reports and conference presentation. Setting and participants Approximately 128 paramedics work across four ambulance stations selected for this trial: two urban (city) and two suburban (small towns or large villages outside urban settings). The participating stations were selected following consultation with ambulance service operational and research leaders, in areas representing diverse populations (in and around one of Southwest England’s largest cities) with the resources to participate. Limiting the geographical area is practical for the research team and EMS operations and avoids cross-contamination to other areas that may participate in a future definitive trial. Clustering by station reflects how EMS operations are organised; randomisation by urban and suburban cluster ensures the intervention is tested across a range of conditions. Clusters will comprise of paramedics based at eligible stations who volunteer to participate in the trial. Eligibility criteria Aged 18 years or above. Health and Care Professions Council (HCPC) registered paramedic (including bank staff and paramedics working light duties) 1 Based primarily (50% shifts or more) at participating ambulance stations. The participant may not enter the study if either of the following applies: Non-paramedic (including student paramedic) Participation in preparatory qualitative focus groups Intervention Facilitators HCPC-registered paramedics Over 18-years old Registered Clinical Supervision Facilitator with the participating ambulance Trust Able to deliver the intervention from at least one of the 4 participating ambulance stations. Recruitment and consent An invitation to read the EMS-SHIELD participant information sheet, ask questions, and complete consent forms will be sent on behalf of the research team to the NHS email addresses of all paramedics registered to work from the participating ambulance stations, by the Head of Operations team overseeing the participating ambulance stations. The Clinical Supervision leads within the host ambulance service will send emails inviting Clinical Supervision Facilitator team members to review the participant information sheet designed for intervention facilitators and to contact the research team with any questions or to express interest in participating. The Chief Investigator (CI) (lead author SJ) will attend in-house team meetings to share information about the study and provide opportunity to discuss the study and to ask questions. Posters and a video recorded by the CI and PPIE representatives will advertise the study in participating stations. Interested participants will have the opportunity to meet with and ask questions of the study team via a range of media. Informed consent will be obtained by the CI from all participants (including intervention facilitators) after they have read the participant information sheet, via an online consent form, returning a scanned copy via email or, if preferred, a paper version before engaging in any study activities. Separate consent forms will be obtained for trial participants willing to participate in process evaluation interviews after the intervention has been delivered. A copy of the consent form counter-signed by the CI will be returned to participants for their records. Randomisation To reduce selection bias, paramedics will be recruited, and then cluster randomisation will be employed, with the ambulance station as the cluster. The CI will use a web-based random generator to allocate one urban and one suburban site to the intervention and control groups. Participating paramedics will be asked to engage according to their group allocation: either a 1-hour EMS-SHIELD session (intervention group, alongside usual practice) or usual practice (no dedicated time at work, with unchanged access to organisational support services). If larger stations with higher numbers of paramedics are randomised to the intervention and the number of consenting paramedics exceeds n = 32 (the estimated number of intervention arm paramedics that have been costed for the trial), random sampling will be employed by the CI using a web-based random generator to select anonymised participant identifiers allocated to the pool of consenting paramedics. This method ensures that all consenting paramedics have an equal chance of being included and the potential for random sampling will be made clear in the participant information sheet. Any consenting paramedics excluded by random sampling will be entered into a prize draw with a chance to win a £40 gift voucher to thank them for expressing their interest. Blinding Due to the design of the study and the nature of the intervention, it is not possible for paramedics, intervention facilitators, or researchers to be blinded to the study group allocation. Sample size As a feasibility trial, sample size will not be guided by a formal power calculation to estimate effect size [ 38 ]. There are approximately 128 paramedics working across the four ambulance stations, and based on previous studies recruiting paramedics, a 50% recruitment rate is anticipated. We aim to recruit 64 paramedics, 32 in the intervention group and 32 in usual practice, with a minimum of 38 (19 in each group) retained at follow-up. The anticipated intervention session attendance rate of 60% is based on previous paramedic studies and sample sizes reported in UK feasibility studies [ 39 ]. Applying this rate yields an exact two-sided 95% confidence interval of 41% to 77%, providing a useful estimated range for planning the definitive trial [ 40 ]. A feasibility study of this size will be sufficient to collect meaningful data on acceptability, adherence, and retention. Intervention The EMS-SHIELD intervention is one, 1-hour session, scheduled during work hours for paramedics to reflect upon their own mental health and well-being. The content and structure of the session is described in Table 1 : Table 1 EMS-SHIELD content and structure Stage Time Content & Process 1. Welcome & ground rules 5 min Greet, explain purpose, and agree on ground rules; including confidentiality and safeguarding parameters as per the protocol. 2. Check-in 5 min Ask how the participant is getting on today to gain a snapshot of current well-being. Use the EMS-specific visual mental health continuum to aid self-identification of well-being status [ 41 ]. 3. Incident Reflection 15 min Invite sharing of a positive/negative work event; explore the emotional/professional impact. 4. Coping Strategies & WAP Completion 20 min Introduce and provide opportunity to review, complete, or update a Wellness Action Plan collaboratively or to simply familiarise themselves with the format, or opt out if they have recently completed a plan or prefer not to engage with this activity. 5. Information & Signposting 10 min Provide Employee Assistance Programme support overview; signpost to an in-house Staying Well Hub support officer if needed. 6. Review & Close 5 min Summarise and reflect on the session, confirm next steps (i.e., confirm timelines for onward support referrals if relevant and trial data collection expectations), and thank the participant. Timings can be flexed to meet individual needs during the session. Time is provided for reflection on practice, where participants can share any negative or positive work-related events. Completion of a wellness action plan is encouraged since such plans are useful for guiding reflection about psychological triggers, strategies for managing stress, and discussing preferred options for sharing feelings and information about health status with managers and colleagues. Current employee support offers are discussed and signposting to appropriate support can be guided as needed. The session will be guided by ground rules as per the participating EMS service Clinical Supervision policy to maximise safety and prioritise confidentiality and consistency (see Additional file 1). Intervention delivery EMS-SHIELD EMS-SHIELD will be delivered by trained peers recruited from an established team of Clinical Supervision Facilitators within the participating ambulance trust. Facilitators will have completed a higher-education Clinical Supervision module and have regular opportunities to attend group meetings and participate in clinical supervision themselves as part of their role. Facilitators will be trained to deliver the EMS-SHIELD intervention by the CI (a trained and experienced clinical supervision lead). Training includes one, face-to-face EMS-SHIELD familiarisation session, National Institute for Health and Care Research (NIHR) Good Clinical Practice (GCP) online training, and education about current employee support options. Training aims to strengthen facilitator confidence and competence in delivering EMS-SHIELD and allows for familiarisation with key processes and trial procedures, including completion of the intervention fidelity checklist (see Additional file 2) with time to seek clarification or ask questions with the research team. Time is planned for facilitators to undertake regular clinical supervision with trained peers throughout the trial to ensure they are well supported. The CI will provide oversight of the supervision process and, where needed, direct clinical supervision for facilitators. Comparator Usual practice Paramedics allocated to usual practice will have no dedicated 1-hour session at work to reflect on their wellbeing; they will have access as usual to organisational employee support services without prompting. Participants will complete the same questionnaires as intervention paramedics, with an additional item that asks for information about any utilisation of usual practice support services to inform the design of a future definitive RCT. Outcomes Feasibility and acceptability are the primary focus of this cluster randomised feasibility trial. Outcomes will therefore be used to determine whether the EMS-SHIELD intervention can be delivered and evaluated as intended within a live NHS ambulance service, and to inform the design of a future definitive trial. Feasibility and acceptability outcomes will be assessed using quantitative and qualitative measures. Participants will be asked to complete digital questionnaires at baseline, 4–6 weeks post-randomisation, and again at 3-months post-randomisation. In addition, intervention facilitators will complete a fidelity checklist after each EMS-SHIELD session to record delivery of core session components, sequence of component delivery, any interruptions, and whether reflection focused mainly on positive or negative work-related experiences. Primary outcomes Primary outcomes relate to feasibility and acceptability. Feasibility outcomes are: Recruitment rate: defined as the proportion of eligible paramedics who consent to participate. Session scheduling: the proportion of planned sessions successfully scheduled into operational rotas. Retention rate: the proportion of participants who remain in the study and complete follow-up questionnaires. Questionnaire completion and completeness: including the proportion of returned questionnaires with usable data at each time point. Time required for data collection and analysis, to inform the practicality of trial procedures. Intervention fidelity: assessed using a facilitator-completed fidelity checklist after each session. Acceptability outcomes are: Session attendance: the proportion of intervention participants who attend their allotted EMS-SHIELD session. Participant satisfaction: assessed through session ratings. Intervention acceptability and experience: assessed using the self-report Theoretical Framework of Acceptability (TFA) questionnaire [ 42 ], in which items are rated on a 5-point Likert scale; and through qualitative process evaluation interviews conducted with a purposive subset of participants and staff involved in delivery. Example questionnaire items include “Did you like or dislike the intervention?” Secondary outcome measures Secondary outcomes are included to provide estimates of statistical quantities for the well-being, attitudinal, and symptom outcomes in each arm to inform sample-size calculations for a future definitive trial, and to assess the feasibility of collecting health economic data. These outcomes are exploratory and will be presented descriptively; this study is not powered to detect between-group differences. Participant-reported outcomes collected at baseline, 4–6 weeks and three months post-randomisation are: Attitudes towards help-seeking: measured using the Attitude Towards Seeking Professional Psychological Help-short form [ 43 ]. Perceived organisational support: measured using the Perceived Organisational Support scale [ 44 ]. Post-traumatic stress symptoms: measured using the PTSD Checklist for DSM-5 (PCL-5) [ 45 ]. Psychological well-being measured using the World Health Organization (WHO)-5 Well-being Index [ 46 ]. Trauma exposure: measured using the Life Events Checklist for DSM-5 (LEC-5) [ 47 ]. The instructions for the LEC-5 will be modified at each time point to reflect traumatic events that may have been experienced since the previous data collection point, enabling identification of new trauma exposure and contextualisation of changes in wellbeing and PCL-5 scores. Health economic data collection feasibility will be explored by requiring participants to complete the following measures at baseline, 4–6 weeks, and three months post-randomisation: The EQ-5D-5L instrument [ 48 ], a generic preference-based measure of health-related quality of life. Recovering Quality of Life Scale (ReQoL-10) [ 49 ], a mental health-specific preference-based quality of life measure. A modified Client Service Receipt Inventory (CSRII) [ 50 ] to capture use of health and social care (e.g., GP visits; medications), travel time to and from health treatment/visits, absence from work, and all associated costs. Intervention-related resource use, including facilitator preparation time, session delivery time, and backfill costs, will also be recorded to inform future economic evaluation. Schedule of outcome assessment Table 2 summarises the outcome domains, measures, and timing of data collection. Table 2 Schedule of outcome assessment Outcome domain Measure Baseline 4–6 weeks post-randomisation* 3 months post-randomisation** Primary outcomes Feasibility Recruitment rate X Sessions scheduled X Retention rate X X Questionnaire completion and completeness X X X Time required for data collection and analysis X X Intervention fidelity checklist (facilitator completed) X Acceptability Session attendance X Session satisfaction rating X Theoretical Framework of Acceptability (TFA) questionnaire X X Qualitative process-evaluation interviews X Secondary outcomes Attitudes to help-seeking Attitude Towards Seeking Professional Psychological Help—Short Form X X X Perceived organisational support Perceived Organisational Support scale X X X Post-traumatic stress symptoms PTSD Checklist for DSM-5 (PCL-5) X X X Trauma exposure Life Events Checklist for DSM-5 (LEC-5) X X X Psychological well-being WHO-5 Well-Being Index X X X Health-related quality of life EQ-5D-5L X X X Mental health-specific quality of life ReQoL-10 X X X Resource use and costs Modified Client Service Receipt Inventory (CSRI) X X X Intervention cost data Preparation, delivery, and backfill/resource-use logs X *Participants in the intervention arm will complete follow-up questionnaires 4–6 weeks post-randomisation to allow time for delivery of the EMS-SHIELD session. Participants in the usual-practice arm will complete the same follow-up measures at 4 weeks post-randomisation. **Interviews will be scheduled after completion of the 3-month questionnaire, at a time convenient to participants Trial stopping rules The criteria for stopping this study early are: Clear evidence of a lack of safety: based on the nature of the intervention, no serious adverse events (SAEs) are anticipated. The trial will be paused and reviewed by the CI and sponsor if any SAE is judged as being plausibly related to the intervention, and will be stopped if more than one such event occurs. Recruitment failure: if paramedic participation is too low, the trial may be stopped due to feasibility concerns. Intervention delivery failure: if the participating ambulance Trust is unable to support the study as planned, stopping may be necessary. Data collection procedure Data will be collected via three sets of questionnaires throughout this trial: Baseline assessment (pre-randomisation) Following consent, participants will complete an online baseline questionnaire. This will include confirmation of eligibility check, demographic characteristics, availability for intervention scheduling, and all baseline participant-reported outcomes. Post-randomisation scheduling: After cluster randomisation, participants in stations allocated to the intervention arm will be notified of their EMS-SHIELD timeslot based on the availability provided in their baseline questionnaire and the availability of the intervention facilitators. Participants may: attend their allocated session; request an alternative session time; or email the researcher to advise of non-attendance; a short optional online questionnaire will be sent to explore non-attendance reasons, alongside an email ascertaining willingness to complete questionnaires at 4-weeks post-randomisation, and 3-month follow-up. Participants who do not attend their allocated session will remain eligible to complete follow-up data collection unless they withdraw from the study. Post-randomisation follow-up Participants in the intervention arm will be asked to complete follow-up questionnaires 4–6 week post-randomisation, allowing sufficient time for session delivery. Participants in the usual-practice arm will complete the same measures at 4-weeks post-randomisation, reflecting an equivalent time interval without the need to accommodate intervention delivery. This approach will enable us to determine the optimal timing of post-randomisation outcome measurement for a definitive trial. At this stage, facilitators will complete fidelity checklists for each EMS-SHIELD session delivered. Three-month follow-up All participants will complete a final online questionnaire at 3-months post-randomisation. This will assess retention, completeness of participant-reported outcomes, and feasibility of health economic data collection. Participants who complete questionnaires at all three time points will be provided with a £30 electronic thank-you voucher following completion of the final 3-month questionnaire. Questionnaire measures Validated self-report measures will be used to assess feasibility-related participant-reported outcomes and to estimate parameters for a future definitive trial. The Attitude Towards Seeking Professional Psychological Help - Short Form consists of 10 items rated on a Likert scale (“strongly disagree” to “strongly agree”; e.g., “I might want to have psychological counselling in the future.”); assesses attitudes towards seeking professional psychological support. The Perceived Organisational Support scale assesses the extent to which employees believe their organisation values their contribution and cares about their well-being across 10-items, using Likert-type response options (7-point Likert scale rated: “strongly disagree” to “Strongly agree”; e.g., “My organisation really cares about my wellbeing”). The PTSD Checklist for the DSM-5 (PCL-5) includes 20-items rated on a 5-point Likert scale (rated “not at all” to “extremely”; e.g., “In the past month, how much you have been bothered by feeling distant or cut off from other people?”). The Life Events Checklist for DSM-5 (LEC-5) contains 17-items covering exposure to potentially traumatic events with 6 response options, e.g. “Happened to me” or “Part of my job”. The WHO-5 Well-Being Index scores psychological well-being using 5 -items (rated on a 5-point Likert scale: “at no time” to “all of the time”; e.g., “I have felt cheerful and in good spirits”). Health-related quality of life will be measured using the EQ-5D-5L instrument, which comprises 5 domains of daily life (i.e. mobility, self-care, usual activities, pain/discomfort, and anxiety/depression), each with 5 ordered levels, rated on a 5-point Likert scale from “no problems” to “extreme problems”; e.g., “I have no pain or discomfort”, alongside a visual analogue scale. Mental health-specific quality of life will be assessed using the ReQoL-10, a 10-item measure rated with 5-point Likert-type responses “none of the time” to “most or all of the time” in response to statements such as; “over the past week I felt lonely.” Resource use and cost data will be collected using a modified Client Service Receipt Inventory (CSRI), adapted with Patient and Public Involvement and Engagement input, which records service use, medication, travel, and work absence. The CSRI will be completed at baseline, 4–6 weeks, and 3-month follow-up; baseline items use a 3-month recall period, and at subsequent timepoints, participants are asked about service use since their last completed CSRI, with the recall window adjusted accordingly. Success criteria Progression to a phase 3 randomised controlled trial will be considered using a pre-determined ‘traffic-light’ system [ 51 ] by the research team (SJ, JW, PW) and the Sponsor (SB) based upon the targets described in Table 3 : Table 3 Progression criteria Domain Criterion Progression criteria Red Amber Green Intervention feasibility Sign up four EMS station 0–1 stations recruited 2–3 stations recruited 4 stations recruited Intervention feasibility Recruitment of ≥ 50% eligible staff at each site < 30% of eligible staff recruited at each site 30% to < 45% of eligible staff recruited at each site ≥ 45% of eligible staff recruited at each site Intervention acceptability Attendance at EMS-SHIELD sessions < 36% of consenting paramedics attend allocated sessions 36% to < 54% of consenting paramedics attend allocated sessions ≥ 54% of consenting paramedics attend allocated sessions Trial methods feasibility Completeness of primary outcome data < 45% complete data at all follow-up time points 45% to < 67.5% complete data at all follow-up time points ≥ 67.5% complete data at all follow-up time points Intervention acceptability Qualitative assessment of acceptability Qualitative findings suggest low acceptability and/or poor organisational fit, with major concerns regarding appropriateness, burden, or continued use Qualitative findings suggest partial or mixed acceptability, with modifications needed to improve appropriateness, burden, or implementation Qualitative findings suggest good acceptability and organisational fit, including perceived appropriateness and intention to continue use Progression criteria Definition of progression threshold Less than 60% of the stated progression target Within 60–90% of the stated progression target Each criterion met or within 10% of stated progression target Suggested action before proceeding to a definitive trial Recommended response to progression outcome Progression contingent upon significant design modification Assess whether major methodological modifications would improve results Review and consider study design or methodological modifications NB: Percentage change measured as relative Risk Monitoring Procedure Participant well-being will be monitored throughout the study using responses to the PTSD checklist for DSM-D (PCL-5). The CI will review all questionnaires at baseline, post-randomisation, and three-month follow-up to identify participants scoring at or above the clinical threshold for PTSD (PCL-5 ≥ 31), which may indicate probable post-traumatic stress [ 52 ]. After submitting each questionnaire, participants will automatically receive tailored email feedback appropriate to their PCL-5 score. Those scoring 30 or below will receive a thank-you message with links to mental health support resources designed for EMS employees and CI contact details. Those scoring 31 or more will receive a similar message thanking them for completing the questionnaire, whilst highlighting that their response may indicate higher levels of post-traumatic stress, reassuring them that they are not alone, and encouraging them to reach out to trusted support such as organisational well-being services, their GP, or local mental health providers. Participants scoring ≥ 31 at the post-randomisation stage will receive an automated end-of-questionnaire message and a direct email via their preferred method of contact from the CI offering assistance to find the right support. For participants scoring ≥ 31 at three-month follow-up, an automated end-of-questionnaire message appropriate to their PCL-5 score will be sent. In addition to the CI sending a direct email to offer assistance, they will suggest a telephone call at a time convenient to follow up on the completed questionnaire. During the call, the CI will ask how they have been getting on and check whether further support is required. If there is no response to the initial email prompt proposing a telephone call, a second email will be sent after seven days. The participating ambulance service's dedicated employee support service are aware of this trial and will be on standby to provide assistance as needed before, during, and after the study, but will not be informed of specific individuals who score above clinical cut-off on the PCL-5. After the final questionnaire, invitations for process evaluation interviews will be distributed by email with the aim to examine experiences of participating with and delivering the intervention alongside contextual factors that might be associated with any variations in outcomes. Qualitative Process Evaluation All participants, intervention facilitators, and managers who supported the trial will be invited to an interview to provide feedback on what worked well and what worked less well. This nested qualitative study will conduct one-to-one qualitative interviews with a purposive sample of 16 trial participants. This consists of 6 intervention participants, 6 usual practice participants, alongside 2 intervention facilitators and 2 station managers. Intervention decliners and completers with improved, unchanged, or reduced well-being scores will be invited to take part. Potential participants will be invited by preferred method of contact (established during trial consent procedure) alongside a written letter of thanks for trial participation in station pigeonholes with a process evaluation participant information sheet. This opportunity will be advertised via station posters and internal newsletters. A £40 electronic gift voucher will be offered to each interview participant. Process Evaluation data collection The CI will facilitate qualitative focus groups via Microsoft-Teams and sessions will last approximately 45–60 minutes. To inform the process evaluation, the research team with PPIE support, will refine interview topic guides mapped to the Medical Research Council process evaluation framework. The aim of the topic guides will be to guide the exploration of factors such as perceived efficacy, satisfaction, and willingness to recommend the intervention to others, alongside perceptions of barriers and facilitators to participation and delivery. Transcripts will be returned to participants for accuracy checks. The findings will then be analysed using reflexive thematic analysis [ 53 ]. Following the return of thematic summaries for participant review, we will deductively map the themes to behaviour change frameworks COM-B and Theoretical Domain Framework categories, creating new categories if needed. This approach, consistent with existing healthcare research, ensures that findings can be applied to real-world settings [ 54 , 55 ]. Safety considerations Ensuring the psychological safety of participants is paramount. Discussion about mental well-being and organisational support may cause distress, and participants can withdraw at any time before the completion of data analysis. Self-reported PTSD symptom severity will be closely monitored, and participants will receive prompts for support sent as previously outlined. A ≥ 10-point increase on the PCL-5 relative to the previous questionnaire will be recorded as an adverse event, as this indicates symptom deterioration [ 56 ]. Facilitators trained to deliver a restorative Clinical Supervision framework, incorporating trauma-informed practice and ground rules such as confidentiality and safeguarding provisions, alongside completion of wellness action plans, will help to guide the session and mitigate any risk posed by disclosure, i.e., suicidal ideation. EMS employee support services will be available, including for PPIE representatives, via dedicated contact details. Adverse and serious adverse events (SAE) will be logged and assessed by the CI to determine any causal relationship with this trial based on the criteria described in Table 4 : Table 4 Serious and Adverse Events: Causality definitions Relationship Description Reasonable possibility that the SAE may have been caused by the intervention? Unrelated There is no evidence of any causal relationship with the trial/intervention Yes/No Unlikely There is little evidence to suggest a causal relationship with the trial/intervention (e.g. the event did not occur within a reasonable time after the intervention). There is another reasonable explanation for the event (e.g. the participant’s clinical condition or other concomitant treatment). Yes/No Possible There is some evidence to suggest a causal relationship with the trial/intervention (e.g. because the event occurs within a reasonable time after the intervention). However, the influence of other factors may have contributed to the event (e.g. participant’s physical health or exposure to a critical incident at work). Yes/No Probable There is evidence to suggest a causal relationship, and the influence of other factors is unlikely. Yes/No Definite There is clear evidence to suggest a causal relationship, and other possible contributing factors can be ruled out. Yes/No Any SAE’s will be reported to the Research Ethics Committee that gave a favourable opinion of the study, where, in the opinion of the CI the event was ‘related’ (resulted from administration of any of the research procedures) and ‘unexpected’ in relation to those procedures. Reports of related and unexpected SAE’s will be submitted within 15 working days of the CI becoming aware of the event, using Health Research Authority reporting procedures. Trial management and oversight The EMS-SHIELD trial will report to a study management group appointed to provide study oversight on behalf of the sponsor and funder. A Trial Steering Committee will not be convened, as the scale and purpose of this study were deemed proportionate for oversight by a study management group. Day-to-day trial management will be the responsibility of the CI with oversight from the supervision team at the University of Oxford. Permission for protocol amendments will be sought from the sponsor and where required from the research ethics committee. This study management group includes one PPIE representative alongside EMS departmental leaders representing research, frontline operations, Education, Equality, Diversity, and Inclusion (ED&I), employee support, and learning and development. Feedback sessions and corrective actions will be coordinated collaboratively with these stakeholders to address discrepancies and deviations in the context of risk assessments. A study related deviation is a departure from the ethically approved study protocol or other study document or process (e.g. consent process or administration of study intervention) or from Good Clinical Practice or any applicable regulatory requirements. Any deviations from the protocol will be documented in a protocol deviation form and filed in the study master file. Statistical design Analyses will be performed on an intent-to-treat basis where possible, i.e., all randomised participants will be included in the analysis. The primary focus of this trial is to assess the feasibility and acceptability of the intervention and study processes using descriptive statistics and process measures, rather than hypothesis testing for statistical significance. However, clinical outcomes will be reported using effect size calculations alongside the direction of difference between the intervention and usual practice groups. Descriptive statistics of numbers of eligible participants, recruitment, attrition, loss to follow-up, attendance at allocated session, and the number of referrals to onward support will be reported via a Consort diagram [ 57 ]. For each outcome measure, the proportion with complete data will be reported in addition to descriptive statistics (means and standard deviations) for both conditions. Mean differences (and 95% confidence intervals) by condition in outcome score at 3-month follow-up will be estimated. The analysis will not be powered to detect differences between conditions on the outcomes. Therefore, where estimated, treatment effects will be used to inform the sample size for a future definitive trial. With regards to cluster-level data, we will report a descriptive comparison of the influence of clusters on uptake of EMS-SHIELD sessions, intervention adherence, and utilisation of self-reported support resources. Including the feasibility of collecting health economic data in this trial is critical, given the financial constraints faced by NHS EMS services. Generating data to underpin the cost-effectiveness of keeping employees well is essential for justifying investment in supportive interventions. Health economic measures will be reported descriptively, using means, standard deviations, counts and ranges, as applicable, by trial arm, at each time point (i.e. baseline, 4–6 weeks and 3 months follow up). The feasibility of using a modified Client Service Receipt Inventory form to capture participants’ use of health and social care (e.g., GP visits; medications), travel time to/from health treatments/visits, as well as time off work, and all associated costs, will be assessed to inform the selection and refinement of resource-use items for a future definitive trial. The extent of missing data will be summarised descriptively at each time point, including the proportion of missing items and missing questionnaires. Patterns of missingness will be examined across trial arms and follow-up points to assess the feasibility of data collection. As this is a feasibility trial, analyses of participant-reported outcomes will be based on available cases only (complete-case analysis), with no imputation of missing data. Data monitoring and storage Source data All documentation will follow GCP standards and comply with the General Data Protection Regulation (GDPR) and Data Protection Act 2018, which require data to be de-identified as soon as it is practical to do so. The processing of the personal data of participants will be minimised by making use of a unique participant study number on all study documents and electronic database(s). All documents will be stored securely and only accessible by study staff and authorised personnel. Access to data Direct access will be granted to authorised representatives from the University of Oxford supervision team and the representatives from the Sponsor’s research and development team for monitoring and/or audit of the study to ensure compliance with regulations. Data will be shared via University of Oxford secure OneDrive files and folders sharing mechanisms. Participants will have the right to request a copy of their own data up until the point that data is anonymised for reporting, whereupon it can no longer be linked to individuals. The study uses coded identifiers and stores identifiable data separately. Transcripts from qualitative interviews will be shared with participants for checking accuracy. Data recording and record keeping Trial data will be labelled with participant identifiers sent by email for questionnaire completion. The name and any other identifying detail will not be included in any trial data electronic file. Consent forms will be stored separately from participant responses (which will only be identifiable through a personal identifier). Questionnaire responses will be exported from Qualtrics as Microsoft-Excel files and thereafter deleted from Qualtrics as soon as practically possible and within 3 months of the last participant completing questionnaires or final participant interview, whichever is later. Transcripts generated from the process evaluation interviews will be anonymised by the CI and the recordings deleted at the point of transcription. Microsoft-Word files (anonymised qualitative transcripts) will be shared via a secure university Virtual Private Network (VPN) and regularly backed up on an encrypted, restricted-access folder on the University of Oxford network (managed by the CI). Any feedback received from email reminders (for scheduled sessions and prompts for data collection timepoints) during the trial will be immediately extracted from the email, anonymised and then stored in the same OneDrive account. Linkage lists will be stored on a restricted-access folder until all data is collected, checked, cleaned, and finalised, with deletion of lists anticipated within 12-months of the completion of data collection. Anonymised, non-identifiable quotations from transcriptions and email feedback may be used within publications to add validity and context to findings with participants’ consent. Data monitoring A formal Data Monitoring Committee will not be convened for this study because this is a feasibility trial, designed primarily to assess trial processes rather than to generate definitive evidence of effectiveness or safety. Study progress, including any adverse incidents, will be reported to a study management group guided by the study monitoring plan (see Table 5 ). Table 5 Study Monitoring Plan Aspect Details Trial Risk Assessment The EMS-SHIELD feasibility trial is classified as low-to-medium risk due to the non-invasive intervention and minimal participant risk. Key risks include incomplete data collection from operational pressures on paramedics and variability in intervention delivery. Monitoring Plan The Chief Investigator (CI) will oversee compliance with the protocol and evaluate data accuracy in relation to source documents. Compliance Checks The CI will review adherence to trial protocol and procedures weekly. Data Verification Assess the accuracy, completeness, and consistency of data against source documents. Monitoring Procedures The CI will follow standard operating procedures to ensure data are generated, documented, and reported in compliance with the protocol, GCP, and regulatory requirements. Study progress, including adverse incidents, will be reported to a study management group. Dissemination Plan Findings will be shared through peer-reviewed publications, conference presentations, and reports to NHS ambulance services, accompanied by accessible visual summaries for EMS staff, PPIE contributors, and advocacy groups, alongside targeted briefs for policymakers and public-facing updates via organisational and university communication channels. Discussion EMS workers are exposed to uniquely high and cumulative occupational stressors that contribute to elevated rates of psychological distress, PTSD, depression, and burnout compared with other healthcare staff and community samples [ 58 ]. Although awareness of these challenges has grown, there remains a lack of evidence on how best to embed sustainable, organisation-wide mental health support within the operational realities of ambulance services. The EMS-SHIELD trial responds to this urgent need by assessing whether a peer-led, well-being intervention in work hours can be delivered and accepted within an NHS ambulance service. A systematic review of the barriers and enablers to organisational support for EMS employee mental health recommended strategies that included strengthening peer connection and psychological safety, rather than focusing solely on individual resilience [ 22 ]. The tension between providing time at work for employees against a backdrop of relentless 999 demand necessitates evidence-based solutions to protect worker well-being whilst maintaining operational capability. EMS-SHIELD integrates behaviour-change and reflective-practice frameworks to position well-being as a shared workplace responsibility rather than a personal burden. The design of this feasibility study aligns closely with EMS research examining complex behavioural and well-being interventions in real operational contexts [ 59 , 60 ]. These studies highlight common methodological challenges in EMS research, for instance, variable shift patterns, limited time, and fluctuating operational demand. By using a cluster design and flexible delivery, EMS-SHIELD aims to capture real-world conditions while assessing feasibility parameters critical for a future definitive trial. As with all feasibility studies, EMS-SHIELD is not designed to test intervention effectiveness. Limitations include potential for recruitment challenges, session disruptions, and heterogeneity in delivery environments. However, documenting these issues and assessing data completeness, fidelity, and engagement is critical for determining whether a future definitive trial is justified. The inclusion of quantitative feasibility metrics and qualitative exploration will provide a comprehensive picture of operational, psychological, and cultural factors influencing uptake. Furthermore, understanding whether collecting health-economic data is practical and acceptable is essential to ensuring a full trial can generate robust cost-effectiveness data, particularly in the context of ongoing NHS transformation and increasing financial pressures. If shown to be feasible and acceptable, EMS-SHIELD could offer a practical model for embedding proactive psychological support within everyday paramedic practice. While not powered to evaluate clinical outcomes, this study will generate important learning on recruitment, fidelity, and data collection, informing progression criteria and contributing to the evidence base on implementing employee well-being interventions in EMS settings. Abbreviations COM-B Capability-Opportunity-Motivation-Behaviour CSRI Client Service Receipt Inventory EMS Emergency Medical Service EMS-SHIELD Emergency Medical Service - Supporting Health, Improving Employee Life, and Duty EQ-5D-5L EuroQol 5-Dimension 5-level GCP Good Clinical Practice GP General Practitioner HRQoL Health-related Quality-of-Life NHS National Health Service (UK) NIHR National Institute for Health and Care Research LEC-5 Life Events Checklist PCL-5 PTSD symptoms checklist PPIE Patient and Public Involvement and Engagement PTSD Post-traumatic Stress Disorder REC Research Ethics Committee ReQoL-10 Recovering Quality of Life – 10 items Declarations Ethics approval and consent to participate This study is sponsored by South Western Ambulance NHS Foundation Trust (SWASFT), supported by the University of Oxford Department of Experimental Psychology, and funded by the NIHR. The study will be conducted in accordance with the protocol approved by the Health Research Authority and Health and Care Research Wales via the London - Bromley Research Ethics Committee on 23 rd October 2025 (Study approval reference 25/LO/0682 and IRAS ID 354334). This study has been designed and will be conducted in compliance with the principles outlined in the Declaration of Helsinki and the Guidelines for Good Clinical Practice (GCP). The protocol, informed consent form, participant information sheets, topic guide and advertising materials have been reviewed and approved by the HRA and the REC. Approval from the sponsor, SWASFT, has also been obtained before submission to the HRA and REC. Any substantial amendments to the approved protocol or related documents will be submitted for further review and approval by the HRA, REC, and sponsor as required. Digital or written informed consent informed consent will be obtained from all participants prior to their inclusion in the study. Consent for publication Not applicable Availability of data and materials In line with this protocol, all study documents are stored securely and accessible only to study staff and authorised personnel. The datasets generated and/or analysed during the current study are not publicly available due to the residual risk of participant re-identification. Data may be requested from the corresponding author on reasonable request and will be shared only where appropriate safeguards are in place to protect participant confidentiality. Competing interests The authors declare that they have no competing interests . Funding Sasha Johnston, Doctoral Research Fellow [NIHR 302983], is funded by the NIHR for this research project. Polly Waite and Mara Violato receive funding from the NIHR Oxford and Thames Valley Applied Research Collaboration and the NIHR Oxford Health Biomedical Research Centre. The views expressed in this publication are those of the authors and not necessarily those of the NIHR, NHS or the UK Department of Health and Social Care. Authors' contributions Funding Acquisition: SJ; Conceptualisation: SJ, JW; Supervision: JW, PW; Methodology: SJ, JW; Writing – Original Draft Preparation: SJ; Writing – Review & Editing: JW, PW; SB, MV; All authors approved the final version of the manuscript for publication. Acknowledgements We would especially like to thank Diana Frost, Lynn Tatnell, Minoo Par, and Ree Ra for their contribution as patient representatives and all employee representatives who shared their lived experience of EMS to inform the design of this research. References Bloom DE, Cafiero E, Jané-Llopis E et al (2011) The Global Economic Burden of Noncommunicable Diseases. 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Published Online First: https://doi.org/0.1186/s12891-023-06834-8 Appelboam A, Osborne R, Ukoumunne OC et al (2025) Evaluation of Out-of-Hospital Use of a Valsalva Assist Device in the Emergency Treatment of Supraventricular Tachycardia. Ann Emerg Med 86:659–673. https://doi.org/10.1016/j.annemergmed.2025.06.623 South Western Ambulance Service NHS Foundation Trust (2025) Safeguarding Policy: Think Family - Child and Adult Footnotes Light duties: a temporary change in working arrangements where paramedics are stood down from frontline clinical duties and assigned to non-patient facing work due to circumstances such as pregnancy or injury. Additional Declarations The authors declare no competing interests. Supplementary Files Additionalfile1EMSSHIELDgroundrules.docx Additional File 1: EMS SHIELD Ground Rules Additionalfile2EMSSHIELDFidelitychecklist.docx EMS SHIELD Additional file 2: Fidelity Checklist Cite Share Download PDF Status: Posted Version 1 posted You are reading this latest preprint version Research Square lets you share your work early, gain feedback from the community, and start making changes to your manuscript prior to peer review in a journal. As a division of Research Square Company, we’re committed to making research communication faster, fairer, and more useful. We do this by developing innovative software and high quality services for the global research community. Our growing team is made up of researchers and industry professionals working together to solve the most critical problems facing scientific publishing. Also discoverable on Platform About Our Team In Review Editorial Policies Advisory Board Help Center Resources Author Services Accessibility API Access RSS feed Manage Cookie Preferences © Research Square 2026 | ISSN 2693-5015 (online) Privacy Policy Terms of Service Do Not Sell My Personal Information {\"props\":{\"pageProps\":{\"initialData\":{\"identity\":\"rs-9542409\",\"acceptedTermsAndConditions\":true,\"allowDirectSubmit\":true,\"archivedVersions\":[],\"articleType\":\"Research Article\",\"associatedPublications\":[],\"authors\":[{\"id\":630384793,\"identity\":\"4d351aaf-0904-4f26-8d80-5341b4713478\",\"order_by\":0,\"name\":\"Sasha 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Oxford\",\"correspondingAuthor\":false,\"prefix\":\"\",\"firstName\":\"Polly\",\"middleName\":\"\",\"lastName\":\"Waite\",\"suffix\":\"\"},{\"id\":630385931,\"identity\":\"05528464-62e5-409d-a0dd-f9680d0adaf1\",\"order_by\":2,\"name\":\"Mara Violato\",\"email\":\"\",\"orcid\":\"https://orcid.org/0000-0002-0484-7706\",\"institution\":\"University of Oxford\",\"correspondingAuthor\":false,\"prefix\":\"\",\"firstName\":\"Mara\",\"middleName\":\"\",\"lastName\":\"Violato\",\"suffix\":\"\"},{\"id\":630385932,\"identity\":\"8bf989ff-d481-405f-9f32-859dd374b478\",\"order_by\":3,\"name\":\"Sarah Black\",\"email\":\"\",\"orcid\":\"https://orcid.org/0000-0001-6678-7502\",\"institution\":\"South Western Ambulance Service NHS Foundation Trust\",\"correspondingAuthor\":false,\"prefix\":\"\",\"firstName\":\"Sarah\",\"middleName\":\"\",\"lastName\":\"Black\",\"suffix\":\"\"},{\"id\":630385933,\"identity\":\"c836314b-d233-4c00-81da-e6fbe01f631d\",\"order_by\":4,\"name\":\"Jennifer Wild\",\"email\":\"\",\"orcid\":\"https://orcid.org/0000-0001-5463-1711\",\"institution\":\"University of Oxford\",\"correspondingAuthor\":false,\"prefix\":\"\",\"firstName\":\"Jennifer\",\"middleName\":\"\",\"lastName\":\"Wild\",\"suffix\":\"\"}],\"badges\":[],\"createdAt\":\"2026-04-27 13:25:15\",\"currentVersionCode\":1,\"declarations\":{\"humanSubjects\":true,\"vertebrateSubjects\":false,\"conflictsOfInterestStatement\":false,\"humanSubjectEthicalGuidelines\":true,\"humanSubjectConsent\":true,\"humanSubjectClinicalTrial\":false,\"humanSubjectCaseReport\":false,\"vertebrateSubjectEthicalGuidelines\":false},\"doi\":\"10.21203/rs.3.rs-9542409/v1\",\"doiUrl\":\"https://doi.org/10.21203/rs.3.rs-9542409/v1\",\"draftVersion\":[],\"editorialEvents\":[],\"editorialNote\":\"\",\"failedWorkflow\":false,\"files\":[{\"id\":108016164,\"identity\":\"0a688221-a4fe-4c01-bfa9-592e0d274717\",\"added_by\":\"auto\",\"created_at\":\"2026-04-28 13:42:05\",\"extension\":\"jpg\",\"order_by\":1,\"title\":\"Figure 1\",\"display\":\"\",\"copyAsset\":false,\"role\":\"figure\",\"size\":1185433,\"visible\":true,\"origin\":\"\",\"legend\":\"\\u003cp\\u003eStudy flow diagram\\u003c/p\\u003e\",\"description\":\"\",\"filename\":\"EMSSHIELDFlowdiagram.jpg\",\"url\":\"https://assets-eu.researchsquare.com/files/rs-9542409/v1/67fbccb9bd2346a8c54cbc68.jpg\"},{\"id\":108809069,\"identity\":\"b41713a7-df58-4fdc-aa0e-5a3d31476691\",\"added_by\":\"auto\",\"created_at\":\"2026-05-08 15:49:21\",\"extension\":\"pdf\",\"order_by\":0,\"title\":\"\",\"display\":\"\",\"copyAsset\":false,\"role\":\"manuscript-pdf\",\"size\":1662712,\"visible\":true,\"origin\":\"\",\"legend\":\"\",\"description\":\"\",\"filename\":\"manuscript.pdf\",\"url\":\"https://assets-eu.researchsquare.com/files/rs-9542409/v1/b3a65323-8540-4203-95e2-918d2a74d804.pdf\"},{\"id\":108016163,\"identity\":\"de000546-fd44-42f4-9638-af962a0c92be\",\"added_by\":\"auto\",\"created_at\":\"2026-04-28 13:42:05\",\"extension\":\"docx\",\"order_by\":1,\"title\":\"\",\"display\":\"\",\"copyAsset\":false,\"role\":\"supplement\",\"size\":24897,\"visible\":true,\"origin\":\"\",\"legend\":\"\\u003cp\\u003eAdditional File 1: EMS SHIELD Ground Rules\\u003c/p\\u003e\",\"description\":\"\",\"filename\":\"Additionalfile1EMSSHIELDgroundrules.docx\",\"url\":\"https://assets-eu.researchsquare.com/files/rs-9542409/v1/3f9de117066d250e2a4f4575.docx\"},{\"id\":108803709,\"identity\":\"2d3787f6-ae3b-460e-8b0b-6ed869beed99\",\"added_by\":\"auto\",\"created_at\":\"2026-05-08 15:04:32\",\"extension\":\"docx\",\"order_by\":2,\"title\":\"\",\"display\":\"\",\"copyAsset\":false,\"role\":\"supplement\",\"size\":23245,\"visible\":true,\"origin\":\"\",\"legend\":\"\\u003cp\\u003eEMS SHIELD Additional file 2: Fidelity Checklist\\u003c/p\\u003e\",\"description\":\"\",\"filename\":\"Additionalfile2EMSSHIELDFidelitychecklist.docx\",\"url\":\"https://assets-eu.researchsquare.com/files/rs-9542409/v1/d9ce796d88b41215f263d871.docx\"}],\"financialInterests\":\"The authors declare no competing interests.\",\"formattedTitle\":\"\\u003cp\\u003eSupporting Health, Improving Employee Life and Duty (SHIELD): Protocol for a cluster randomised controlled feasibility trial of dedicated time at work for Emergency Medical Service worker mental health\\u003c/p\\u003e\",\"fulltext\":[{\"header\":\"Background\",\"content\":\"\\u003cp\\u003eThe World Economic Forum projected that over half the global economic burden due to non-communicable diseases will be caused by mental ill health by 2030 [\\u003cspan citationid=\\\"CR1\\\" class=\\\"CitationRef\\\"\\u003e1\\u003c/span\\u003e]. Emergency Medical Service (EMS) workers are routinely exposed to trauma, long working hours, fatigue, and organisational stressors leading to rates of post-traumatic stress disorder and suicide that exceed those in other UK National Health Service (NHS) professions and the community samples [\\u003cspan additionalcitationids=\\\"CR3 CR4 CR5 CR6\\\" citationid=\\\"CR2\\\" class=\\\"CitationRef\\\"\\u003e2\\u003c/span\\u003e\\u0026ndash;\\u003cspan citationid=\\\"CR7\\\" class=\\\"CitationRef\\\"\\u003e7\\u003c/span\\u003e]. Investigations commissioned by UK ambulance Trusts have raised concerns about the rate of suicide deaths among EMS staff, prompting calls for targeted prevention strategies [\\u003cspan citationid=\\\"CR8\\\" class=\\\"CitationRef\\\"\\u003e8\\u003c/span\\u003e, \\u003cspan citationid=\\\"CR9\\\" class=\\\"CitationRef\\\"\\u003e9\\u003c/span\\u003e]. Furthermore, UK EMS employees are stark outliers among NHS staff groups for mental ill health related sickness absence and employee dismissal for misconduct, which raises broader questions about culture and employee support [\\u003cspan citationid=\\\"CR10\\\" class=\\\"CitationRef\\\"\\u003e10\\u003c/span\\u003e, \\u003cspan citationid=\\\"CR11\\\" class=\\\"CitationRef\\\"\\u003e11\\u003c/span\\u003e]. However, employees often avoid disclosing mental health issues due to perceived stigma, fear of career repercussions, and a broader sense of feeling unsupported by their employer [\\u003cspan citationid=\\\"CR12\\\" class=\\\"CitationRef\\\"\\u003e12\\u003c/span\\u003e, \\u003cspan citationid=\\\"CR13\\\" class=\\\"CitationRef\\\"\\u003e13\\u003c/span\\u003e]. These conditions have led to EMS employees reporting the highest harassment, burnout, and bullying rates among NHS staff groups and being the least likely group to report feeling safe to speak up, undermining workplace psychological safety and compromising patient outcomes [\\u003cspan additionalcitationids=\\\"CR15 CR16\\\" citationid=\\\"CR14\\\" class=\\\"CitationRef\\\"\\u003e14\\u003c/span\\u003e\\u0026ndash;\\u003cspan citationid=\\\"CR17\\\" class=\\\"CitationRef\\\"\\u003e17\\u003c/span\\u003e]. Several studies link these factors with medical errors, suboptimal patient care, increased motor vehicle accidents, depression, absenteeism, staff turnover, and low organisational commitment [\\u003cspan citationid=\\\"CR18\\\" class=\\\"CitationRef\\\"\\u003e18\\u003c/span\\u003e, \\u003cspan citationid=\\\"CR19\\\" class=\\\"CitationRef\\\"\\u003e19\\u003c/span\\u003e]. Despite growing recognition of these challenges and acknowledgement of the need for proactive approaches to staff well-being within EMS, many employees report multiple barriers to help-seeking, including stigma, perceived weakness, and a lack of time during work hours, alongside feeling too exhausted to engage with services outside of work [\\u003cspan citationid=\\\"CR20\\\" class=\\\"CitationRef\\\"\\u003e20\\u003c/span\\u003e, \\u003cspan citationid=\\\"CR21\\\" class=\\\"CitationRef\\\"\\u003e21\\u003c/span\\u003e].\\u003c/p\\u003e \\u003cp\\u003ePrior work identified that EMS culture, which emphasises stoicism and self-reliance, discourages openness. To address these issues and the gaps in the evidence-base, this study was underpinned by three preparatory studies and systematic Patient and Public Involvement and Engagement (PPIE). Early preparatory work included a systematic review [\\u003cspan citationid=\\\"CR22\\\" class=\\\"CitationRef\\\"\\u003e22\\u003c/span\\u003e] and qualitative exploration with EMS employees [\\u003cspan citationid=\\\"CR23\\\" class=\\\"CitationRef\\\"\\u003e23\\u003c/span\\u003e] of the barriers and facilitators to seeking and accessing organisational support, both of which identified the need for interventions congruent with professional identify and operational norms. Staff reported a preference for structured opportunities for reflection facilitated within work hours by trained peers. Despite evidence of mistrust and indiscretion among colleagues, EMS staff want to talk with peers who understand their work context rather than with people who do not. This was a critical factor in enabling staff to speak candidly about work-related issues.\\u003c/p\\u003e \\u003cp\\u003eEvidence suggests that self-reflective practice may be a promising tool for high-risk occupations [\\u003cspan citationid=\\\"CR24\\\" class=\\\"CitationRef\\\"\\u003e24\\u003c/span\\u003e]. However, not all reflection is adaptive. Rumination, the repetitive, passive focus on the meaning of distressing events and their implications, is common among EMS staff who often replay critical incidents in ways that can intensify stress [\\u003cspan citationid=\\\"CR25\\\" class=\\\"CitationRef\\\"\\u003e25\\u003c/span\\u003e, \\u003cspan citationid=\\\"CR26\\\" class=\\\"CitationRef\\\"\\u003e26\\u003c/span\\u003e]. Unlike constructive reflection, rumination is a robust maintenance factor for depression and predicts the development of PTSD in paramedics [\\u003cspan citationid=\\\"CR27\\\" class=\\\"CitationRef\\\"\\u003e27\\u003c/span\\u003e]. Therefore, simply providing time at work to reflect may not be enough, as rumination predicts poor mental health [\\u003cspan citationid=\\\"CR27\\\" class=\\\"CitationRef\\\"\\u003e27\\u003c/span\\u003e] and may hinder reflective practice and help-seeking [\\u003cspan citationid=\\\"CR28\\\" class=\\\"CitationRef\\\"\\u003e28\\u003c/span\\u003e]. Grounded in these findings, EMS-SHIELD is a behaviourally informed, peer-facilitated one-hour session providing dedicated space for reflection, structured check-ins, and signposting to support. It draws on clinical supervision principles [\\u003cspan citationid=\\\"CR29\\\" class=\\\"CitationRef\\\"\\u003e29\\u003c/span\\u003e] and the Theoretical Domains and COM-B (Capability-Opportunity-Motivation-Behaviour) behaviour change frameworks [\\u003cspan additionalcitationids=\\\"CR31 CR32\\\" citationid=\\\"CR30\\\" class=\\\"CitationRef\\\"\\u003e30\\u003c/span\\u003e\\u0026ndash;\\u003cspan citationid=\\\"CR33\\\" class=\\\"CitationRef\\\"\\u003e33\\u003c/span\\u003e], to embed reflection as a normative organisational behaviour rather than a remedial activity.\\u003c/p\\u003e \\u003cp\\u003eThe final content and format of the intervention were agreed through an eDelphi consensus study with experts in mental health, psychology, and EMS [\\u003cspan citationid=\\\"CR34\\\" class=\\\"CitationRef\\\"\\u003e34\\u003c/span\\u003e]. Through PPIE work, this intervention was named EMS-SHIELD - Supporting Health, Improving Employee Life and Duty. EMS-SHIELD aims to normalise discussion about mental health at work, reduce stigma, and establish clear expectations for participation in self-care, mirroring the success of mandatory workplace safety procedures [\\u003cspan citationid=\\\"CR35\\\" class=\\\"CitationRef\\\"\\u003e35\\u003c/span\\u003e].\\u003c/p\\u003e \\u003cp\\u003eThe aim of this cluster randomised feasibility trial will be to evaluate the EMS-SHIELD intervention within a UK NHS ambulance service. The primary objectives are to determine feasibility, in terms of paramedic recruitment, scheduling and delivery of the intervention, and data completeness, and acceptability based on session attendance rates and participant experience. Secondary objectives include estimating statistical parameters needed to power a definitive trial for well-being, attitudinal, and symptom outcomes in each arm, and evaluating the feasibility of collecting health economic data. A pre-specified progression criterion, together with any identified barriers and facilitators to implementation, will guide the design of a future definitive trial.\\u003c/p\\u003e\"},{\"header\":\"Methods\",\"content\":\"\\u003cdiv id=\\\"Sec3\\\" class=\\\"Section2\\\"\\u003e \\u003ch2\\u003eDesign\\u003c/h2\\u003e \\u003cp\\u003eThis feasibility study will adopt a parallel-group, two-arm, pragmatic exploratory cluster randomised controlled design. The study design adheres to the Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT) guidelines [\\u003cspan citationid=\\\"CR36\\\" class=\\\"CitationRef\\\"\\u003e36\\u003c/span\\u003e] and the CONSORT statement extension to randomised pilot and feasibility trials [\\u003cspan citationid=\\\"CR37\\\" class=\\\"CitationRef\\\"\\u003e37\\u003c/span\\u003e]. Using a 1:1 allocation ratio, four ambulance stations (clusters) within one UK ambulance service will be randomised to usual practice (no dedicated time at work and individuals contact organisational support services unprompted) or to EMS-SHIELD (1-hour dedicated, structured wellbeing session at work with signposting to support resources as indicated), with a nested qualitative process evaluation. Usual practice was chosen as the comparator because it reflects the current standard approach to paramedic well-being support, allowing assessment of whether adding EMS-SHIELD offers a feasible and acceptable enhancement to existing care. Recruitment will begin in April 2026, and the trial is planned to continue for 6 months. A CONSORT-style study flow diagram is in Fig.\\u0026nbsp;\\u003cspan refid=\\\"Fig1\\\" class=\\\"InternalRef\\\"\\u003e1\\u003c/span\\u003e.\\u003c/p\\u003e \\u003cp\\u003e \\u003c/p\\u003e \\u003c/div\\u003e\\n\\u003ch3\\u003ePatient and public involvement and engagement (PPIE)\\u003c/h3\\u003e\\n\\u003cp\\u003eThe study design was co-produced with a dedicated group of EMS staff and PPIE contributors, who played key roles in shaping the recruitment strategy and advocating for the inclusion of qualitative interviews to enhance data richness and reduce survey fatigue during the process evaluation stage. A recruitment video co-created by PPIE members, felt to be useful for highlighting the link between employee care and patient care, will be used to encourage paramedic participation. PPIE will include a data analysis workshop to interpret study findings collaboratively, co-production of lay summaries for ambulance service reports and conference presentation.\\u003c/p\\u003e\\n\\u003ch3\\u003eSetting and participants\\u003c/h3\\u003e\\n\\u003cp\\u003eApproximately 128 paramedics work across four ambulance stations selected for this trial: two urban (city) and two suburban (small towns or large villages outside urban settings). The participating stations were selected following consultation with ambulance service operational and research leaders, in areas representing diverse populations (in and around one of Southwest England\\u0026rsquo;s largest cities) with the resources to participate. Limiting the geographical area is practical for the research team and EMS operations and avoids cross-contamination to other areas that may participate in a future definitive trial. Clustering by station reflects how EMS operations are organised; randomisation by urban and suburban cluster ensures the intervention is tested across a range of conditions. Clusters will comprise of paramedics based at eligible stations who volunteer to participate in the trial.\\u003c/p\\u003e\\n\\u003ch3\\u003eEligibility criteria\\u003c/h3\\u003e\\n\\u003cp\\u003e \\u003cul\\u003e \\u003cli\\u003e \\u003cp\\u003eAged 18 years or above.\\u003c/p\\u003e \\u003c/li\\u003e \\u003cli\\u003e \\u003cp\\u003eHealth and Care Professions Council (HCPC) registered paramedic (including bank staff and paramedics working light duties)\\u003csup\\u003e1\\u003c/sup\\u003e\\u003c/p\\u003e \\u003c/li\\u003e \\u003cli\\u003e \\u003cp\\u003eBased primarily (50% shifts or more) at participating ambulance stations.\\u003c/p\\u003e \\u003c/li\\u003e \\u003c/ul\\u003e \\u003c/p\\u003e \\u003cp\\u003eThe participant may not enter the study if either of the following applies:\\u003c/p\\u003e \\u003cp\\u003e \\u003cul\\u003e \\u003cli\\u003e \\u003cp\\u003eNon-paramedic (including student paramedic)\\u003c/p\\u003e \\u003c/li\\u003e \\u003cli\\u003e \\u003cp\\u003eParticipation in preparatory qualitative focus groups\\u003c/p\\u003e \\u003c/li\\u003e \\u003c/ul\\u003e \\u003c/p\\u003e\\n\\u003ch3\\u003eIntervention Facilitators\\u003c/h3\\u003e\\n\\u003cp\\u003e \\u003cul\\u003e \\u003cli\\u003e \\u003cp\\u003eHCPC-registered paramedics\\u003c/p\\u003e \\u003c/li\\u003e \\u003cli\\u003e \\u003cp\\u003eOver 18-years old\\u003c/p\\u003e \\u003c/li\\u003e \\u003cli\\u003e \\u003cp\\u003eRegistered Clinical Supervision Facilitator with the participating ambulance Trust\\u003c/p\\u003e \\u003c/li\\u003e \\u003cli\\u003e \\u003cp\\u003eAble to deliver the intervention from at least one of the 4 participating ambulance stations.\\u003c/p\\u003e \\u003c/li\\u003e \\u003c/ul\\u003e \\u003c/p\\u003e \\u003cdiv id=\\\"Sec8\\\" class=\\\"Section2\\\"\\u003e \\u003ch2\\u003eRecruitment and consent\\u003c/h2\\u003e \\u003cp\\u003eAn invitation to read the EMS-SHIELD participant information sheet, ask questions, and complete consent forms will be sent on behalf of the research team to the NHS email addresses of all paramedics registered to work from the participating ambulance stations, by the Head of Operations team overseeing the participating ambulance stations. The Clinical Supervision leads within the host ambulance service will send emails inviting Clinical Supervision Facilitator team members to review the participant information sheet designed for intervention facilitators and to contact the research team with any questions or to express interest in participating. The Chief Investigator (CI) (lead author SJ) will attend in-house team meetings to share information about the study and provide opportunity to discuss the study and to ask questions. Posters and a video recorded by the CI and PPIE representatives will advertise the study in participating stations. Interested participants will have the opportunity to meet with and ask questions of the study team via a range of media.\\u003c/p\\u003e \\u003cp\\u003e \\u003cstrong\\u003eInformed consent\\u003c/strong\\u003e \\u003cp\\u003ewill be obtained by the CI from all participants (including intervention facilitators) after they have read the participant information sheet, via an online consent form, returning a scanned copy via email or, if preferred, a paper version before engaging in any study activities. Separate consent forms will be obtained for trial participants willing to participate in process evaluation interviews after the intervention has been delivered. A copy of the consent form counter-signed by the CI will be returned to participants for their records.\\u003c/p\\u003e \\u003c/p\\u003e \\u003c/div\\u003e\\n\\u003ch3\\u003eRandomisation\\u003c/h3\\u003e\\n\\u003cp\\u003eTo reduce selection bias, paramedics will be recruited, and then cluster randomisation will be employed, with the ambulance station as the cluster. The CI will use a web-based random generator to allocate one urban and one suburban site to the intervention and control groups. Participating paramedics will be asked to engage according to their group allocation: either a 1-hour EMS-SHIELD session (intervention group, alongside usual practice) or usual practice (no dedicated time at work, with unchanged access to organisational support services).\\u003c/p\\u003e \\u003cp\\u003eIf larger stations with higher numbers of paramedics are randomised to the intervention and the number of consenting paramedics exceeds n\\u0026thinsp;=\\u0026thinsp;32 (the estimated number of intervention arm paramedics that have been costed for the trial), random sampling will be employed by the CI using a web-based random generator to select anonymised participant identifiers allocated to the pool of consenting paramedics. This method ensures that all consenting paramedics have an equal chance of being included and the potential for random sampling will be made clear in the participant information sheet. Any consenting paramedics excluded by random sampling will be entered into a prize draw with a chance to win a \\u0026pound;40 gift voucher to thank them for expressing their interest.\\u003c/p\\u003e\\n\\u003ch3\\u003eBlinding\\u003c/h3\\u003e\\n\\u003cp\\u003eDue to the design of the study and the nature of the intervention, it is not possible for paramedics, intervention facilitators, or researchers to be blinded to the study group allocation.\\u003c/p\\u003e \\u003cdiv id=\\\"Sec11\\\" class=\\\"Section2\\\"\\u003e \\u003ch2\\u003eSample size\\u003c/h2\\u003e \\u003cp\\u003eAs a feasibility trial, sample size will not be guided by a formal power calculation to estimate effect size [\\u003cspan citationid=\\\"CR38\\\" class=\\\"CitationRef\\\"\\u003e38\\u003c/span\\u003e]. There are approximately 128 paramedics working across the four ambulance stations, and based on previous studies recruiting paramedics, a 50% recruitment rate is anticipated. We aim to recruit 64 paramedics, 32 in the intervention group and 32 in usual practice, with a minimum of 38 (19 in each group) retained at follow-up. The anticipated intervention session attendance rate of 60% is based on previous paramedic studies and sample sizes reported in UK feasibility studies [\\u003cspan citationid=\\\"CR39\\\" class=\\\"CitationRef\\\"\\u003e39\\u003c/span\\u003e]. Applying this rate yields an exact two-sided 95% confidence interval of 41% to 77%, providing a useful estimated range for planning the definitive trial [\\u003cspan citationid=\\\"CR40\\\" class=\\\"CitationRef\\\"\\u003e40\\u003c/span\\u003e]. A feasibility study of this size will be sufficient to collect meaningful data on acceptability, adherence, and retention.\\u003c/p\\u003e \\u003c/div\\u003e \\u003cdiv id=\\\"Sec12\\\" class=\\\"Section2\\\"\\u003e \\u003ch2\\u003eIntervention\\u003c/h2\\u003e \\u003cp\\u003eThe EMS-SHIELD intervention is one, 1-hour session, scheduled during work hours for paramedics to reflect upon their own mental health and well-being. The content and structure of the session is described in Table\\u0026nbsp;\\u003cspan refid=\\\"Tab1\\\" class=\\\"InternalRef\\\"\\u003e1\\u003c/span\\u003e:\\u003c/p\\u003e \\u003cp\\u003e \\u003cdiv class=\\\"gridtable\\\"\\u003e\\u003ctable float=\\\"Yes\\\" id=\\\"Tab1\\\" border=\\\"1\\\"\\u003e \\u003ccaption language=\\\"En\\\"\\u003e \\u003cdiv class=\\\"CaptionNumber\\\"\\u003eTable 1\\u003c/div\\u003e \\u003cdiv class=\\\"CaptionContent\\\"\\u003e \\u003cp\\u003e\\u003cem\\u003eEMS-SHIELD content and structure\\u003c/em\\u003e\\u003c/p\\u003e \\u003c/div\\u003e \\u003c/caption\\u003e \\u003ccolgroup cols=\\\"3\\\"\\u003e \\u003cdiv align=\\\"left\\\" class=\\\"colspec\\\" colname=\\\"c1\\\" colnum=\\\"1\\\"\\u003e\\u003c/div\\u003e \\u003cdiv align=\\\"left\\\" class=\\\"colspec\\\" colname=\\\"c2\\\" colnum=\\\"2\\\"\\u003e\\u003c/div\\u003e \\u003cdiv align=\\\"left\\\" class=\\\"colspec\\\" colname=\\\"c3\\\" colnum=\\\"3\\\"\\u003e\\u003c/div\\u003e \\u003cthead\\u003e \\u003ctr\\u003e \\u003cth align=\\\"left\\\" colname=\\\"c1\\\"\\u003e \\u003cp\\u003eStage\\u003c/p\\u003e \\u003c/th\\u003e \\u003cth align=\\\"left\\\" colname=\\\"c2\\\"\\u003e \\u003cp\\u003eTime\\u003c/p\\u003e \\u003c/th\\u003e \\u003cth align=\\\"left\\\" colname=\\\"c3\\\"\\u003e \\u003cp\\u003eContent \\u0026amp; Process\\u003c/p\\u003e \\u003c/th\\u003e \\u003c/tr\\u003e \\u003c/thead\\u003e \\u003ctbody\\u003e \\u003ctr\\u003e \\u003ctd align=\\\"left\\\" colname=\\\"c1\\\"\\u003e \\u003cp\\u003e1. Welcome \\u0026amp; ground rules\\u003c/p\\u003e \\u003c/td\\u003e \\u003ctd align=\\\"left\\\" colname=\\\"c2\\\"\\u003e \\u003cp\\u003e5 min\\u003c/p\\u003e \\u003c/td\\u003e \\u003ctd align=\\\"left\\\" colname=\\\"c3\\\"\\u003e \\u003cp\\u003eGreet, explain purpose, and agree on ground rules; including confidentiality and safeguarding parameters as per the protocol.\\u003c/p\\u003e \\u003c/td\\u003e \\u003c/tr\\u003e \\u003ctr\\u003e \\u003ctd align=\\\"left\\\" colname=\\\"c1\\\"\\u003e \\u003cp\\u003e2. Check-in\\u003c/p\\u003e \\u003c/td\\u003e \\u003ctd align=\\\"left\\\" colname=\\\"c2\\\"\\u003e \\u003cp\\u003e5 min\\u003c/p\\u003e \\u003c/td\\u003e \\u003ctd align=\\\"left\\\" colname=\\\"c3\\\"\\u003e \\u003cp\\u003eAsk how the participant is getting on today to gain a snapshot of current well-being. Use the EMS-specific visual mental health continuum to aid self-identification of well-being status [\\u003cspan citationid=\\\"CR41\\\" class=\\\"CitationRef\\\"\\u003e41\\u003c/span\\u003e].\\u003c/p\\u003e \\u003c/td\\u003e \\u003c/tr\\u003e \\u003ctr\\u003e \\u003ctd align=\\\"left\\\" colname=\\\"c1\\\"\\u003e \\u003cp\\u003e3. Incident Reflection\\u003c/p\\u003e \\u003c/td\\u003e \\u003ctd align=\\\"left\\\" colname=\\\"c2\\\"\\u003e \\u003cp\\u003e15 min\\u003c/p\\u003e \\u003c/td\\u003e \\u003ctd align=\\\"left\\\" colname=\\\"c3\\\"\\u003e \\u003cp\\u003eInvite sharing of a positive/negative work event; explore the emotional/professional impact.\\u003c/p\\u003e \\u003c/td\\u003e \\u003c/tr\\u003e \\u003ctr\\u003e \\u003ctd align=\\\"left\\\" colname=\\\"c1\\\"\\u003e \\u003cp\\u003e4. Coping Strategies \\u0026amp; WAP Completion\\u003c/p\\u003e \\u003c/td\\u003e \\u003ctd align=\\\"left\\\" colname=\\\"c2\\\"\\u003e \\u003cp\\u003e20 min\\u003c/p\\u003e \\u003c/td\\u003e \\u003ctd align=\\\"left\\\" colname=\\\"c3\\\"\\u003e \\u003cp\\u003eIntroduce and provide opportunity to review, complete, or update a Wellness Action Plan collaboratively or to simply familiarise themselves with the format, or opt out if they have recently completed a plan or prefer not to engage with this activity.\\u003c/p\\u003e \\u003c/td\\u003e \\u003c/tr\\u003e \\u003ctr\\u003e \\u003ctd align=\\\"left\\\" colname=\\\"c1\\\"\\u003e \\u003cp\\u003e5. Information \\u0026amp; Signposting\\u003c/p\\u003e \\u003c/td\\u003e \\u003ctd align=\\\"left\\\" colname=\\\"c2\\\"\\u003e \\u003cp\\u003e10 min\\u003c/p\\u003e \\u003c/td\\u003e \\u003ctd align=\\\"left\\\" colname=\\\"c3\\\"\\u003e \\u003cp\\u003eProvide Employee Assistance Programme support overview; signpost to an in-house Staying Well Hub support officer if needed.\\u003c/p\\u003e \\u003c/td\\u003e \\u003c/tr\\u003e \\u003ctr\\u003e \\u003ctd align=\\\"left\\\" colname=\\\"c1\\\"\\u003e \\u003cp\\u003e6. Review \\u0026amp; Close\\u003c/p\\u003e \\u003c/td\\u003e \\u003ctd align=\\\"left\\\" colname=\\\"c2\\\"\\u003e \\u003cp\\u003e5 min\\u003c/p\\u003e \\u003c/td\\u003e \\u003ctd align=\\\"left\\\" colname=\\\"c3\\\"\\u003e \\u003cp\\u003eSummarise and reflect on the session, confirm next steps (i.e., confirm timelines for onward support referrals if relevant and trial data collection expectations), and thank the participant.\\u003c/p\\u003e \\u003c/td\\u003e \\u003c/tr\\u003e \\u003ctr\\u003e \\u003ctd align=\\\"left\\\" colspan=\\\"3\\\" nameend=\\\"c3\\\" namest=\\\"c1\\\"\\u003e \\u003cp\\u003eTimings can be flexed to meet individual needs during the session.\\u003c/p\\u003e \\u003c/td\\u003e \\u003c/tr\\u003e \\u003c/tbody\\u003e \\u003c/colgroup\\u003e \\u003c/table\\u003e\\u003c/div\\u003e \\u003c/p\\u003e \\u003cp\\u003eTime is provided for reflection on practice, where participants can share any negative or positive work-related events. Completion of a wellness action plan is encouraged since such plans are useful for guiding reflection about psychological triggers, strategies for managing stress, and discussing preferred options for sharing feelings and information about health status with managers and colleagues. Current employee support offers are discussed and signposting to appropriate support can be guided as needed. The session will be guided by ground rules as per the participating EMS service Clinical Supervision policy to maximise safety and prioritise confidentiality and consistency (see Additional file 1).\\u003c/p\\u003e \\u003cp\\u003e \\u003cstrong\\u003eIntervention delivery\\u003c/strong\\u003e \\u003cp\\u003eEMS-SHIELD\\u003c/p\\u003e \\u003c/p\\u003e \\u003cp\\u003eEMS-SHIELD will be delivered by trained peers recruited from an established team of Clinical Supervision Facilitators within the participating ambulance trust. Facilitators will have completed a higher-education Clinical Supervision module and have regular opportunities to attend group meetings and participate in clinical supervision themselves as part of their role. Facilitators will be trained to deliver the EMS-SHIELD intervention by the CI (a trained and experienced clinical supervision lead). Training includes one, face-to-face EMS-SHIELD familiarisation session, National Institute for Health and Care Research (NIHR) Good Clinical Practice (GCP) online training, and education about current employee support options. Training aims to strengthen facilitator confidence and competence in delivering EMS-SHIELD and allows for familiarisation with key processes and trial procedures, including completion of the intervention fidelity checklist (see Additional file 2) with time to seek clarification or ask questions with the research team. Time is planned for facilitators to undertake regular clinical supervision with trained peers throughout the trial to ensure they are well supported. The CI will provide oversight of the supervision process and, where needed, direct clinical supervision for facilitators.\\u003c/p\\u003e \\u003cp\\u003e \\u003cstrong\\u003eComparator\\u003c/strong\\u003e \\u003cp\\u003eUsual practice\\u003c/p\\u003e \\u003c/p\\u003e \\u003cp\\u003eParamedics allocated to usual practice will have no dedicated 1-hour session at work to reflect on their wellbeing; they will have access as usual to organisational employee support services without prompting. Participants will complete the same questionnaires as intervention paramedics, with an additional item that asks for information about any utilisation of usual practice support services to inform the design of a future definitive RCT.\\u003c/p\\u003e \\u003c/div\\u003e \\u003cdiv id=\\\"Sec13\\\" class=\\\"Section2\\\"\\u003e \\u003ch2\\u003eOutcomes\\u003c/h2\\u003e \\u003cp\\u003eFeasibility and acceptability are the primary focus of this cluster randomised feasibility trial. Outcomes will therefore be used to determine whether the EMS-SHIELD intervention can be delivered and evaluated as intended within a live NHS ambulance service, and to inform the design of a future definitive trial.\\u003c/p\\u003e \\u003cp\\u003eFeasibility and acceptability outcomes will be assessed using quantitative and qualitative measures. Participants will be asked to complete digital questionnaires at baseline, 4\\u0026ndash;6 weeks post-randomisation, and again at 3-months post-randomisation. In addition, intervention facilitators will complete a fidelity checklist after each EMS-SHIELD session to record delivery of core session components, sequence of component delivery, any interruptions, and whether reflection focused mainly on positive or negative work-related experiences.\\u003c/p\\u003e \\u003c/div\\u003e \\u003cdiv id=\\\"Sec14\\\" class=\\\"Section2\\\"\\u003e \\u003ch2\\u003ePrimary outcomes\\u003c/h2\\u003e \\u003cp\\u003ePrimary outcomes relate to feasibility and acceptability.\\u003c/p\\u003e \\u003cp\\u003eFeasibility outcomes are:\\u003c/p\\u003e \\u003cp\\u003e \\u003cul\\u003e \\u003cli\\u003e \\u003cp\\u003eRecruitment rate: defined as the proportion of eligible paramedics who consent to participate.\\u003c/p\\u003e \\u003c/li\\u003e \\u003cli\\u003e \\u003cp\\u003eSession scheduling: the proportion of planned sessions successfully scheduled into operational rotas.\\u003c/p\\u003e \\u003c/li\\u003e \\u003cli\\u003e \\u003cp\\u003eRetention rate: the proportion of participants who remain in the study and complete follow-up questionnaires.\\u003c/p\\u003e \\u003c/li\\u003e \\u003cli\\u003e \\u003cp\\u003eQuestionnaire completion and completeness: including the proportion of returned questionnaires with usable data at each time point.\\u003c/p\\u003e \\u003c/li\\u003e \\u003cli\\u003e \\u003cp\\u003eTime required for data collection and analysis, to inform the practicality of trial procedures.\\u003c/p\\u003e \\u003c/li\\u003e \\u003cli\\u003e \\u003cp\\u003eIntervention fidelity: assessed using a facilitator-completed fidelity checklist after each session.\\u003c/p\\u003e \\u003c/li\\u003e \\u003c/ul\\u003e \\u003c/p\\u003e \\u003cp\\u003eAcceptability outcomes are:\\u003c/p\\u003e \\u003cp\\u003e \\u003cul\\u003e \\u003cli\\u003e \\u003cp\\u003eSession attendance: the proportion of intervention participants who attend their allotted EMS-SHIELD session.\\u003c/p\\u003e \\u003c/li\\u003e \\u003cli\\u003e \\u003cp\\u003eParticipant satisfaction: assessed through session ratings.\\u003c/p\\u003e \\u003c/li\\u003e \\u003cli\\u003e \\u003cp\\u003eIntervention acceptability and experience: assessed using the self-report Theoretical Framework of Acceptability (TFA) questionnaire [\\u003cspan citationid=\\\"CR42\\\" class=\\\"CitationRef\\\"\\u003e42\\u003c/span\\u003e], in which items are rated on a 5-point Likert scale; and through qualitative process evaluation interviews conducted with a purposive subset of participants and staff involved in delivery. Example questionnaire items include \\u0026ldquo;Did you like or dislike the intervention?\\u0026rdquo;\\u003c/p\\u003e \\u003c/li\\u003e \\u003c/ul\\u003e \\u003c/p\\u003e \\u003c/div\\u003e \\u003cdiv id=\\\"Sec15\\\" class=\\\"Section2\\\"\\u003e \\u003ch2\\u003eSecondary outcome measures\\u003c/h2\\u003e \\u003cp\\u003eSecondary outcomes are included to provide estimates of statistical quantities for the well-being, attitudinal, and symptom outcomes in each arm to inform sample-size calculations for a future definitive trial, and to assess the feasibility of collecting health economic data. These outcomes are exploratory and will be presented descriptively; this study is not powered to detect between-group differences. Participant-reported outcomes collected at baseline, 4\\u0026ndash;6 weeks and three months post-randomisation are:\\u003c/p\\u003e \\u003cp\\u003e \\u003cul\\u003e \\u003cli\\u003e \\u003cp\\u003eAttitudes towards help-seeking: measured using the Attitude Towards Seeking Professional Psychological Help-short form [\\u003cspan citationid=\\\"CR43\\\" class=\\\"CitationRef\\\"\\u003e43\\u003c/span\\u003e].\\u003c/p\\u003e \\u003c/li\\u003e \\u003cli\\u003e \\u003cp\\u003ePerceived organisational support: measured using the Perceived Organisational Support scale [\\u003cspan citationid=\\\"CR44\\\" class=\\\"CitationRef\\\"\\u003e44\\u003c/span\\u003e].\\u003c/p\\u003e \\u003c/li\\u003e \\u003cli\\u003e \\u003cp\\u003ePost-traumatic stress symptoms: measured using the PTSD Checklist for DSM-5 (PCL-5) [\\u003cspan citationid=\\\"CR45\\\" class=\\\"CitationRef\\\"\\u003e45\\u003c/span\\u003e].\\u003c/p\\u003e \\u003c/li\\u003e \\u003cli\\u003e \\u003cp\\u003ePsychological well-being measured using the World Health Organization (WHO)-5 Well-being Index [\\u003cspan citationid=\\\"CR46\\\" class=\\\"CitationRef\\\"\\u003e46\\u003c/span\\u003e].\\u003c/p\\u003e \\u003c/li\\u003e \\u003cli\\u003e \\u003cp\\u003eTrauma exposure: measured using the Life Events Checklist for DSM-5 (LEC-5) [\\u003cspan citationid=\\\"CR47\\\" class=\\\"CitationRef\\\"\\u003e47\\u003c/span\\u003e].\\u003c/p\\u003e \\u003c/li\\u003e \\u003c/ul\\u003e \\u003c/p\\u003e \\u003cp\\u003eThe instructions for the LEC-5 will be modified at each time point to reflect traumatic events that may have been experienced since the previous data collection point, enabling identification of new trauma exposure and contextualisation of changes in wellbeing and PCL-5 scores.\\u003c/p\\u003e \\u003cp\\u003eHealth economic data collection feasibility will be explored by requiring participants to complete the following measures at baseline, 4\\u0026ndash;6 weeks, and three months post-randomisation:\\u003c/p\\u003e \\u003cp\\u003e \\u003cul\\u003e \\u003cli\\u003e \\u003cp\\u003eThe EQ-5D-5L instrument [\\u003cspan citationid=\\\"CR48\\\" class=\\\"CitationRef\\\"\\u003e48\\u003c/span\\u003e], a generic preference-based measure of health-related quality of life.\\u003c/p\\u003e \\u003c/li\\u003e \\u003cli\\u003e \\u003cp\\u003eRecovering Quality of Life Scale (ReQoL-10) [\\u003cspan citationid=\\\"CR49\\\" class=\\\"CitationRef\\\"\\u003e49\\u003c/span\\u003e], a mental health-specific preference-based quality of life measure.\\u003c/p\\u003e \\u003c/li\\u003e \\u003cli\\u003e \\u003cp\\u003eA modified Client Service Receipt Inventory (CSRII) [\\u003cspan citationid=\\\"CR50\\\" class=\\\"CitationRef\\\"\\u003e50\\u003c/span\\u003e] to capture use of health and social care (e.g., GP visits; medications), travel time to and from health treatment/visits, absence from work, and all associated costs.\\u003c/p\\u003e \\u003c/li\\u003e \\u003c/ul\\u003e \\u003c/p\\u003e \\u003cp\\u003eIntervention-related resource use, including facilitator preparation time, session delivery time, and backfill costs, will also be recorded to inform future economic evaluation.\\u003c/p\\u003e \\u003c/div\\u003e \\u003cdiv id=\\\"Sec16\\\" class=\\\"Section2\\\"\\u003e \\u003ch2\\u003eSchedule of outcome assessment\\u003c/h2\\u003e \\u003cp\\u003eTable\\u0026nbsp;\\u003cspan refid=\\\"Tab2\\\" class=\\\"InternalRef\\\"\\u003e2\\u003c/span\\u003e summarises the outcome domains, measures, and timing of data collection.\\u003c/p\\u003e \\u003cp\\u003e \\u003cdiv class=\\\"gridtable\\\"\\u003e\\u003ctable float=\\\"Yes\\\" id=\\\"Tab2\\\" border=\\\"1\\\"\\u003e \\u003ccaption language=\\\"En\\\"\\u003e \\u003cdiv class=\\\"CaptionNumber\\\"\\u003eTable 2\\u003c/div\\u003e \\u003cdiv class=\\\"CaptionContent\\\"\\u003e \\u003cp\\u003e\\u003cem\\u003eSchedule of outcome assessment\\u003c/em\\u003e\\u003c/p\\u003e \\u003c/div\\u003e \\u003c/caption\\u003e \\u003ccolgroup cols=\\\"5\\\"\\u003e \\u003cdiv align=\\\"left\\\" class=\\\"colspec\\\" colname=\\\"c1\\\" colnum=\\\"1\\\"\\u003e\\u003c/div\\u003e \\u003cdiv align=\\\"left\\\" class=\\\"colspec\\\" colname=\\\"c2\\\" colnum=\\\"2\\\"\\u003e\\u003c/div\\u003e \\u003cdiv align=\\\"left\\\" class=\\\"colspec\\\" colname=\\\"c3\\\" colnum=\\\"3\\\"\\u003e\\u003c/div\\u003e \\u003cdiv align=\\\"left\\\" class=\\\"colspec\\\" colname=\\\"c4\\\" colnum=\\\"4\\\"\\u003e\\u003c/div\\u003e \\u003cdiv align=\\\"left\\\" class=\\\"colspec\\\" colname=\\\"c5\\\" colnum=\\\"5\\\"\\u003e\\u003c/div\\u003e \\u003cthead\\u003e \\u003ctr\\u003e \\u003cth align=\\\"left\\\" colname=\\\"c1\\\"\\u003e \\u003cp\\u003eOutcome domain\\u003c/p\\u003e \\u003c/th\\u003e \\u003cth align=\\\"left\\\" colname=\\\"c2\\\"\\u003e \\u003cp\\u003eMeasure\\u003c/p\\u003e \\u003c/th\\u003e \\u003cth align=\\\"left\\\" colname=\\\"c3\\\"\\u003e \\u003cp\\u003eBaseline\\u003c/p\\u003e \\u003c/th\\u003e \\u003cth align=\\\"left\\\" colname=\\\"c4\\\"\\u003e \\u003cp\\u003e4\\u0026ndash;6 weeks post-randomisation*\\u003c/p\\u003e \\u003c/th\\u003e \\u003cth align=\\\"left\\\" colname=\\\"c5\\\"\\u003e \\u003cp\\u003e3 months post-randomisation**\\u003c/p\\u003e \\u003c/th\\u003e \\u003c/tr\\u003e \\u003c/thead\\u003e \\u003ctbody\\u003e \\u003ctr\\u003e \\u003ctd align=\\\"left\\\" colspan=\\\"5\\\" nameend=\\\"c5\\\" namest=\\\"c1\\\"\\u003e \\u003cp\\u003ePrimary outcomes\\u003c/p\\u003e \\u003c/td\\u003e \\u003c/tr\\u003e \\u003ctr\\u003e \\u003ctd align=\\\"left\\\" colname=\\\"c1\\\" morerows=\\\"5\\\" rowspan=\\\"6\\\"\\u003e \\u003cp\\u003eFeasibility\\u003c/p\\u003e \\u003c/td\\u003e \\u003ctd align=\\\"left\\\" colname=\\\"c2\\\"\\u003e \\u003cp\\u003eRecruitment rate\\u003c/p\\u003e \\u003c/td\\u003e \\u003ctd align=\\\"left\\\" colname=\\\"c3\\\"\\u003e \\u003cp\\u003eX\\u003c/p\\u003e \\u003c/td\\u003e \\u003ctd align=\\\"left\\\" colname=\\\"c4\\\"\\u003e\\u0026nbsp;\\u003c/td\\u003e \\u003ctd align=\\\"left\\\" colname=\\\"c5\\\"\\u003e\\u0026nbsp;\\u003c/td\\u003e \\u003c/tr\\u003e \\u003ctr\\u003e \\u003ctd align=\\\"left\\\" colname=\\\"c2\\\"\\u003e \\u003cp\\u003eSessions scheduled\\u003c/p\\u003e \\u003c/td\\u003e \\u003ctd align=\\\"left\\\" colname=\\\"c3\\\"\\u003e\\u0026nbsp;\\u003c/td\\u003e \\u003ctd align=\\\"left\\\" colname=\\\"c4\\\"\\u003e \\u003cp\\u003eX\\u003c/p\\u003e \\u003c/td\\u003e \\u003ctd align=\\\"left\\\" colname=\\\"c5\\\"\\u003e\\u0026nbsp;\\u003c/td\\u003e \\u003c/tr\\u003e \\u003ctr\\u003e \\u003ctd align=\\\"left\\\" colname=\\\"c2\\\"\\u003e \\u003cp\\u003eRetention rate\\u003c/p\\u003e \\u003c/td\\u003e \\u003ctd align=\\\"left\\\" colname=\\\"c3\\\"\\u003e\\u0026nbsp;\\u003c/td\\u003e \\u003ctd align=\\\"left\\\" colname=\\\"c4\\\"\\u003e \\u003cp\\u003eX\\u003c/p\\u003e \\u003c/td\\u003e \\u003ctd align=\\\"left\\\" colname=\\\"c5\\\"\\u003e \\u003cp\\u003eX\\u003c/p\\u003e \\u003c/td\\u003e \\u003c/tr\\u003e \\u003ctr\\u003e \\u003ctd align=\\\"left\\\" colname=\\\"c2\\\"\\u003e \\u003cp\\u003eQuestionnaire completion and completeness\\u003c/p\\u003e \\u003c/td\\u003e \\u003ctd align=\\\"left\\\" colname=\\\"c3\\\"\\u003e \\u003cp\\u003eX\\u003c/p\\u003e \\u003c/td\\u003e \\u003ctd align=\\\"left\\\" colname=\\\"c4\\\"\\u003e \\u003cp\\u003eX\\u003c/p\\u003e \\u003c/td\\u003e \\u003ctd align=\\\"left\\\" colname=\\\"c5\\\"\\u003e \\u003cp\\u003eX\\u003c/p\\u003e \\u003c/td\\u003e \\u003c/tr\\u003e \\u003ctr\\u003e \\u003ctd align=\\\"left\\\" colname=\\\"c2\\\"\\u003e \\u003cp\\u003eTime required for data collection and analysis\\u003c/p\\u003e \\u003c/td\\u003e \\u003ctd align=\\\"left\\\" colname=\\\"c3\\\"\\u003e\\u0026nbsp;\\u003c/td\\u003e \\u003ctd align=\\\"left\\\" colname=\\\"c4\\\"\\u003e \\u003cp\\u003eX\\u003c/p\\u003e \\u003c/td\\u003e \\u003ctd align=\\\"left\\\" colname=\\\"c5\\\"\\u003e \\u003cp\\u003eX\\u003c/p\\u003e \\u003c/td\\u003e \\u003c/tr\\u003e \\u003ctr\\u003e \\u003ctd align=\\\"left\\\" colname=\\\"c2\\\"\\u003e \\u003cp\\u003eIntervention fidelity checklist (facilitator completed)\\u003c/p\\u003e \\u003c/td\\u003e \\u003ctd align=\\\"left\\\" colname=\\\"c3\\\"\\u003e\\u0026nbsp;\\u003c/td\\u003e \\u003ctd align=\\\"left\\\" colname=\\\"c4\\\"\\u003e \\u003cp\\u003eX\\u003c/p\\u003e \\u003c/td\\u003e \\u003ctd align=\\\"left\\\" colname=\\\"c5\\\"\\u003e\\u0026nbsp;\\u003c/td\\u003e \\u003c/tr\\u003e \\u003ctr\\u003e \\u003ctd align=\\\"left\\\" colname=\\\"c1\\\" morerows=\\\"3\\\" rowspan=\\\"4\\\"\\u003e \\u003cp\\u003eAcceptability\\u003c/p\\u003e \\u003c/td\\u003e \\u003ctd align=\\\"left\\\" colname=\\\"c2\\\"\\u003e \\u003cp\\u003eSession attendance\\u003c/p\\u003e \\u003c/td\\u003e \\u003ctd align=\\\"left\\\" colname=\\\"c3\\\"\\u003e\\u0026nbsp;\\u003c/td\\u003e \\u003ctd align=\\\"left\\\" colname=\\\"c4\\\"\\u003e \\u003cp\\u003eX\\u003c/p\\u003e \\u003c/td\\u003e \\u003ctd align=\\\"left\\\" colname=\\\"c5\\\"\\u003e\\u0026nbsp;\\u003c/td\\u003e \\u003c/tr\\u003e \\u003ctr\\u003e \\u003ctd align=\\\"left\\\" colname=\\\"c2\\\"\\u003e \\u003cp\\u003eSession satisfaction rating\\u003c/p\\u003e \\u003c/td\\u003e \\u003ctd align=\\\"left\\\" colname=\\\"c3\\\"\\u003e\\u0026nbsp;\\u003c/td\\u003e \\u003ctd align=\\\"left\\\" colname=\\\"c4\\\"\\u003e \\u003cp\\u003eX\\u003c/p\\u003e \\u003c/td\\u003e \\u003ctd align=\\\"left\\\" colname=\\\"c5\\\"\\u003e\\u0026nbsp;\\u003c/td\\u003e \\u003c/tr\\u003e \\u003ctr\\u003e \\u003ctd align=\\\"left\\\" colname=\\\"c2\\\"\\u003e \\u003cp\\u003eTheoretical Framework of Acceptability (TFA) questionnaire\\u003c/p\\u003e \\u003c/td\\u003e \\u003ctd align=\\\"left\\\" colname=\\\"c3\\\"\\u003e\\u0026nbsp;\\u003c/td\\u003e \\u003ctd align=\\\"left\\\" colname=\\\"c4\\\"\\u003e \\u003cp\\u003eX\\u003c/p\\u003e \\u003c/td\\u003e \\u003ctd align=\\\"left\\\" colname=\\\"c5\\\"\\u003e \\u003cp\\u003eX\\u003c/p\\u003e \\u003c/td\\u003e \\u003c/tr\\u003e \\u003ctr\\u003e \\u003ctd align=\\\"left\\\" colname=\\\"c2\\\"\\u003e \\u003cp\\u003eQualitative process-evaluation interviews\\u003c/p\\u003e \\u003c/td\\u003e \\u003ctd align=\\\"left\\\" colname=\\\"c3\\\"\\u003e\\u0026nbsp;\\u003c/td\\u003e \\u003ctd align=\\\"left\\\" colname=\\\"c4\\\"\\u003e\\u0026nbsp;\\u003c/td\\u003e \\u003ctd align=\\\"left\\\" colname=\\\"c5\\\"\\u003e \\u003cp\\u003eX\\u003c/p\\u003e \\u003c/td\\u003e \\u003c/tr\\u003e \\u003ctr\\u003e \\u003ctd align=\\\"left\\\" colspan=\\\"5\\\" nameend=\\\"c5\\\" namest=\\\"c1\\\"\\u003e \\u003cp\\u003eSecondary outcomes\\u003c/p\\u003e \\u003c/td\\u003e \\u003c/tr\\u003e \\u003ctr\\u003e \\u003ctd align=\\\"left\\\" colname=\\\"c1\\\"\\u003e \\u003cp\\u003eAttitudes to help-seeking\\u003c/p\\u003e \\u003c/td\\u003e \\u003ctd align=\\\"left\\\" colname=\\\"c2\\\"\\u003e \\u003cp\\u003eAttitude Towards Seeking Professional Psychological Help\\u0026mdash;Short Form\\u003c/p\\u003e \\u003c/td\\u003e \\u003ctd align=\\\"left\\\" colname=\\\"c3\\\"\\u003e \\u003cp\\u003eX\\u003c/p\\u003e \\u003c/td\\u003e \\u003ctd align=\\\"left\\\" colname=\\\"c4\\\"\\u003e \\u003cp\\u003eX\\u003c/p\\u003e \\u003c/td\\u003e \\u003ctd align=\\\"left\\\" colname=\\\"c5\\\"\\u003e \\u003cp\\u003eX\\u003c/p\\u003e \\u003c/td\\u003e \\u003c/tr\\u003e \\u003ctr\\u003e \\u003ctd align=\\\"left\\\" colname=\\\"c1\\\"\\u003e \\u003cp\\u003ePerceived organisational support\\u003c/p\\u003e \\u003c/td\\u003e \\u003ctd align=\\\"left\\\" colname=\\\"c2\\\"\\u003e \\u003cp\\u003ePerceived Organisational Support scale\\u003c/p\\u003e \\u003c/td\\u003e \\u003ctd align=\\\"left\\\" colname=\\\"c3\\\"\\u003e \\u003cp\\u003eX\\u003c/p\\u003e \\u003c/td\\u003e \\u003ctd align=\\\"left\\\" colname=\\\"c4\\\"\\u003e \\u003cp\\u003eX\\u003c/p\\u003e \\u003c/td\\u003e \\u003ctd align=\\\"left\\\" colname=\\\"c5\\\"\\u003e \\u003cp\\u003eX\\u003c/p\\u003e \\u003c/td\\u003e \\u003c/tr\\u003e \\u003ctr\\u003e \\u003ctd align=\\\"left\\\" colname=\\\"c1\\\"\\u003e \\u003cp\\u003ePost-traumatic stress symptoms\\u003c/p\\u003e \\u003c/td\\u003e \\u003ctd align=\\\"left\\\" colname=\\\"c2\\\"\\u003e \\u003cp\\u003ePTSD Checklist for DSM-5 (PCL-5)\\u003c/p\\u003e \\u003c/td\\u003e \\u003ctd align=\\\"left\\\" colname=\\\"c3\\\"\\u003e \\u003cp\\u003eX\\u003c/p\\u003e \\u003c/td\\u003e \\u003ctd align=\\\"left\\\" colname=\\\"c4\\\"\\u003e \\u003cp\\u003eX\\u003c/p\\u003e \\u003c/td\\u003e \\u003ctd align=\\\"left\\\" colname=\\\"c5\\\"\\u003e \\u003cp\\u003eX\\u003c/p\\u003e \\u003c/td\\u003e \\u003c/tr\\u003e \\u003ctr\\u003e \\u003ctd align=\\\"left\\\" colname=\\\"c1\\\"\\u003e \\u003cp\\u003eTrauma exposure\\u003c/p\\u003e \\u003c/td\\u003e \\u003ctd align=\\\"left\\\" colname=\\\"c2\\\"\\u003e \\u003cp\\u003eLife Events Checklist for DSM-5 (LEC-5)\\u003c/p\\u003e \\u003c/td\\u003e \\u003ctd align=\\\"left\\\" colname=\\\"c3\\\"\\u003e \\u003cp\\u003eX\\u003c/p\\u003e \\u003c/td\\u003e \\u003ctd align=\\\"left\\\" colname=\\\"c4\\\"\\u003e \\u003cp\\u003eX\\u003c/p\\u003e \\u003c/td\\u003e \\u003ctd align=\\\"left\\\" colname=\\\"c5\\\"\\u003e \\u003cp\\u003eX\\u003c/p\\u003e \\u003c/td\\u003e \\u003c/tr\\u003e \\u003ctr\\u003e \\u003ctd align=\\\"left\\\" colname=\\\"c1\\\"\\u003e \\u003cp\\u003ePsychological well-being\\u003c/p\\u003e \\u003c/td\\u003e \\u003ctd align=\\\"left\\\" colname=\\\"c2\\\"\\u003e \\u003cp\\u003eWHO-5 Well-Being Index\\u003c/p\\u003e \\u003c/td\\u003e \\u003ctd align=\\\"left\\\" colname=\\\"c3\\\"\\u003e \\u003cp\\u003eX\\u003c/p\\u003e \\u003c/td\\u003e \\u003ctd align=\\\"left\\\" colname=\\\"c4\\\"\\u003e \\u003cp\\u003eX\\u003c/p\\u003e \\u003c/td\\u003e \\u003ctd align=\\\"left\\\" colname=\\\"c5\\\"\\u003e \\u003cp\\u003eX\\u003c/p\\u003e \\u003c/td\\u003e \\u003c/tr\\u003e \\u003ctr\\u003e \\u003ctd align=\\\"left\\\" colname=\\\"c1\\\"\\u003e \\u003cp\\u003eHealth-related quality of life\\u003c/p\\u003e \\u003c/td\\u003e \\u003ctd align=\\\"left\\\" colname=\\\"c2\\\"\\u003e \\u003cp\\u003eEQ-5D-5L\\u003c/p\\u003e \\u003c/td\\u003e \\u003ctd align=\\\"left\\\" colname=\\\"c3\\\"\\u003e \\u003cp\\u003eX\\u003c/p\\u003e \\u003c/td\\u003e \\u003ctd align=\\\"left\\\" colname=\\\"c4\\\"\\u003e \\u003cp\\u003eX\\u003c/p\\u003e \\u003c/td\\u003e \\u003ctd align=\\\"left\\\" colname=\\\"c5\\\"\\u003e \\u003cp\\u003eX\\u003c/p\\u003e \\u003c/td\\u003e \\u003c/tr\\u003e \\u003ctr\\u003e \\u003ctd align=\\\"left\\\" colname=\\\"c1\\\"\\u003e \\u003cp\\u003eMental health-specific quality of life\\u003c/p\\u003e \\u003c/td\\u003e \\u003ctd align=\\\"left\\\" colname=\\\"c2\\\"\\u003e \\u003cp\\u003eReQoL-10\\u003c/p\\u003e \\u003c/td\\u003e \\u003ctd align=\\\"left\\\" colname=\\\"c3\\\"\\u003e \\u003cp\\u003eX\\u003c/p\\u003e \\u003c/td\\u003e \\u003ctd align=\\\"left\\\" colname=\\\"c4\\\"\\u003e \\u003cp\\u003eX\\u003c/p\\u003e \\u003c/td\\u003e \\u003ctd align=\\\"left\\\" colname=\\\"c5\\\"\\u003e \\u003cp\\u003eX\\u003c/p\\u003e \\u003c/td\\u003e \\u003c/tr\\u003e \\u003ctr\\u003e \\u003ctd align=\\\"left\\\" colname=\\\"c1\\\"\\u003e \\u003cp\\u003eResource use and costs\\u003c/p\\u003e \\u003c/td\\u003e \\u003ctd align=\\\"left\\\" colname=\\\"c2\\\"\\u003e \\u003cp\\u003eModified Client Service Receipt Inventory (CSRI)\\u003c/p\\u003e \\u003c/td\\u003e \\u003ctd align=\\\"left\\\" colname=\\\"c3\\\"\\u003e \\u003cp\\u003eX\\u003c/p\\u003e \\u003c/td\\u003e \\u003ctd align=\\\"left\\\" colname=\\\"c4\\\"\\u003e \\u003cp\\u003eX\\u003c/p\\u003e \\u003c/td\\u003e \\u003ctd align=\\\"left\\\" colname=\\\"c5\\\"\\u003e \\u003cp\\u003eX\\u003c/p\\u003e \\u003c/td\\u003e \\u003c/tr\\u003e \\u003ctr\\u003e \\u003ctd align=\\\"left\\\" colname=\\\"c1\\\"\\u003e \\u003cp\\u003eIntervention cost data\\u003c/p\\u003e \\u003c/td\\u003e \\u003ctd align=\\\"left\\\" colname=\\\"c2\\\"\\u003e \\u003cp\\u003ePreparation, delivery, and backfill/resource-use logs\\u003c/p\\u003e \\u003c/td\\u003e \\u003ctd align=\\\"left\\\" colname=\\\"c3\\\"\\u003e\\u0026nbsp;\\u003c/td\\u003e \\u003ctd align=\\\"left\\\" colname=\\\"c4\\\"\\u003e \\u003cp\\u003eX\\u003c/p\\u003e \\u003c/td\\u003e \\u003ctd align=\\\"left\\\" colname=\\\"c5\\\"\\u003e\\u0026nbsp;\\u003c/td\\u003e \\u003c/tr\\u003e \\u003ctr\\u003e \\u003ctd align=\\\"left\\\" colspan=\\\"5\\\" nameend=\\\"c5\\\" namest=\\\"c1\\\"\\u003e \\u003cp\\u003e*Participants in the intervention arm will complete follow-up questionnaires 4\\u0026ndash;6 weeks post-randomisation to allow time for delivery of the EMS-SHIELD session. Participants in the usual-practice arm will complete the same follow-up measures at 4 weeks post-randomisation.\\u003c/p\\u003e \\u003c/td\\u003e \\u003c/tr\\u003e \\u003c/tbody\\u003e \\u003c/colgroup\\u003e \\u003ctfoot\\u003e \\u003ctr\\u003e\\u003ctd colspan=\\\"5\\\"\\u003e**Interviews will be scheduled after completion of the 3-month questionnaire, at a time convenient to participants\\u003c/td\\u003e\\u003c/tr\\u003e \\u003c/tfoot\\u003e \\u003c/table\\u003e\\u003c/div\\u003e \\u003c/p\\u003e \\u003c/div\\u003e \\u003cdiv id=\\\"Sec17\\\" class=\\\"Section2\\\"\\u003e \\u003ch2\\u003eTrial stopping rules\\u003c/h2\\u003e \\u003cp\\u003eThe criteria for stopping this study early are:\\u003c/p\\u003e \\u003cp\\u003e \\u003col\\u003e \\u003cspan\\u003e \\u003cli\\u003e \\u003cp\\u003eClear evidence of a lack of safety: based on the nature of the intervention, no serious adverse events (SAEs) are anticipated. The trial will be paused and reviewed by the CI and sponsor if any SAE is judged as being plausibly related to the intervention, and will be stopped if more than one such event occurs.\\u003c/p\\u003e \\u003c/li\\u003e \\u003c/span\\u003e \\u003cspan\\u003e \\u003cli\\u003e \\u003cp\\u003eRecruitment failure: if paramedic participation is too low, the trial may be stopped due to feasibility concerns.\\u003c/p\\u003e \\u003c/li\\u003e \\u003c/span\\u003e \\u003cspan\\u003e \\u003cli\\u003e \\u003cp\\u003eIntervention delivery failure: if the participating ambulance Trust is unable to support the study as planned, stopping may be necessary.\\u003c/p\\u003e \\u003c/li\\u003e \\u003c/span\\u003e \\u003c/ol\\u003e \\u003c/p\\u003e \\u003c/div\\u003e \\u003cdiv id=\\\"Sec18\\\" class=\\\"Section2\\\"\\u003e \\u003ch2\\u003eData collection procedure\\u003c/h2\\u003e \\u003cp\\u003eData will be collected via three sets of questionnaires throughout this trial:\\u003c/p\\u003e \\u003c/div\\u003e \\u003cdiv id=\\\"Sec19\\\" class=\\\"Section2\\\"\\u003e \\u003ch2\\u003eBaseline assessment (pre-randomisation)\\u003c/h2\\u003e \\u003cp\\u003eFollowing consent, participants will complete an online baseline questionnaire. This will include confirmation of eligibility check, demographic characteristics, availability for intervention scheduling, and all baseline participant-reported outcomes.\\u003c/p\\u003e \\u003c/div\\u003e \\u003cdiv id=\\\"Sec20\\\" class=\\\"Section2\\\"\\u003e \\u003ch2\\u003ePost-randomisation scheduling:\\u003c/h2\\u003e \\u003cp\\u003eAfter cluster randomisation, participants in stations allocated to the intervention arm will be notified of their EMS-SHIELD timeslot based on the availability provided in their baseline questionnaire and the availability of the intervention facilitators. Participants may:\\u003c/p\\u003e \\u003cp\\u003e \\u003cul\\u003e \\u003cli\\u003e \\u003cp\\u003eattend their allocated session;\\u003c/p\\u003e \\u003c/li\\u003e \\u003cli\\u003e \\u003cp\\u003erequest an alternative session time; or\\u003c/p\\u003e \\u003c/li\\u003e \\u003cli\\u003e \\u003cp\\u003eemail the researcher to advise of non-attendance; a short optional online questionnaire will be sent to explore non-attendance reasons, alongside an email ascertaining willingness to complete questionnaires at 4-weeks post-randomisation, and 3-month follow-up. Participants who do not attend their allocated session will remain eligible to complete follow-up data collection unless they withdraw from the study.\\u003c/p\\u003e \\u003c/li\\u003e \\u003c/ul\\u003e \\u003c/p\\u003e \\u003c/div\\u003e \\u003cdiv id=\\\"Sec21\\\" class=\\\"Section2\\\"\\u003e \\u003ch2\\u003ePost-randomisation follow-up\\u003c/h2\\u003e \\u003cp\\u003eParticipants in the intervention arm will be asked to complete follow-up questionnaires 4\\u0026ndash;6 week post-randomisation, allowing sufficient time for session delivery. Participants in the usual-practice arm will complete the same measures at 4-weeks post-randomisation, reflecting an equivalent time interval without the need to accommodate intervention delivery. This approach will enable us to determine the optimal timing of post-randomisation outcome measurement for a definitive trial. At this stage, facilitators will complete fidelity checklists for each EMS-SHIELD session delivered.\\u003c/p\\u003e \\u003c/div\\u003e \\u003cdiv id=\\\"Sec22\\\" class=\\\"Section2\\\"\\u003e \\u003ch2\\u003eThree-month follow-up\\u003c/h2\\u003e \\u003cp\\u003eAll participants will complete a final online questionnaire at 3-months post-randomisation. This will assess retention, completeness of participant-reported outcomes, and feasibility of health economic data collection.\\u003c/p\\u003e \\u003cp\\u003eParticipants who complete questionnaires at all three time points will be provided with a \\u0026pound;30 electronic thank-you voucher following completion of the final 3-month questionnaire.\\u003c/p\\u003e \\u003cdiv id=\\\"Sec23\\\" class=\\\"Section3\\\"\\u003e \\u003ch2\\u003eQuestionnaire measures\\u003c/h2\\u003e \\u003cp\\u003eValidated self-report measures will be used to assess feasibility-related participant-reported outcomes and to estimate parameters for a future definitive trial. The Attitude Towards Seeking Professional Psychological Help - Short Form consists of 10 items rated on a Likert scale (\\u0026ldquo;strongly disagree\\u0026rdquo; to \\u0026ldquo;strongly agree\\u0026rdquo;; e.g., \\u0026ldquo;I might want to have psychological counselling in the future.\\u0026rdquo;); assesses attitudes towards seeking professional psychological support. The Perceived Organisational Support scale assesses the extent to which employees believe their organisation values their contribution and cares about their well-being across 10-items, using Likert-type response options (7-point Likert scale rated: \\u0026ldquo;strongly disagree\\u0026rdquo; to \\u0026ldquo;Strongly agree\\u0026rdquo;; e.g., \\u0026ldquo;My organisation really cares about my wellbeing\\u0026rdquo;). The PTSD Checklist for the DSM-5 (PCL-5) includes 20-items rated on a 5-point Likert scale (rated \\u0026ldquo;not at all\\u0026rdquo; to \\u0026ldquo;extremely\\u0026rdquo;; e.g., \\u0026ldquo;In the past month, how much you have been bothered by feeling distant or cut off from other people?\\u0026rdquo;). The Life Events Checklist for DSM-5 (LEC-5) contains 17-items covering exposure to potentially traumatic events with 6 response options, e.g. \\u0026ldquo;Happened to me\\u0026rdquo; or \\u0026ldquo;Part of my job\\u0026rdquo;. The WHO-5 Well-Being Index scores psychological well-being using 5 -items (rated on a 5-point Likert scale: \\u0026ldquo;at no time\\u0026rdquo; to \\u0026ldquo;all of the time\\u0026rdquo;; e.g., \\u0026ldquo;I have felt cheerful and in good spirits\\u0026rdquo;). Health-related quality of life will be measured using the EQ-5D-5L instrument, which comprises 5 domains of daily life (i.e. mobility, self-care, usual activities, pain/discomfort, and anxiety/depression), each with 5 ordered levels, rated on a 5-point Likert scale from \\u0026ldquo;no problems\\u0026rdquo; to \\u0026ldquo;extreme problems\\u0026rdquo;; e.g., \\u0026ldquo;I have no pain or discomfort\\u0026rdquo;, alongside a visual analogue scale. Mental health-specific quality of life will be assessed using the ReQoL-10, a 10-item measure rated with 5-point Likert-type responses \\u0026ldquo;none of the time\\u0026rdquo; to \\u0026ldquo;most or all of the time\\u0026rdquo; in response to statements such as; \\u0026ldquo;over the past week I felt lonely.\\u0026rdquo; Resource use and cost data will be collected using a modified Client Service Receipt Inventory (CSRI), adapted with Patient and Public Involvement and Engagement input, which records service use, medication, travel, and work absence. The CSRI will be completed at baseline, 4\\u0026ndash;6 weeks, and 3-month follow-up; baseline items use a 3-month recall period, and at subsequent timepoints, participants are asked about service use since their last completed CSRI, with the recall window adjusted accordingly.\\u003c/p\\u003e \\u003c/div\\u003e \\u003c/div\\u003e \\u003cdiv id=\\\"Sec24\\\" class=\\\"Section2\\\"\\u003e \\u003ch2\\u003eSuccess criteria\\u003c/h2\\u003e \\u003cp\\u003eProgression to a phase 3 randomised controlled trial will be considered using a pre-determined \\u0026lsquo;traffic-light\\u0026rsquo; system [\\u003cspan citationid=\\\"CR51\\\" class=\\\"CitationRef\\\"\\u003e51\\u003c/span\\u003e] by the research team (SJ, JW, PW) and the Sponsor (SB) based upon the targets described in Table\\u0026nbsp;\\u003cspan refid=\\\"Tab3\\\" class=\\\"InternalRef\\\"\\u003e3\\u003c/span\\u003e:\\u003c/p\\u003e \\u003cp\\u003e \\u003cdiv class=\\\"gridtable\\\"\\u003e\\u003ctable float=\\\"Yes\\\" id=\\\"Tab3\\\" border=\\\"1\\\"\\u003e \\u003ccaption language=\\\"En\\\"\\u003e \\u003cdiv class=\\\"CaptionNumber\\\"\\u003eTable 3\\u003c/div\\u003e \\u003cdiv class=\\\"CaptionContent\\\"\\u003e \\u003cp\\u003e\\u003cem\\u003eProgression criteria\\u003c/em\\u003e\\u003c/p\\u003e \\u003c/div\\u003e \\u003c/caption\\u003e \\u003ccolgroup cols=\\\"5\\\"\\u003e \\u003cdiv align=\\\"left\\\" class=\\\"colspec\\\" colname=\\\"c1\\\" colnum=\\\"1\\\"\\u003e\\u003c/div\\u003e \\u003cdiv align=\\\"left\\\" class=\\\"colspec\\\" colname=\\\"c2\\\" colnum=\\\"2\\\"\\u003e\\u003c/div\\u003e \\u003cdiv align=\\\"left\\\" class=\\\"colspec\\\" colname=\\\"c3\\\" colnum=\\\"3\\\"\\u003e\\u003c/div\\u003e \\u003cdiv align=\\\"left\\\" class=\\\"colspec\\\" colname=\\\"c4\\\" colnum=\\\"4\\\"\\u003e\\u003c/div\\u003e \\u003cdiv align=\\\"left\\\" class=\\\"colspec\\\" colname=\\\"c5\\\" colnum=\\\"5\\\"\\u003e\\u003c/div\\u003e \\u003cthead\\u003e \\u003ctr\\u003e \\u003cth align=\\\"left\\\" colname=\\\"c1\\\" morerows=\\\"1\\\" rowspan=\\\"2\\\"\\u003e \\u003cp\\u003eDomain\\u003c/p\\u003e \\u003c/th\\u003e \\u003cth align=\\\"left\\\" colname=\\\"c2\\\" morerows=\\\"1\\\" rowspan=\\\"2\\\"\\u003e \\u003cp\\u003eCriterion\\u003c/p\\u003e \\u003c/th\\u003e \\u003cth align=\\\"left\\\" colspan=\\\"3\\\" nameend=\\\"c5\\\" namest=\\\"c3\\\"\\u003e \\u003cp\\u003eProgression criteria\\u003c/p\\u003e \\u003c/th\\u003e \\u003c/tr\\u003e \\u003ctr\\u003e \\u003cth align=\\\"left\\\" colname=\\\"c3\\\"\\u003e \\u003cp\\u003eRed\\u003c/p\\u003e \\u003c/th\\u003e \\u003cth align=\\\"left\\\" colname=\\\"c4\\\"\\u003e \\u003cp\\u003eAmber\\u003c/p\\u003e \\u003c/th\\u003e \\u003cth align=\\\"left\\\" colname=\\\"c5\\\"\\u003e \\u003cp\\u003eGreen\\u003c/p\\u003e \\u003c/th\\u003e \\u003c/tr\\u003e \\u003c/thead\\u003e \\u003ctbody\\u003e \\u003ctr\\u003e \\u003ctd align=\\\"left\\\" colname=\\\"c1\\\"\\u003e \\u003cp\\u003e\\u003cb\\u003eIntervention feasibility\\u003c/b\\u003e\\u003c/p\\u003e \\u003c/td\\u003e \\u003ctd align=\\\"left\\\" colname=\\\"c2\\\"\\u003e \\u003cp\\u003eSign up four EMS station\\u003c/p\\u003e \\u003c/td\\u003e \\u003ctd align=\\\"left\\\" colname=\\\"c3\\\"\\u003e \\u003cp\\u003e0\\u0026ndash;1 stations recruited\\u003c/p\\u003e \\u003c/td\\u003e \\u003ctd align=\\\"left\\\" colname=\\\"c4\\\"\\u003e \\u003cp\\u003e2\\u0026ndash;3 stations recruited\\u003c/p\\u003e \\u003c/td\\u003e \\u003ctd align=\\\"left\\\" colname=\\\"c5\\\"\\u003e \\u003cp\\u003e4 stations recruited\\u003c/p\\u003e \\u003c/td\\u003e \\u003c/tr\\u003e \\u003ctr\\u003e \\u003ctd align=\\\"left\\\" colname=\\\"c1\\\"\\u003e \\u003cp\\u003e\\u003cb\\u003eIntervention feasibility\\u003c/b\\u003e\\u003c/p\\u003e \\u003c/td\\u003e \\u003ctd align=\\\"left\\\" colname=\\\"c2\\\"\\u003e \\u003cp\\u003eRecruitment of \\u0026ge;\\u0026thinsp;50% eligible staff at each site\\u003c/p\\u003e \\u003c/td\\u003e \\u003ctd align=\\\"left\\\" colname=\\\"c3\\\"\\u003e \\u003cp\\u003e\\u0026lt;\\u0026thinsp;30% of eligible staff recruited at each site\\u003c/p\\u003e \\u003c/td\\u003e \\u003ctd align=\\\"left\\\" colname=\\\"c4\\\"\\u003e \\u003cp\\u003e30% to \\u0026lt;\\u0026thinsp;45% of eligible staff recruited at each site\\u003c/p\\u003e \\u003c/td\\u003e \\u003ctd align=\\\"left\\\" colname=\\\"c5\\\"\\u003e \\u003cp\\u003e\\u0026ge;\\u0026thinsp;45% of eligible staff recruited at each site\\u003c/p\\u003e \\u003c/td\\u003e \\u003c/tr\\u003e \\u003ctr\\u003e \\u003ctd align=\\\"left\\\" colname=\\\"c1\\\"\\u003e \\u003cp\\u003e\\u003cb\\u003eIntervention acceptability\\u003c/b\\u003e\\u003c/p\\u003e \\u003c/td\\u003e \\u003ctd align=\\\"left\\\" colname=\\\"c2\\\"\\u003e \\u003cp\\u003eAttendance at EMS-SHIELD sessions\\u003c/p\\u003e \\u003c/td\\u003e \\u003ctd align=\\\"left\\\" colname=\\\"c3\\\"\\u003e \\u003cp\\u003e\\u0026lt;\\u0026thinsp;36% of consenting paramedics attend allocated sessions\\u003c/p\\u003e \\u003c/td\\u003e \\u003ctd align=\\\"left\\\" colname=\\\"c4\\\"\\u003e \\u003cp\\u003e36% to \\u0026lt;\\u0026thinsp;54% of consenting paramedics attend allocated sessions\\u003c/p\\u003e \\u003c/td\\u003e \\u003ctd align=\\\"left\\\" colname=\\\"c5\\\"\\u003e \\u003cp\\u003e\\u0026ge;\\u0026thinsp;54% of consenting paramedics attend allocated sessions\\u003c/p\\u003e \\u003c/td\\u003e \\u003c/tr\\u003e \\u003ctr\\u003e \\u003ctd align=\\\"left\\\" colname=\\\"c1\\\"\\u003e \\u003cp\\u003e\\u003cb\\u003eTrial methods feasibility\\u003c/b\\u003e\\u003c/p\\u003e \\u003c/td\\u003e \\u003ctd align=\\\"left\\\" colname=\\\"c2\\\"\\u003e \\u003cp\\u003eCompleteness of primary outcome data\\u003c/p\\u003e \\u003c/td\\u003e \\u003ctd align=\\\"left\\\" colname=\\\"c3\\\"\\u003e \\u003cp\\u003e\\u0026lt;\\u0026thinsp;45% complete data at all follow-up time points\\u003c/p\\u003e \\u003c/td\\u003e \\u003ctd align=\\\"left\\\" colname=\\\"c4\\\"\\u003e \\u003cp\\u003e45% to \\u0026lt;\\u0026thinsp;67.5% complete data at all follow-up time points\\u003c/p\\u003e \\u003c/td\\u003e \\u003ctd align=\\\"left\\\" colname=\\\"c5\\\"\\u003e \\u003cp\\u003e\\u0026ge;\\u0026thinsp;67.5% complete data at all follow-up time points\\u003c/p\\u003e \\u003c/td\\u003e \\u003c/tr\\u003e \\u003ctr\\u003e \\u003ctd align=\\\"left\\\" colname=\\\"c1\\\"\\u003e \\u003cp\\u003e\\u003cb\\u003eIntervention acceptability\\u003c/b\\u003e\\u003c/p\\u003e \\u003c/td\\u003e \\u003ctd align=\\\"left\\\" colname=\\\"c2\\\"\\u003e \\u003cp\\u003eQualitative assessment of acceptability\\u003c/p\\u003e \\u003c/td\\u003e \\u003ctd align=\\\"left\\\" colname=\\\"c3\\\"\\u003e \\u003cp\\u003eQualitative findings suggest low acceptability and/or poor organisational fit, with major concerns regarding appropriateness, burden, or continued use\\u003c/p\\u003e \\u003c/td\\u003e \\u003ctd align=\\\"left\\\" colname=\\\"c4\\\"\\u003e \\u003cp\\u003eQualitative findings suggest partial or mixed acceptability, with modifications needed to improve appropriateness, burden, or implementation\\u003c/p\\u003e \\u003c/td\\u003e \\u003ctd align=\\\"left\\\" colname=\\\"c5\\\"\\u003e \\u003cp\\u003eQualitative findings suggest good acceptability and organisational fit, including perceived appropriateness and intention to continue use\\u003c/p\\u003e \\u003c/td\\u003e \\u003c/tr\\u003e \\u003ctr\\u003e \\u003ctd align=\\\"left\\\" colname=\\\"c1\\\"\\u003e \\u003cp\\u003e\\u003cb\\u003eProgression criteria\\u003c/b\\u003e\\u003c/p\\u003e \\u003c/td\\u003e \\u003ctd align=\\\"left\\\" colname=\\\"c2\\\"\\u003e \\u003cp\\u003eDefinition of progression threshold\\u003c/p\\u003e \\u003c/td\\u003e \\u003ctd align=\\\"left\\\" colname=\\\"c3\\\"\\u003e \\u003cp\\u003eLess than 60% of the stated progression target\\u003c/p\\u003e \\u003c/td\\u003e \\u003ctd align=\\\"left\\\" colname=\\\"c4\\\"\\u003e \\u003cp\\u003eWithin 60\\u0026ndash;90% of the stated progression target\\u003c/p\\u003e \\u003c/td\\u003e \\u003ctd align=\\\"left\\\" colname=\\\"c5\\\"\\u003e \\u003cp\\u003eEach criterion met or within 10% of stated progression target\\u003c/p\\u003e \\u003c/td\\u003e \\u003c/tr\\u003e \\u003ctr\\u003e \\u003ctd align=\\\"left\\\" colname=\\\"c1\\\"\\u003e \\u003cp\\u003e\\u003cb\\u003eSuggested action before proceeding to a definitive trial\\u003c/b\\u003e\\u003c/p\\u003e \\u003c/td\\u003e \\u003ctd align=\\\"left\\\" colname=\\\"c2\\\"\\u003e \\u003cp\\u003eRecommended response to progression outcome\\u003c/p\\u003e \\u003c/td\\u003e \\u003ctd align=\\\"left\\\" colname=\\\"c3\\\"\\u003e \\u003cp\\u003eProgression contingent upon significant design modification\\u003c/p\\u003e \\u003c/td\\u003e \\u003ctd align=\\\"left\\\" colname=\\\"c4\\\"\\u003e \\u003cp\\u003eAssess whether major methodological modifications would improve results\\u003c/p\\u003e \\u003c/td\\u003e \\u003ctd align=\\\"left\\\" colname=\\\"c5\\\"\\u003e \\u003cp\\u003eReview and consider study design or methodological modifications\\u003c/p\\u003e \\u003c/td\\u003e \\u003c/tr\\u003e \\u003c/tbody\\u003e \\u003c/colgroup\\u003e \\u003ctfoot\\u003e \\u003ctr\\u003e\\u003ctd colspan=\\\"5\\\"\\u003eNB: Percentage change measured as relative\\u003c/td\\u003e\\u003c/tr\\u003e \\u003c/tfoot\\u003e \\u003c/table\\u003e\\u003c/div\\u003e \\u003c/p\\u003e \\u003cdiv id=\\\"Sec25\\\" class=\\\"Section3\\\"\\u003e \\u003ch2\\u003eRisk Monitoring Procedure\\u003c/h2\\u003e \\u003cp\\u003eParticipant well-being will be monitored throughout the study using responses to the PTSD checklist for DSM-D (PCL-5). The CI will review all questionnaires at baseline, post-randomisation, and three-month follow-up to identify participants scoring at or above the clinical threshold for PTSD (PCL-5\\u0026thinsp;\\u0026ge;\\u0026thinsp;31), which may indicate probable post-traumatic stress [\\u003cspan citationid=\\\"CR52\\\" class=\\\"CitationRef\\\"\\u003e52\\u003c/span\\u003e].\\u003c/p\\u003e \\u003cp\\u003eAfter submitting each questionnaire, participants will automatically receive tailored email feedback appropriate to their PCL-5 score. Those scoring 30 or below will receive a thank-you message with links to mental health support resources designed for EMS employees and CI contact details. Those scoring 31 or more will receive a similar message thanking them for completing the questionnaire, whilst highlighting that their response may indicate higher levels of post-traumatic stress, reassuring them that they are not alone, and encouraging them to reach out to trusted support such as organisational well-being services, their GP, or local mental health providers.\\u003c/p\\u003e \\u003cp\\u003eParticipants scoring\\u0026thinsp;\\u0026ge;\\u0026thinsp;31 at the post-randomisation stage will receive an automated end-of-questionnaire message and a direct email via their preferred method of contact from the CI offering assistance to find the right support. For participants scoring\\u0026thinsp;\\u0026ge;\\u0026thinsp;31 at three-month follow-up, an automated end-of-questionnaire message appropriate to their PCL-5 score will be sent. In addition to the CI sending a direct email to offer assistance, they will suggest a telephone call at a time convenient to follow up on the completed questionnaire. During the call, the CI will ask how they have been getting on and check whether further support is required. If there is no response to the initial email prompt proposing a telephone call, a second email will be sent after seven days. The participating ambulance service's dedicated employee support service are aware of this trial and will be on standby to provide assistance as needed before, during, and after the study, but will not be informed of specific individuals who score above clinical cut-off on the PCL-5.\\u003c/p\\u003e \\u003cp\\u003eAfter the final questionnaire, invitations for process evaluation interviews will be distributed by email with the aim to examine experiences of participating with and delivering the intervention alongside contextual factors that might be associated with any variations in outcomes.\\u003c/p\\u003e \\u003c/div\\u003e \\u003cdiv id=\\\"Sec26\\\" class=\\\"Section3\\\"\\u003e \\u003ch2\\u003eQualitative Process Evaluation\\u003c/h2\\u003e \\u003cp\\u003eAll participants, intervention facilitators, and managers who supported the trial will be invited to an interview to provide feedback on what worked well and what worked less well. This nested qualitative study will conduct one-to-one qualitative interviews with a purposive sample of 16 trial participants. This consists of 6 intervention participants, 6 usual practice participants, alongside 2 intervention facilitators and 2 station managers. Intervention decliners and completers with improved, unchanged, or reduced well-being scores will be invited to take part. Potential participants will be invited by preferred method of contact (established during trial consent procedure) alongside a written letter of thanks for trial participation in station pigeonholes with a process evaluation participant information sheet. This opportunity will be advertised via station posters and internal newsletters. A \\u0026pound;40 electronic gift voucher will be offered to each interview participant.\\u003c/p\\u003e \\u003c/div\\u003e \\u003cdiv id=\\\"Sec27\\\" class=\\\"Section3\\\"\\u003e \\u003ch2\\u003eProcess Evaluation data collection\\u003c/h2\\u003e \\u003cp\\u003eThe CI will facilitate qualitative focus groups via Microsoft-Teams and sessions will last approximately 45\\u0026ndash;60 minutes. To inform the process evaluation, the research team with PPIE support, will refine interview topic guides mapped to the Medical Research Council process evaluation framework. The aim of the topic guides will be to guide the exploration of factors such as perceived efficacy, satisfaction, and willingness to recommend the intervention to others, alongside perceptions of barriers and facilitators to participation and delivery. Transcripts will be returned to participants for accuracy checks. The findings will then be analysed using reflexive thematic analysis [\\u003cspan citationid=\\\"CR53\\\" class=\\\"CitationRef\\\"\\u003e53\\u003c/span\\u003e]. Following the return of thematic summaries for participant review, we will deductively map the themes to behaviour change frameworks COM-B and Theoretical Domain Framework categories, creating new categories if needed. This approach, consistent with existing healthcare research, ensures that findings can be applied to real-world settings [\\u003cspan citationid=\\\"CR54\\\" class=\\\"CitationRef\\\"\\u003e54\\u003c/span\\u003e, \\u003cspan citationid=\\\"CR55\\\" class=\\\"CitationRef\\\"\\u003e55\\u003c/span\\u003e].\\u003c/p\\u003e \\u003c/div\\u003e \\u003c/div\\u003e \\u003cdiv id=\\\"Sec28\\\" class=\\\"Section2\\\"\\u003e \\u003ch2\\u003eSafety considerations\\u003c/h2\\u003e \\u003cp\\u003eEnsuring the psychological safety of participants is paramount. Discussion about mental well-being and organisational support may cause distress, and participants can withdraw at any time before the completion of data analysis. Self-reported PTSD symptom severity will be closely monitored, and participants will receive prompts for support sent as previously outlined. A \\u0026ge;\\u0026thinsp;10-point increase on the PCL-5 relative to the previous questionnaire will be recorded as an adverse event, as this indicates symptom deterioration [\\u003cspan citationid=\\\"CR56\\\" class=\\\"CitationRef\\\"\\u003e56\\u003c/span\\u003e]. Facilitators trained to deliver a restorative Clinical Supervision framework, incorporating trauma-informed practice and ground rules such as confidentiality and safeguarding provisions, alongside completion of wellness action plans, will help to guide the session and mitigate any risk posed by disclosure, i.e., suicidal ideation. EMS employee support services will be available, including for PPIE representatives, via dedicated contact details. Adverse and serious adverse events (SAE) will be logged and assessed by the CI to determine any causal relationship with this trial based on the criteria described in Table\\u0026nbsp;\\u003cspan refid=\\\"Tab4\\\" class=\\\"InternalRef\\\"\\u003e4\\u003c/span\\u003e:\\u003c/p\\u003e \\u003cp\\u003e \\u003cdiv class=\\\"gridtable\\\"\\u003e\\u003ctable float=\\\"Yes\\\" id=\\\"Tab4\\\" border=\\\"1\\\"\\u003e \\u003ccaption language=\\\"En\\\"\\u003e \\u003cdiv class=\\\"CaptionNumber\\\"\\u003eTable 4\\u003c/div\\u003e \\u003cdiv class=\\\"CaptionContent\\\"\\u003e \\u003cp\\u003e\\u003cem\\u003eSerious and Adverse Events: Causality definitions\\u003c/em\\u003e\\u003c/p\\u003e \\u003c/div\\u003e \\u003c/caption\\u003e \\u003ccolgroup cols=\\\"3\\\"\\u003e \\u003cdiv align=\\\"left\\\" class=\\\"colspec\\\" colname=\\\"c1\\\" colnum=\\\"1\\\"\\u003e\\u003c/div\\u003e \\u003cdiv align=\\\"left\\\" class=\\\"colspec\\\" colname=\\\"c2\\\" colnum=\\\"2\\\"\\u003e\\u003c/div\\u003e \\u003cdiv align=\\\"left\\\" class=\\\"colspec\\\" colname=\\\"c3\\\" colnum=\\\"3\\\"\\u003e\\u003c/div\\u003e \\u003cthead\\u003e \\u003ctr\\u003e \\u003cth align=\\\"left\\\" colname=\\\"c1\\\"\\u003e \\u003cp\\u003eRelationship\\u003c/p\\u003e \\u003c/th\\u003e \\u003cth align=\\\"left\\\" colname=\\\"c2\\\"\\u003e \\u003cp\\u003eDescription\\u003c/p\\u003e \\u003c/th\\u003e \\u003cth align=\\\"left\\\" colname=\\\"c3\\\"\\u003e \\u003cp\\u003eReasonable possibility that the SAE may have been caused by the intervention?\\u003c/p\\u003e \\u003c/th\\u003e \\u003c/tr\\u003e \\u003c/thead\\u003e \\u003ctbody\\u003e \\u003ctr\\u003e \\u003ctd align=\\\"left\\\" colname=\\\"c1\\\"\\u003e \\u003cp\\u003eUnrelated\\u003c/p\\u003e \\u003c/td\\u003e \\u003ctd align=\\\"left\\\" colname=\\\"c2\\\"\\u003e \\u003cp\\u003eThere is no evidence of any causal relationship with the trial/intervention\\u003c/p\\u003e \\u003c/td\\u003e \\u003ctd align=\\\"left\\\" colname=\\\"c3\\\"\\u003e \\u003cp\\u003eYes/No\\u003c/p\\u003e \\u003c/td\\u003e \\u003c/tr\\u003e \\u003ctr\\u003e \\u003ctd align=\\\"left\\\" colname=\\\"c1\\\"\\u003e \\u003cp\\u003eUnlikely\\u003c/p\\u003e \\u003c/td\\u003e \\u003ctd align=\\\"left\\\" colname=\\\"c2\\\"\\u003e \\u003cp\\u003eThere is little evidence to suggest a causal relationship with the trial/intervention (e.g. the event did not occur within a reasonable time after the intervention). There is another reasonable explanation for the event (e.g. the participant\\u0026rsquo;s clinical condition or other concomitant treatment).\\u003c/p\\u003e \\u003c/td\\u003e \\u003ctd align=\\\"left\\\" colname=\\\"c3\\\"\\u003e \\u003cp\\u003eYes/No\\u003c/p\\u003e \\u003c/td\\u003e \\u003c/tr\\u003e \\u003ctr\\u003e \\u003ctd align=\\\"left\\\" colname=\\\"c1\\\"\\u003e \\u003cp\\u003ePossible\\u003c/p\\u003e \\u003c/td\\u003e \\u003ctd align=\\\"left\\\" colname=\\\"c2\\\"\\u003e \\u003cp\\u003eThere is some evidence to suggest a causal relationship with the trial/intervention (e.g. because the event occurs within a reasonable time after the intervention). However, the influence of other factors may have contributed to the event (e.g. participant\\u0026rsquo;s physical health or exposure to a critical incident at work).\\u003c/p\\u003e \\u003c/td\\u003e \\u003ctd align=\\\"left\\\" colname=\\\"c3\\\"\\u003e \\u003cp\\u003eYes/No\\u003c/p\\u003e \\u003c/td\\u003e \\u003c/tr\\u003e \\u003ctr\\u003e \\u003ctd align=\\\"left\\\" colname=\\\"c1\\\"\\u003e \\u003cp\\u003eProbable\\u003c/p\\u003e \\u003c/td\\u003e \\u003ctd align=\\\"left\\\" colname=\\\"c2\\\"\\u003e \\u003cp\\u003eThere is evidence to suggest a causal relationship, and the influence of other factors is unlikely.\\u003c/p\\u003e \\u003c/td\\u003e \\u003ctd align=\\\"left\\\" colname=\\\"c3\\\"\\u003e \\u003cp\\u003eYes/No\\u003c/p\\u003e \\u003c/td\\u003e \\u003c/tr\\u003e \\u003ctr\\u003e \\u003ctd align=\\\"left\\\" colname=\\\"c1\\\"\\u003e \\u003cp\\u003eDefinite\\u003c/p\\u003e \\u003c/td\\u003e \\u003ctd align=\\\"left\\\" colname=\\\"c2\\\"\\u003e \\u003cp\\u003eThere is clear evidence to suggest a causal relationship, and other possible contributing factors can be ruled out.\\u003c/p\\u003e \\u003c/td\\u003e \\u003ctd align=\\\"left\\\" colname=\\\"c3\\\"\\u003e \\u003cp\\u003eYes/No\\u003c/p\\u003e \\u003c/td\\u003e \\u003c/tr\\u003e \\u003c/tbody\\u003e \\u003c/colgroup\\u003e \\u003c/table\\u003e\\u003c/div\\u003e \\u003c/p\\u003e \\u003cp\\u003eAny SAE\\u0026rsquo;s will be reported to the Research Ethics Committee that gave a favourable opinion of the study, where, in the opinion of the CI the event was \\u0026lsquo;related\\u0026rsquo; (resulted from administration of any of the research procedures) and \\u0026lsquo;unexpected\\u0026rsquo; in relation to those procedures. Reports of related and unexpected SAE\\u0026rsquo;s will be submitted within 15 working days of the CI becoming aware of the event, using Health Research Authority reporting procedures.\\u003c/p\\u003e \\u003c/div\\u003e \\u003cdiv id=\\\"Sec29\\\" class=\\\"Section2\\\"\\u003e \\u003ch2\\u003eTrial management and oversight\\u003c/h2\\u003e \\u003cp\\u003eThe EMS-SHIELD trial will report to a study management group appointed to provide study oversight on behalf of the sponsor and funder. A Trial Steering Committee will not be convened, as the scale and purpose of this study were deemed proportionate for oversight by a study management group. Day-to-day trial management will be the responsibility of the CI with oversight from the supervision team at the University of Oxford. Permission for protocol amendments will be sought from the sponsor and where required from the research ethics committee. This study management group includes one PPIE representative alongside EMS departmental leaders representing research, frontline operations, Education, Equality, Diversity, and Inclusion (ED\\u0026amp;I), employee support, and learning and development. Feedback sessions and corrective actions will be coordinated collaboratively with these stakeholders to address discrepancies and deviations in the context of risk assessments. A study related deviation is a departure from the ethically approved study protocol or other study document or process (e.g. consent process or administration of study intervention) or from Good Clinical Practice or any applicable regulatory requirements. Any deviations from the protocol will be documented in a protocol deviation form and filed in the study master file.\\u003c/p\\u003e \\u003c/div\\u003e\\n\\u003ch3\\u003eStatistical design\\u003c/h3\\u003e\\n\\u003cp\\u003eAnalyses will be performed on an intent-to-treat basis where possible, i.e., all randomised participants will be included in the analysis. The primary focus of this trial is to assess the feasibility and acceptability of the intervention and study processes using descriptive statistics and process measures, rather than hypothesis testing for statistical significance. However, clinical outcomes will be reported using effect size calculations alongside the direction of difference between the intervention and usual practice groups. Descriptive statistics of numbers of eligible participants, recruitment, attrition, loss to follow-up, attendance at allocated session, and the number of referrals to onward support will be reported via a Consort diagram [\\u003cspan citationid=\\\"CR57\\\" class=\\\"CitationRef\\\"\\u003e57\\u003c/span\\u003e]. For each outcome measure, the proportion with complete data will be reported in addition to descriptive statistics (means and standard deviations) for both conditions. Mean differences (and 95% confidence intervals) by condition in outcome score at 3-month follow-up will be estimated. The analysis will not be powered to detect differences between conditions on the outcomes. Therefore, where estimated, treatment effects will be used to inform the sample size for a future definitive trial. With regards to cluster-level data, we will report a descriptive comparison of the influence of clusters on uptake of EMS-SHIELD sessions, intervention adherence, and utilisation of self-reported support resources.\\u003c/p\\u003e \\u003cp\\u003eIncluding the feasibility of collecting health economic data in this trial is critical, given the financial constraints faced by NHS EMS services. Generating data to underpin the cost-effectiveness of keeping employees well is essential for justifying investment in supportive interventions. Health economic measures will be reported descriptively, using means, standard deviations, counts and ranges, as applicable, by trial arm, at each time point (i.e. baseline, 4\\u0026ndash;6 weeks and 3 months follow up). The feasibility of using a modified Client Service Receipt Inventory form to capture participants\\u0026rsquo; use of health and social care (e.g., GP visits; medications), travel time to/from health treatments/visits, as well as time off work, and all associated costs, will be assessed to inform the selection and refinement of resource-use items for a future definitive trial.\\u003c/p\\u003e \\u003cp\\u003eThe extent of missing data will be summarised descriptively at each time point, including the proportion of missing items and missing questionnaires. Patterns of missingness will be examined across trial arms and follow-up points to assess the feasibility of data collection. As this is a feasibility trial, analyses of participant-reported outcomes will be based on available cases only (complete-case analysis), with no imputation of missing data.\\u003c/p\\u003e \\u003cdiv id=\\\"Sec31\\\" class=\\\"Section2\\\"\\u003e \\u003ch2\\u003eData monitoring and storage\\u003c/h2\\u003e \\u003cdiv id=\\\"Sec32\\\" class=\\\"Section3\\\"\\u003e \\u003ch2\\u003eSource data\\u003c/h2\\u003e \\u003cp\\u003eAll documentation will follow GCP standards and comply with the General Data Protection Regulation (GDPR) and Data Protection Act 2018, which require data to be de-identified as soon as it is practical to do so. The processing of the personal data of participants will be minimised by making use of a unique participant study number on all study documents and electronic database(s). All documents will be stored securely and only accessible by study staff and authorised personnel.\\u003c/p\\u003e \\u003cdiv id=\\\"Sec33\\\" class=\\\"Section4\\\"\\u003e \\u003ch2\\u003eAccess to data\\u003c/h2\\u003e \\u003cp\\u003eDirect access will be granted to authorised representatives from the University of Oxford supervision team and the representatives from the Sponsor\\u0026rsquo;s research and development team for monitoring and/or audit of the study to ensure compliance with regulations. Data will be shared via University of Oxford secure OneDrive files and folders sharing mechanisms. Participants will have the right to request a copy of their own data up until the point that data is anonymised for reporting, whereupon it can no longer be linked to individuals. The study uses coded identifiers and stores identifiable data separately. Transcripts from qualitative interviews will be shared with participants for checking accuracy.\\u003c/p\\u003e \\u003c/div\\u003e \\u003c/div\\u003e \\u003cdiv id=\\\"Sec34\\\" class=\\\"Section3\\\"\\u003e \\u003ch2\\u003eData recording and record keeping\\u003c/h2\\u003e \\u003cp\\u003eTrial data will be labelled with participant identifiers sent by email for questionnaire completion. The name and any other identifying detail will not be included in any trial data electronic file. Consent forms will be stored separately from participant responses (which will only be identifiable through a personal identifier). Questionnaire responses will be exported from Qualtrics as Microsoft-Excel files and thereafter deleted from Qualtrics as soon as practically possible and within 3 months of the last participant completing questionnaires or final participant interview, whichever is later. Transcripts generated from the process evaluation interviews will be anonymised by the CI and the recordings deleted at the point of transcription. Microsoft-Word files (anonymised qualitative transcripts) will be shared via a secure university Virtual Private Network (VPN) and regularly backed up on an encrypted, restricted-access folder on the University of Oxford network (managed by the CI). Any feedback received from email reminders (for scheduled sessions and prompts for data collection timepoints) during the trial will be immediately extracted from the email, anonymised and then stored in the same OneDrive account. Linkage lists will be stored on a restricted-access folder until all data is collected, checked, cleaned, and finalised, with deletion of lists anticipated within 12-months of the completion of data collection. Anonymised, non-identifiable quotations from transcriptions and email feedback may be used within publications to add validity and context to findings with participants\\u0026rsquo; consent.\\u003c/p\\u003e \\u003c/div\\u003e \\u003c/div\\u003e\\n\\u003ch3\\u003eData monitoring\\u003c/h3\\u003e\\n\\u003cp\\u003eA formal Data Monitoring Committee will not be convened for this study because this is a feasibility trial, designed primarily to assess trial processes rather than to generate definitive evidence of effectiveness or safety. Study progress, including any adverse incidents, will be reported to a study management group guided by the study monitoring plan (see Table\\u0026nbsp;\\u003cspan refid=\\\"Tab5\\\" class=\\\"InternalRef\\\"\\u003e5\\u003c/span\\u003e).\\u003c/p\\u003e \\u003cp\\u003e \\u003cdiv class=\\\"gridtable\\\"\\u003e\\u003ctable float=\\\"Yes\\\" id=\\\"Tab5\\\" border=\\\"1\\\"\\u003e \\u003ccaption language=\\\"En\\\"\\u003e \\u003cdiv class=\\\"CaptionNumber\\\"\\u003eTable 5\\u003c/div\\u003e \\u003cdiv class=\\\"CaptionContent\\\"\\u003e \\u003cp\\u003e\\u003cem\\u003eStudy Monitoring Plan\\u003c/em\\u003e\\u003c/p\\u003e \\u003c/div\\u003e \\u003c/caption\\u003e \\u003ccolgroup cols=\\\"2\\\"\\u003e \\u003cdiv align=\\\"left\\\" class=\\\"colspec\\\" colname=\\\"c1\\\" colnum=\\\"1\\\"\\u003e\\u003c/div\\u003e \\u003cdiv align=\\\"left\\\" class=\\\"colspec\\\" colname=\\\"c2\\\" colnum=\\\"2\\\"\\u003e\\u003c/div\\u003e \\u003cthead\\u003e \\u003ctr\\u003e \\u003cth align=\\\"left\\\" colname=\\\"c1\\\"\\u003e \\u003cp\\u003eAspect\\u003c/p\\u003e \\u003c/th\\u003e \\u003cth align=\\\"left\\\" colname=\\\"c2\\\"\\u003e \\u003cp\\u003eDetails\\u003c/p\\u003e \\u003c/th\\u003e \\u003c/tr\\u003e \\u003c/thead\\u003e \\u003ctbody\\u003e \\u003ctr\\u003e \\u003ctd align=\\\"left\\\" colname=\\\"c1\\\"\\u003e \\u003cp\\u003e\\u003cb\\u003eTrial Risk Assessment\\u003c/b\\u003e\\u003c/p\\u003e \\u003c/td\\u003e \\u003ctd align=\\\"left\\\" colname=\\\"c2\\\"\\u003e \\u003cp\\u003eThe EMS-SHIELD feasibility trial is classified as low-to-medium risk due to the non-invasive intervention and minimal participant risk. Key risks include incomplete data collection from operational pressures on paramedics and variability in intervention delivery.\\u003c/p\\u003e \\u003c/td\\u003e \\u003c/tr\\u003e \\u003ctr\\u003e \\u003ctd align=\\\"left\\\" colname=\\\"c1\\\"\\u003e \\u003cp\\u003e\\u003cb\\u003eMonitoring Plan\\u003c/b\\u003e\\u003c/p\\u003e \\u003c/td\\u003e \\u003ctd align=\\\"left\\\" colname=\\\"c2\\\"\\u003e \\u003cp\\u003eThe Chief Investigator (CI) will oversee compliance with the protocol and evaluate data accuracy in relation to source documents.\\u003c/p\\u003e \\u003c/td\\u003e \\u003c/tr\\u003e \\u003ctr\\u003e \\u003ctd align=\\\"left\\\" colname=\\\"c1\\\"\\u003e \\u003cp\\u003e\\u003cb\\u003eCompliance Checks\\u003c/b\\u003e\\u003c/p\\u003e \\u003c/td\\u003e \\u003ctd align=\\\"left\\\" colname=\\\"c2\\\"\\u003e \\u003cp\\u003eThe CI will review adherence to trial protocol and procedures weekly.\\u003c/p\\u003e \\u003c/td\\u003e \\u003c/tr\\u003e \\u003ctr\\u003e \\u003ctd align=\\\"left\\\" colname=\\\"c1\\\"\\u003e \\u003cp\\u003e\\u003cb\\u003eData Verification\\u003c/b\\u003e\\u003c/p\\u003e \\u003c/td\\u003e \\u003ctd align=\\\"left\\\" colname=\\\"c2\\\"\\u003e \\u003cp\\u003eAssess the accuracy, completeness, and consistency of data against source documents.\\u003c/p\\u003e \\u003c/td\\u003e \\u003c/tr\\u003e \\u003ctr\\u003e \\u003ctd align=\\\"left\\\" colname=\\\"c1\\\"\\u003e \\u003cp\\u003e\\u003cb\\u003eMonitoring Procedures\\u003c/b\\u003e\\u003c/p\\u003e \\u003c/td\\u003e \\u003ctd align=\\\"left\\\" colname=\\\"c2\\\"\\u003e \\u003cp\\u003eThe CI will follow standard operating procedures to ensure data are generated, documented, and reported in compliance with the protocol, GCP, and regulatory requirements. Study progress, including adverse incidents, will be reported to a study management group.\\u003c/p\\u003e \\u003c/td\\u003e \\u003c/tr\\u003e \\u003c/tbody\\u003e \\u003c/colgroup\\u003e \\u003c/table\\u003e\\u003c/div\\u003e \\u003c/p\\u003e\\n\\u003ch3\\u003eDissemination Plan\\u003c/h3\\u003e\\n\\u003cp\\u003eFindings will be shared through peer-reviewed publications, conference presentations, and reports to NHS ambulance services, accompanied by accessible visual summaries for EMS staff, PPIE contributors, and advocacy groups, alongside targeted briefs for policymakers and public-facing updates via organisational and university communication channels.\\u003c/p\\u003e\"},{\"header\":\"Discussion\",\"content\":\"\\u003cp\\u003eEMS workers are exposed to uniquely high and cumulative occupational stressors that contribute to elevated rates of psychological distress, PTSD, depression, and burnout compared with other healthcare staff and community samples [\\u003cspan citationid=\\\"CR58\\\" class=\\\"CitationRef\\\"\\u003e58\\u003c/span\\u003e]. Although awareness of these challenges has grown, there remains a lack of evidence on how best to embed sustainable, organisation-wide mental health support within the operational realities of ambulance services. The EMS-SHIELD trial responds to this urgent need by assessing whether a peer-led, well-being intervention in work hours can be delivered and accepted within an NHS ambulance service. A systematic review of the barriers and enablers to organisational support for EMS employee mental health recommended strategies that included strengthening peer connection and psychological safety, rather than focusing solely on individual resilience [\\u003cspan citationid=\\\"CR22\\\" class=\\\"CitationRef\\\"\\u003e22\\u003c/span\\u003e]. The tension between providing time at work for employees against a backdrop of relentless 999 demand necessitates evidence-based solutions to protect worker well-being whilst maintaining operational capability. EMS-SHIELD integrates behaviour-change and reflective-practice frameworks to position well-being as a shared workplace responsibility rather than a personal burden.\\u003c/p\\u003e \\u003cp\\u003eThe design of this feasibility study aligns closely with EMS research examining complex behavioural and well-being interventions in real operational contexts [\\u003cspan citationid=\\\"CR59\\\" class=\\\"CitationRef\\\"\\u003e59\\u003c/span\\u003e, \\u003cspan citationid=\\\"CR60\\\" class=\\\"CitationRef\\\"\\u003e60\\u003c/span\\u003e]. These studies highlight common methodological challenges in EMS research, for instance, variable shift patterns, limited time, and fluctuating operational demand. By using a cluster design and flexible delivery, EMS-SHIELD aims to capture real-world conditions while assessing feasibility parameters critical for a future definitive trial.\\u003c/p\\u003e \\u003cp\\u003eAs with all feasibility studies, EMS-SHIELD is not designed to test intervention effectiveness. Limitations include potential for recruitment challenges, session disruptions, and heterogeneity in delivery environments. However, documenting these issues and assessing data completeness, fidelity, and engagement is critical for determining whether a future definitive trial is justified. The inclusion of quantitative feasibility metrics and qualitative exploration will provide a comprehensive picture of operational, psychological, and cultural factors influencing uptake. Furthermore, understanding whether collecting health-economic data is practical and acceptable is essential to ensuring a full trial can generate robust cost-effectiveness data, particularly in the context of ongoing NHS transformation and increasing financial pressures.\\u003c/p\\u003e \\u003cp\\u003eIf shown to be feasible and acceptable, EMS-SHIELD could offer a practical model for embedding proactive psychological support within everyday paramedic practice. While not powered to evaluate clinical outcomes, this study will generate important learning on recruitment, fidelity, and data collection, informing progression criteria and contributing to the evidence base on implementing employee well-being interventions in EMS settings.\\u003c/p\\u003e\"},{\"header\":\"Abbreviations\",\"content\":\"\\u003cdiv class=\\\"DefinitionList\\\"\\u003e \\u003cdiv class=\\\"DefinitionListEntry\\\"\\u003e \\u003cdiv class=\\\"Term\\\"\\u003eCOM-B\\u003c/div\\u003e \\u003cdiv class=\\\"Description\\\"\\u003e \\u003cp\\u003eCapability-Opportunity-Motivation-Behaviour\\u003c/p\\u003e \\u003c/div\\u003e \\u003c/div\\u003e \\u003cdiv class=\\\"DefinitionListEntry\\\"\\u003e \\u003cdiv class=\\\"Term\\\"\\u003eCSRI\\u003c/div\\u003e \\u003cdiv class=\\\"Description\\\"\\u003e \\u003cp\\u003eClient Service Receipt Inventory\\u003c/p\\u003e \\u003c/div\\u003e \\u003c/div\\u003e \\u003cdiv class=\\\"DefinitionListEntry\\\"\\u003e \\u003cdiv class=\\\"Term\\\"\\u003eEMS\\u003c/div\\u003e \\u003cdiv class=\\\"Description\\\"\\u003e \\u003cp\\u003eEmergency Medical Service\\u003c/p\\u003e \\u003c/div\\u003e \\u003c/div\\u003e \\u003cdiv class=\\\"DefinitionListEntry\\\"\\u003e \\u003cdiv class=\\\"Term\\\"\\u003eEMS-SHIELD\\u003c/div\\u003e \\u003cdiv class=\\\"Description\\\"\\u003e \\u003cp\\u003eEmergency Medical Service - Supporting Health, Improving Employee Life, and Duty\\u003c/p\\u003e \\u003c/div\\u003e \\u003c/div\\u003e \\u003cdiv class=\\\"DefinitionListEntry\\\"\\u003e \\u003cdiv class=\\\"Term\\\"\\u003eEQ-5D-5L\\u003c/div\\u003e \\u003cdiv class=\\\"Description\\\"\\u003e \\u003cp\\u003eEuroQol 5-Dimension 5-level\\u003c/p\\u003e \\u003c/div\\u003e \\u003c/div\\u003e \\u003cdiv class=\\\"DefinitionListEntry\\\"\\u003e \\u003cdiv class=\\\"Term\\\"\\u003eGCP\\u003c/div\\u003e \\u003cdiv class=\\\"Description\\\"\\u003e \\u003cp\\u003eGood Clinical Practice\\u003c/p\\u003e \\u003c/div\\u003e \\u003c/div\\u003e \\u003cdiv class=\\\"DefinitionListEntry\\\"\\u003e \\u003cdiv class=\\\"Term\\\"\\u003eGP\\u003c/div\\u003e \\u003cdiv class=\\\"Description\\\"\\u003e \\u003cp\\u003eGeneral Practitioner\\u003c/p\\u003e \\u003c/div\\u003e \\u003c/div\\u003e \\u003cdiv class=\\\"DefinitionListEntry\\\"\\u003e \\u003cdiv class=\\\"Term\\\"\\u003eHRQoL\\u003c/div\\u003e \\u003cdiv class=\\\"Description\\\"\\u003e \\u003cp\\u003eHealth-related Quality-of-Life\\u003c/p\\u003e \\u003c/div\\u003e \\u003c/div\\u003e \\u003cdiv class=\\\"DefinitionListEntry\\\"\\u003e \\u003cdiv class=\\\"Term\\\"\\u003eNHS\\u003c/div\\u003e \\u003cdiv class=\\\"Description\\\"\\u003e \\u003cp\\u003eNational Health Service (UK)\\u003c/p\\u003e \\u003c/div\\u003e \\u003c/div\\u003e \\u003cdiv class=\\\"DefinitionListEntry\\\"\\u003e \\u003cdiv class=\\\"Term\\\"\\u003eNIHR\\u003c/div\\u003e \\u003cdiv class=\\\"Description\\\"\\u003e \\u003cp\\u003eNational Institute for Health and Care Research\\u003c/p\\u003e \\u003c/div\\u003e \\u003c/div\\u003e \\u003cdiv class=\\\"DefinitionListEntry\\\"\\u003e \\u003cdiv class=\\\"Term\\\"\\u003eLEC-5\\u003c/div\\u003e \\u003cdiv class=\\\"Description\\\"\\u003e \\u003cp\\u003eLife Events Checklist\\u003c/p\\u003e \\u003c/div\\u003e \\u003c/div\\u003e \\u003cdiv class=\\\"DefinitionListEntry\\\"\\u003e \\u003cdiv class=\\\"Term\\\"\\u003ePCL-5\\u003c/div\\u003e \\u003cdiv class=\\\"Description\\\"\\u003e \\u003cp\\u003ePTSD symptoms checklist\\u003c/p\\u003e \\u003c/div\\u003e \\u003c/div\\u003e \\u003cdiv class=\\\"DefinitionListEntry\\\"\\u003e \\u003cdiv class=\\\"Term\\\"\\u003ePPIE\\u003c/div\\u003e \\u003cdiv class=\\\"Description\\\"\\u003e \\u003cp\\u003ePatient and Public Involvement and Engagement\\u003c/p\\u003e \\u003c/div\\u003e \\u003c/div\\u003e \\u003cdiv class=\\\"DefinitionListEntry\\\"\\u003e \\u003cdiv class=\\\"Term\\\"\\u003ePTSD\\u003c/div\\u003e \\u003cdiv class=\\\"Description\\\"\\u003e \\u003cp\\u003ePost-traumatic Stress Disorder\\u003c/p\\u003e \\u003c/div\\u003e \\u003c/div\\u003e \\u003cdiv class=\\\"DefinitionListEntry\\\"\\u003e \\u003cdiv class=\\\"Term\\\"\\u003eREC\\u003c/div\\u003e \\u003cdiv class=\\\"Description\\\"\\u003e \\u003cp\\u003eResearch Ethics Committee\\u003c/p\\u003e \\u003c/div\\u003e \\u003c/div\\u003e \\u003cdiv class=\\\"DefinitionListEntry\\\"\\u003e \\u003cdiv class=\\\"Term\\\"\\u003eReQoL-10\\u003c/div\\u003e \\u003cdiv class=\\\"Description\\\"\\u003e \\u003cp\\u003eRecovering Quality of Life \\u0026ndash; 10 items\\u003c/p\\u003e \\u003c/div\\u003e \\u003c/div\\u003e \\u003c/div\\u003e\"},{\"header\":\"Declarations\",\"content\":\"\\u003cp\\u003e\\u003cstrong\\u003eEthics approval and consent to participate\\u003c/strong\\u003e\\u003c/p\\u003e\\n\\u003cp\\u003eThis study is sponsored by South Western Ambulance NHS Foundation Trust (SWASFT), supported by the University of Oxford Department of Experimental Psychology, and funded by the NIHR. The study will be conducted in accordance with the protocol approved by\\u0026nbsp;the Health Research Authority and Health and Care Research Wales via the London - Bromley Research Ethics Committee on 23\\u003csup\\u003erd\\u003c/sup\\u003e October 2025 (Study approval reference 25/LO/0682 and IRAS ID 354334). This study has been designed and will be conducted in compliance with the principles outlined in the Declaration of Helsinki and the Guidelines for Good Clinical Practice (GCP). The protocol, informed consent form, participant information sheets, topic guide and advertising materials have been reviewed and approved by the HRA and the REC. Approval from the sponsor, SWASFT, has also been obtained before submission to the HRA and REC. Any substantial amendments to the approved protocol or related documents will be submitted for further review and approval by the HRA, REC, and sponsor as required. Digital or written informed consent informed consent will be obtained from all participants prior to their inclusion in the study.\\u0026nbsp;\\u003c/p\\u003e\\n\\u003cp\\u003e\\u003cstrong\\u003eConsent for publication\\u003c/strong\\u003e\\u003c/p\\u003e\\n\\u003cp\\u003eNot applicable\\u0026nbsp;\\u003c/p\\u003e\\n\\u003cp\\u003e\\u003cstrong\\u003eAvailability of data and materials\\u003c/strong\\u003e\\u003c/p\\u003e\\n\\u003cp\\u003eIn line with this protocol, all study documents are stored securely and accessible only to study staff and authorised personnel. The datasets generated and/or analysed during the current study are not publicly available due to the residual risk of participant re-identification. Data may be requested from the corresponding author on reasonable request and will be shared only where appropriate safeguards are in place to protect participant confidentiality.\\u0026nbsp;\\u003c/p\\u003e\\n\\u003cp\\u003e\\u003cstrong\\u003eCompeting interests\\u003c/strong\\u003e\\u003c/p\\u003e\\n\\u003cp\\u003eThe authors declare that they have no competing interests\\u003cstrong\\u003e.\\u003c/strong\\u003e\\u003cstrong\\u003e\\u0026nbsp;\\u003c/strong\\u003e\\u003c/p\\u003e\\n\\u003cp\\u003e\\u003cstrong\\u003eFunding\\u003c/strong\\u003e\\u003c/p\\u003e\\n\\u003cp\\u003eSasha Johnston, Doctoral Research Fellow [NIHR 302983], is funded by the NIHR for this research project. Polly Waite and Mara Violato receive funding from the NIHR Oxford and Thames Valley Applied Research Collaboration and the NIHR Oxford Health Biomedical Research Centre. The views expressed in this publication are those of the authors and not necessarily those of the NIHR, NHS or the UK Department of Health and Social Care.\\u0026nbsp;\\u003c/p\\u003e\\n\\u003cp\\u003e\\u003cstrong\\u003eAuthors\\u0026apos; contributions\\u003c/strong\\u003e\\u003c/p\\u003e\\n\\u003cp\\u003eFunding Acquisition: SJ; Conceptualisation: SJ, JW; Supervision: JW, PW; Methodology: SJ, JW; Writing \\u0026ndash; Original Draft Preparation: SJ; Writing \\u0026ndash; Review \\u0026amp; Editing: JW, PW; SB, MV; All authors approved the final version of the manuscript for publication.\\u0026nbsp;\\u003c/p\\u003e\\n\\u003cp\\u003e\\u003cstrong\\u003eAcknowledgements\\u003c/strong\\u003e\\u003c/p\\u003e\\n\\u003cp\\u003eWe would especially like to thank Diana Frost, Lynn Tatnell, Minoo Par, and Ree Ra for their contribution as patient representatives and all employee representatives who shared their lived experience of EMS to inform the design of this research.\\u0026nbsp;\\u003c/p\\u003e\"},{\"header\":\"References\",\"content\":\"\\u003col\\u003e\\u003cli\\u003e\\u003cspan\\u003eBloom DE, Cafiero E, Jan\\u0026eacute;-Llopis E et al (2011) The Global Economic Burden of Noncommunicable Diseases. PGDA Working Papers. \\u003cspan class=\\\"ExternalRef\\\"\\u003e\\u003cspan class=\\\"RefSource\\\"\\u003ehttps://www.weforum.org/publications/global-economic-burden-non-communicable-diseases/\\u003c/span\\u003e\\u003cspan address=\\\"https://www.weforum.org/publications/global-economic-burden-non-communicable-diseases/\\\" targettype=\\\"URL\\\" class=\\\"RefTarget\\\"\\u003e\\u003c/span\\u003e\\u003c/span\\u003e\\u003c/span\\u003e\\u003c/li\\u003e \\u003cli\\u003e\\u003cspan\\u003eRoy D, Weyman A, Nolan P (2020) Self-preservation comes at a cost: Why British National Health Service paramedics might be choosing a healthier, but poorer, retirement. SAGE Open Med 8. \\u003cspan class=\\\"ExternalRef\\\"\\u003e\\u003cspan class=\\\"RefSource\\\"\\u003ehttps://doi.org/10.1177/2050312120901545\\u003c/span\\u003e\\u003cspan address=\\\"10.1177/2050312120901545\\\" targettype=\\\"DOI\\\" class=\\\"RefTarget\\\"\\u003e\\u003c/span\\u003e\\u003c/span\\u003e\\u003c/span\\u003e\\u003c/li\\u003e \\u003cli\\u003e\\u003cspan\\u003eMind (2019) Mental Health in the Emergency Services: Our 2019 Survey Results - Ambulance Service. \\u003cspan class=\\\"ExternalRef\\\"\\u003e\\u003cspan class=\\\"RefSource\\\"\\u003ehttps://www.mind.org.uk/media-a/4847/2019-survey-ambulance-service-summary.pdf\\u003c/span\\u003e\\u003cspan address=\\\"https://www.mind.org.uk/media-a/4847/2019-survey-ambulance-service-summary.pdf\\\" targettype=\\\"URL\\\" class=\\\"RefTarget\\\"\\u003e\\u003c/span\\u003e\\u003c/span\\u003e\\u003c/span\\u003e\\u003c/li\\u003e \\u003cli\\u003e\\u003cspan\\u003ePetrie K, Milligan-Saville J, Gayed A et al (2018) Prevalence of PTSD and common mental disorders amongst ambulance personnel: a systematic review and meta-analysis. Soc Psychiatry Psychiatr Epidemiol 53:897\\u0026ndash;909. \\u003cspan class=\\\"ExternalRef\\\"\\u003e\\u003cspan class=\\\"RefSource\\\"\\u003ehttps://doi.org/10.1007/s00127-018-1539-5\\u003c/span\\u003e\\u003cspan address=\\\"10.1007/s00127-018-1539-5\\\" targettype=\\\"DOI\\\" class=\\\"RefTarget\\\"\\u003e\\u003c/span\\u003e\\u003c/span\\u003e\\u003c/span\\u003e\\u003c/li\\u003e \\u003cli\\u003e\\u003cspan\\u003eStevelink S, Pernet D, Dregan A et al (2020) The mental health of emergency services personnel in the UK Biobank: a comparison with the working population. Eur J Psychotraumatol 11. \\u003cspan class=\\\"ExternalRef\\\"\\u003e\\u003cspan class=\\\"RefSource\\\"\\u003ehttps://doi.org/10.1080/20008198.2020.1799477\\u003c/span\\u003e\\u003cspan address=\\\"10.1080/20008198.2020.1799477\\\" targettype=\\\"DOI\\\" class=\\\"RefTarget\\\"\\u003e\\u003c/span\\u003e\\u003c/span\\u003e\\u003c/span\\u003e\\u003c/li\\u003e \\u003cli\\u003e\\u003cspan\\u003eMind (2021) Behind the Mask: How the coronavirus pandemic impacted the mental health of emergency responders. \\u003cspan class=\\\"ExternalRef\\\"\\u003e\\u003cspan class=\\\"RefSource\\\"\\u003ehttps://www.mind.org.uk/media/7246/blue-light-behind-the-mask-report-en-2021.pdf\\u003c/span\\u003e\\u003cspan address=\\\"https://www.mind.org.uk/media/7246/blue-light-behind-the-mask-report-en-2021.pdf\\\" targettype=\\\"URL\\\" class=\\\"RefTarget\\\"\\u003e\\u003c/span\\u003e\\u003c/span\\u003e\\u003c/span\\u003e\\u003c/li\\u003e \\u003cli\\u003e\\u003cspan\\u003ePetrie K, Spittal M, Zeritis S et al (2022) Psychological Medicine Suicide among emergency service workers: a retrospective mortality study of national coronial data, 2001\\u0026ndash;2017. 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Front Public Health 11:1130875. \\u003cspan class=\\\"ExternalRef\\\"\\u003e\\u003cspan class=\\\"RefSource\\\"\\u003ehttps://doi.org/10.3389/FPUBH.2023.1130875/BIBTEX\\u003c/span\\u003e\\u003cspan address=\\\"10.3389/FPUBH.2023.1130875/BIBTEX\\\" targettype=\\\"DOI\\\" class=\\\"RefTarget\\\"\\u003e\\u003c/span\\u003e\\u003c/span\\u003e\\u003c/span\\u003e\\u003c/li\\u003e \\u003cli\\u003e\\u003cspan\\u003eBlanchard BE, Johnson M, Campbell SB et al (2023) Minimal important difference metrics and test\\u0026ndash;retest reliability of the PTSD Checklist for DSM-5 with a primary care sample. 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BMJ 345. \\u003cspan class=\\\"ExternalRef\\\"\\u003e\\u003cspan class=\\\"RefSource\\\"\\u003ehttps://doi.org/10.1136/BMJ.E5661\\u003c/span\\u003e\\u003cspan address=\\\"10.1136/BMJ.E5661\\\" targettype=\\\"DOI\\\" class=\\\"RefTarget\\\"\\u003e\\u003c/span\\u003e\\u003c/span\\u003e\\u003c/span\\u003e\\u003c/li\\u003e \\u003cli\\u003e\\u003cspan\\u003eLawn S, Roberts L, Willis E et al (2020) The effects of emergency medical service work on the psychological, physical, and social well-being of ambulance personnel: A systematic review of qualitative research. BMC Psychiatry 20:348. \\u003cspan class=\\\"ExternalRef\\\"\\u003e\\u003cspan class=\\\"RefSource\\\"\\u003ehttps://doi.org/10.1186/s12888-020-02752-4\\u003c/span\\u003e\\u003cspan address=\\\"10.1186/s12888-020-02752-4\\\" targettype=\\\"DOI\\\" class=\\\"RefTarget\\\"\\u003e\\u003c/span\\u003e\\u003c/span\\u003e\\u003c/span\\u003e\\u003c/li\\u003e \\u003cli\\u003e\\u003cspan\\u003eDavies K, Weale V, Oakman J (2023) A participatory ergonomics intervention to re-design work and improve the musculoskeletal health of paramedics: protocol for a cluster randomised controlled trial. Published Online First: https://doi.org/0.1186/s12891-023-06834-8\\u003c/span\\u003e\\u003c/li\\u003e \\u003cli\\u003e\\u003cspan\\u003eAppelboam A, Osborne R, Ukoumunne OC et al (2025) Evaluation of Out-of-Hospital Use of a Valsalva Assist Device in the Emergency Treatment of Supraventricular Tachycardia. Ann Emerg Med 86:659\\u0026ndash;673. \\u003cspan class=\\\"ExternalRef\\\"\\u003e\\u003cspan class=\\\"RefSource\\\"\\u003ehttps://doi.org/10.1016/j.annemergmed.2025.06.623\\u003c/span\\u003e\\u003cspan address=\\\"10.1016/j.annemergmed.2025.06.623\\\" targettype=\\\"DOI\\\" class=\\\"RefTarget\\\"\\u003e\\u003c/span\\u003e\\u003c/span\\u003e\\u003c/span\\u003e\\u003c/li\\u003e \\u003cli\\u003e\\u003cspan\\u003eSouth Western Ambulance Service NHS Foundation Trust (2025) Safeguarding Policy: Think Family - Child and Adult\\u003c/span\\u003e\\u003c/li\\u003e\\u003c/ol\\u003e\"},{\"header\":\"Footnotes\",\"content\":\"\\u003col\\u003e\\u003cli\\u003e\\u003cspan\\u003e Light duties: a temporary change in working arrangements where paramedics are stood down from frontline clinical duties and assigned to non-patient facing work due to circumstances such as pregnancy or injury.\\u003c/span\\u003e\\u003c/li\\u003e\\u003c/ol\\u003e\"}],\"fulltextSource\":\"\",\"fullText\":\"\",\"funders\":[{\"identity\":\"7210d237-6512-4b79-b815-de8894edbf4d\",\"identifier\":\"10.13039/501100000272\",\"name\":\"National Institute for Health Research\",\"awardNumber\":\"302983\",\"order_by\":0}],\"hasAdminPriorityOnWorkflow\":false,\"hasManuscriptDocX\":true,\"hasOptedInToPreprint\":true,\"hasPassedJournalQc\":\"\",\"hasAnyPriority\":true,\"hideJournal\":true,\"highlight\":\"\",\"institution\":\"South Western Ambulance Service NHS Foundation Trust\",\"isAcceptedByJournal\":false,\"isAuthorSuppliedPdf\":false,\"isDeskRejected\":\"\",\"isHiddenFromSearch\":false,\"isInQc\":false,\"isInWorkflow\":false,\"isPdf\":false,\"isPdfUpToDate\":true,\"isWithdrawnOrRetracted\":false,\"journal\":{\"display\":true,\"email\":\"info@researchsquare.com\",\"identity\":\"researchsquare\",\"isNatureJournal\":false,\"hasQc\":true,\"allowDirectSubmit\":true,\"externalIdentity\":\"\",\"sideBox\":\"\",\"snPcode\":\"\",\"submissionUrl\":\"/submission\",\"title\":\"Research Square\",\"twitterHandle\":\"researchsquare\",\"acdcEnabled\":true,\"dfaEnabled\":false,\"editorialSystem\":\"\",\"reportingPortfolio\":\"\",\"inReviewEnabled\":false,\"inReviewRevisionsEnabled\":true},\"keywords\":\"Feasibility trial, Cluster randomised trial, Paramedic mental health, Peer support, Behaviour change frameworks, Health economics, Organisational well-being\",\"lastPublishedDoi\":\"10.21203/rs.3.rs-9542409/v1\",\"lastPublishedDoiUrl\":\"https://doi.org/10.21203/rs.3.rs-9542409/v1\",\"license\":{\"name\":\"CC BY 4.0\",\"url\":\"https://creativecommons.org/licenses/by/4.0/\"},\"manuscriptAbstract\":\"\\u003ch2\\u003eIntroduction\\u003c/h2\\u003e \\u003cp\\u003eEmergency Medical Service (EMS) personnel experience elevated levels of psychological distress, trauma exposure, and mental ill health than the general population and other NHS staff groups. Despite the availability of support services, uptake remains poor due to stigma, fear of negative career consequences, workplace culture, and a lack of time at work. EMS-SHIELD (Supporting Health, Improving Employee Life and Duty), is a structured peer-led 1-hour session, scheduled during work hours to promote reflection, well-being check-ins, and signposting to support resources. Preparatory studies suggest this approach aligns with EMS professional identity, organisational culture, and employee norms favouring peer support.\\u003c/p\\u003e\\u003ch2\\u003eMethods\\u003c/h2\\u003e \\u003cp\\u003eA two-arm, cluster randomised controlled feasibility trial will assess recruitment, retention, intervention delivery, and trial procedures in one UK NHS ambulance service in Southwest England. Approximately 128 paramedics working across four ambulance stations will be invited to participate, targeting a recruitment rate of at least 50%. The four stations (two urban, two suburban) will then be randomised (1:1 by station) to EMS-SHIELD (intervention: dedicated time at work with signposting to relevant support resources) or usual practice (no dedicated time at work; unchanged access to standard support services). Trained peers will deliver EMS-SHIELD with fidelity monitored using standardised checklists. Questionnaires will be collected at baseline (pre-randomisation), 4\\u0026ndash;6 week post-randomisation, and 3-months post-randomisation. Primary outcomes include feasibility metrics (recruitment, retention rates, fidelity, questionnaire completeness), alongside acceptability metrics (session attendance and qualitative interviews exploring experiences). Secondary outcomes provide preliminary estimates of well-being, post-traumatic stress disorder symptoms, perceptions of organisational support, attitudes towards help-seeking, trauma exposure, health-related quality of life, and resource utilisation. Analyses will be descriptive with confidence intervals for feasibility metrics, and qualitative data will be examined using reflexive thematic analysis informed by behaviour change frameworks.\\u003c/p\\u003e\\u003ch2\\u003eDiscussion\\u003c/h2\\u003e \\u003cp\\u003eThis study will determine whether dedicated time for structured peer reflection in work hours is feasible and acceptable in a live EMS setting and whether trial procedures and health economic data collection are practicable. Findings will inform progression to a larger definitive trial to examine effectiveness for improving employee mental health and perception of organisational support at work, alongside cost-effectiveness evaluation.\\u003c/p\\u003e\\u003ch2\\u003eTrial registration\\u003c/h2\\u003e \\u003cp\\u003eThe protocol for this study has been registered with the ISRCTN register: \\u003cspan class=\\\"ExternalRef\\\"\\u003e\\u003cspan class=\\\"RefSource\\\"\\u003ehttps://doi.org/10.1186/ISRCTN12172690\\u003c/span\\u003e\\u003cspan address=\\\"10.1186/ISRCTN12172690\\\" targettype=\\\"DOI\\\" class=\\\"RefTarget\\\"\\u003e\\u003c/span\\u003e\\u003c/span\\u003e; date of registration: 6th November 2025.\\u003c/p\\u003e\",\"manuscriptTitle\":\"Supporting Health, Improving Employee Life and Duty (SHIELD): Protocol for a cluster randomised controlled feasibility trial of dedicated time at work for Emergency Medical Service worker mental health\",\"msid\":\"\",\"msnumber\":\"\",\"nonDraftVersions\":[{\"code\":1,\"date\":\"2026-04-28 13:42:01\",\"doi\":\"10.21203/rs.3.rs-9542409/v1\",\"editorialEvents\":[{\"type\":\"communityComments\",\"content\":0}],\"status\":\"published\",\"journal\":{\"display\":true,\"email\":\"info@researchsquare.com\",\"identity\":\"researchsquare\",\"isNatureJournal\":false,\"hasQc\":true,\"allowDirectSubmit\":true,\"externalIdentity\":\"\",\"sideBox\":\"\",\"snPcode\":\"\",\"submissionUrl\":\"/submission\",\"title\":\"Research Square\",\"twitterHandle\":\"researchsquare\",\"acdcEnabled\":true,\"dfaEnabled\":false,\"editorialSystem\":\"\",\"reportingPortfolio\":\"\",\"inReviewEnabled\":false,\"inReviewRevisionsEnabled\":true}}],\"origin\":\"\",\"ownerIdentity\":\"9e94279a-ba92-4e61-b203-f7b6a4393cd4\",\"owner\":[],\"postedDate\":\"April 28th, 2026\",\"published\":true,\"recentEditorialEvents\":[],\"rejectedJournal\":[],\"revision\":\"\",\"amendment\":\"\",\"status\":\"posted\",\"subjectAreas\":[{\"id\":67093610,\"name\":\"Psychology\"},{\"id\":67093611,\"name\":\"Health Economics and Outcomes Research\"},{\"id\":67093612,\"name\":\"Critical Care \\u0026 Emergency Medicine\"},{\"id\":67093613,\"name\":\"Health Policy\"},{\"id\":67093614,\"name\":\"Leadership and Ethics\"}],\"tags\":[],\"updatedAt\":\"2026-04-28T13:42:01+00:00\",\"versionOfRecord\":[],\"versionCreatedAt\":\"2026-04-28 13:42:01\",\"video\":\"\",\"vorDoi\":\"\",\"vorDoiUrl\":\"\",\"workflowStages\":[]},\"version\":\"v1\",\"identity\":\"rs-9542409\",\"journalConfig\":\"researchsquare\"},\"__N_SSP\":true},\"page\":\"/article/[identity]/[[...version]]\",\"query\":{\"redirect\":\"/article/rs-9542409\",\"identity\":\"rs-9542409\",\"version\":[\"v1\"]},\"buildId\":\"XKTyCvWXoU3ODBz1xrDgd\",\"isFallback\":false,\"isExperimentalCompile\":false,\"dynamicIds\":[84888],\"gssp\":true,\"scriptLoader\":[]}","source_license":"CC-BY-4.0","license_restricted":false}