Secure care hospital evaluation of manualised interpersonal art-psychotherapy (SCHEMA): A randomised controlled trial protocol

Intellectual disability, borderline intellectual functioning, secure care, Art Psychotherapy, aggression. ALL Metrics - Views Downloads How to cite this article Hackett SS, Foscarini-Craggs P, Aafjes-van Doorn K et al. Secure care hospital evaluation of manualised interpersonal art-psychotherapy (SCHEMA): A randomised controlled trial protocol [version 1; peer review: 2 approved]. NIHR Open Res 2025, 5:21 (https://doi.org/10.3310/nihropenres.13801.1) NOTE: If applicable, it is important to ensure the information in square brackets after the title is included in all citations of this article. Export Citation Sciwheel EndNote Ref. Manager Bibtex ProCite Sente Select a format first ▬ ✚ Study Protocol [version 1; peer review: 2 approved] Simon S. Hackett https://orcid.org/0000-0002-7861-5991 1,2, Paula Foscarini-Craggs https://orcid.org/0000-0001-9511-696X 3, Katie Aafjes-van Doorn https://orcid.org/0000-0003-2584-5897 4, [...] Matthew Franklin5, Muhammad Riaz https://orcid.org/0000-0002-5512-1745 3, Ania Zubala6, Jennifer Condie https://orcid.org/0009-0005-1991-1706 3, Iain McKinnon https://orcid.org/0000-0002-5760-9824 1,2, Arman Iranpour1,2, Toni Leigh Harrison1,2, Sophie Rose https://orcid.org/0009-0001-0172-8138 3, Elizabeth Randell https://orcid.org/0000-0002-1606-3175 3, Rachel McNamara https://orcid.org/0000-0002-7280-1611 3Simon S. Hackett https://orcid.org/0000-0002-7861-5991 1,2, Paula Foscarini-Craggs https://orcid.org/0000-0001-9511-696X 3, [...] Katie Aafjes-van Doorn https://orcid.org/0000-0003-2584-5897 4, Matthew Franklin5, Muhammad Riaz https://orcid.org/0000-0002-5512-1745 3, Ania Zubala6, Jennifer Condie https://orcid.org/0009-0005-1991-1706 3, Iain McKinnon https://orcid.org/0000-0002-5760-9824 1,2, Arman Iranpour1,2, Toni Leigh Harrison1,2, Sophie Rose https://orcid.org/0009-0001-0172-8138 3, Elizabeth Randell https://orcid.org/0000-0002-1606-3175 3, Rachel McNamara https://orcid.org/0000-0002-7280-1611 3 PUBLISHED 07 Mar 2025 Author details Author details 1 Faculty of Medical Sciences, Baddiley-Clark Building, Richardson Road, Newcastle University Population Health Sciences Institute, Newcastle upon Tyne, England, NE2 4AX, UK 2 Tyne and Wear NHS Foundation Trust, Jubilee Rd, Cumbria Northumberland, Newcastle upon Tyne, England, NE3 3X, UK 3 Centre for Trials Research, Neuadd Meirionnydd, Heath Park, Cardiff University, Cardiff, Wales, CF14 4YS, UK 4 West Yangsi Rd, New York University Shanghai, Pudong Xin Qu 567, Shanghai, 200124, China 5 Sheffield Centre for Health and Related Research (SCHARR), School of Medicine and Population Health, Regent Court, 30 Regent Street, The University of Sheffield, Sheffield, England, S1 4DA, UK 6 Centre for Brain Sciences, Kennedy Tower. Royal Edinburgh Hospital, Morningside Place, The University of Edinburgh, Edinburgh, EH10 5HF, UK 2 Tyne and Wear NHS Foundation Trust, Jubilee Rd, Cumbria Northumberland, Newcastle upon Tyne, England, NE3 3X, UK 3 Centre for Trials Research, Neuadd Meirionnydd, Heath Park, Cardiff University, Cardiff, Wales, CF14 4YS, UK 4 West Yangsi Rd, New York University Shanghai, Pudong Xin Qu 567, Shanghai, 200124, China 5 Sheffield Centre for Health and Related Research (SCHARR), School of Medicine and Population Health, Regent Court, 30 Regent Street, The University of Sheffield, Sheffield, England, S1 4DA, UK 6 Centre for Brain Sciences, Kennedy Tower. Royal Edinburgh Hospital, Morningside Place, The University of Edinburgh, Edinburgh, EH10 5HF, UK Simon S. Hackett Roles: Conceptualization, Funding Acquisition, Investigation, Methodology, Supervision, Writing – Original Draft Preparation Roles: Conceptualization, Funding Acquisition, Investigation, Methodology, Supervision, Writing – Original Draft Preparation Paula Foscarini-Craggs Roles: Investigation, Methodology, Project Administration, Validation, Writing – Review & Editing Roles: Investigation, Methodology, Project Administration, Validation, Writing – Review & Editing Katie Aafjes-van Doorn Roles: Conceptualization, Formal Analysis, Methodology, Writing – Review & Editing Roles: Conceptualization, Formal Analysis, Methodology, Writing – Review & Editing Matthew Franklin Roles: Conceptualization, Formal Analysis, Methodology, Writing – Review & Editing Roles: Conceptualization, Formal Analysis, Methodology, Writing – Review & Editing Muhammad Riaz Roles: Formal Analysis, Methodology, Validation, Writing – Review & Editing Roles: Formal Analysis, Methodology, Validation, Writing – Review & Editing Ania Zubala Roles: Conceptualization, Formal Analysis, Methodology, Writing – Review & Editing Roles: Conceptualization, Formal Analysis, Methodology, Writing – Review & Editing Jennifer Condie Roles: Formal Analysis, Writing – Review & Editing Roles: Formal Analysis, Writing – Review & Editing Iain McKinnon Roles: Methodology, Resources, Writing – Review & Editing Roles: Methodology, Resources, Writing – Review & Editing Arman Iranpour Roles: Data Curation, Investigation, Writing – Review & Editing Roles: Data Curation, Investigation, Writing – Review & Editing Toni Leigh Harrison Roles: Formal Analysis, Investigation, Writing – Review & Editing Roles: Formal Analysis, Investigation, Writing – Review & Editing Sophie Rose Roles: Data Curation, Investigation, Validation, Writing – Review & Editing Roles: Data Curation, Investigation, Validation, Writing – Review & Editing Elizabeth Randell Roles: Funding Acquisition, Investigation, Methodology, Project Administration, Writing – Review & Editing Roles: Funding Acquisition, Investigation, Methodology, Project Administration, Writing – Review & Editing Rachel McNamara Roles: Conceptualization, Funding Acquisition, Methodology, Writing – Review & Editing Roles: Conceptualization, Funding Acquisition, Methodology, Writing – Review & Editing OPEN PEER REVIEW REVIEWER STATUS Within the criminal Justice System in the UK one-third of prisoners self-identified as having a learning difficulty and/or disability. This is broadly consistent with formal assessment of the needs of offenders, with 29% of the offender population having a learning disability. In the UK, NHS and private/independent sector secure care (Forensic) provides assessment and treatment for men and women who have come into contact within the Criminal Justice System and have mental health needs, a personality disorder, and/a learning disability. Patients in these services are often detained under the Mental Health Act (1983) and/or have licence conditions that have been set by the Ministry of Justice. Interpersonal art psychotherapy was developed within secure care as an accessible psychological intervention for adults with mild intellectual disabilities or borderline intellectual functioning. A feasibility randomised controlled trial of interpersonal art psychotherapy showed that assessment of key feasibility objectives were met and the trial procedures were acceptable, indicating progression to a definitive trial. This is a two-arm single blind randomised controlled trial of effectiveness comparing manualised interpersonal art psychotherapy and Usual Care (UC) to UC. The Randomised Controlled Trial (RCT) will be conducted in a minimum of 10 secure care hospitals (NHS & Independent) with secure care (Forensic) facilities and will recruit 150 participants. The trial design includes an integrated assessment of cost-effectiveness. Individuals with intellectual disabilities and borderline intellectual functioning were involved in the design and set up of the trial. The trial is currently open to recruitment for participants from eight NHS and private/independent secure care sites in the UK. A full report of study results will be published on completion of the trial. ISRCTN57406593 (ISRCTN registry, 2024). This published protocol corresponds with version 6, dated 12.08.2024. Some people with learning difficulties (learning disabilities and borderline intellectual functioning) who commit a crime and go to court can be sent to prison or to a hospital with secure care. People with learning difficulties in secure care are more likely to stay there longer than people without a learning difficulty. Records show that people in secure care hurt either themselves or others more often than in other mental health hospitals. Lots of psychological therapies available to help people with mental health difficulties are based on talking, which might not always be the best approach for people with learning difficulties. People who struggle with reading information and communication can find visual and art-based approaches a helpful way to understand and manage their own mental health needs. Interpersonal art psychotherapy has been designed to help people in secure care (forensic) services with learning difficulties Within interpersonal art psychotherapy people to use creative ways to communicate and discuss this with a therapist. We want to find out if interpersonal art psychotherapy is helpful and value for money for people with learning disabilities who are in secure care. We will be testing if interpersonal art psychotherapy works better than the usual care that people receive. To do this we will need to recruit 150 people and put them into groups by chance, with half having interpersonal art psychotherapy and half will have usual care. This is called a randomised controlled trial (RCT). We will find out if interpersonal art psychotherapy can help people who are in secure care to improve their mood, become less distressed, and not hurt themselves or others. We think that this research will give people with a learning difficulty more choice about accessing psychotherapy in secure care. Intellectual disability, borderline intellectual functioning, secure care, Art Psychotherapy, aggression. Corresponding Author(s) Simon S. Hackett ([email protected]) Grant information: This project is funded by the National Institute for Health and Care Research (NIHR) under its [‘HEE/NIHR ICA Programme’ (Grant Reference Number PB-PG- NIHR301264)]. The views expressed are those of the authors and not necessarily those of the NIHR or the Department of Health and Social Care. The funders had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript. Copyright: © 2025 Hackett SS et al. This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited. How to cite: Hackett SS, Foscarini-Craggs P, Aafjes-van Doorn K et al. Secure care hospital evaluation of manualised interpersonal art-psychotherapy (SCHEMA): A randomised controlled trial protocol [version 1; peer review: 2 approved]. NIHR Open Res 2025, 5:21 (https://doi.org/10.3310/nihropenres.13801.1) First published: 07 Mar 2025, 5:21 (https://doi.org/10.3310/nihropenres.13801.1) Latest published: 28 May 2025, 5:21 (https://doi.org/10.3310/nihropenres.13801.2) The funders had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript. There is a newer version of this article available. of this article available. Within the Criminal Justice System (CJS) in the UK one-third of prisoners self-identified as having a learning difficulty and/or disability (Criminal Justice Joint Inspection, 2021). This is broadly consistent with formal assessment of the needs of offenders, with 29% of the offender population having an intellectual disability/developmental disability (IDD) (Criminal Justice Joint Inspection, 2021). The care of people with IDD within the CJS is relatively advanced in UK, however, offenders with IDD experience difficulties at all stages (Chester, 2018). Secure care (Forensic) provision is available in the UK NHS and private/independent sector for the assessment and treatment for men and women who have come into contact within the Criminal Justice System and have mental health needs, a personality disorder, and/a learning/intellectual disability (ID). There are three levels of security across adult secure care inpatient services, (i) high, for adults posing an immediate risk to the public and who must not be able to escape; (ii) medium, for adults presenting a serious risk of harm to others whose escape must be prevented; (iii) low, for adults who present a significant risk of harm to others whose escape must be impeded (NHS England, 2018b). A significant proportion of patients in secure care in England, 24% in high and 17.4% in medium, are consider ‘long-stayers’, being in hospital for five or more continuous years (Hare Duke et al., 2018) with risks of experiencing adverse outcomes following discharge (Westhead et al., 2023). Patients with ID being treated on a secure care ward are more likely to stay in hospital for longer (>10 years in high secure, 5 years in medium secure or 15 years in a mix of high and medium secure settings) compared to patients on other types of secure mental health wards (Hare Duke et al., 2018). In the UK secure care services are reported to consume a fifth of the overall mental health budget for a small share of the patient population, approximately 8000 patients, within UK mental health service (Tully et al., 2024). In a subset of this provision, secure care for people with ID, three high secure hospitals in England provide just over 700 beds and around 60 medium secure units providing around 3500 beds, with nearly 35% of those beds provided by the independent sector (Taylor & Lindsay, 2018). The health expenditure for ID secure care is estimated at over £300 million per annum (Morrissey et al., 2017). There have been a range of innovations in psychosocial interventions for reducing violence and aggression (Wigham et al., 2022). Specifically in secure care, a systematic review of RCTs of psychological interventions offered to forensic/secure mental health inpatients (n=9 studies including 523 participants) reported that current practice is based on limited evidence with no consistent significant findings (MacInnes & Masino, 2019). The study sample sizes ranged from 14 to 112. A low risk of bias assessment indicated that good quality RCTs can be undertaken within inpatient medium to high secure care settings. To our knowledge, no economic evaluations have been conducted in the reported studies (MacInnes & Masino, 2019). Results from a systematic review and meta-analysis of controlled evaluations of psychological interventions for forensic mental health inpatients, based on 28 studies involving 1422 individuals, showed that psychological treatment had no benefit over the comparator condition on many relevant domains including impulsivity, empathy, coping skills, anger or inpatient violence (Gilling McIntosh et al., 2021). A systematic review of 23 Arts Therapies studies in forensic care, including a narrative synthesis and meta-analysis, reported significant outcomes for psychiatric symptoms and psychological and social functioning (Abbing et al., 2023). Mechanisms of change were identified as being an improvement in regulatory processes, such as self-regulation of emotion, stress regulation, impulse regulation, cognitive regulation, social regulation, behaviour regulation, and self-management. Because of their experiential, less verbal approach, arts therapies were also highlighted as being relevant for people in the criminal justice system with mild intellectual disability (MID) or borderline intellectual functioning (BIF) (Abbing et al., 2023). Aggressive behaviour and self-harm are common in people MID/BIF (IQ 50–85), particularly in secure care (Dixon-Gordon et al., 2012; Nieuwenhuis et al., 2022; van Swieten et al., 2024). Recommendations for complex interventions for aggressive behaviour in adults with ID include the development of effective communication and trusting relationships between service users, carers, professionals, and within staff teams as being essential to facilitate effective intervention delivery (Royston et al., 2023). Interpersonal art psychotherapy was developed within secure care as an accessible psychosocial intervention for adults with MID/BIF through utilising art-based approaches and the inclusion of relational and interpersonal components within treatment (Hackett, 2023; Hackett & Aafjes-van Doorn, 2019; Hackett et al., 2017; Hackett et al., 2020). A feasibility RCT of Interpersonal Art Psychotherapy showed that assessment of key feasibility objectives were met and the trial procedures were acceptable, indicating progression to a definitive trial (Hackett et al., 2020). In addition, between-group differences of interpersonal art psychotherapy versus the delayed treatment control showed a ‘signal’ effect-size of .65 for total scores and .93 in the verbal aggression sub-scale (Hackett et al., 2020; Power et al., 2023). The aim of this trial is to answer the following research question: Does interpersonal art psychotherapy reduce (i) the frequency and severity of aggressive incidents and/or (ii) patient self-reported distress associated with psychiatric symptoms in adults within secure care who have MID/BIF compared to usual care (UC). To assess the effectiveness of interpersonal art psychotherapy in reducing the frequency and severity aggressive behaviour in adult secure care. 1. To determine if interpersonal art psychotherapy is cost-effective compared to UC. 2. To explore patient characteristics and psychotherapeutic processes/mechanisms within interpersonal art psychotherapy that are influential to treatment outcomes. 3. To explore the longitudinal changes in aggressive behaviour after receiving art psychotherapy. 4. To evaluate changes in patient distress relating to psychiatric symptoms When and how were the patients/public first involved in the research? Extensive Patient and Public Involvement (PPI) consultation took place with ‘Research Abilities’ group (Research Abilities, 2023) during the research funding application development process. How were the research question(s) developed and informed by their priorities, experience, and preferences? The testing of Art Psychotherapy as an accessible psychological treatment, less reliant upon verbal communication, was viewed as an important research topic by people with lived experience of having a learning disability or borderline intellectual functioning. How were patients/public involved in: Individual consultation meetings took place with patients in secure care. As a result, changes were made to interpersonal art psychotherapy worksheets, with greater inclusion of ‘easy read’ and visual materials. (a) the design and conduct of the study? PPI has informed the development of this research design, specifically allowing all participants who have been allocated to UC only to access the intervention after leaving the study. (b) choice of outcome measures? Measures of personal distress were included as a secondary outcome measure in response to PPI consultation with patients in secure care, this being indicated as a patient priority. (c) recruitment to the study? The Plain Language Summary was informed and revised in response to intensive engagement and detailed comments from PPI panel members at the NIHR Research Support Service (RSS). PPI consultation took place to support development of the study Participant Information Sheet (PIS), study consent form, and accessible study recruitment information video. How were (or will) patients/public be involved in choosing the methods and agreeing plans for dissemination of the study results to participants and linked communities? Additional PPI activity is planned for the development of accessible and ‘easy read’ study dissemination materials. This is a two-arm single blind randomised controlled trial of effectiveness comparing manualised interpersonal art psychotherapy and UC to UC. The RCT will be conducted in a minimum of 10 secure care hospitals (NHS & Independent) with secure care (Forensic) facilities and will recruit 150 participants. The trial design includes an integrated assessment of and cost-effectiveness. Individuals with ID/BIF were involved in the design and set up of the trial. Participants are eligible for the trial if they meet the following inclusion criteria and none of the exclusion criteria apply. • An inpatient in a secure hospital/unit/service with the presence of learning disability/borderline intellectual functioning indicated by either (a) meeting validated assessment criteria (recognised cognitive testing and adapting functioning assessment), or (b) a score of 57 or below on the Learning Disability Screening Questionnaire (LDSQ) (McKenzie et al., 2012) (a LDSQ copyright license has been obtained for the purposes of the study). • Age 18 to 60 years. • Able to give informed consent. • A current or historic HONOS (Health of the Nation Outcome Scale) (Royal College of Psychiatrists, 2023) score between 1 and 4 for item 1 (i.e. fitting the descriptors- ‘Overactive, aggressive, disruptive, or agitated behaviour’ / ‘Behavioural problems directed at others’). • The participant's involvement in the study is supported by their responsible clinician and/or multidisciplinary team (MDT). • Unable to give informed consent as assessed by the clinical team. • Learning disability/borderline intellectual functioning not indicated based on a validated assessment or screening questionnaire (i.e. not meeting validated assessment criteria or a LDSQ Score >57). • A HONOS score of 0 for item 1. • Planned discharge within 9 months of the start of the study. • Unstable/unmanaged psychotic symptoms requiring active assessment or treatment including medication dose titration (i.e., dose adjustment in the previous 4 weeks or with potential further dose adjustment planned for the following 4 weeks). Informed consent: Site staff will screen potential participants for inclusion into the trial. All participants who match all inclusion criteria and no exclusion criteria will be approached to discuss the trial and provide with the study information sheet. Participants will be given at least 24 hours to consider the trial and informed consent would be taken by an art therapist involved in the trial. As part of the consent procedure participants will be asked if they are happy for intervention sessions to be audio recorded and for their study data to be stored and shared to support future research projects. Participants could decline both of these options and still participate in the trial. Interpersonal art psychotherapy is a manualised intervention delivered by a trained Health and Care Professions Council (HCPC) registered art psychotherapist. Interpersonal art psychotherapy approach/principles, specific instructions, detailed techniques and intervention delivery approach are described in a standardised therapist manual allowing replication. The intervention is delivered by an art psychotherapist who has completed interpersonal art psychotherapy manual training, treatment fidelity checks, and is receiving clinical supervision (Hackett et al., 2020). The therapy is scheduled for 12 1-hour individual sessions and 3 optional 1-hour sessions can be added at any time point for personalised support and reasonable adjustments required for a participant with specific communication/learning and/or therapeutic need. Interpersonal art psychotherapy includes seven components arranged as follows; (1) personal goals; (2) coping responses and self-management; (3) relationships; (4) life events; (5) interpersonal themes; (6) imagined future; and (7) final review. Participants have an option to write a letter directly to members of their care team to inform them about the things they are trying to achieve during the intervention and to highlight any personal support needs. Participants completing 5 out of the 7 therapy components listed above will be considered as having completed the intervention. Within inpatient secure care UC involves assessment and treatment by specialist professionals. The MDT (multi-disciplinary team) model uses the Care Programme Approach (CPA) (NHS England, 2018a) to coordinate and plan care. MDTs comprise psychiatrists, clinical and forensic psychologists, mental health and ID nursing staff, and Allied Health Professionals (AHPs). MDTs conduct risk assessment/formulation and management, recovery-focused care and/or positive behaviour support (PBS) (NHS England, 2018a). Patients have access to psychotherapy/psycho-educational work and/or specific offence-related treatment and/or pharmacotherapy treatment. We will identify specific characteristics of UC at the study sites using a standardised pro-forma checklist and will use the TiDieR checklist to describe and present this information (Hoffmann et al., 2014). This will inform the cost-effectiveness analysis and identify any cross-site variation. Assessing treatment fidelity is important for multi-site studies to ensure that treatments are operationalised and monitored for differentiation, competency and adherence (Borrelli, 2011). Therapist adherence to the interpersonal art psychotherapy manual within a feasibility study were estimated at 82.25% (Hackett et al., 2020). All sessions will be audio recorded and a sample of 3 timepoints (sessions 2,7,12) for 3 participants across 9 therapists (27% of sessions) will be rated by raters independent to treatment and any other trial procedures, using the interpersonal art psychotherapy therapist checklist, incorporating tested methods for assessing treatment fidelity (Hackett et al., 2020). Once in the trial, participants are not allowed to take part in any other individual art therapy programmes. Once participants who have been randomised to UC only have left the study, they can access to interpersonal art psychotherapy within their secure care service. This option for participants was included in response to Patient and Public Involvement (PPI) consultation. The primary outcome is the frequency/severity of incidents of aggressive behaviour as measured by the Modified Overt Aggression Scale (MOAS) (Kay et al., 1988). The MOAS will be completed by healthcare staff at baseline, and then again at 19 weeks and 38 weeks post-randomisation. The primary outcome timepoint is at 19 weeks. The MOAS is an observer-rated measure of frequency and severity of aggression ( 10 observations over 7 days), (intra-class correlation coefficient (ICC) of 0.94-0.91) (Kay et al., 1988). Previous research has used the MOAS scale to assess incidents of aggressive and challenging behaviour among adults with intellectual disabilities (Cohen et al., 2010). The MOAS was found to be a reliable measure for assessing the effectiveness of psychological interventions in people with ID and has been explored in both research (Oliver et al., 2007) and clinical settings (Ratey & Gutheil, 1991) The secondary outcome measures are as follows: 1. Cost-effectiveness of art psychotherapy will be based on estimating the incremental quality-adjusted life years (QALYs) and costs between trial-arms. QALYs will be based on the EuroQoL EQ-5D-3L (self-reported based on the adapted EQ-5D-3L for learning difficulties, proxy-reported based on the EQ-5D-3L Proxy Version-1) and Recovering Quality of Life 10-item version (ReQoL-10; both self and proxy-reported) for deriving the ReQoL Utility Index (ReQoL-UI) as collected at baseline, 19-week, and 38-weeks post-randomisation. Costs will be based on applying unit costs to resource-use compiled using a bespoke resource use measure (RUM; e.g., collecting data on GP appointments, A&E attendance, medication) informed by the patient’s clinicals records, as completed at 19 weeks (i.e., resource use from baseline to 19-weeks) and 38 weeks (i.e., resource use from 20-weeks to 38-weeks) post-baseline. 2. Psychotherapy processes will be evaluated through observer-analysis of transcribed audio-recorded therapy sessions using the Working Alliance Inventory-Observer Ratings Scale (WAI-O), Dual-role Relationship Inventory-Revised (DRI-R), the ‘interpersonal art psychotherapy therapist checklist’, as well as linguistic analysis of change in patients’ use of anger-related words and relational words/pronouns, using the Linguistic Inquiry and Word Count (LIWC) software. 3. Longitudinal changes in aggressive behaviour will be assessed weekly between week 19 and week 38 post-randomisation using the MOAS. 4. Patient distress attributed to psychiatric symptoms as measured by the Brief Symptom Inventory (BSI) Positive Symptom Distress Index (PSDI) (Derogatis, 1993). A schedule and timeline of procedures for enrolments, intervention, and assessments for participants is shown in Table 1. Our feasibility study (Hackett et al., 2020) showed a difference of 5 points on the MOAS scale at follow-up with a common standard deviation of 10 points and a correlation of (0.25) between the baseline and post-treatment MOAS scores. We assumed a minimum of 2 therapists per site and 1% intraclass correlation (ICC) of the MOAS scores within the same therapist, we aim to recruit 75 participants in each arm to detect the above difference of 5 points of the MOAS score at follow-up between the two groups with a two-sided significance level of 5% and a power of 80% and an attrition rate of 20%. This calculation is based on the repeated measures ANCOVA. A total target of 150 (75 per arm) participants will be recruited. Participants will receive a total of £50 in ‘recognition payment’ during their participation in the trial (National Institute for Health and Care Research, 2024). The MOAS represents the minimum dataset and where possible trial activities were modular allowing participants to withdraw from individual elements while staying in the trial for other elements. Participants have the right to withdraw consent for participation in any aspect of the trial at any time. We will randomly allocate participants to interpersonal art psychotherapy or UC in a 1:1 ratio (1 participant allocated to UC for every 1 allocated to the intervention arm) using randomly permuted blocks stratified by sex and diagnosis of psychosis. The final randomisation list will be generated by an independent statistician who will not be involved in the trial and securely uploaded to the randomisation module on the REDCap database. Site staff can register and randomise participants through the RedCap trial database which will be available 24 hours a day. The trial statistician who will conduct the final data analysis and the research support staff completing the primary outcome assessment will be blind to allocation. Trial statistician will remain blind to treatment allocation during data cleaning and testing of analysis syntax (using dummy randomisation data). Once cleaning has been completed and the analysis syntax has been finalised, treatment allocation will be requested. As the trial art therapist, and Principal Investigator (PI) at site will not be blinded to treatment allocation, there is no planned unblinded or emergency unblinding procedures in place. Any accidental unblinding, i.e. research support staff become unblinded, will be tracked through the trial unblinding log. Information regarding participant treatment and data collection is displayed in Figure 1. Trial data will be collected using both electronic data capture (EDC) through REDCap and paper forms. Participant facing questionnaires (quality of life questionnaires, and BSI) will be completed on paper and then entered into the EDC system. The system will include all the necessary validation to ensure a level of data quality. All data management processes, including quality control checks of paper forms entered onto the database, will be fully detailed in the trial data management plan. Missing, unused & spurious data. Missing data will be investigated for cause and extent. If required, the Statistical and Health Economic Analysis Plan (SHEAP) will detail the methods to be used to deal with missing data. Any missing data will be queried with the sites using the resolution workflow in REDCap to ensure that this is missing, and a code will be assigned using the database. Procedures for reporting deviation(s) from the original SHEAP. These will be submitted as substantial amendments where applicable and recorded in subsequent versions of the protocol and SHEAP. Inclusion in analysis. The primary analysis for the trial will be performed on an intention-to-treat basis therefore all participants who are randomised will be included in the analysis and so this will be conducted under the treatment policy estimate strategy. As the per the Good Clinical Practice (GCP), the definition of Source Data is “All information in original records and certified copies of original records of clinical findings, observations or other activities in a clinical trial necessary for the reconstruction and evaluation of the trial. Source data are contained in source documents.” For any data element, there can only be one set of source data , and this will be defined in the site source data agreement. The source data information for SCHEMA will come from a variety of sources (see Table 2). Data will be collected using an electronic Case Report Form system (CRF) with paper CRF back up. There will also be data collected from participants’ medical notes and patient-reported questionnaires. All delegated staff at the sites will receive appropriate training to complete the CRFs. Protocol/GCP non-compliance. The PI will report any divergencies from the trial protocol or principles of GCP to the central trial team by email as soon as they become aware of it. The central trial team will review the divergence against the protocol, and local standard operating procedures (SOP) to determine the nature and severity. All divergences will be reported to the Sponsor. Sponsor details. Cumbria, Northumberland, Tyne and Wear NHS Foundation Trust, St. Nicholas Hospital Jubilee Road Gosforth Newcastle upon Tyne NE3 3XT.Contact email: [email protected] The sponsor did/will not have any involvement in study design, data collection, management, analysis and interpretation of data, or writing of the report. Outcome/effectiveness analysis. The analysis of the primary outcome MOAS will be performed using analysis of covariance, modelling 19 weeks follow-up MOAS score controlling for baseline MOAS score. Reflecting the sample size calculation analyses will be undertaken with 2-level hierarchical models with participants clustered within therapists. Secondary outcomes will be analysed in a similar way. Multiple imputations will be used in case of missing values in scores. The results will be summarised using point estimates, 2-sided 95% confidence intervals and p-values. Data analysis will be in accordance with a pre-specified statistical analysis plan. Psychotherapy process analysis. It has been recommended that future research on psychological interventions for institutional aggression should include an assessment of patient characteristics and interpersonal styles that facilitate participation and progress during treatment (Daffern et al., 2008). These process analyses will be conducted on samples of treatment sessions for each patient, to reflect the segments of the treatment and change over time. The reading of the session transcripts together with the process coding of the WAI-O and DRI-I are expected to take about 1.5 hours per session. Working Alliance Inventory-Observer version (WAI-O). The WAI-O (Darchuk et al., 2000) is a 12-item measure of the working alliance as measured by an observer. This brief WAI-O was developed from the original 36 item Working Alliance Inventory (WAI) (Horvath & Greenberg, 1989). The WAI-O contains three subscales: agreement on tasks, agreement on goals, and development of bonds, each with 4 items rated on 7-point Likert-type scales (7 = high). The client and therapist reported WAI was adapted to fit an observer perspective (the WAI-O) by altering the pronouns (Tichenor & Hill, 1989). The WAI-O will be rated by two independent judges for the sessions. The working alliance score used in analyses will be averaged between the two raters across a sample of sessions for each patient. Dual Role Relationship Inventory (DRI-R-SF). The Dual-Relationship Inventory-Short Form is a 9-item abbreviated versions of the Dual Role-Relationship Inventory (30 items) that assesses the quality of relationships in mandated treatment settings (Gochyyev & Skeem, 2019). The DRI-SF is a nine-item relationship instrument with items rated on a 7-point Likert-type-scale: 1 = never, 2 = rarely, 3 = occasionally, 4 = sometimes, 5 = often, 6 = very often, and 7 = always. A higher DRI-SF total score indicates a better quality of client-supervising officer relationship. The DRI-R-SF assesses three relationship aspects; caring-fairness, toughness, and trust. The DRI-R-SF has shown high internal consistency and predictive validity for probation violations and revocation, and moderate inter-item correlations. Linguistic Analysis of Word Count (LIWC-2022). We will apply the text analysis software LIWC-2022 to the transcripts of the sessions (LIWC-22, 2022). We specifically will analyse the change in frequency of patients’ anger-related word use over the course of treatment, and the change in affiliation/pronoun use. As with the other two process measures, we will use the transcripts from a sample of sessions per treatment as a proxy of the treatment process as a whole. A sub-group analysis of differences between therapy responders and non-responders will be completed. Full details of the analysis will be included in the primary trial SHEAP. The qualitative analysis will include a minimum of 20 audio-recorded and transcribed interviews integrated into the RCT (Davis et al., 2019). A five step framework analysis will be completed, including data familiarisation, identifying a framework, indexing, charting, and mapping and interpretation (Ritchie & Spencer, 1994) from a sample of n=20 qualitative interviews. Based upon guidance on how to develop complex interventions to improve health qualitative interviews and analysis have been included to support a process evaluation around retention, experiences of the trial and intervention, fidelity, dose, and reach (O'Cathain et al., 2019). We will invite up to 10 participants (recruited from both arms) and 10 study therapists to engage in semi-structured qualitative interviews. Full details of analysis will be included in the qualitative analysis plan. Interview schedules for study therapists will focus on their experiences of intervention delivery, their experiences of training and supervision, seeking examples from therapists about their ‘in-therapy’ responses from the participants, and implications for clinical practice implementation. A within-trial cost-effectiveness analysis will be conducted using the same statistical methods as the primary outcome (i.e., 2-level hierarchical model) (Glick et al., 2014). Costs will focus on the incremental costs/resource-use of providing art psychotherapy relative to UC and downstream resource-use collected via a bespoke resource-use measure (RUM) proforma based on patients’ care records (e.g. wider staff engagement and medications). Completion of the RUM involves research staff checking the patient notes for what resources the patient has used based on the proforma, which they then confirm with ward staff. Costs will be estimated based on attaching unit costs to resource-use data, with unit costs sourced from commonly used UK sources (BMJ, 2024; Jones, 2024; NHS England, 2023). Incremental effectiveness will be based on two preference-based measures: EQ-5D-3L (EuroQol, 2024), and ReQoL-UI derived from the ReQoL-10 (Keetharuth et al., 2024). These measures will include both a self-reported (i.e., by the patient) and proxy-completed (i.e., by ward staff) version. For proxy-completion, we have specified that at each time point both the EQ-5D-3L and ReQoL-10 should be completed by the same person (i.e., same ward staff member) and where possible it should be the same person across time points, but we recognise that might not always be possible. We will record who has completed the proxy-response. For the EQ-5D-3L, the self-reported version is based on the adapted EQ-5D-3L for adults with mild to moderate learning disabilities (O’Dwyer et al., 2024); whereas the proxy-version is the EQ-5D-3L Proxy Version-1 (EuroQol, 2024). There are no adapted or proxy versions of the ReQoL-10; therefore, the self-reported and proxy-reported versions are both the traditional ReQoL-10. The EQ-5D-3L and ReQoL-UI both have a utility index (UI) which can be used to elicit quality-adjusted life years (QALYs). The UI for the EQ-5D-3L and ReQoL-UI will be based on the relevant UK value set, respectively (Dolan, 1997; Keetharuth et al., 2021). These measures have underlying conceptual and methodological considerations relevant to the patient population and intended outcomes from art psychotherapy improvements. As such, the choice of preference-based measure as the ‘primary’ outcome for the economic evaluation will be based on a within-study psychometric analysis. This post-hoc psychometric analysis will be conducted based on construct validity (i.e., correlation and effect sizes relative to clinical outcomes) and responsiveness (i.e., standardised response means, and floor and ceiling effects) relative to the other primary and secondary outcome measures, as has been done to judge the relative appropriate use of the EQ-5D (-5L) and ReQoL-UI for cost-effectiveness analyses previously (Franklin et al., 2021; Franklin et al., 2022). The cost-effectiveness results using all measures will be reported and discussed; the psychometric analyses will be conducted and the choice of primary measure will be detailed in our SHEAP before conducting the cost-effectiveness analyses. Point-estimate cost-effectiveness will be presented using incremental cost-effectiveness ratios. Bootstrapping will be used to report bootstrapped standard errors, and to estimate the probability of cost-effectiveness relative to a range of cost-effectiveness thresholds (including NICE’s £20,000 to £30,000 per QALY threshold) to be presented using cost-effectiveness planes and cost-effectiveness acceptability curves (Glick et al., 2014). Sensitivity analyses will be used to assess point estimate uncertainty. TMG (Trial Management Group) and Advisory Group (AG). The TMG will have regular meetings (every 4–6 weeks) prior to and during the study (Y1–4) chaired by the Chief Investigator (CI) with CTR support. TMG members will sign up to the remit and conditions set out in the TMG Charter. TSC (Trial Steering Committee). This is an low-risk trial therefore a Independent Data Monitoring Committee (IDMC) will not be convened, unless recommended by the Trial Steering Committee (TSC). TSC membership will comprise of members who are independent of the trial taking up positions as chair, statistician, expert therapist, and a public member having signed-up to the remit and conditions as set out in the TSC Charter. Monitoring. Trial specific monitoring activity is determined by the risks outlined within the clinical trial risk assessment and the overall determination of risk. All activities will be fully documented within the trial monitoring plan and deviations appropriately recorded by the trial and sponsorship team. Safety reporting. It is expected that all Serious Adverse Events (SAEs) be reported no later than 24 hours after knowledge of the event by the site PI or delegated site staff, unless an exemption has been specified within the protocol. Safety reporting terms for the trial are shown in Table 3 and guidance for determining intervention causality is shown in Table 4. *Note: The term ‘life-threatening’ in the definition of serious refers to an event in which the trial participant was a risk of death at the time of the event, or it is suspected that used of continued use of the product would result in the subjects death; it does not refer to and event which hypothetically might have caused death if it were more severe. **Note: Hospitalisation is defined as an impatient admission, regardless of the length of stay even if the hospitalisation is a precautionary measure for continued observation. Pre-planned hospitalisation e.g. for pre-existing conditions which have not worsened, or elective procedures, does not constitute and SAE. Trial Specific SAE Reporting requirements. There is an additional event that is being classed as an SAE for the purposes of this trial and therefore must follow the SAE reporting guidelines: Incidences of self-harm recorded in clinical/case notes. The local site PI or appropriately delegated individual will be responsible for assessing the causality of the event, i.e. whether the event was caused by the intervention or another significant factor. All SAE will be reviewed for expectedness by CI or another appropriately delegated individual who is independent of the site. The trial is participant to inspection by Research Ethics Committee (REC) as the regulatory body. The trial may also be participant to inspection and audit by Cumbria, Northumberland, Tyne, and Wear NHS Foundation Trust, under their remit as Sponsor. This protocol and related trial documents were reviewed by the London-City & East REC and received full approval on 13/01/2023 (REC ID: 23/LO/0026; IRAS project ID: 319325). All participants will be approached to provide written consent prior to being entered into the trial. The CTR will act to preserve participant confidentiality and will not disclose or reproduce any information by which participants could be identified, except where specific consent is obtained. Data will be stored securely and will be registered in accordance with the General Data Protection Regulation 2016 and Data Protection Act 2018. The data custodian is Cumbria, Northumberland, Tyne and Wear NHS Foundation Trust. Publication policy. All publications and presentations relating to the trial will be detailed in the publication policy which will be drafted and authorised by the TMG. It will state principles for publication, describe a process for developing output, contain a map of intended outputs and specify a timeline for delivery. The publication policy will respect the rights of all contributors to be adequately represented in outputs (e.g. authorship and acknowledgements) and for the trial to be appropriately acknowledged. Authorship of parallel studies initiated outside of the TMG will be according to the individuals involved in the project but must acknowledge the contribution of the TMG and the CTR. We will include PPI consultees in the development of accessible ‘easy read’ summaries of results and accessible materials. No underlying data are associated with this article. The Statistical Analysis Plan (SAP) will be made publicly available in an open-source publication prior to data analysis being started. The CTR will act to preserve participant confidentiality and will not disclose or reproduce any information by which participants could be identified, except where specific consent is obtained. Data will be stored securely and will be registered in accordance with the GDPR 2016 and DPA 2018. The data custodian is Cumbria, Northumberland, Tyne and Wear NHS Foundation Trust. ISRCTN registry: Secure care hospital evaluation of art therapy https://doi.org/10.1186/ISRCTN57406593 This project contains the following extended data: OSF: SPIRIT Checklist (Chan et al., 2013) For ‘Secure care hospital evaluation of manualised interpersonal art-psychotherapy (SCHEMA): A randomised controlled trial protocol.’ https://doi.org/10.17605/OSF.IO/V53F4 (Foscarini-Craggs, 2025) Data are available under the terms of the Creative Commons Zero "No rights reserved" data waiver (CC0 1.0 Public domain dedication). We would like to thank members of the ‘Research Abilities’ group and Patient and Public Involvement (PPI) contributors from NHS secure care, Northgate Hospital, Cumbria, Northumberland, Tyne & Wear NHS Foundation Trust. We are grateful to members of our independent Trial Steering Committee (TSC), Professor Andrew Forrester (Chair), Dr Thomas Chadwick (Statistician), Dr Kate Rothwell (Psychotherapist), Anita Kniveton (Public Member). Dr Simon Hackett is supported by funding from Health Education England (HEE) and the National Institute for Health and Care Research (NIHR) Integrated Clinical Academic (ICA) programme via a Senior Clinical Lectureship (SCL) fellowship. HEE/NIHR SCL award co-applicants were Prof. John Baker, University of Leads; Prof. Joy Duxbury, University of Cumbria; Prof. Mark H Freeston, Newcastle University; Prof. Val Huet, University of Herefordshire; Prof. Eileen Kaner, Newcastle University, UK. This study received support from the NIHR Research Support Service and NIHR Research Delivery Network. Faculty Opinions recommendedReferences - Abbing A, Haeyen S, Nyapati S, et al.: Effectiveness and mechanisms of the arts therapies in forensic care. 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Publisher Full Text Author details Author details 1 Faculty of Medical Sciences, Baddiley-Clark Building, Richardson Road, Newcastle University Population Health Sciences Institute, Newcastle upon Tyne, England, NE2 4AX, UK 2 Tyne and Wear NHS Foundation Trust, Jubilee Rd, Cumbria Northumberland, Newcastle upon Tyne, England, NE3 3X, UK 3 Centre for Trials Research, Neuadd Meirionnydd, Heath Park, Cardiff University, Cardiff, Wales, CF14 4YS, UK 4 West Yangsi Rd, New York University Shanghai, Pudong Xin Qu 567, Shanghai, 200124, China 5 Sheffield Centre for Health and Related Research (SCHARR), School of Medicine and Population Health, Regent Court, 30 Regent Street, The University of Sheffield, Sheffield, England, S1 4DA, UK 6 Centre for Brain Sciences, Kennedy Tower. Royal Edinburgh Hospital, Morningside Place, The University of Edinburgh, Edinburgh, EH10 5HF, UK 2 Tyne and Wear NHS Foundation Trust, Jubilee Rd, Cumbria Northumberland, Newcastle upon Tyne, England, NE3 3X, UK 3 Centre for Trials Research, Neuadd Meirionnydd, Heath Park, Cardiff University, Cardiff, Wales, CF14 4YS, UK 4 West Yangsi Rd, New York University Shanghai, Pudong Xin Qu 567, Shanghai, 200124, China 5 Sheffield Centre for Health and Related Research (SCHARR), School of Medicine and Population Health, Regent Court, 30 Regent Street, The University of Sheffield, Sheffield, England, S1 4DA, UK 6 Centre for Brain Sciences, Kennedy Tower. Royal Edinburgh Hospital, Morningside Place, The University of Edinburgh, Edinburgh, EH10 5HF, UK Simon S. Hackett Roles: Conceptualization, Funding Acquisition, Investigation, Methodology, Supervision, Writing – Original Draft Preparation Roles: Conceptualization, Funding Acquisition, Investigation, Methodology, Supervision, Writing – Original Draft Preparation Paula Foscarini-Craggs Roles: Investigation, Methodology, Project Administration, Validation, Writing – Review & Editing Roles: Investigation, Methodology, Project Administration, Validation, Writing – Review & Editing Katie Aafjes-van Doorn Roles: Conceptualization, Formal Analysis, Methodology, Writing – Review & Editing Roles: Conceptualization, Formal Analysis, Methodology, Writing – Review & Editing Matthew Franklin Roles: Conceptualization, Formal Analysis, Methodology, Writing – Review & Editing Roles: Conceptualization, Formal Analysis, Methodology, Writing – Review & Editing Muhammad Riaz Roles: Formal Analysis, Methodology, Validation, Writing – Review & Editing Roles: Formal Analysis, Methodology, Validation, Writing – Review & Editing Ania Zubala Roles: Conceptualization, Formal Analysis, Methodology, Writing – Review & Editing Roles: Conceptualization, Formal Analysis, Methodology, Writing – Review & Editing Jennifer Condie Roles: Formal Analysis, Writing – Review & Editing Roles: Formal Analysis, Writing – Review & Editing Iain McKinnon Roles: Methodology, Resources, Writing – Review & Editing Roles: Methodology, Resources, Writing – Review & Editing Arman Iranpour Roles: Data Curation, Investigation, Writing – Review & Editing Roles: Data Curation, Investigation, Writing – Review & Editing Toni Leigh Harrison Roles: Formal Analysis, Investigation, Writing – Review & Editing Roles: Formal Analysis, Investigation, Writing – Review & Editing Sophie Rose Roles: Data Curation, Investigation, Validation, Writing – Review & Editing Roles: Data Curation, Investigation, Validation, Writing – Review & Editing Elizabeth Randell Roles: Funding Acquisition, Investigation, Methodology, Project Administration, Writing – Review & Editing Roles: Funding Acquisition, Investigation, Methodology, Project Administration, Writing – Review & Editing Rachel McNamara Roles: Conceptualization, Funding Acquisition, Methodology, Writing – Review & Editing Roles: Conceptualization, Funding Acquisition, Methodology, Writing – Review & Editing Competing interests No competing interests were disclosed. Grant information This project is funded by the National Institute for Health and Care Research (NIHR) under its [‘HEE/NIHR ICA Programme’ (Grant Reference Number PB-PG- NIHR301264)]. The views expressed are those of the authors and not necessarily those of the NIHR or the Department of Health and Social Care. The funders had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript. The funders had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript. Article Versions (2) Copyright © 2025 Hackett SS et al. This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited. metrics VIEWS $counts.viewCount downloads Citations CITE how to cite this article Hackett SS, Foscarini-Craggs P, Aafjes-van Doorn K et al. Secure care hospital evaluation of manualised interpersonal art-psychotherapy (SCHEMA): A randomised controlled trial protocol [version 1; peer review: 2 approved]. NIHR Open Res 2025, 5:21 (https://doi.org/10.3310/nihropenres.13801.1) NOTE: If applicable, it is important to ensure the information in square brackets after the title is included in all citations of this article. track receive updates on this article Track an article to receive email alerts on any updates to this article. Current Reviewer Status: ? Key to Reviewer Statuses VIEW HIDE ApprovedThe paper is scientifically sound in its current form and only minor, if any, improvements are suggested Approved with reservations A number of small changes, sometimes more significant revisions are required to address specific details and improve the papers academic merit. Not approvedFundamental flaws in the paper seriously undermine the findings and conclusions Version 1 VERSION 1 PUBLISHED 07 Mar 2025 Views 0 How to cite this report: Gentle E. Reviewer Report For: Secure care hospital evaluation of manualised interpersonal art-psychotherapy (SCHEMA): A randomised controlled trial protocol [version 1; peer review: 2 approved]. NIHR Open Res 2025, 5:21 (https://doi.org/10.3310/nihropenres.14993.r34953) The direct URL for this report is: https://openresearch.nihr.ac.uk/articles/5-21/v1#referee-response-34953 https://openresearch.nihr.ac.uk/articles/5-21/v1#referee-response-34953 NOTE: it is important to ensure the information in square brackets after the title is included in this citation. Reviewer Report 15 Apr 2025 Approved VIEWS 0 Review Secure care hospital evaluation of manualised interpersonal art-psychotherapy (SCHEMA): A randomised controlled trial protocol is methodologically complex yet clear enough to be repeatable. The abstract described the study. It uses fairly accessible language to describe ... Continue reading I confirm that I have read this submission and believe that I have an appropriate level of expertise to confirm that it is of an acceptable scientific standard. Close Secure care hospital evaluation of manualised interpersonal art-psychotherapy (SCHEMA): A randomised controlled trial protocol is methodologically complex yet clear enough to be repeatable. The abstract described the study. It uses fairly accessible language to describe ... Continue reading Review Secure care hospital evaluation of manualised interpersonal art-psychotherapy (SCHEMA): A randomised controlled trial protocol is methodologically complex yet clear enough to be repeatable. The abstract described the study. It uses fairly accessible language to describe the study. I would reword this sentence: A feasibility randomised controlled trial of interpersonal art psychotherapy showed that assessment of key feasibility objectives were met and the trial procedures were acceptable, indicating progression to a definitive trial. E.g. A feasibility study was conducted of a controlled trial of utilising interpersonal art psychotherapy and showed that assessment of the key feasibility objectives were met and the trial procedures were acceptable, indicating progression to a definitive trial. This is an important factor when designing an intricate and sophisticated research project with people who do not work in the scientific field, which often applies to the participants. The introduction is clearly and succinctly outlined with relevant research incorporated. This section segued easily into the more involved yet comprehensive methods section. The method questions helped this section by giving it clarity and order, making it easy to follow. The inclusive research design with a randomised control study method strengthens the research. The inclusivity of the research is described in enough detail to show the authenticity of the authors in ensuring ethical protocols are not just followed but expanded upon. This helps show other researchers the value in inclusive research. Title: For someone outside the UK it may be useful to put forensic in brackets after secure care in paragraph 2 in the Introduction, I suggest you to please revise the sentences -

and/or learning disability and in paragraph 2 in the Introduction- unless this is a way of writing and/or that I am unfamiliar with".

a personality disorder, and/a learning disability - change to and/or

a personality disorder, and/a learning/intellectual disability (ID) - change to and/or

Third paragraph: considered long stayers

How were people involved? Prohibited treatments section does not flow easily Statistical Methods are not my speciality. However, this section is described well. The qualitative analysis section could be clearer in its language and/or have a diagram that clarifies the process P12 **Note: Hospitalisation is defined as an impatient admission, regardless of the length of stay even if the hospitalisation is a precautionary measure for continued observation. Pre-planned hospitalisation e.g. for pre-existing conditions which have not worsened, or elective procedures, does not constitute and SAE. I found this paper to be thorough, carefully conceived and with demonstrable inclusion of participants. I am looking forward to reading the paper on completion of the project. It sounds valuable to the participants and to the incarceration systems for people within secure hospital settings globally. Secure care hospital evaluation of manualised interpersonal art-psychotherapy (SCHEMA): A randomised controlled trial protocol is methodologically complex yet clear enough to be repeatable. The abstract described the study. It uses fairly accessible language to describe the study. I would reword this sentence: A feasibility randomised controlled trial of interpersonal art psychotherapy showed that assessment of key feasibility objectives were met and the trial procedures were acceptable, indicating progression to a definitive trial. E.g. A feasibility study was conducted of a controlled trial of utilising interpersonal art psychotherapy and showed that assessment of the key feasibility objectives were met and the trial procedures were acceptable, indicating progression to a definitive trial. This is an important factor when designing an intricate and sophisticated research project with people who do not work in the scientific field, which often applies to the participants. The introduction is clearly and succinctly outlined with relevant research incorporated. This section segued easily into the more involved yet comprehensive methods section. The method questions helped this section by giving it clarity and order, making it easy to follow. The inclusive research design with a randomised control study method strengthens the research. The inclusivity of the research is described in enough detail to show the authenticity of the authors in ensuring ethical protocols are not just followed but expanded upon. This helps show other researchers the value in inclusive research. Title: For someone outside the UK it may be useful to put forensic in brackets after secure care in paragraph 2 in the Introduction, I suggest you to please revise the sentences -

and/or learning disability and in paragraph 2 in the Introduction- unless this is a way of writing and/or that I am unfamiliar with".

a personality disorder, and/a learning disability - change to and/or

a personality disorder, and/a learning/intellectual disability (ID) - change to and/or

Third paragraph: considered long stayers

How were people involved? Prohibited treatments section does not flow easily Statistical Methods are not my speciality. However, this section is described well. The qualitative analysis section could be clearer in its language and/or have a diagram that clarifies the process P12 **Note: Hospitalisation is defined as an impatient admission, regardless of the length of stay even if the hospitalisation is a precautionary measure for continued observation. Pre-planned hospitalisation e.g. for pre-existing conditions which have not worsened, or elective procedures, does not constitute and SAE. I found this paper to be thorough, carefully conceived and with demonstrable inclusion of participants. I am looking forward to reading the paper on completion of the project. It sounds valuable to the participants and to the incarceration systems for people within secure hospital settings globally. - Is the rationale for, and objectives of, the study clearly described? Yes - Is the study design appropriate for the research question? Yes - Are sufficient details of the methods provided to allow replication by others? Yes - Are the datasets clearly presented in a useable and accessible format? Not applicable Competing Interests: Simon S Hackett invited me, along with a few others to write a chapter for his book. I was offering an Australian perspective. I completed the chapter early last year, and the book will be published this year, though we did not work closely. I met him once during a zoom and his co-editor did most of the communication Reviewer Expertise: Art therapy, community arts therapy, qualitative and inclusive research, mental health, neurodiversity CITE HOW TO CITE THIS REPORT Gentle E. Reviewer Report For: Secure care hospital evaluation of manualised interpersonal art-psychotherapy (SCHEMA): A randomised controlled trial protocol [version 1; peer review: 2 approved]. NIHR Open Res 2025, 5:21 (https://doi.org/10.3310/nihropenres.14993.r34953) The direct URL for this report is: https://openresearch.nihr.ac.uk/articles/5-21/v1#referee-response-34953 https://openresearch.nihr.ac.uk/articles/5-21/v1#referee-response-34953 NOTE: it is important to ensure the information in square brackets after the title is included in all citations of this article. - Author Response 28 May 2025Simon Hackett, Faculty of Medical Sciences, Baddiley-Clark Building, Richardson Road, Newcastle University Population Health Sciences Institute, Newcastle upon Tyne, NE2 4AX, UK28 May 2025Author ResponseTitle: For someone outside the UK it may be useful to put forensic in brackets after secure care Response: Additional text, (forensic), has been added to the title. ... Continue reading Title: For someone outside the UK it may be useful to put forensic in brackets after secure care Response: Additional text, (forensic), has been added to the title. in paragraph 2 in the Introduction, I suggest you to please revise the sentences -

and/or learning disability and in paragraph 2 in the Introduction- unless this is a way of writing and/or that I am unfamiliar with".

a personality disorder, and/a learning disability - change to and/or

a personality disorder, and/a learning/intellectual disability (ID) - change to and/or Response: Thank you, wording has been changed as suggested.

Third paragraph: considered long stayers Response: Thank you, wording has been changed as suggested.

Prohibited treatments section does not flow easily Response: Thank you, this section has been edited to improve readability. The qualitative analysis section could be clearer in its language and/or have a diagram that clarifies the process Response: The language in the qualitative analysis section has been revised and edited. P12 **Note: Hospitalisation is defined as an impatient admission. Response: Thank you, wording has been changed as suggested.Title: For someone outside the UK it may be useful to put forensic in brackets after secure careCompeting Interests: Dr Emma Gentle is a chapter contributory to an edited collection that Dr Simon Hackett is a co-editor for. The edited volume is currently at a pre-publication stage. Close Response: Additional text, (forensic), has been added to the title. in paragraph 2 in the Introduction, I suggest you to please revise the sentences -

and/or learning disability and in paragraph 2 in the Introduction- unless this is a way of writing and/or that I am unfamiliar with".

a personality disorder, and/a learning disability - change to and/or

a personality disorder, and/a learning/intellectual disability (ID) - change to and/or Response: Thank you, wording has been changed as suggested.

Third paragraph: considered long stayers Response: Thank you, wording has been changed as suggested.

Prohibited treatments section does not flow easily Response: Thank you, this section has been edited to improve readability. The qualitative analysis section could be clearer in its language and/or have a diagram that clarifies the process Response: The language in the qualitative analysis section has been revised and edited. P12 **Note: Hospitalisation is defined as an impatient admission. Response: Thank you, wording has been changed as suggested. COMMENTS ON THIS REPORT - Author Response 28 May 2025Simon Hackett, Faculty of Medical Sciences, Baddiley-Clark Building, Richardson Road, Newcastle University Population Health Sciences Institute, Newcastle upon Tyne, NE2 4AX, UK28 May 2025Author ResponseTitle: For someone outside the UK it may be useful to put forensic in brackets after secure care Response: Additional text, (forensic), has been added to the title. ... Continue reading Title: For someone outside the UK it may be useful to put forensic in brackets after secure care Response: Additional text, (forensic), has been added to the title. in paragraph 2 in the Introduction, I suggest you to please revise the sentences -

and/or learning disability and in paragraph 2 in the Introduction- unless this is a way of writing and/or that I am unfamiliar with".

a personality disorder, and/a learning disability - change to and/or

a personality disorder, and/a learning/intellectual disability (ID) - change to and/or Response: Thank you, wording has been changed as suggested.

Third paragraph: considered long stayers Response: Thank you, wording has been changed as suggested.

Prohibited treatments section does not flow easily Response: Thank you, this section has been edited to improve readability. The qualitative analysis section could be clearer in its language and/or have a diagram that clarifies the process Response: The language in the qualitative analysis section has been revised and edited. P12 **Note: Hospitalisation is defined as an impatient admission. Response: Thank you, wording has been changed as suggested.Title: For someone outside the UK it may be useful to put forensic in brackets after secure careCompeting Interests: Dr Emma Gentle is a chapter contributory to an edited collection that Dr Simon Hackett is a co-editor for. The edited volume is currently at a pre-publication stage. Close Response: Additional text, (forensic), has been added to the title. in paragraph 2 in the Introduction, I suggest you to please revise the sentences -

and/or learning disability and in paragraph 2 in the Introduction- unless this is a way of writing and/or that I am unfamiliar with".

a personality disorder, and/a learning disability - change to and/or

a personality disorder, and/a learning/intellectual disability (ID) - change to and/or Response: Thank you, wording has been changed as suggested.

Third paragraph: considered long stayers Response: Thank you, wording has been changed as suggested.

Prohibited treatments section does not flow easily Response: Thank you, this section has been edited to improve readability. The qualitative analysis section could be clearer in its language and/or have a diagram that clarifies the process Response: The language in the qualitative analysis section has been revised and edited. P12 **Note: Hospitalisation is defined as an impatient admission. Response: Thank you, wording has been changed as suggested. Views 0 How to cite this report: Havsteen-Franklin D. Reviewer Report For: Secure care hospital evaluation of manualised interpersonal art-psychotherapy (SCHEMA): A randomised controlled trial protocol [version 1; peer review: 2 approved]. NIHR Open Res 2025, 5:21 (https://doi.org/10.3310/nihropenres.14993.r34956) The direct URL for this report is: https://openresearch.nihr.ac.uk/articles/5-21/v1#referee-response-34956 https://openresearch.nihr.ac.uk/articles/5-21/v1#referee-response-34956 NOTE: it is important to ensure the information in square brackets after the title is included in this citation. Reviewer Report 10 Apr 2025 Approved VIEWS 0 This protocol is methodologically robust, ethically grounded, and addresses a significant clinical gap in forensic care for individuals with mild intellectual disability and borderline intellectual functioning. However a few areas could benefit from refinement: Comparator (UC) ... Continue reading 2. Feaster DJ, Mikulich-Gilbertson S, Brincks AM: Modeling site effects in the design and analysis of multi-site trials.Am J Drug Alcohol Abuse. 2011; 37 (5): 383-91 PubMed Abstract | Publisher Full Text 3. Kearney A, Daykin A, Shaw ARG, Lane AJ, et al.: Identifying research priorities for effective retention strategies in clinical trials.Trials. 2017; 18 (1): 406 PubMed Abstract | Publisher Full Text 4. Franklin M, Enrique A, Palacios J, Richards D: Psychometric assessment of EQ-5D-5L and ReQoL measures in patients with anxiety and depression: construct validity and responsiveness.Qual Life Res. 2021; 30 (9): 2633-2647 PubMed Abstract | Publisher Full Text 5. Janse P, Geurtzen N, Scappini A, Hutschemaekers G: Disentangling the Therapist Effect: Clustering Therapists by Using Different Treatment Outcomes.Adm Policy Ment Health. 2024; 51 (5): 769-779 PubMed Abstract | Publisher Full Text 6. Carr C, Feldtkeller B, French J, Havsteen-Franklin D, et al.: What makes us the same? What makes us different? Development of a shared model and manual of group therapy practice across art therapy, dance movement therapy and music therapy within community mental health care. The Arts in Psychotherapy. 2021; 72. Publisher Full Text 7. Meier D, Tschacher W, Frommer A, Moggi F, et al.: Growth curves of common factors in psychotherapy: Multilevel growth modelling and outcome analysis.Clin Psychol Psychother. 2023; 30 (5): 1095-1110 PubMed Abstract | Publisher Full Text 8. Baker J, Stringer H, McKean C: Ensuring treatment fidelity in intervention studies: Developing a checklist and scoring system within a behaviour change paradigm.Int J Lang Commun Disord. 2024; 59 (1): 379-395 PubMed Abstract | Publisher Full Text 9. O'Cathain A, Croot L, Duncan E, Rousseau N, et al.: Guidance on how to develop complex interventions to improve health and healthcare.BMJ Open. 2019; 9 (8): e029954 PubMed Abstract | Publisher Full Text 10. Pons-Vigués M, Berenguera A, Coma-Auli N, March S, et al.: Qualitative evaluation of a complex intervention to implement health promotion activities according to healthcare attendees and health professionals: EIRA study (phase II).BMJ Open. 2019; 9 (3): e023872 PubMed Abstract | Publisher Full Text 11. Hennink MM, Kaiser BN, Marconi VC: Code Saturation Versus Meaning Saturation: How Many Interviews Are Enough?. Qual Health Res. 2017; 27 (4): 591-608 PubMed Abstract | Publisher Full Text 12. Vasileiou K, Barnett J, Thorpe S, Young T: Characterising and justifying sample size sufficiency in interview-based studies: systematic analysis of qualitative health research over a 15-year period.BMC Med Res Methodol. 2018; 18 (1): 148 PubMed Abstract | Publisher Full Text 13. Sterba SK: Partially nested designs in psychotherapy trials: A review of modeling developments.Psychother Res. 2017; 27 (4): 425-436 PubMed Abstract | Publisher Full Text I confirm that I have read this submission and believe that I have an appropriate level of expertise to confirm that it is of an acceptable scientific standard. Close Comparator (UC) ... Continue reading This protocol is methodologically robust, ethically grounded, and addresses a significant clinical gap in forensic care for individuals with mild intellectual disability and borderline intellectual functioning. However a few areas could benefit from refinement: Comparator (UC) The comparator is defined as multidisciplinary team-based usual care (UC), yet significant variability is likely across NHS and independent sector sites. This could dilute treatment effects or complicate interpretation unless carefully accounted for in the analysis1(Ref-1). It also would be helpful to know whether site-level variability will be modelled 2,3. Attrition Management Given the extended follow-up period (up to 9 months), more detail on how attrition will be monitored and managed would be helpful, particularly regarding safeguarding statistical power and data integrity4. Secondary Outcome Measures While ReQoL UI and EQ-5D-3L are appropriate and widely used, their responsiveness and conceptual alignment with this specific population could be further justified5. Further, in the event of discordant results, it would be useful to clarify how these would be interpreted in the analysis. Data Governance and Accessibility A minor point, but explicitly stating where the data will be deposited and how this aligns with ethical and governance approvals for NIHR open access would be beneficial. Workforce and Implementation Considerations It might be helpful to describe how differences in therapist practices and contextual implementation factors might influence outcomes or be considered in future workforce planning - especially in consideration of scalability6,7,8,9. Qualitative Component The qualitative sample size (n=20 across participants and therapists) may be sufficient for thematic saturation in focused studies. However, given the complexity of the intervention and setting, further justification could be given as to why this number is considered sufficient for addressing the intended implementation and experiential questions10,11,12,13.

This protocol responds to a critical evidence gap using a thoughtful and well-articulated trial design. The recommendations above are intended to enhance clarity and utility of the protocol but are not prerequisites for publication. The protocol design aligns well with the standards expected for NIHR Open Research and is ready for indexing in its current form. Comparator (UC) The comparator is defined as multidisciplinary team-based usual care (UC), yet significant variability is likely across NHS and independent sector sites. This could dilute treatment effects or complicate interpretation unless carefully accounted for in the analysis1(Ref-1). It also would be helpful to know whether site-level variability will be modelled 2,3. Attrition Management Given the extended follow-up period (up to 9 months), more detail on how attrition will be monitored and managed would be helpful, particularly regarding safeguarding statistical power and data integrity4. Secondary Outcome Measures While ReQoL UI and EQ-5D-3L are appropriate and widely used, their responsiveness and conceptual alignment with this specific population could be further justified5. Further, in the event of discordant results, it would be useful to clarify how these would be interpreted in the analysis. Data Governance and Accessibility A minor point, but explicitly stating where the data will be deposited and how this aligns with ethical and governance approvals for NIHR open access would be beneficial. Workforce and Implementation Considerations It might be helpful to describe how differences in therapist practices and contextual implementation factors might influence outcomes or be considered in future workforce planning - especially in consideration of scalability6,7,8,9. Qualitative Component The qualitative sample size (n=20 across participants and therapists) may be sufficient for thematic saturation in focused studies. However, given the complexity of the intervention and setting, further justification could be given as to why this number is considered sufficient for addressing the intended implementation and experiential questions10,11,12,13.

This protocol responds to a critical evidence gap using a thoughtful and well-articulated trial design. The recommendations above are intended to enhance clarity and utility of the protocol but are not prerequisites for publication. The protocol design aligns well with the standards expected for NIHR Open Research and is ready for indexing in its current form. - Is the rationale for, and objectives of, the study clearly described? Yes - Is the study design appropriate for the research question? Yes - Are sufficient details of the methods provided to allow replication by others? Yes - Are the datasets clearly presented in a useable and accessible format? Not applicable

1. Sammour YM, Spertus JA, Kennedy K, Morrow DA, et al.: Site-level variability in the processes of care and outcomes over time among patients with COVID-19 and myocardial injury: Insights from the American Heart Association's COVID-19 Cardiovascular Disease Registry.Am Heart J Plus. 2023; 27: 100265 PubMed Abstract | Publisher Full Text2. Feaster DJ, Mikulich-Gilbertson S, Brincks AM: Modeling site effects in the design and analysis of multi-site trials.Am J Drug Alcohol Abuse. 2011; 37 (5): 383-91 PubMed Abstract | Publisher Full Text 3. Kearney A, Daykin A, Shaw ARG, Lane AJ, et al.: Identifying research priorities for effective retention strategies in clinical trials.Trials. 2017; 18 (1): 406 PubMed Abstract | Publisher Full Text 4. Franklin M, Enrique A, Palacios J, Richards D: Psychometric assessment of EQ-5D-5L and ReQoL measures in patients with anxiety and depression: construct validity and responsiveness.Qual Life Res. 2021; 30 (9): 2633-2647 PubMed Abstract | Publisher Full Text 5. Janse P, Geurtzen N, Scappini A, Hutschemaekers G: Disentangling the Therapist Effect: Clustering Therapists by Using Different Treatment Outcomes.Adm Policy Ment Health. 2024; 51 (5): 769-779 PubMed Abstract | Publisher Full Text 6. Carr C, Feldtkeller B, French J, Havsteen-Franklin D, et al.: What makes us the same? What makes us different? Development of a shared model and manual of group therapy practice across art therapy, dance movement therapy and music therapy within community mental health care. The Arts in Psychotherapy. 2021; 72. Publisher Full Text 7. Meier D, Tschacher W, Frommer A, Moggi F, et al.: Growth curves of common factors in psychotherapy: Multilevel growth modelling and outcome analysis.Clin Psychol Psychother. 2023; 30 (5): 1095-1110 PubMed Abstract | Publisher Full Text 8. Baker J, Stringer H, McKean C: Ensuring treatment fidelity in intervention studies: Developing a checklist and scoring system within a behaviour change paradigm.Int J Lang Commun Disord. 2024; 59 (1): 379-395 PubMed Abstract | Publisher Full Text 9. O'Cathain A, Croot L, Duncan E, Rousseau N, et al.: Guidance on how to develop complex interventions to improve health and healthcare.BMJ Open. 2019; 9 (8): e029954 PubMed Abstract | Publisher Full Text 10. Pons-Vigués M, Berenguera A, Coma-Auli N, March S, et al.: Qualitative evaluation of a complex intervention to implement health promotion activities according to healthcare attendees and health professionals: EIRA study (phase II).BMJ Open. 2019; 9 (3): e023872 PubMed Abstract | Publisher Full Text 11. Hennink MM, Kaiser BN, Marconi VC: Code Saturation Versus Meaning Saturation: How Many Interviews Are Enough?. Qual Health Res. 2017; 27 (4): 591-608 PubMed Abstract | Publisher Full Text 12. Vasileiou K, Barnett J, Thorpe S, Young T: Characterising and justifying sample size sufficiency in interview-based studies: systematic analysis of qualitative health research over a 15-year period.BMC Med Res Methodol. 2018; 18 (1): 148 PubMed Abstract | Publisher Full Text 13. Sterba SK: Partially nested designs in psychotherapy trials: A review of modeling developments.Psychother Res. 2017; 27 (4): 425-436 PubMed Abstract | Publisher Full Text Competing Interests: No competing interests were disclosed. Reviewer Expertise: Arts Psychotherapies; NHS Clinical Practice; Complex Interventions in Mental Health; Practice-Based Research; Psychotherapy Methodology; Arts and Health. CITE HOW TO CITE THIS REPORT Havsteen-Franklin D. Reviewer Report For: Secure care hospital evaluation of manualised interpersonal art-psychotherapy (SCHEMA): A randomised controlled trial protocol [version 1; peer review: 2 approved]. NIHR Open Res 2025, 5:21 (https://doi.org/10.3310/nihropenres.14993.r34956) The direct URL for this report is: https://openresearch.nihr.ac.uk/articles/5-21/v1#referee-response-34956 https://openresearch.nihr.ac.uk/articles/5-21/v1#referee-response-34956 NOTE: it is important to ensure the information in square brackets after the title is included in all citations of this article. - Author Response 28 May 2025Simon Hackett, Faculty of Medical Sciences, Baddiley-Clark Building, Richardson Road, Newcastle University Population Health Sciences Institute, Newcastle upon Tyne, NE2 4AX, UK28 May 2025Author ResponseComparator (UC) The comparator is defined as multidisciplinary team-based usual care (UC), yet significant variability is likely across NHS and independent sector sites. This could dilute treatment effects or complicate ... Continue reading Comparator (UC) The comparator is defined as multidisciplinary team-based usual care (UC), yet significant variability is likely across NHS and independent sector sites. This could dilute treatment effects or complicate interpretation unless carefully accounted for in the analysis1(Ref-1). It also would be helpful to know whether site-level variability will be modelled 2,3. Response: Site-level variability will not be modelled. To describe potential site variability, as set out under the protocol heading ‘Comparator’, ‘We will identify specific characteristics of UC at the study sites using a standardised pro-forma checklist and will use the TiDieR checklist to describe and present this information ( Hoffmann et al., 2014).’ Attrition Management Given the extended follow-up period (up to 9 months), more detail on how attrition will be monitored and managed would be helpful, particularly regarding safeguarding statistical power and data integrity4. Response: Attrition rates will be regularly monitored at TMG meetings and if a site has an unusually high withdrawal rate, the trial team will meet with them to discuss. This information has been added to the recruitment and withdrawal section. Secondary Outcome Measures While ReQoL UI and EQ-5D-3L are appropriate and widely used, their responsiveness and conceptual alignment with this specific population could be further justified5. Further, in the event of discordant results, it would be useful to clarify how these would be interpreted in the analysis. Response: We are unaware of any existing research that has examined the psychometric properties of the ReQoL-UI and EQ-5D-3L in the specific patient population of interest for our trial. This is part of the rational for the proposed psychometric analyses using our trial data that will be conducted and reported before the economic evaluation is conducted. In the case of discordant results based on the ReQoL-UI and EQ-5D-3L, we will reflect on the psychometric results to explain this discordance. For example, our proposed assessment of construct validity between the MOAS and BSI and ReQoL and EQ-5D-3L will aid with understanding the “conceptual alignment” (as suggested by the reviewer) between these measures (noting the MOAS is our primary outcome, thus a key measure of interest for our psychometric assessment), and our assessment of responsiveness / sensitivity (across and between measures) will aid with understanding “responsiveness” (as suggested by the reviewer). As such, the psychometric analyses will provide the evidence required to address such justifications (or not) for using the ReQoL-UI and EQ-5D-3L in our trial and for future trials. We have added the following paragraph to the ‘cost-effectiveness’ section of the paper to address the reviewer’s comment: “We are unaware of any previous psychometric results that aid with understanding the appropriateness of the EQ-5D-3L and ReQoL measures in our trial’s patient population of interest; thus, our proposed psychometric analyses can aid such measure justification in our trial and future trials in a similar patient population where similar outcomes are of interest.” Data Governance and Accessibility A minor point, but explicitly stating where the data will be deposited and how this aligns with ethical and governance approvals for NIHR open access would be beneficial. Response: We recognise and support ensuring that data is made available for future research. Participants had the option to consent for their data to shared for future research. We have added a sentence to the informed consent section that explains that data from participants have consent for their data to be shared will be uploaded to the Open Science Framework data repository. A similar sentence has also been added to the data availability section. Workforce and Implementation Considerations It might be helpful to describe how differences in therapist practices and contextual implementation factors might influence outcomes or be considered in future workforce planning - especially in consideration of scalability6,7,8,9. Response: This topic, ‘workforce and implementation considerations’ does not form part of the current study protocol. We will report upon ‘Compliance and treatment fidelity’, and therefore describe any differences in manual adherence by therapists during intervention delivery that might influence outcomes. Qualitative Component The qualitative sample size (n=20 across participants and therapists) may be sufficient for thematic saturation in focused studies. However, given the complexity of the intervention and setting, further justification could be given as to why this number is considered sufficient for addressing the intended implementation and experiential questions10,11,12,13. Response: Further justification for sample size has been included, with additions made to the qualitative analysis. Additional supporting references - Pons-Vigués M, Berenguera A, Coma-Auli N, March S, et al. (2019) and - Guest, G., Bunce, A., & Johnson, L. (2006) have now been included.Comparator (UC)Competing Interests: Professor Havsteen-Franklin and the corresponding author Dr Simon Hackett were both invited to be panel members in the same session at the 17th European Arts Therapies Conference. We both named as authors on one publication (2023) https://doi.org/10.1016/j.aip.2023.102003 Close The comparator is defined as multidisciplinary team-based usual care (UC), yet significant variability is likely across NHS and independent sector sites. This could dilute treatment effects or complicate interpretation unless carefully accounted for in the analysis1(Ref-1). It also would be helpful to know whether site-level variability will be modelled 2,3. Response: Site-level variability will not be modelled. To describe potential site variability, as set out under the protocol heading ‘Comparator’, ‘We will identify specific characteristics of UC at the study sites using a standardised pro-forma checklist and will use the TiDieR checklist to describe and present this information ( Hoffmann et al., 2014).’ Attrition Management Given the extended follow-up period (up to 9 months), more detail on how attrition will be monitored and managed would be helpful, particularly regarding safeguarding statistical power and data integrity4. Response: Attrition rates will be regularly monitored at TMG meetings and if a site has an unusually high withdrawal rate, the trial team will meet with them to discuss. This information has been added to the recruitment and withdrawal section. Secondary Outcome Measures While ReQoL UI and EQ-5D-3L are appropriate and widely used, their responsiveness and conceptual alignment with this specific population could be further justified5. Further, in the event of discordant results, it would be useful to clarify how these would be interpreted in the analysis. Response: We are unaware of any existing research that has examined the psychometric properties of the ReQoL-UI and EQ-5D-3L in the specific patient population of interest for our trial. This is part of the rational for the proposed psychometric analyses using our trial data that will be conducted and reported before the economic evaluation is conducted. In the case of discordant results based on the ReQoL-UI and EQ-5D-3L, we will reflect on the psychometric results to explain this discordance. For example, our proposed assessment of construct validity between the MOAS and BSI and ReQoL and EQ-5D-3L will aid with understanding the “conceptual alignment” (as suggested by the reviewer) between these measures (noting the MOAS is our primary outcome, thus a key measure of interest for our psychometric assessment), and our assessment of responsiveness / sensitivity (across and between measures) will aid with understanding “responsiveness” (as suggested by the reviewer). As such, the psychometric analyses will provide the evidence required to address such justifications (or not) for using the ReQoL-UI and EQ-5D-3L in our trial and for future trials. We have added the following paragraph to the ‘cost-effectiveness’ section of the paper to address the reviewer’s comment: “We are unaware of any previous psychometric results that aid with understanding the appropriateness of the EQ-5D-3L and ReQoL measures in our trial’s patient population of interest; thus, our proposed psychometric analyses can aid such measure justification in our trial and future trials in a similar patient population where similar outcomes are of interest.” Data Governance and Accessibility A minor point, but explicitly stating where the data will be deposited and how this aligns with ethical and governance approvals for NIHR open access would be beneficial. Response: We recognise and support ensuring that data is made available for future research. Participants had the option to consent for their data to shared for future research. We have added a sentence to the informed consent section that explains that data from participants have consent for their data to be shared will be uploaded to the Open Science Framework data repository. A similar sentence has also been added to the data availability section. Workforce and Implementation Considerations It might be helpful to describe how differences in therapist practices and contextual implementation factors might influence outcomes or be considered in future workforce planning - especially in consideration of scalability6,7,8,9. Response: This topic, ‘workforce and implementation considerations’ does not form part of the current study protocol. We will report upon ‘Compliance and treatment fidelity’, and therefore describe any differences in manual adherence by therapists during intervention delivery that might influence outcomes. Qualitative Component The qualitative sample size (n=20 across participants and therapists) may be sufficient for thematic saturation in focused studies. However, given the complexity of the intervention and setting, further justification could be given as to why this number is considered sufficient for addressing the intended implementation and experiential questions10,11,12,13. Response: Further justification for sample size has been included, with additions made to the qualitative analysis. Additional supporting references - Pons-Vigués M, Berenguera A, Coma-Auli N, March S, et al. (2019) and - Guest, G., Bunce, A., & Johnson, L. (2006) have now been included. COMMENTS ON THIS REPORT - Author Response 28 May 2025Simon Hackett, Faculty of Medical Sciences, Baddiley-Clark Building, Richardson Road, Newcastle University Population Health Sciences Institute, Newcastle upon Tyne, NE2 4AX, UK28 May 2025Author ResponseComparator (UC) The comparator is defined as multidisciplinary team-based usual care (UC), yet significant variability is likely across NHS and independent sector sites. This could dilute treatment effects or complicate ... Continue reading Comparator (UC) The comparator is defined as multidisciplinary team-based usual care (UC), yet significant variability is likely across NHS and independent sector sites. This could dilute treatment effects or complicate interpretation unless carefully accounted for in the analysis1(Ref-1). It also would be helpful to know whether site-level variability will be modelled 2,3. Response: Site-level variability will not be modelled. To describe potential site variability, as set out under the protocol heading ‘Comparator’, ‘We will identify specific characteristics of UC at the study sites using a standardised pro-forma checklist and will use the TiDieR checklist to describe and present this information ( Hoffmann et al., 2014).’ Attrition Management Given the extended follow-up period (up to 9 months), more detail on how attrition will be monitored and managed would be helpful, particularly regarding safeguarding statistical power and data integrity4. Response: Attrition rates will be regularly monitored at TMG meetings and if a site has an unusually high withdrawal rate, the trial team will meet with them to discuss. This information has been added to the recruitment and withdrawal section. Secondary Outcome Measures While ReQoL UI and EQ-5D-3L are appropriate and widely used, their responsiveness and conceptual alignment with this specific population could be further justified5. Further, in the event of discordant results, it would be useful to clarify how these would be interpreted in the analysis. Response: We are unaware of any existing research that has examined the psychometric properties of the ReQoL-UI and EQ-5D-3L in the specific patient population of interest for our trial. This is part of the rational for the proposed psychometric analyses using our trial data that will be conducted and reported before the economic evaluation is conducted. In the case of discordant results based on the ReQoL-UI and EQ-5D-3L, we will reflect on the psychometric results to explain this discordance. For example, our proposed assessment of construct validity between the MOAS and BSI and ReQoL and EQ-5D-3L will aid with understanding the “conceptual alignment” (as suggested by the reviewer) between these measures (noting the MOAS is our primary outcome, thus a key measure of interest for our psychometric assessment), and our assessment of responsiveness / sensitivity (across and between measures) will aid with understanding “responsiveness” (as suggested by the reviewer). As such, the psychometric analyses will provide the evidence required to address such justifications (or not) for using the ReQoL-UI and EQ-5D-3L in our trial and for future trials. We have added the following paragraph to the ‘cost-effectiveness’ section of the paper to address the reviewer’s comment: “We are unaware of any previous psychometric results that aid with understanding the appropriateness of the EQ-5D-3L and ReQoL measures in our trial’s patient population of interest; thus, our proposed psychometric analyses can aid such measure justification in our trial and future trials in a similar patient population where similar outcomes are of interest.” Data Governance and Accessibility A minor point, but explicitly stating where the data will be deposited and how this aligns with ethical and governance approvals for NIHR open access would be beneficial. Response: We recognise and support ensuring that data is made available for future research. Participants had the option to consent for their data to shared for future research. We have added a sentence to the informed consent section that explains that data from participants have consent for their data to be shared will be uploaded to the Open Science Framework data repository. A similar sentence has also been added to the data availability section. Workforce and Implementation Considerations It might be helpful to describe how differences in therapist practices and contextual implementation factors might influence outcomes or be considered in future workforce planning - especially in consideration of scalability6,7,8,9. Response: This topic, ‘workforce and implementation considerations’ does not form part of the current study protocol. We will report upon ‘Compliance and treatment fidelity’, and therefore describe any differences in manual adherence by therapists during intervention delivery that might influence outcomes. Qualitative Component The qualitative sample size (n=20 across participants and therapists) may be sufficient for thematic saturation in focused studies. However, given the complexity of the intervention and setting, further justification could be given as to why this number is considered sufficient for addressing the intended implementation and experiential questions10,11,12,13. Response: Further justification for sample size has been included, with additions made to the qualitative analysis. Additional supporting references - Pons-Vigués M, Berenguera A, Coma-Auli N, March S, et al. (2019) and - Guest, G., Bunce, A., & Johnson, L. (2006) have now been included.Comparator (UC)Competing Interests: Professor Havsteen-Franklin and the corresponding author Dr Simon Hackett were both invited to be panel members in the same session at the 17th European Arts Therapies Conference. We both named as authors on one publication (2023) https://doi.org/10.1016/j.aip.2023.102003 Close The comparator is defined as multidisciplinary team-based usual care (UC), yet significant variability is likely across NHS and independent sector sites. This could dilute treatment effects or complicate interpretation unless carefully accounted for in the analysis1(Ref-1). It also would be helpful to know whether site-level variability will be modelled 2,3. Response: Site-level variability will not be modelled. To describe potential site variability, as set out under the protocol heading ‘Comparator’, ‘We will identify specific characteristics of UC at the study sites using a standardised pro-forma checklist and will use the TiDieR checklist to describe and present this information ( Hoffmann et al., 2014).’ Attrition Management Given the extended follow-up period (up to 9 months), more detail on how attrition will be monitored and managed would be helpful, particularly regarding safeguarding statistical power and data integrity4. Response: Attrition rates will be regularly monitored at TMG meetings and if a site has an unusually high withdrawal rate, the trial team will meet with them to discuss. This information has been added to the recruitment and withdrawal section. Secondary Outcome Measures While ReQoL UI and EQ-5D-3L are appropriate and widely used, their responsiveness and conceptual alignment with this specific population could be further justified5. Further, in the event of discordant results, it would be useful to clarify how these would be interpreted in the analysis. Response: We are unaware of any existing research that has examined the psychometric properties of the ReQoL-UI and EQ-5D-3L in the specific patient population of interest for our trial. This is part of the rational for the proposed psychometric analyses using our trial data that will be conducted and reported before the economic evaluation is conducted. In the case of discordant results based on the ReQoL-UI and EQ-5D-3L, we will reflect on the psychometric results to explain this discordance. For example, our proposed assessment of construct validity between the MOAS and BSI and ReQoL and EQ-5D-3L will aid with understanding the “conceptual alignment” (as suggested by the reviewer) between these measures (noting the MOAS is our primary outcome, thus a key measure of interest for our psychometric assessment), and our assessment of responsiveness / sensitivity (across and between measures) will aid with understanding “responsiveness” (as suggested by the reviewer). As such, the psychometric analyses will provide the evidence required to address such justifications (or not) for using the ReQoL-UI and EQ-5D-3L in our trial and for future trials. We have added the following paragraph to the ‘cost-effectiveness’ section of the paper to address the reviewer’s comment: “We are unaware of any previous psychometric results that aid with understanding the appropriateness of the EQ-5D-3L and ReQoL measures in our trial’s patient population of interest; thus, our proposed psychometric analyses can aid such measure justification in our trial and future trials in a similar patient population where similar outcomes are of interest.” Data Governance and Accessibility A minor point, but explicitly stating where the data will be deposited and how this aligns with ethical and governance approvals for NIHR open access would be beneficial. Response: We recognise and support ensuring that data is made available for future research. Participants had the option to consent for their data to shared for future research. We have added a sentence to the informed consent section that explains that data from participants have consent for their data to be shared will be uploaded to the Open Science Framework data repository. A similar sentence has also been added to the data availability section. Workforce and Implementation Considerations It might be helpful to describe how differences in therapist practices and contextual implementation factors might influence outcomes or be considered in future workforce planning - especially in consideration of scalability6,7,8,9. Response: This topic, ‘workforce and implementation considerations’ does not form part of the current study protocol. We will report upon ‘Compliance and treatment fidelity’, and therefore describe any differences in manual adherence by therapists during intervention delivery that might influence outcomes. Qualitative Component The qualitative sample size (n=20 across participants and therapists) may be sufficient for thematic saturation in focused studies. However, given the complexity of the intervention and setting, further justification could be given as to why this number is considered sufficient for addressing the intended implementation and experiential questions10,11,12,13. Response: Further justification for sample size has been included, with additions made to the qualitative analysis. Additional supporting references - Pons-Vigués M, Berenguera A, Coma-Auli N, March S, et al. (2019) and - Guest, G., Bunce, A., & Johnson, L. (2006) have now been included. Alongside their report, reviewers assign a status to the article: - Approved - Approved with reservations - Not approved | Invited Reviewers | || |---|---|---| | 1 | 2 | | | Version 2 (revision) 28 May 25 | || | Version 1 07 Mar 25 | read | read | Sign up for content alerts You are now signed up to receive this alert Alongside their report, reviewers assign a status to the article: Approved - the paper is scientifically sound in its current form and only minor, if any, improvements are suggested Approved with reservations - A number of small changes, sometimes more significant revisions are required to address specific details and improve the papers academic merit. Not approved - fundamental flaws in the paper seriously undermine the findings and conclusions Provide sufficient details of any financial or non-financial competing interests to enable users to assess whether your comments might lead a reasonable person to question your impartiality. 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