Stepped psychological care in post-stroke aphasia: Feasibility protocol to evaluate the co- designed “Kalmer” online relaxation intervention

Stepped psychological care in post-stroke aphasia: Feasibility protocol to evaluate the co- designed “Kalmer” online relaxation intervention | Research Square window.SnipcartSettings = { analytics: { enabled: false } }; (function() { var accessVector = localStorage.getItem('access_vector') || ''; window.dataLayer = window.dataLayer || []; if (accessVector) { window.dataLayer.push({ user: { profile: { profileInfo: { snid: accessVector } } } }); } })(); (function(w,d,s,l,i){w[l]=w[l]||[];w[l].push({'gtm.start':new Date().getTime(),event:'gtm.js'});var f=d.getElementsByTagName(s)[0],j=d.createElement(s),dl=l!='dataLayer'?'&l='+l:'';j.async=true;j.src='https://www.googletagmanager.com/gtm.js?id='+i+dl;f.parentNode.insertBefore(j,f);})(window,document,'script','dataLayer','GTM-K279D39R'); Browse Preprints In Review Journals COVID-19 Preprints AJE Video Bytes Research Tools Research Promotion AJE Professional Editing AJE Rubriq About Preprint Platform In Review Editorial Policies Our Team Advisory Board Help Center Sign In Submit a Preprint Cite Share Download PDF Research Article Stepped psychological care in post-stroke aphasia: Feasibility protocol to evaluate the co- designed “Kalmer” online relaxation intervention Rebecca El-Helou, Brooke Ryan, Katerina Hilari, Ian Kneebone This is a preprint; it has not been peer reviewed by a journal. https://doi.org/ 10.21203/rs.3.rs-3872461/v1 This work is licensed under a CC BY 4.0 License Status: Under Revision Version 1 posted 10 You are reading this latest preprint version Abstract Background : People with stroke are at greater risk of experiencing depression and anxiety. The prevalence of these difficulties in those with the communication disorder aphasia after stroke is even higher. Relaxation training is recommended as part of stepped care for mental health difficulties for those with stroke. The potential impact of the online co-designed Kalmer relaxation intervention and thus its place within stepped care for people with post stroke aphasia is unknown. Methods/design: This study will determine the feasibility and potential efficacy of the Kalmer relaxation intervention on people with post stroke aphasia and who met the cut off on screening instruments for anxiety and/or depression. Primary outcomes will be assessed using two observer rated scales; the Behavioural Outcomes of Anxiety (BOA) and the Stroke Aphasia Depression Questionnaire - 10 item (SADQ-10). A case series design will utilise a multiple baseline procedure. Up to 12 participants will be recruited. Consent procedures modified for those with aphasia will be employed. The Reliable Change Index will be used to determine the interventions impact on anxiety and depressive symptoms. Participants will be followed-up at 3- and 6-month intervals. Discussion : This study represents the first known evaluation of the online co-designed Kalmer relaxation intervention program. The results will have implications for recommending its inclusion as a recommended treatment at Step 2 of mental health care for people with aphasia after stroke. Figures Figure 1 1. Introduction Anxiety and depression are common after stroke and while distressing in their own right, also impact recovery outcomes. The point prevalence of anxiety after stroke is around 25% (1) and it is associated with reduced daily functional abilities, quality of life, and relationships (2-4). The point prevalence rate for depression is around 31% (5) and it is associated with reduced functional outcome and increased mortality (6). Co-morbid depression and anxiety occurs at a rate of about 12 to 14% of cases(7, 8). Quality data is absent, however the rates of anxiety and depression are likely substantially higher in those with the communication disorder aphasia after stroke(9, 10). While systematic reviews provide support for the efficacy of treatments like cognitive behaviour therapy for the treatment of anxiety and depression after stroke (11, 12) those with aphasia are often excluded from studies and mental health interventions due to their presumed inability to engage in talk-based approaches or concerns they can complete measures meaningfully.. Additionally, research also demonstrates that stroke clinicians lack the training and self-efficacy in supporting people with aphasia with their mental health (13). Stepped care in mental health works on the basis that people should at first, be offered the least intrusive management according to their needs (14). This model has been proposed as an approach to mental health specific to people with stroke (15, 16). There are four levels proposed in Kneebone et al.’s (2016) elaboration of the model(16). Given the high rates of difficulty encountered after a stroke, the first level considers services that could be offered to everyone as a preventive measure. Step 2 considers treatment offered to those with less severe symptoms. Relaxation training is an evidence-based treatment for anxiety and depression in the non-stroke population (17, 18). Particularly of relevance to those with stroke is the fact the benefits of relaxation training are evident for older people and those with physical health complaints (18). Several studies suggest relaxation will be useful for those with anxiety after stroke. A descriptive trial suggested relaxation impacted on tension levels when delivered in a group format (19) and a small randomised controlled trial of a self-help relaxation CD in those without significant communication or cognitive problems after stroke showed a positive impact on anxiety at post treatment, 2, 3 and 12 month follow-up (20, 21). Further, a reduction in depression scores was evident in those with anxiety after stroke who received the training (22). Supporting the opportunity relaxation proposes for treatment of those with reduced communication ability after stroke, there is evidence relaxation training is acceptable to those with aphasia after stroke (23) and it has been found to impact an observational measure of anxiety with this population (24). It is notable relaxation training is considered an appropriate intervention at both Step 1 and Step 2 of stepped care for mental health post stroke (16). 2. Study Aims and Hypotheses 2.1 Aims : The aim of the proposed investigation is to trial the feasibility and preliminary efficacy of an online relaxation intervention co-designed with people who have aphasia – the “Kalmer” intervention (25). The impact of the intervention on both anxiety and/or depression on people with aphasia after stroke will be considered. It is expected that use of a relaxation video will significantly reduce these mental health symptoms. Hypothesis 1 : Use of a relaxation video will significantly reduce anxiety in stroke survivors with aphasia Hypothesis 2 : Use of a relaxation video will significantly reduce depression in stroke survivors with aphasia 3. Method 3.1 Study Design A case series design will be employed. 3.2 Process of Consent: During the recruitment phase, all participants will be emailed a participant information sheet and consent form and will have adequate time to read over it with their carers/family members and will be given the opportunity to ask questions. The participant information sheet and consent form (PICF) was designed by two speech pathologists to be communicatively accessible to participants. The researchers will use teleconference calls to explain the research verbally and using supportive communication strategies. For those with mild aphasia, a phone call will be offered as an alternative option to a video call.working with people with aphasia, will use her clinical judgement to assess the nature and severity of the participants’ communication impairment prior to offering the phone call as an option. The researchers will check participants’ understanding of the study using supportive communication strategies for people with Aphasia. For phone interviews, the researchers, will assess participants’ understanding of the information provided and capacity to provide consent through specific processes. Specifically, the researchers will ask participants three questions that require a yes/no response to ensure that participants have understood and remembered key information about the study (e.g. Are you able to withdraw from the study at any time? Yes or No). If participants answer questions correctly (with supportive communication), then they are deemed to have the capacity to consent. Furthermore, ALL participants will be given the opportunity to have family members present while the researcher is explaining the research and obtaining informed consent for both phone and teleconference interviews. Informed consent will be taken in accordance with the National Health and Medical Research Council (2007) flexible guidelines on obtaining informed consent. Participants will have the option to either sign, scan and email back consent forms OR they can read the participant information sheets and consent forms in advance and give verbal consent during the teleconference/phone call interviews. At the start of the teleconference or phone call, the researchers will remind all participants of what the study involves and ask for their consent. Participants will also be able to give consent via a teleconference poll with the help of their carers. The time and date of verbal consent will be recorded on consent forms and consent from teleconference polls will be downloaded and saved as a file. 3.3. Participants To be eligible participants will need to have aphasia due to stroke, based on self and/or family report and confirmed by the researchers. Inclusion criteria comprise: 1. Score 80% or below on the Carer COAST scale (26) a measure of communication ability completed by a carer. 2. A score of 17 or more on the Behavioural Outcomes of Anxiety scale completed by a carer and/or family member 3. A score of 6 or more in the Stroke Aphasia Depression Questionnaire (SADQ 10). 4. Support of a carer with regular (daily) contact with the person with aphasia. Exclusion criteria comprise: 1. Medically unstable as indicated by the person with aphasia and/or carer. 2. The presence of any other significant psychiatric disorder other than anxiety or depressive disorder as assessed via both self report and the clinical judgement of the psychologist on the research team. 3. Serious suicidal intent (in the opinion of the interviewing psychologist). Family members of people with aphasia will be treated as a separate participant group and we will obtain consent from them as well, as they are completing outcome measures and will participate in phone or teleconference interviews. In such instances, we will obtain consent from both family members and the person with aphasia. Family members will need to be over 18 to be included in the study. 3.4 Procedure Figure1 displays the study flow. We aim to recruit 12 participants using online advertisements on the Stroke Foundation (Australia) website and other social media platforms e.g., Facebook, aphasia support group websites. If recruitment is slower than needed for the timeframe of this study (6 months), we will also recruit participants in the UK, from an established database at City, University of London. Figure 1 about here The study is aninvestigator initiated, repeated measures feasibility case series. Four baseline assessments will be completed, once a week for four weeks, via a phone call/teleconference by a psychologist. Pre-familiarisation with testing procedures for this study will also occur at the point of first contact. This will be followed by the 5-week intervention. A t end of treatment, three and six months later, participants will be reassessed on all outcome measures. 3.5 Measures: Initial phone call/teleconference screen and assessment will take place at baseline prior to the commencement of the intervention phase. 3.5.1 Demographic questionnaire: This questionnaire will seek information such as age, living circumstances, sex, marital status, date of stroke, type of stroke, medications, other psychiatric diagnosis, main vocational activity (past/present) and carer details including nature of relationship (e.g., spouse/sibling). 3.5.1 Assessment of Functional Ability : Functional ability will be assessed at baseline only using the Nottingham Everyday Activities of Daily Living Scale (EADL)(27). This form could be filled out by carers or carers and participants together if they are able. 3.5.2 Assessment of Aphasia : Carer COAST scale (26) a measure of communication ability completed by a carer and administereded at baseline only. 3.5.3 Assessment of Anxiety : The Behavioural Outcomes of Anxiety scale (24, 28) will be used to measure anxiety. It is an observer-rated instrument filled out by someone who knows the patient well (e.g., a carer). The BOA will be administered to determine eligibility for the trial and as an outcome measure at pre, post treatment and at 3 and 6 month follow-ups. The carer BOA has acceptable psychometric properties including. sensitivity and specificity when used with people who have aphasia(28). 3.5.4 Assessment of Depression : The Community Stroke Aphasia Depression Questionnaire – 10 item (SADQ 10), an observer rated measure, will be used to assess for depression in our participants. The SADQ will be administered to determine eligibility for the trial and as an outcome measure at pre, post treatment and at 3 and 6 month follow-ups. The SADQ 10 is a valid and reliable instrument for assessing depressed mood in people with aphasia(29). 3.6 Materials: Kalmer Relaxation Intervention: The Kalmer relaxation intervention is comprised of a series of co-designed (25) recordings. There are 16 videos in total, these recordings include: Introduction to the intervention Psycho-education video delivered by a co-design participant a live demonstration of Progressive Muscle Relaxation (PMR) Diaphragmatic or yogic breathing Progressive Muscle Relaxation Guided imaginal relaxation with rainforest, ocean, fireplace, and waterfall settings. There are two versions of each of the relaxation recordings, one for people requiring low communication support where the videos contain a higher complexity of spoken language, and the second, for people requiring high communication support with a lower complexity of spoken language. 3.6 Intervention Immediately, following baseline assessments, participants will have access to the co-designed Kalmer relaxation intervention(25) . Participants will be asked to view the videos at least 5 times per week for 5 weeks. Participants (with their carers if required) and will also receive additional therapeutic support in the form of weekly teleconference or phone sessions during the 5 week intervention periodThe support from the psychologist will involve reminders to practice, as well as addressing any issues participants may encounter using the intervention. 3.7 Data analytic plan It is intended to recruit between 10 to 12 participants for the case series design with each individual acting as their own control in assessing pre and post treatment data. Having at least 10 individuals will allow the researchers to assess how robust the effects are and whether there are any unique effects. Descriptive statistics, e.g. age, gender, years since stroke etc) will be used as appropriate to describe participant demographic characteristic. For outcomes, as this is a single case design, the data will not be subjected to extensive statistical analysis. First, changes in scores on the dependent variables only will be subjected to visual scrutiny. Subsequently, if improvement appears evident, reliable change will be calculated for each participant using the Leeds Reliable Change Index Calculator (30). This involves subtracting the post treatment score from the pre-treatment score and dividing this by the standard error of the difference. The standard error of the difference describes the spread of distribution of change scores that would be expected if no actual change had occurred. This procedure adheres to the method of determining reliable change as developed by Jacobson and Truax in 1992 (31).. Baseline scores will be considered using the same method to establish stability in advance of the intervention. 4. Discussion This is the first known relaxation intervention co-designed by and for people with aphasia after stroke. It aims to treat anxiety and /or depression and, on that account, has the potential to improve longer-term stroke outcomes. Being online and co-designed means, it is likely accessible to many in the target population. The intervention is of reasonably low demand in terms of any therapist input so it might be integrated into the treatment arsenals of numerous stroke clinician disciplines, including, but not restricted the speech-language therapists. Future directions: Future directions of this study include, RCTs of the relaxation intervention in the stroke population. This intervention may also be trialled in other clinical populations such as people living with traumatic brain injury, Dementia, or Multiple Sclerosis. Study status Ethical apporval for the trial was received from the Human Research Ethics Committees at the University of Technology Sydney (HREC REF NO. ETH22-7466: REDS – Reducing Emotional Distress in stroke survivors with Aphasia and reciprocal approval from City, University of London, School of Health and Psychological Sciences (REC Ref no._ ETH2223-0400. The trial was pre-registered on the Australian Clinical Trial Registry Reg # ACTRN12621001051831. The first participant was enrolled on 27/02/2022. Declarations Funding Not applicable Conflicts of interest/Competing interests Nil Data availability Not applicable Code availability (software application or custom code) Not applicable Authors' contributions Authors RE-H, BR, IK made a substantial contribution to the conception and design of the work, author KH contributed to aspects of the design once the study was underway. All authors drafted the work and revised it critically for important intellectual content. Further, all authors approved the version to be published and have agreed to be accountable for all aspects of the work in ensuring that questions related to the accuracy or integrity of any part of the work are appropriately investigated and resolved. Data availability statement: The data of this study is not available or accessible to maintain the confidentiality and privacy of research participants and given there has been no ethical approval for the data from this study to be analysed or used again by other researchers. References Cumming TB, Blomstrand C, Skoog I, Linden T. The high prevalence of anxiety disorders after stroke. The American Journal of Geriatric Psychiatry. 2016;24(2):154-60. Åström M. Generalized anxiety disorder in stroke patients: a 3-year longitudinal study. Stroke. 1996;27(2):270-5. Carod-Artal FJ, Egido JA. Quality of life after stroke: the importance of a good recovery. Cerebrovascular diseases. 2009;27(Suppl. 1):204-14. West R, Hill K, Hewison J, Knapp P, House A. Psychological disorders after stroke are an important influence on functional outcomes: a prospective cohort study. Stroke. 2010;41(8):1723-7. Hackett ML, Pickles K. Part I: frequency of depression after stroke: an updated systematic review and meta-analysis of observational studies. International Journal of Stroke. 2014;9(8):1017-25. Kutlubaev MA, Hackett ML. Part II: predictors of depression after stroke and impact of depression on stroke outcome: an updated systematic review of observational studies. International Journal of Stroke. 2014;9(8):1026-36. Barker-Collo SL. Depression and anxiety 3 months post stroke: prevalence and correlates. Archives of Clinical Neuropsychology. 2007;22(4):519-31. Sagen U, Vik TG, Moum T, Mørland T, Finset A, Dammen T. Screening for anxiety and depression after stroke: Comparison of the Hospital Anxiety and Depression Scale and the Montgomery and Åsberg Depression Rating Scale. Journal of psychosomatic research. 2009;67(4):325-32. Shehata GA, El Mistikawi T, Al Sayed KR, Hassan HS. The effect of aphasia upon personality traits, depression and anxiety among stroke patients. Journal of affective disorders. 2015;172:312-4. Morris R, Eccles A, Ryan B, Kneebone II. Prevalence of anxiety in people with aphasia after stroke. Aphasiology. 2017;31(12):1410-5. Ahrens J, Shao R, Blackport D, Macaluso S, Viana R, Teasell R, et al. Cognitive-behavioral therapy for managing depressive and anxiety symptoms after stroke: a systematic review and meta-analysis. Topics in Stroke Rehabilitation. 2023;30(4):368-83. Wang S-B, Wang Y-Y, Zhang Q-E, Wu S-L, Ng CH, Ungvari GS, et al. Cognitive behavioral therapy for post-stroke depression: a meta-analysis. Journal of affective disorders. 2018;235:589-96. Baker C, Worrall L, Rose M, Ryan B. Stroke health professionals’ management of depression after post-stroke aphasia: a qualitative study. Disability and Rehabilitation. 2021;43(2):217-28. England N. NHS Talking Therapies, for anxiety and depression. 2023. Improvement N. Psychological care after stroke. Kneebone II. Stepped psychological care after stroke. Disability and rehabilitation. 2016;38(18):1836-43. Jorm AF, Morgan AJ, Hetrick SE. Relaxation for depression. Cochrane Database of Systematic Reviews. 2008(4). Manzoni GM, Pagnini F, Castelnuovo G, Molinari E. Relaxation training for anxiety: a ten-years systematic review with meta-analysis. BMC psychiatry. 2008;8(1):1-12. Kneebone I, Walker-Samuel N, Swanston J, Otto E. Relaxation training after stroke: potential to reduce anxiety. Disability and rehabilitation. 2014;36(9):771-4. Golding K, Kneebone I, Fife-Schaw C. Self-help relaxation for post-stroke anxiety: A randomised, controlled pilot study. Clinical rehabilitation. 2016;30(2):174-80. Golding K, Fife-Schaw C, Kneebone I. Twelve month follow-up on a randomised controlled trial of relaxation training for post-stroke anxiety. Clinical rehabilitation. 2017;31(9):1164-7. Golding K, Fife-Schaw C, Kneebone I. A pilot randomized controlled trial of self-help relaxation to reduce post-stroke depression. Clinical rehabilitation. 2018;32(6):747-51. Wang X, Thiel L, Graff Nd, editors. Mindfulness and Relaxation Techniques for Stroke Survivors with Aphasia: A Feasibility and Acceptability Study. Healthcare; 2022: MDPI. Eccles A, Morris R, Kneebone I. Psychometric properties of the Behavioural Outcomes of Anxiety questionnaire in stroke patients with aphasia. Clinical Rehabilitation. 2017;31(3):369-78. El-Helou R, Ryan B, Kneebone I. Development of the “Kalmer” relaxation intervention: co-design with stroke survivors with aphasia. Disability and Rehabilitation. 2023;45(9):1517-29. Long A, Hesketh A, Bowen A. Communication outcome after stroke: a new measure of the carer’s perspective. Clinical Rehabilitation. 2009;23(9):846-56. Nouri F, Lincoln N. An extended activities of daily living scale for stroke patients. Clinical rehabilitation. 1987;1(4):301-5. Linley‐Adams B, Morris R, Kneebone I. The Behavioural Outcomes of Anxiety scale (BOA): a preliminary validation in stroke survivors. British journal of clinical psychology. 2014;53(4):451-67. Bennett H, Thomas S, Austen R, Morris A, Lincoln N. Validation of screening measures for assessing mood in stroke patients. British Journal of Clinical Psychology. 2006;45(3):367-76. Agostinis A, Morley S, Dowzer C. The Leeds Reliable Change Index Calculator. Retrieved form: http://www. leeds. ac. uk/lihs/psychiatry/dclin/rcic. html; 2008. Jacobson NS, Truax P. Clinical significance: a statistical approach to defining meaningful change in psychotherapy research. 1992. Additional Declarations No competing interests reported. Supplementary Files protocolTheTIDieR.docx Cite Share Download PDF Status: Under Revision Version 1 posted Editorial decision: Revision requested 13 Mar, 2024 Reviews received at journal 13 Mar, 2024 Reviews received at journal 07 Mar, 2024 Reviewers agreed at journal 07 Mar, 2024 Reviewers agreed at journal 03 Mar, 2024 Reviewers agreed at journal 28 Feb, 2024 Reviewers invited by journal 26 Feb, 2024 Editor assigned by journal 06 Feb, 2024 Submission checks completed at journal 06 Feb, 2024 First submitted to journal 17 Jan, 2024 You are reading this latest preprint version Research Square lets you share your work early, gain feedback from the community, and start making changes to your manuscript prior to peer review in a journal. As a division of Research Square Company, we’re committed to making research communication faster, fairer, and more useful. We do this by developing innovative software and high quality services for the global research community. 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Also discoverable on Platform About Our Team In Review Editorial Policies Advisory Board Help Center Resources Author Services Accessibility API Access RSS feed Manage Cookie Preferences © Research Square 2026 | ISSN 2693-5015 (online) Privacy Policy Terms of Service Do Not Sell My Personal Information {"props":{"pageProps":{"initialData":{"identity":"rs-3872461","acceptedTermsAndConditions":true,"allowDirectSubmit":false,"archivedVersions":[],"articleType":"Research Article","associatedPublications":[],"authors":[{"id":271279025,"identity":"51ef8a7a-3f50-473b-8479-cad57108205f","order_by":0,"name":"Rebecca El-Helou","email":"data:image/png;base64,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","orcid":"","institution":"University of Technology Sydney","correspondingAuthor":true,"prefix":"","firstName":"Rebecca","middleName":"","lastName":"El-Helou","suffix":""},{"id":271279026,"identity":"0a767bf4-4a79-4479-b188-76998aad8e1d","order_by":1,"name":"Brooke Ryan","email":"","orcid":"","institution":"University of Technology Sydney","correspondingAuthor":false,"prefix":"","firstName":"Brooke","middleName":"","lastName":"Ryan","suffix":""},{"id":271279027,"identity":"c6860f42-9dc8-45f8-8cfe-13977c5253f1","order_by":2,"name":"Katerina Hilari","email":"","orcid":"","institution":"City, University of London","correspondingAuthor":false,"prefix":"","firstName":"Katerina","middleName":"","lastName":"Hilari","suffix":""},{"id":271279028,"identity":"aa83cb82-2661-4fcd-8143-e339941c49c3","order_by":3,"name":"Ian Kneebone","email":"","orcid":"","institution":"University of Technology Sydney","correspondingAuthor":false,"prefix":"","firstName":"Ian","middleName":"","lastName":"Kneebone","suffix":""}],"badges":[],"createdAt":"2024-01-17 09:31:54","currentVersionCode":1,"declarations":"","doi":"10.21203/rs.3.rs-3872461/v1","doiUrl":"https://doi.org/10.21203/rs.3.rs-3872461/v1","draftVersion":[],"editorialEvents":[],"editorialNote":"","failedWorkflow":false,"files":[{"id":50820110,"identity":"9bb9192d-31f5-40f1-832f-4557996f8bd7","added_by":"auto","created_at":"2024-02-07 20:38:34","extension":"png","order_by":1,"title":"Figure 1","display":"","copyAsset":false,"role":"figure","size":32044,"visible":true,"origin":"","legend":"\u003cp\u003e\u003cu\u003e\u003cstrong\u003eFlow Diagram\u003c/strong\u003e\u003c/u\u003e\u003c/p\u003e","description":"","filename":"1.png","url":"https://assets-eu.researchsquare.com/files/rs-3872461/v1/1029bc9ff12766ce3323339e.png"},{"id":50820540,"identity":"dc97410b-10d8-4acf-8533-e00acb9188b0","added_by":"auto","created_at":"2024-02-07 20:46:34","extension":"pdf","order_by":0,"title":"","display":"","copyAsset":false,"role":"manuscript-pdf","size":350958,"visible":true,"origin":"","legend":"","description":"","filename":"manuscript.pdf","url":"https://assets-eu.researchsquare.com/files/rs-3872461/v1/c42ff0b3-04ed-4adc-9c41-94938c3d4d1d.pdf"},{"id":50820108,"identity":"f136ff3f-0296-4175-9bb1-1f9b2a9e6a73","added_by":"auto","created_at":"2024-02-07 20:38:34","extension":"docx","order_by":1,"title":"","display":"","copyAsset":false,"role":"supplement","size":27944,"visible":true,"origin":"","legend":"","description":"","filename":"protocolTheTIDieR.docx","url":"https://assets-eu.researchsquare.com/files/rs-3872461/v1/993b9348e2592e233ca3f706.docx"}],"financialInterests":"No competing interests reported.","formattedTitle":"Stepped psychological care in post-stroke aphasia: Feasibility protocol to evaluate the co- designed “Kalmer” online relaxation intervention","fulltext":[{"header":"1.\tIntroduction","content":"\u003cp\u003eAnxiety and depression are common after stroke and while distressing in their own right, also impact recovery outcomes. The point prevalence of anxiety after stroke is around 25%\u0026nbsp;(1)\u0026nbsp;and it is associated with reduced daily functional abilities, quality of life, and relationships\u0026nbsp;(2-4). The point prevalence rate for depression is around 31%\u0026nbsp;(5)\u0026nbsp;and it is associated with reduced functional outcome and increased mortality\u0026nbsp;(6). Co-morbid depression and anxiety occurs at a rate of about 12 to 14% of cases(7, 8). Quality data is absent, however the rates of anxiety and depression are likely substantially higher in those with the communication disorder aphasia after stroke(9, 10).\u0026nbsp;\u003c/p\u003e\n\u003cp\u003eWhile systematic reviews provide support for the efficacy of treatments like cognitive behaviour therapy for the treatment of anxiety and depression after stroke\u0026nbsp;(11, 12)\u0026nbsp;those with aphasia are often excluded from studies and mental health interventions due to their presumed inability to engage in talk-based approaches or concerns they can complete measures meaningfully.. Additionally, research also demonstrates that stroke clinicians lack the training and self-efficacy in supporting people with aphasia with their mental health\u0026nbsp;(13).\u003c/p\u003e\n\u003cp\u003eStepped care in mental health works on the basis that people should at first, be offered the least intrusive management according to their needs\u0026nbsp;(14). This model has been proposed as an approach to mental health specific to people with stroke\u0026nbsp;(15, 16). There are four levels proposed in Kneebone et al.\u0026rsquo;s (2016) elaboration of the model(16).\u0026nbsp;Given the high rates of difficulty encountered after a stroke, the first level considers services that could be offered to everyone as a preventive measure. Step 2 considers treatment offered to those with less severe symptoms.\u0026nbsp;\u003c/p\u003e\n\u003cp\u003eRelaxation training is an evidence-based treatment for anxiety and depression in the non-stroke population (17, 18). Particularly of relevance to those with stroke is the fact the benefits of relaxation training are evident for older people and those with physical health complaints (18). \u0026nbsp;Several studies suggest relaxation will be useful for those with anxiety after stroke. A descriptive trial suggested relaxation impacted on tension levels when delivered in a group format (19) and a small randomised controlled trial of a self-help relaxation CD in those without significant communication or cognitive problems after stroke showed a positive impact on anxiety at post treatment, 2, 3 and 12 month follow-up (20, 21). Further, a reduction in depression scores was evident in those with anxiety after stroke who received the training (22). Supporting the opportunity relaxation proposes for treatment of those with reduced communication ability after stroke, there is evidence relaxation training is acceptable to those with aphasia after stroke (23) and it has been found to impact an observational measure of anxiety with this population (24). \u0026nbsp;It is notable relaxation training is considered an appropriate intervention at both Step 1 and Step 2 of stepped care for mental health post stroke (16).\u003c/p\u003e"},{"header":"2.\tStudy Aims and Hypotheses","content":"\u003cp\u003e\u003cstrong\u003e2.1 Aims\u003c/strong\u003e:\u0026nbsp;\u003c/p\u003e\n\u003cp\u003eThe aim of the proposed investigation is to trial the feasibility and preliminary efficacy of an online relaxation intervention co-designed with people who have aphasia \u0026ndash; the \u0026ldquo;Kalmer\u0026rdquo; intervention (25). \u0026nbsp;The impact of the intervention on both anxiety and/or depression on people with aphasia after stroke will be considered. It is expected that use of a relaxation video will significantly reduce these mental health symptoms. \u0026nbsp;\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eHypothesis 1\u003c/strong\u003e: Use of a relaxation video will significantly reduce anxiety in stroke survivors with aphasia\u0026nbsp;\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eHypothesis 2\u003c/strong\u003e: Use of a relaxation video will significantly reduce depression in stroke survivors with aphasia\u0026nbsp;\u003c/p\u003e"},{"header":"3.\tMethod","content":"\u003cp\u003e\u003cstrong\u003e3.1 Study Design\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eA case series design will be employed.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003e3.2 Process of Consent:\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eDuring the recruitment phase, all participants will be emailed a participant information sheet and consent form and will have adequate time to read over it with their carers/family members and will be given the opportunity to ask questions. The participant information sheet and consent form (PICF) was designed by two speech pathologists to be communicatively accessible to participants. The researchers will use teleconference calls to explain the research verbally and using supportive communication strategies. For those with mild aphasia, a phone call will be offered as an alternative option to a video call.working with people with aphasia, will use her clinical judgement to assess the nature and severity of the participants\u0026rsquo; communication impairment prior to offering the phone call as an option.\u003c/p\u003e\n\u003cp\u003eThe researchers will check participants\u0026rsquo; understanding of the study using supportive communication strategies for people with Aphasia. For phone interviews, the researchers, will assess participants\u0026rsquo; understanding of the information provided and capacity to provide consent through specific processes. Specifically, the researchers will ask participants three questions that require a yes/no response to ensure that participants have understood and remembered key information about the study (e.g. Are you able to withdraw from the study at any time? Yes or No). If participants answer questions correctly (with supportive communication), then they are deemed to have the capacity to consent. Furthermore, ALL participants will be given the opportunity to have family members present while the researcher is explaining the research and obtaining informed consent for both phone and teleconference interviews.\u003c/p\u003e\n\u003cp\u003eInformed consent will be taken in accordance with the National Health and Medical Research Council (2007) flexible guidelines on obtaining informed consent. Participants will have the option to either sign, scan and email back consent forms OR they can read the participant information sheets and consent forms in advance and give verbal consent during the teleconference/phone call interviews. At the start of the teleconference or phone call, the researchers will remind all participants of what the study involves and ask for their consent. Participants will also be able to give consent via a teleconference poll with the help of their carers. The time and date of verbal consent will be recorded on consent forms and consent from teleconference polls will be downloaded and saved as a file.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003e3.3. Participants\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eTo be eligible participants will need to have aphasia due to stroke, based on self and/or family report and confirmed by the researchers. Inclusion criteria comprise: 1. Score 80% or below on the Carer COAST scale (26) a measure of communication ability completed by a carer. 2. A score of 17 or more on the Behavioural Outcomes of Anxiety scale completed by a carer and/or family member 3. A score of 6 or more in the Stroke Aphasia Depression Questionnaire (SADQ 10). 4. Support of a carer with regular (daily) contact with the person with aphasia.\u003c/p\u003e\n\u003cp\u003eExclusion criteria comprise: 1. Medically unstable as indicated by the person with aphasia and/or carer. 2. The presence of any other significant psychiatric disorder other than anxiety or depressive disorder as assessed via both self report and the clinical judgement of the psychologist on the research team. 3. Serious suicidal intent (in the opinion of the interviewing psychologist).\u003c/p\u003e\n\u003cp\u003eFamily members of people with aphasia will be treated as a separate participant group and we will obtain consent from them as well, as they are completing outcome measures and will participate in phone or teleconference interviews. In such instances, we will obtain consent from both family members and the person with aphasia. Family members will need to be over 18 to be included in the study.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003e3.4 Procedure\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eFigure1 displays the study flow. We aim to recruit 12 participants using online advertisements on the Stroke Foundation (Australia) website and other social media platforms e.g., Facebook, aphasia support group websites. If recruitment is slower than needed for the timeframe of this study (6 months), we will also recruit participants in the UK, from an established database at City, University of London.\u003c/p\u003e\n\u003cp\u003eFigure 1 about here\u003c/p\u003e\n\u003cp\u003eThe study is aninvestigator initiated, repeated measures feasibility case series. Four baseline assessments will be completed, once a week for four weeks, via a phone call/teleconference by a psychologist. Pre-familiarisation with testing procedures for this study will also occur at the point of first contact. This will be followed by the 5-week intervention. A t end of treatment, three and six months later, participants will be reassessed on all outcome measures.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003e3.5 Measures:\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eInitial phone call/teleconference screen and assessment will take place at baseline prior to the commencement of the intervention phase.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003e3.5.1 Demographic questionnaire:\u0026nbsp;\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eThis questionnaire will seek information such as age, living circumstances, sex, marital status, date of stroke, type of stroke, medications, other psychiatric diagnosis, main vocational activity (past/present) and carer details including nature of relationship (e.g., spouse/sibling).\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003e3.5.1 Assessment of Functional Ability\u003c/strong\u003e: Functional ability will be assessed at baseline only using the Nottingham Everyday Activities of Daily Living Scale (EADL)(27). This form could be filled out by carers or carers and participants together if they are able.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003e3.5.2 Assessment of Aphasia\u003c/strong\u003e: Carer COAST scale (26) a measure of communication ability completed by a carer and administereded at baseline only.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003e3.5.3 Assessment of Anxiety\u003c/strong\u003e:\u003c/p\u003e\n\u003cp\u003eThe Behavioural Outcomes of Anxiety scale (24, 28) will be used to measure anxiety. It is an observer-rated instrument filled out by someone who knows the patient well (e.g., a carer). The BOA will be administered to determine eligibility for the trial and as an outcome measure at pre, post treatment and at 3 and 6 month follow-ups. The carer BOA has acceptable psychometric properties including. sensitivity and specificity when used with people who have aphasia(28).\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003e3.5.4 Assessment of Depression\u003c/strong\u003e: The Community Stroke Aphasia Depression Questionnaire \u0026ndash; 10 item (SADQ 10), an observer rated measure, will be used to assess for depression in our participants. The SADQ will be administered to determine eligibility for the trial and as an outcome measure at pre, post treatment and at 3 and 6 month follow-ups. The SADQ 10 is a valid and reliable instrument for assessing depressed mood in people with aphasia(29).\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003e3.6 Materials:\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eKalmer Relaxation Intervention:\u003c/p\u003e\n\u003cp\u003eThe Kalmer relaxation intervention is comprised of a series of co-designed (25) recordings. There are 16 videos in total, these recordings include:\u003c/p\u003e\n\u003cul\u003e\n \u003cli\u003eIntroduction to the intervention\u003c/li\u003e\n \u003cli\u003ePsycho-education video delivered by a co-design participant\u003c/li\u003e\n \u003cli\u003ea live demonstration of Progressive Muscle Relaxation (PMR)\u003c/li\u003e\n \u003cli\u003eDiaphragmatic or yogic breathing\u003c/li\u003e\n \u003cli\u003eProgressive Muscle Relaxation\u003c/li\u003e\n \u003cli\u003eGuided imaginal relaxation with rainforest, ocean, fireplace, and waterfall settings.\u003c/li\u003e\n\u003c/ul\u003e\n\u003cp\u003eThere are two versions of each of the relaxation recordings, one for people requiring low communication support where the videos contain a higher complexity of spoken language, and the second, for people requiring high communication support with a lower complexity of spoken language.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003e3.6 Intervention\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eImmediately, following baseline assessments, participants will have access to the co-designed Kalmer relaxation intervention(25) . Participants will be asked to view the videos at least 5 times per week for 5 weeks. Participants (with their carers if required) and will also receive additional therapeutic support in the form of weekly teleconference or phone sessions during the 5 week intervention periodThe support from the psychologist will involve reminders to practice, as well as addressing any issues participants may encounter using the intervention.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003e3.7 Data analytic plan\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eIt is intended to recruit between 10 to 12 participants for the case series design with each individual acting as their own control in assessing pre and post treatment data. Having at least 10 individuals will allow the researchers to assess how robust the effects are and whether there are any unique effects.\u003c/p\u003e\n\u003cp\u003eDescriptive statistics, e.g. age, gender, years since stroke etc) will be used as appropriate to describe participant demographic characteristic. For outcomes, as this is a single case design, the data will not be subjected to extensive statistical analysis. First, changes in scores on the dependent variables only will be subjected to visual scrutiny. Subsequently, if improvement appears evident, reliable change will be calculated for each participant using the Leeds Reliable Change Index Calculator (30). This involves subtracting the post treatment score from the pre-treatment score and dividing this by the standard error of the difference. The standard error of the difference describes the spread of distribution of change scores that would be expected if no actual change had occurred. This procedure adheres to the method of determining reliable change as developed by Jacobson and Truax in 1992 (31).. Baseline scores will be considered using the same method to establish stability in advance of the intervention.\u003c/p\u003e"},{"header":"4. Discussion","content":"\u003cp\u003eThis is the first known relaxation intervention co-designed by and for people with aphasia after stroke. It aims to treat anxiety and /or depression and, on that account, has the potential to improve longer-term stroke outcomes. Being online and co-designed means, it is likely accessible to many in the target population. The intervention is of reasonably low demand in terms of any therapist input so it might be integrated into the treatment arsenals of numerous stroke clinician disciplines, including, but not restricted the speech-language therapists.\u0026nbsp;\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eFuture directions:\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eFuture directions of this study include, RCTs of the relaxation intervention in the stroke population. This intervention may also be trialled in other clinical populations such as people living with traumatic brain injury, Dementia, or Multiple Sclerosis.\u0026nbsp;\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eStudy status\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eEthical apporval for the trial was received from the Human Research Ethics Committees at the University of Technology Sydney (HREC REF NO. ETH22-7466: REDS \u0026ndash; Reducing Emotional Distress in stroke survivors with Aphasia and reciprocal approval from City, University of London, School of Health and Psychological Sciences (REC Ref no._ ETH2223-0400. \u0026nbsp;The trial was pre-registered on the Australian Clinical Trial Registry Reg # ACTRN12621001051831. The first participant was enrolled \u0026nbsp;on 27/02/2022.\u003c/p\u003e"},{"header":"Declarations","content":"\u003cp\u003e\u003cstrong\u003eFunding\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eNot applicable\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eConflicts of interest/Competing interests\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eNil\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eData availability\u0026nbsp;\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eNot applicable\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eCode availability (software application or custom code)\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eNot applicable\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eAuthors\u0026apos; contributions\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eAuthors RE-H, BR, IK made a substantial contribution to the conception and design of the work, author KH contributed to aspects of the design once the study was underway. All authors drafted the work and revised it critically for important intellectual content. Further, all authors approved the version to be published and have agreed to be accountable for all aspects of the work in ensuring that questions related to the accuracy or integrity of any part of the work are appropriately investigated and resolved.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eData availability statement:\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eThe data of this study is not available or accessible to maintain the confidentiality and privacy of research participants and given there has been no ethical approval for the data from this study to be analysed or used again by other researchers.\u0026nbsp;\u003c/p\u003e"},{"header":"References","content":"\u003col\u003e\n\u003cli\u003eCumming TB, Blomstrand C, Skoog I, Linden T. The high prevalence of anxiety disorders after stroke. The American Journal of Geriatric Psychiatry. 2016;24(2):154-60.\u003c/li\u003e\n\u003cli\u003eÅström M. Generalized anxiety disorder in stroke patients: a 3-year longitudinal study. Stroke. 1996;27(2):270-5.\u003c/li\u003e\n\u003cli\u003eCarod-Artal FJ, Egido JA. Quality of life after stroke: the importance of a good recovery. Cerebrovascular diseases. 2009;27(Suppl. 1):204-14.\u003c/li\u003e\n\u003cli\u003eWest R, Hill K, Hewison J, Knapp P, House A. Psychological disorders after stroke are an important influence on functional outcomes: a prospective cohort study. Stroke. 2010;41(8):1723-7.\u003c/li\u003e\n\u003cli\u003eHackett ML, Pickles K. Part I: frequency of depression after stroke: an updated systematic review and meta-analysis of observational studies. International Journal of Stroke. 2014;9(8):1017-25.\u003c/li\u003e\n\u003cli\u003eKutlubaev MA, Hackett ML. Part II: predictors of depression after stroke and impact of depression on stroke outcome: an updated systematic review of observational studies. International Journal of Stroke. 2014;9(8):1026-36.\u003c/li\u003e\n\u003cli\u003eBarker-Collo SL. Depression and anxiety 3 months post stroke: prevalence and correlates. Archives of Clinical Neuropsychology. 2007;22(4):519-31.\u003c/li\u003e\n\u003cli\u003eSagen U, Vik TG, Moum T, M\u0026oslash;rland T, Finset A, Dammen T. Screening for anxiety and depression after stroke: Comparison of the Hospital Anxiety and Depression Scale and the Montgomery and \u0026Aring;sberg Depression Rating Scale. Journal of psychosomatic research. 2009;67(4):325-32.\u003c/li\u003e\n\u003cli\u003eShehata GA, El Mistikawi T, Al Sayed KR, Hassan HS. The effect of aphasia upon personality traits, depression and anxiety among stroke patients. Journal of affective disorders. 2015;172:312-4.\u003c/li\u003e\n\u003cli\u003eMorris R, Eccles A, Ryan B, Kneebone II. Prevalence of anxiety in people with aphasia after stroke. Aphasiology. 2017;31(12):1410-5.\u003c/li\u003e\n\u003cli\u003eAhrens J, Shao R, Blackport D, Macaluso S, Viana R, Teasell R, et al. Cognitive-behavioral therapy for managing depressive and anxiety symptoms after stroke: a systematic review and meta-analysis. Topics in Stroke Rehabilitation. 2023;30(4):368-83.\u003c/li\u003e\n\u003cli\u003eWang S-B, Wang Y-Y, Zhang Q-E, Wu S-L, Ng CH, Ungvari GS, et al. Cognitive behavioral therapy for post-stroke depression: a meta-analysis. Journal of affective disorders. 2018;235:589-96.\u003c/li\u003e\n\u003cli\u003eBaker C, Worrall L, Rose M, Ryan B. Stroke health professionals\u0026rsquo; management of depression after post-stroke aphasia: a qualitative study. Disability and Rehabilitation. 2021;43(2):217-28.\u003c/li\u003e\n\u003cli\u003eEngland N. NHS Talking Therapies, for anxiety and depression. 2023.\u003c/li\u003e\n\u003cli\u003eImprovement N. Psychological care after stroke.\u003c/li\u003e\n\u003cli\u003eKneebone II. Stepped psychological care after stroke. Disability and rehabilitation. 2016;38(18):1836-43.\u003c/li\u003e\n\u003cli\u003eJorm AF, Morgan AJ, Hetrick SE. Relaxation for depression. Cochrane Database of Systematic Reviews. 2008(4).\u003c/li\u003e\n\u003cli\u003eManzoni GM, Pagnini F, Castelnuovo G, Molinari E. Relaxation training for anxiety: a ten-years systematic review with meta-analysis. BMC psychiatry. 2008;8(1):1-12.\u003c/li\u003e\n\u003cli\u003eKneebone I, Walker-Samuel N, Swanston J, Otto E. Relaxation training after stroke: potential to reduce anxiety. Disability and rehabilitation. 2014;36(9):771-4.\u003c/li\u003e\n\u003cli\u003eGolding K, Kneebone I, Fife-Schaw C. Self-help relaxation for post-stroke anxiety: A randomised, controlled pilot study. Clinical rehabilitation. 2016;30(2):174-80.\u003c/li\u003e\n\u003cli\u003eGolding K, Fife-Schaw C, Kneebone I. Twelve month follow-up on a randomised controlled trial of relaxation training for post-stroke anxiety. Clinical rehabilitation. 2017;31(9):1164-7.\u003c/li\u003e\n\u003cli\u003eGolding K, Fife-Schaw C, Kneebone I. A pilot randomized controlled trial of self-help relaxation to reduce post-stroke depression. Clinical rehabilitation. 2018;32(6):747-51.\u003c/li\u003e\n\u003cli\u003eWang X, Thiel L, Graff Nd, editors. Mindfulness and Relaxation Techniques for Stroke Survivors with Aphasia: A Feasibility and Acceptability Study. Healthcare; 2022: MDPI.\u003c/li\u003e\n\u003cli\u003eEccles A, Morris R, Kneebone I. Psychometric properties of the Behavioural Outcomes of Anxiety questionnaire in stroke patients with aphasia. Clinical Rehabilitation. 2017;31(3):369-78.\u003c/li\u003e\n\u003cli\u003eEl-Helou R, Ryan B, Kneebone I. Development of the \u0026ldquo;Kalmer\u0026rdquo; relaxation intervention: co-design with stroke survivors with aphasia. Disability and Rehabilitation. 2023;45(9):1517-29.\u003c/li\u003e\n\u003cli\u003eLong A, Hesketh A, Bowen A. Communication outcome after stroke: a new measure of the carer\u0026rsquo;s perspective. Clinical Rehabilitation. 2009;23(9):846-56.\u003c/li\u003e\n\u003cli\u003eNouri F, Lincoln N. An extended activities of daily living scale for stroke patients. Clinical rehabilitation. 1987;1(4):301-5.\u003c/li\u003e\n\u003cli\u003eLinley‐Adams B, Morris R, Kneebone I. The Behavioural Outcomes of Anxiety scale (BOA): a preliminary validation in stroke survivors. British journal of clinical psychology. 2014;53(4):451-67.\u003c/li\u003e\n\u003cli\u003eBennett H, Thomas S, Austen R, Morris A, Lincoln N. Validation of screening measures for assessing mood in stroke patients. British Journal of Clinical Psychology. 2006;45(3):367-76.\u003c/li\u003e\n\u003cli\u003eAgostinis A, Morley S, Dowzer C. The Leeds Reliable Change Index Calculator. Retrieved form: http://www. leeds. ac. uk/lihs/psychiatry/dclin/rcic. html; 2008.\u003c/li\u003e\n\u003cli\u003eJacobson NS, Truax P. Clinical significance: a statistical approach to defining meaningful change in psychotherapy research. 1992.\u003c/li\u003e\n\u003c/ol\u003e"}],"fulltextSource":"","fullText":"","funders":[],"hasAdminPriorityOnWorkflow":false,"hasManuscriptDocX":true,"hasOptedInToPreprint":true,"hasPassedJournalQc":"","hasAnyPriority":false,"hideJournal":false,"highlight":"","institution":"","isAcceptedByJournal":false,"isAuthorSuppliedPdf":false,"isDeskRejected":"","isHiddenFromSearch":false,"isInQc":false,"isInWorkflow":false,"isPdf":false,"isPdfUpToDate":true,"isWithdrawnOrRetracted":false,"journal":{"display":true,"email":"[email protected]","identity":"discover-psychology","isNatureJournal":false,"hasQc":true,"allowDirectSubmit":false,"externalIdentity":"discpsy","sideBox":"Learn more about [Discover Psychology](https://www.springer.com/44202)","snPcode":"","submissionUrl":"","title":"Discover Psychology","twitterHandle":"","acdcEnabled":true,"dfaEnabled":true,"editorialSystem":"stoa","reportingPortfolio":"Discover Series","inReviewEnabled":true,"inReviewRevisionsEnabled":true},"keywords":"","lastPublishedDoi":"10.21203/rs.3.rs-3872461/v1","lastPublishedDoiUrl":"https://doi.org/10.21203/rs.3.rs-3872461/v1","license":{"name":"CC BY 4.0","url":"https://creativecommons.org/licenses/by/4.0/"},"manuscriptAbstract":"\u003cp\u003e\u003cstrong\u003eBackground\u003c/strong\u003e: People with stroke are at greater risk of experiencing depression and anxiety. The prevalence of these difficulties in those with the communication disorder aphasia after stroke is even higher. Relaxation training is recommended as part of stepped care for mental health difficulties for those with stroke. The potential impact of the online co-designed Kalmer relaxation intervention and thus its place within stepped care for people with post stroke aphasia is unknown.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eMethods/design:\u003c/strong\u003e This study will determine the feasibility and potential efficacy of the Kalmer relaxation intervention on people with post stroke aphasia and who met the cut off on screening instruments for anxiety and/or depression. Primary outcomes will be assessed using two observer rated scales; the Behavioural Outcomes of Anxiety (BOA) and the Stroke Aphasia Depression Questionnaire - 10 item (SADQ-10). A case series design will utilise a multiple baseline procedure. Up to 12 participants will be recruited. Consent procedures modified for those with aphasia will be employed. The Reliable Change Index will be used to determine the interventions impact on anxiety and depressive symptoms. Participants will be followed-up at 3- and 6-month intervals.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eDiscussion\u003c/strong\u003e: This study represents the first known evaluation of the online co-designed Kalmer relaxation intervention program. The results will have implications for recommending its inclusion as a recommended treatment at Step 2 of mental health care for people with aphasia after stroke.\u003c/p\u003e","manuscriptTitle":"Stepped psychological care in post-stroke aphasia: Feasibility protocol to evaluate the co- designed “Kalmer” online relaxation intervention","msid":"","msnumber":"","nonDraftVersions":[{"code":1,"date":"2024-02-07 20:38:29","doi":"10.21203/rs.3.rs-3872461/v1","editorialEvents":[{"type":"communityComments","content":0},{"type":"decision","content":"Revision requested","date":"2024-03-14T00:57:17+00:00","index":"","fulltext":""},{"type":"editorInvitedReview","content":"","date":"2024-03-13T15:34:05+00:00","index":"hide","fulltext":""},{"type":"editorInvitedReview","content":"","date":"2024-03-07T15:47:09+00:00","index":"hide","fulltext":""},{"type":"reviewerAgreed","content":"051daaa0-e644-401c-b89e-12d28ccc8f45","date":"2024-03-07T13:41:16+00:00","index":"hide","fulltext":""},{"type":"reviewerAgreed","content":"81bb27f0-5586-4ff1-9ee8-8eb0b4b0cd2e","date":"2024-03-03T08:17:48+00:00","index":"hide","fulltext":""},{"type":"reviewerAgreed","content":"c4884177-91a8-409d-a10f-922ff4d165db","date":"2024-02-28T19:36:13+00:00","index":"hide","fulltext":""},{"type":"reviewersInvited","content":"","date":"2024-02-26T08:41:55+00:00","index":"","fulltext":""},{"type":"editorAssigned","content":"","date":"2024-02-06T05:48:39+00:00","index":"","fulltext":""},{"type":"checksComplete","content":"","date":"2024-02-06T05:18:44+00:00","index":"","fulltext":""},{"type":"submitted","content":"Discover Psychology","date":"2024-01-17T09:27:26+00:00","index":"","fulltext":""}],"status":"published","journal":{"display":true,"email":"[email protected]","identity":"discover-psychology","isNatureJournal":false,"hasQc":true,"allowDirectSubmit":false,"externalIdentity":"discpsy","sideBox":"Learn more about [Discover Psychology](https://www.springer.com/44202)","snPcode":"","submissionUrl":"","title":"Discover Psychology","twitterHandle":"","acdcEnabled":true,"dfaEnabled":true,"editorialSystem":"stoa","reportingPortfolio":"Discover Series","inReviewEnabled":true,"inReviewRevisionsEnabled":true}}],"origin":"","ownerIdentity":"f2a2bc93-ad81-496e-b76f-31f4b2d6f932","owner":[],"postedDate":"February 7th, 2024","published":true,"recentEditorialEvents":[],"rejectedJournal":[],"revision":"","amendment":"","status":"in-revision","subjectAreas":[],"tags":[],"updatedAt":"2024-03-14T00:59:36+00:00","versionOfRecord":[],"versionCreatedAt":"2024-02-07 20:38:29","video":"","vorDoi":"","vorDoiUrl":"","workflowStages":[]},"version":"v1","identity":"rs-3872461","journalConfig":"researchsquare"},"__N_SSP":true},"page":"/article/[identity]/[[...version]]","query":{"redirect":"/article/rs-3872461","identity":"rs-3872461","version":["v1"]},"buildId":"qtupq5eGEP_6zYnWcrvyt","isFallback":false,"isExperimentalCompile":false,"dynamicIds":[84888],"gssp":true,"scriptLoader":[]}