{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2025,12,31]],"date-time":"2025-12-31T17:55:43Z","timestamp":1767203743592,"version":"build-2238731810"},"update-to":[{"DOI":"10.3310\/nihropenres.13801.1","type":"new_version","label":"New version","source":"publisher","updated":{"date-parts":[[2025,5,28]],"date-time":"2025-05-28T00:00:00Z","timestamp":1748390400000}}],"reference-count":58,"publisher":"National Institute for Health and Care Research","license":[{"start":{"date-parts":[[2025,5,28]],"date-time":"2025-05-28T00:00:00Z","timestamp":1748390400000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"funder":[{"DOI":"10.13039\/501100000272","name":"National Institute for Health and Care Research","doi-asserted-by":"publisher","award":["NIHR301264"],"award-info":[{"award-number":["NIHR301264"]}],"id":[{"id":"10.13039\/501100000272","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["openresearch.nihr.ac.uk"],"crossmark-restriction":false},"short-container-title":["NIHR Open Res"],"abstract":"<ns3:p>Background 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\/or 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. Methods 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 &amp; Independent) with secure care (Forensic) facilities and will recruit 150 participants. The trial design includes an integrated assessment of cost-effectiveness. Results 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. Conclusions A full report of study results will be published on completion of the trial. The trial has been registered ISRCTN57406593 (ISRCTN registry, 2024). This published protocol corresponds with version 6, dated 12.08.2024.<\/ns3:p>","DOI":"10.3310\/nihropenres.13801.2","type":"journal-article","created":{"date-parts":[[2025,5,28]],"date-time":"2025-05-28T12:25:09Z","timestamp":1748435109000},"page":"21","update-policy":"https:\/\/doi.org\/10.3310\/nihropenres.crossmark-policy","source":"Crossref","is-referenced-by-count":0,"title":["Secure care (forensic) hospital evaluation of manualised interpersonal art-psychotherapy (SCHEMA): A randomised controlled trial protocol"],"prefix":"10.3310","volume":"5","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-7861-5991","authenticated-orcid":false,"given":"Simon S.","family":"Hackett","sequence":"first","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-9511-696X","authenticated-orcid":false,"given":"Paula","family":"Foscarini-Craggs","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-2584-5897","authenticated-orcid":false,"given":"Katie","family":"Aafjes-van Doorn","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Matthew","family":"Franklin","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-5512-1745","authenticated-orcid":false,"given":"Muhammad","family":"Riaz","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Ania","family":"Zubala","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0009-0005-1991-1706","authenticated-orcid":false,"given":"Jennifer","family":"Condie","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-5760-9824","authenticated-orcid":false,"given":"Iain","family":"McKinnon","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Arman","family":"Iranpour","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Toni","family":"Leigh Harrison","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0009-0001-0172-8138","authenticated-orcid":false,"given":"Sophie","family":"Rose","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-1606-3175","authenticated-orcid":false,"given":"Elizabeth","family":"Randell","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-7280-1611","authenticated-orcid":false,"given":"Rachel","family":"McNamara","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"6221","published-online":{"date-parts":[[2025,5,28]]},"reference":[{"key":"ref-1","doi-asserted-by":"publisher","DOI":"10.3389\/fpsyt.2023.1128252","article-title":"Effectiveness and mechanisms of the arts therapies in forensic care. 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status","group":{"name":"current-referee-status","label":"Current Referee Status"}},{"value":"10.3310\/nihropenres.14993.r34956, Dominik Havsteen-Franklin, Brunel University London, London, 10 Apr 2025, version 1, indexed","URL":"https:\/\/openresearch.nihr.ac.uk\/articles\/5-21\/v1#referee-response-34956","order":0,"name":"referee-response-34956","label":"Referee Report","group":{"name":"article-reports","label":"Article Reports"}},{"value":"<b>Simon Hackett<\/b>; \n<i>Posted: 09 May 2025<\/i>; \n<b>Comparator (UC)<\/b> 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 analysis\n<sup>1<\/sup>(Ref-1). It also would be helpful to know whether site-level variability will be modelled&nbsp;\n<sup>2,3<\/sup>.  \n<b>Response:<\/b> Site-level variability will not be modelled. To describe potential site variability, as set out under the protocol heading \u2018Comparator\u2019, \n<i>\u2018<\/i>\n<i>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).\u2019<\/i>  \n<b>Attrition Management<\/b> 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 integrity\n<sup>4<\/sup>.  \n<b>Response:<\/b> 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.  \n<b>Secondary Outcome Measures<\/b> While ReQoL UI and EQ-5D-3L are appropriate and widely used, their responsiveness and conceptual alignment with this specific population could be further justified\n<sup>5<\/sup>. Further, in the event of discordant results, it would be useful to clarify how these would be interpreted in the analysis.  \n<b>Response:<\/b> 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 \u201cconceptual alignment\u201d (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 \u201cresponsiveness\u201d (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 \u2018cost-effectiveness\u2019 section of the paper to address the reviewer\u2019s comment: \u201cWe are unaware of any previous psychometric results that aid with understanding the appropriateness of the EQ-5D-3L and ReQoL measures in our trial\u2019s 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.\u201d  \n<b>Data Governance and Accessibility<\/b> 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.  \n<b>Response:<\/b> 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.  \n<b>Workforce and Implementation Considerations<\/b> 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 scalability\n<sup>6,7,8,9<\/sup>.  \n<b>Response:<\/b> This topic, \u2018workforce and implementation considerations\u2019 does not form part of the current study protocol. We will report upon \u2018Compliance and treatment fidelity\u2019, and therefore describe any differences in manual adherence by therapists during intervention delivery that might influence outcomes.  \n<b>Qualitative Component<\/b> 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 questions\n<sup>10,11,12,13<\/sup>.  \n<b>Response:<\/b> Further justification for sample size has been included, with additions made to the qualitative analysis. Additional supporting references - Pons-Vigu&eacute;s M, Berenguera A, Coma-Auli N, March S, et al. (2019) and - Guest, G., Bunce, A., &amp; Johnson, L. (2006) have now been included.","URL":"https:\/\/openresearch.nihr.ac.uk\/articles\/5-21\/v2#referee-comment-3433","order":1,"name":"referee-comment-3433","label":"Referee Comment","group":{"name":"article-reports","label":"Article Reports"}},{"value":"10.3310\/nihropenres.14993.r34953, Emma Gentle, Health, Southern Cross University, New South Wales, 15 Apr 2025, version 1, indexed","URL":"https:\/\/openresearch.nihr.ac.uk\/articles\/5-21\/v1#referee-response-34953","order":2,"name":"referee-response-34953","label":"Referee Report","group":{"name":"article-reports","label":"Article Reports"}},{"value":"<b>Simon Hackett<\/b>; \n<i>Posted: 09 May 2025<\/i>; Title: For someone outside the UK it may be useful to put forensic in brackets after secure care  \n<b>Response: <\/b>Additional text, (forensic), has been added to the title.\n<b> <\/b>  in paragraph 2 in the&nbsp;Introduction, I suggest you to please revise the sentences -&nbsp;  \n<i>Background: and\/or learning disability and in paragraph 2 in the&nbsp;Introduction- unless this is a way of writing and\/or that I am unfamiliar with&quot;.&nbsp;<\/i>  \n<i>Background: a personality disorder, and\/a learning disability&nbsp;- change to and\/or<\/i> \n<i>Introduction: a personality disorder, and\/a learning\/intellectual disability (ID)&nbsp;- change to and\/or<\/i>  \n<b>Response:<\/b>\n<i> <\/i>Thank you, wording has been changed as suggested.  Introduction Third paragraph: considered long stayers  \n<b>Response:<\/b> Thank you, wording has been changed as suggested.  Methods   Prohibited treatments section does not flow easily  \n<b>Response: <\/b>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  \n<b>Response: <\/b>The language in the qualitative analysis section has been revised and edited.  P12 **Note: Hospitalisation is defined as an&nbsp;\n<u>impatient&nbsp;<\/u>admission.  \n<b>Response:<\/b> Thank you, wording has been changed as suggested.","URL":"https:\/\/openresearch.nihr.ac.uk\/articles\/5-21\/v2#referee-comment-3434","order":3,"name":"referee-comment-3434","label":"Referee Comment","group":{"name":"article-reports","label":"Article Reports"}},{"value":"This project is funded by the National Institute for Health and Care Research (NIHR) under its [\u2018HEE\/NIHR ICA Programme\u2019 (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.","order":4,"name":"grant-information","label":"Grant Information"},{"value":"This is an open access article distributed under the terms of the Creative Commons Attribution Licence, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.","order":0,"name":"copyright-info","label":"Copyright"}]}}