安全护理医院对手动人际艺术心理治疗的评估（SCHEMA）：一项随机对照试验方案。
Secure care hospital evaluation of manualised interpersonal art-psychotherapy (SCHEMA): A randomised controlled trial protocol.
作者信息
Hackett Simon S, Foscarini-Craggs Paula, Aafjes-van Doorn Katie, Franklin Matthew, Riaz Muhammad, Zubala Ania, Condie Jennifer, McKinnon Iain, Iranpour Arman, Leigh Harrison Toni, Rose Sophie, Randell Elizabeth, McNamara Rachel
机构信息
Faculty of Medical Sciences, Baddiley-Clark Building, Richardson Road, Newcastle University Population Health Sciences Institute, Newcastle upon Tyne, England, NE2 4AX, UK.
Tyne and Wear NHS Foundation Trust, Jubilee Rd, Cumbria Northumberland, Newcastle upon Tyne, England, NE3 3X, UK.
出版信息
NIHR Open Res. 2025 Mar 7;5:21. doi: 10.3310/nihropenres.13801.1. eCollection 2025.
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/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.
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 & 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.
背景
在英国刑事司法系统中，三分之一的囚犯自我认定有学习困难和/或残疾。这与对罪犯需求的正式评估大致一致，有29%的罪犯群体有学习障碍。在英国，国民保健服务体系（NHS）以及私立/独立部门的安全护理（法医）机构，为那些在刑事司法系统中接触过且有心理健康需求、人格障碍和/或学习障碍的男性和女性提供评估和治疗。这些服务中的患者通常根据《1983年精神健康法》被拘留，和/或有司法部设定的许可条件。人际艺术心理治疗是在安全护理环境中开发的，作为一种针对轻度智力残疾或边缘智力功能成年人的可及心理干预措施。一项人际艺术心理治疗的可行性随机对照试验表明，关键可行性目标的评估得到了满足，试验程序是可接受的，这表明可以推进到确定性试验。
方法
这是一项双臂单盲随机对照试验，比较手册化人际艺术心理治疗与常规护理（UC）对UC的有效性。随机对照试验（RCT）将在至少10家拥有安全护理（法医）设施的安全护理医院（NHS和独立机构）中进行，将招募150名参与者。试验设计包括成本效益的综合评估。
结果
有智力残疾和边缘智力功能的个体参与了试验的设计和设立。该试验目前正在英国的8个NHS和私立/独立安全护理地点招募参与者。
结论
试验完成后将发表研究结果的完整报告。
试验已注册
ISRCTN57406593（ISRCTN注册库，2024年）。本发表的方案与2024年8月12日的第6版一致。
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