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

<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>