On the Road to Recovery psychological therapy versus treatment as usual for forensic mental health patients: study protocol for a randomized controlled feasibility trial.

Background: On the Road to Recovery (OTRTR) is a brief low intensity group psychological therapy that aims to improve patients' insight into their mental disorder and develop adaptive coping skills to help manage distress. OTRTR is currently delivered in forensic mental health services in Scotland. However, to date, this therapy has not been evaluated as to its effectiveness or safety for forensic patients.

Methods: This is a parallel-group feasibility randomized controlled trial with single-blind assessments comparing OTRTR therapy to treatment as usual (TAU) for forensic mental health patients. Fifty participants will be recruited from high, medium, and low secure forensic mental health services in Scotland. Participants will receive OTRTR for approximately 12 weeks or continue treatment as usual for 12 weeks. The trial's primary aims relate to testing the acceptability and feasibility of key trial procedures that would be necessary for a definitive RCT of OTRTR. The secondary aims include estimating therapeutic effect sizes on clinical outcomes including insight and coping skills. The study design also features an adverse event monitoring plan to estimate the safety of OTRTR for participants, as well as use of intensive longitudinal methods to identify "key ingredients" to the OTRTR therapy protocol.

Discussion: This study will inform the design and sample size for a future full-scale randomized controlled trial (RCT), which will be conducted to determine the effectiveness of the On the Road to Recovery intervention in improving forensic mental health patients' clinical insight and coping skills.

Trial registration: ISRCTN Registry, ISRCTN75126867 registered 27 July 2017.