Feasibility randomised controlled trial of ‘On the Road to Recovery’

Primary study outcomes relate to the feasibility and acceptability of key trial procedures
1. Number of eligible participants identified over the study period, indexed by the total number of participants identified across sites who meet eligibility criteria.
2. Rate of recruitment into the trial, measured in two ways: the proportion of eligible participants who consent to participate, and the number of participants enrolled into the study each month during the recruitment period
3. Adherence to randomization procedure: the number of instances where the actual treatment allocation differed from assigned allocation, measured after all participants have been randomised
4. Overall completion rate of OTRTR therapy and average number of sessions attended (in proportion to number of sessions offered). Participants will be considered to have completed OTRTR if they attended at least 80% of the offered sessions. Measured at post treatment timepoint, T2
5. Reasons for study drop-out. Participants will have the option to provide a reason for why they wish to discontinue to the study, collected by the researcher at the time of exit from the study
6. Overall completion rate of primary clinical outcome measures weekly during treatment phase. The proportion of BIS and CSQ forms completed as intended each week during the treatment phase (between T1 and T2)
7. Completion rate of standardized recording forms by OTRTR therapy facilitators based on therapy content delivered, measured by proportion of complete forms at post treatment timepoint, T2
8. Number of participants lost to follow up and reasons, measured at post treatment timepoint T2 and 3-month follow up T3
9. Safety of OTRTR, measured using descriptive statistics for frequency of observed adverse events (AEs) and serious adverse events (SAEs) across treatment conditions. The incident rate of SAEs for study participants is also compared to the rate observed for each participant in the 12 weeks prior to enrolment in the study. This reference data will be requested from the local site clinical effectiveness departments or equivalents following study completion. An AE is considered to have occurred if either of the following takes place: a participant is removed from the study at the request of their responsible medical officer (RMO) due to significant deterioration in the patient’s mental state and/or behaviour, and a participant’s global CORE-34-OM score (indexes overall psychiatric distress) increases from the previous assessment to an extent that is both clinically significant and reliable (as defined in Evans et al., 2002). An SAE is considered to have occurred if a participant commits an act of violence resulting in injury to another person, commits serious self-harm, attempted suicide, or suicide
10. Average duration (in minutes) of assessments at baseline (T1), post-treatment (T2), and 3-month follow up (T3)
11. Acceptability of the OTRTR programme and trial for participants, assessed in optional post-study interview analysed using thematic analysis

Secondary outcomes relate to estimating the therapeutic effects on the following outcomes. All clinical outcomes will be measured at baseline (T1), post intervention (T2), and 3-month follow up (T3). Effect sizes will be calculated by comparing group means at T2 covarying for T1 differences; repeated using T3 means to estimate maintenance of therapeutic effects. Change in institution-recorded incidents of aggression and violence, as well as institutional privileges will be analysed using descriptive statistics only.

Primary clinical outcomes:
1. Insight into mental disorder, measured using the Birchwood Insight Scale (Birchwood et al., 1994)
2. Use of adaptive coping skills, measured using the Coping Styles Questionnaire (Roger et al., 1993)

Secondary clinical outcomes:
3. Self-rated psychological distress, measured using the Clinical Outcomes in Routine Evaluation (Evans et al., 2000)
4. Self esteem, measured using the Rosenberg Self Esteem Scale (Rosenberg, 1965)
5. Recovery progress, measured using the Questionnaire on the Process of Recovery (Neil et al., 2009)
6. Psychiatric symptom severity, measured using the Brief Psychiatric Rating Scale (Overall & Gorham, 1962)
7. Institution-recorded incidents of physical aggression and violence. The number of incidents of violence/aggression during the study treatment phase and 3-month follow up period will be compared across treatment groups. This information will be requested from the local site clinical effectiveness department (or local equivalent) as participants complete the 3-month follow up period
8. Institutional privileges (e.g. grounds access, unsupervised phone calls, patient outings). Changes in institutional privileges (e.g. increased grounds access, unsupervised phone calls, patient outings) will be measured for all participants during the study at T2 and T3. This information will be collected from the local site clinical effectiveness department (or local equivalent) as participants complete T3