Improving Social Recovery in Psychosis (ISRIP): a definitive randomised controlled trial and process evaluation of Social Recovery Therapy compared to treatment as usual for people with psychosis and severe social disability

Background: Schizophrenia spectrum disorders are the mental health problems most frequently associated with poor social outcome and the personal and economic costs are large, particularly for those from minoritised groups. Existing psychosocial interventions have small and short-term effects on social functioning, with effects being weakest for people experiencing more severe social disability. We have conducted two early phase randomised controlled trials of a novel intervention, Social Recovery Therapy (SRT) with promising effects, but a definitive trial is needed to demonstrate effectiveness and confirm wider implementation. Aims and objectives: Our primary hypothesis is that in people experiencing persistent social disability in the context of a schizophrenia spectrum diagnosis, Social Recovery Therapy plus Treatment as Usual (SRT+TAU) will be superior to TAU alone on the primary outcome of time spent in structured activity, using the Time Use Survey. Secondary outcomes will include psychotic symptoms, mood, hopefulness, and quality of life. We will also test the hypothesis that SRT will be cost-effective compared to TAU. We will collect data on intervention maintenance effects at 24 months using data from patient records on employment and education, service engagement, and relapse. Alongside the trial we will conduct a mixed methods process evaluation to understand implementation, causal mechanisms and contextual factors which shape outcomes; with a particular focus on the experiences of underserved groups and any adaptations required to increase cultural sensitivity. Methods: We will conduct a randomised controlled trial comparing SRT+TAU with TAU alone on assessor-blinded outcomes. We will recruit a diverse group of participants (N = 350) with non-affective psychosis (schizophrenia, schizophreniform, schizoaffective or delusional disorder) who are working age adults presenting with less than 30 hours in structured activity per week. SRT will be delivered by non-expert psychological practitioners working in community mental health services (Assistant Psychologists, Clinical Associate Psychologists, Mental Health and Wellbeing Practitioners) trained and supervised by expert SRT therapists. We will collect quantitative and qualitative data on how the intervention was delivered and received. We will interview service users and their families about their experiences of the intervention. In addition, we will interview SRT therapists and wider NHS stakeholders to inform our understanding about implementation. Themes will be mapped onto Normalisation Process Theory constructs and used to develop a process and system-based implementation model. Timeline: The study will be delivered over 52 months. Assessments are at baseline, 9 months, 15 months, and 24 months. The intervention is delivered over 9 months. Anticipated impact and dissemination: The research will generate high quality evidence regarding the effectiveness of SRT. The process evaluation will generate high quality mixed methods evidence to inform wider implementation of SRT in routine clinical practice. An SRT treatment manual and training package will be made freely available.