Social recovery therapy in combination with early intervention services for enhancement of social recovery in patients with first-episode psychosis (SUPEREDEN3): a single-blind, randomised controlled trial07 Feb 2018
SUMMARY Background: We conducted a randomised controlled trial to evaluate the efficacy of enhancing social recovery from First Episode Psychosis (FEP) by augmenting Early Intervention Service (EIS) provision with Social Recovery Therapy (SRT). The primary hypothesis was that SRT plus EIS would lead to improvements in social recovery. Methods: SUPEREDEN3 was an assessor blind randomised controlled trial. It was conducted at 4 specialist Early Intervention Services across the UK. Participants had (a) been clients of Early Intervention Services for 12-30 months; and (b) showed persistent and severe social disability defined as engaged in less than 30 hours per week of structured activity. Participants were randomised 1:1. Assessment of outcomes was conducted at baseline, 9 months (post intervention) and 15 month follow up. The primary outcome was time spent in structured activity at 9 months. The trial is registered (ISRCTN61621571). Findings: 75 (49%) of 154 participants were assigned to SRT plus EIS and 79 (51%) were assigned to EIS alone. At 9 months 143 participants (93%) provided data on the primary outcome. Randomisation to SRT plus EIS was associated with an increase in structured activity of 8.1 hours greater than EIS alone (95% CI 2.5 to 13.6; p = 0.0050). Jointly modelling loss to follow up and secondary outcomes provided supportive evidence of continued effects of SRT plus EIS. Interpretation: The findings show a clinically important benefit of enhanced social recovery for the SRT plus EIS group on the primary outcome of structured activity. Funding: National Institute for Health Research (NIHR).