Moderated Online Social Therapy for Carers of Early Psychosis Clients in Real-World Settings: Cluster Randomized Controlled Trial.

BACKGROUND:Family carers of youth recovering from early psychosis experience significant stress; however, access to effective family interventions is poor. Digital interventions provide a promising solution. OBJECTIVE:Our objective was to evaluate across multiple Australian early psychosis services the effectiveness of a novel, web-based early psychosis intervention for carers. METHODS:In this cluster randomized controlled trial conducted across multiple Australian early psychosis services, our digital moderated online social therapy for carers (Altitudes) plus enhanced family treatment as usual (TAU) was compared with TAU alone on the primary outcome of perceived stress and secondary outcomes including mental health symptoms and family variables at the 6-month follow-up. RESULTS:Eighty-six caregivers were randomized and data were available for 74 young people in their care. Our primary hypothesis that carers randomized to Altitudes+TAU would report greater improvements in perceived stress at follow-up compared with carers randomized to TAU alone was not supported, with the TAU alone group showing more improvement. For secondary outcomes, the TAU alone group showed improved mindfulness over time. Regardless of group assignment, we observed improvements in satisfaction with life, quality of life, emotional overinvolvement, and burden of care. In contrast, hair cortisol concentration increased. Post hoc analyses revealed more contact with early psychosis services in the intervention group compared to TAU alone and that improvements in perceived stress and social support were associated with use of the intervention in the Altitudes+TAU group. In this study, 80% (12/15) reported a positive experience with Altitudes and 93% (14/15) would recommend it to others. CONCLUSIONS:Our trial did not show a treatment effect for Altitudes in perceived stress. However, our post hoc analysis indicated that the amount of use of Altitudes related to improvements in stress and social support. Additional design work is indicated to continue users' engagement and to significantly improve outcomes in problem-solving, communication, and self-care. TRIAL REGISTRATION:Australian and New Zealand Clinical Trials Registry ACTRN12617000942358; https://trialsearch.who.int/Trial2.aspx?TrialID=ACTRN12617000942358.