A randomized Controlled Trial of Moderated Online Social Therapy for Carers of Early Psychosis Clients in Real World Settings: The East-West Altitudes Study (Preprint)

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 online early psychosis intervention for carers. METHODS In this cluster RCT conducted across multiple Australian early psychosis services, our digital moderated online social therapy for carers (Altitudes) was compared with enhanced family treatment as usual (TAU) on the primary outcome of perceived stress and secondary outcomes including mental health symptoms and family variables at 6 months follow-up. RESULTS 86 caregivers were randomized and data was available for 74 young people. Our primary hypothesis that carers randomized to Altitudes would report greater improvements in perceived stress at follow-up compared with carers randomized to TAU was not supported with the TAU group showing more improvement (p=.032). For secondary outcomes, the TAU group showed improved mindfulness over time (p=.036). Regardless of group assignment, we observed improvements in satisfaction with life (p=.043), quality of life (p=.037), emotional over-involvement (p=.012) and burden of care (p=.005). In contrast, hair cortisol concentration increased (p=.041). Post hoc analyses revealed more contact with early psychosis services in the intervention group compared to TAU (p=.006) and that improvements in perceived stress (p=.008) and social support (p=0.015) were associated with use of the intervention in the Altitudes group. 80% reported a positive experience with Altitudes and 93% 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 amount of use of Altitudes related to improvements in stress and social support. Additional design work is indicated to sustain users’ engagement and to significantly improve outcomes in problem solving, communication, and self-care. CLINICALTRIAL ACTRN12617000942358p