Results from a randomized controlled trial investigating effectiveness of a community-based intervention on empowerment of people with severe mental illness.

PURPOSE

The effectiveness of community mental health services with respect to enhancing empowerment among patients with severe mental illness (SMI) has rarely been investigated. In this multicenter trial the effectiveness of a community mental health intervention (acronym: GBV) added to treatment as usual (TAU) compared to TAU alone was investigated.

METHODS

In a randomized controlled multicenter trial with twelve sites spread across Germany, people living with SMI aged 18-82 years were investigated over 24 months. The trial was conducted from 2020 to 2023, a time period affected by the Covid-19 pandemic. The intervention was delivered by multiprofessional GBV teams based on the Functional Assertive Community Treatment (FACT) program and was supplemented by strategies that increase the degree of self-determination. The primary outcome was measured by the Assessment of Empowerment in Patients with Affective and Schizophrenic Disorders (EPAS). Difference in difference (DiD) effect sizes were estimated on an intention-to-treat basis.

RESULTS

A total of 929 persons with SMI were randomly assigned to the GBV plus TAU intervention (n = 470) or to TAU alone (n = 459). The dropout rate over 24 months amounted to 28%. DiD effect sizes over 24 months indicate significant treatment effects for empowerment (d = 0.27; 95% CI = 0.14 0.40). Serious adverse events (SAE) were reported for 15 (3.2%) participants in the GBV + TAU vs. 17 (3.7%) in the TAU group.

CONCLUSION

The addition of GBV to TAU, for patients with SMI, can be recommended as an effective measure to improve key psychosocial outcomes in mental health care settings across Germany.

TRIAL REGISTRATION

German Clinical Trial Register, DRKS00019086. Registered on 3 January 2020, https://drks.de/search/de/trial/DRKS00019086 .