Resource-oriented interventions for patients with severe mental illnesses in low- and middle-income countries: trials in Bosnia-Herzegovina, Colombia and Uganda.

Background: Severe mental illness (SMI) presents a major burden to societies worldwide. Low- and middle-income countries (LMICs) often do not have sufficient financial resources and qualified staff to provide extensive specialised services for outpatients with SMI. Our research therefore aims to explore and test low-cost interventions that use existing resources in routine patient-clinician meetings, families and communities.

Methods: In Bosnia-Herzegovina, Colombia and Uganda, three psychosocial interventions will be tested, i.e. making patient-clinician meetings therapeutically effective through DIALOG+, family involvement in multi-family group meetings, and support for patients in befriending schemes with volunteers. All interventions will be provided to patients with SMI, delivered over a six-month period and evaluated with assessments at baseline and after six and 12 months. We will conduct nine trials including non-controlled trials, non-randomised controlled trials and randomised controlled trials (RCTs). Core outcome criteria will be used across all studies. However, details of study delivery and additional outcome criteria vary to accommodate local contexts, interests and priorities. The studies will be analysed separately, but with the option to compare and combine findings.

Discussion: The approach provides the opportunity to learn from commonalities and differences in the results and experiences across the three resource-oriented approaches and the three countries. If successfully implemented the studies can lead to more extensive research and are expected to inform health policies and clinical practice of community care for patients with SMI in the three participating countries and other LMICs.

Trial Registration: All RCTs were registered prospectively and non-randomised trials retrospectively within the ISRCTN Registry. DIALOG+ in Uganda: ISRCTN25146122 (Date of Registration: 20/11/2018, prospective); DIALOG+ in Colombia: ISRCTN83333181 (Date of Registration: 20/11/2018, prospective); DIALOG+ in Bosnia-Herzegovina: ISRCTN13347129 (Date of Registration: 20/11/2018, prospective); Volunteer Support in Uganda: ISRCTN86689958 (Date of Registration: 04/03/2019, retrospective); Volunteer Support in Colombia: ISRCTN72241383 (Date of Registration: 04/03/2019, retrospective);Volunteer Support in Bosnia-Herzegovina: ISRCTN51290984 (Date of Registration: 20/11/2018, prospective); Family Involvement in Uganda: ISRCTN78948497 (Date of Registration: 04/03/2019, retrospective); Family Involvement in Colombia: ISRCTN11440755 (Date of Registration: 04/03/2019, retrospective); Family Involvement in Bosnia-Herzegovina: ISRCTN13347355 (Date of Registration: 20/11/2018, prospective).