Treating depressive symptomatology in Congolese Refugees in Uganda and Rwanda: Adapting and Evaluating Community-based Sociotherapy

Refugees experience elevated rates of mental health difficulties including depression and post-traumatic stress disorder*1,2,3. Refugees face a wide-range of daily stressors (e.g. lack of access to basic resources, lack of safety and security, risk of family violence) that impact on mental health*4. Guidelines exist for delivering psychosocial support in emergency situations*5, but contention remains about which approaches are most effective, and whether these interventions can be delivered at sufficient scale*6. An absence of highly-skilled professionals means that the 'task-sharing' of roles to lay people is required*7. Community-based approaches offer promise for treating common mental disorders, are socially acceptable, and can decrease pressure on primary healthcare*8,9.

Conflict in the Democratic Republic of Congo has led to large numbers of Congolese refugees in Rwanda and Uganda. Community-based Sociotherapy (CBS) has been delivered to over 20,000 people in Rwanda since 2005 to promote community connections and individual wellbeing after the genocide of 1994*10. CBS is delivered by lay-facilitators over fifteen weekly 3-hour group sessions. The WHO described CBS as an approach that uses 'the interactions between individuals and their social environment to facilitate the re-establishment of values, norms, and relationships...and at the same time provide the opportunity for debate, the sharing of experiences and coping mechanisms'*11, Compared with usual care, CBS resulted in significantly increased civic participation and significantly decreased distress in conflict-affected people in Rwanda at 8 months follow-up*12. The UNHCR has noted the potential of CBS for refugees*13, but it has not yet been evaluated in these populations.

The project will use a mix of disciplines to: 1) adapt CBS and assessment measures for use with Congolese refugees in Rwanda and Uganda; 2) investigate the efficacy and cost-effectiveness of adapted CBS (aCBS) for reducing depressive symptoms in Congolese refugees, and determine whether changes in levels of social capital and daily stressors are integral to changes in depressive symptoms; 3) develop implementation guidance for adapting and disseminating aCBS for refugees across diverse settings in conjunction with the UNHCR.

In the first phase, the Design, Implementation, Monitoring and Evaluation (DIME) approach*14 (which utilises key informant interviews and focus groups) will be used to adapt assessment measures and aCBS content. Then a 2-arm cluster randomised controlled trial (with pilot phase) will compare aCBS to an enhanced care as usual (i.e. training for NGO workers in mental health guidelines and reviewing referral pahways). Adult Congolese refugees (apart from those with complex mental health difficulties, active suicidal ideation and/or intellectual disabilities) will be eligible to participate. This will avoid the risk of participants being stigmatised by the use of mental health labels. Analyses will take account of levels of depressive symptoms (PHQ-9*15), and whether they meet criteria for a depression on the Mini-Internal Neuropsychiatric Interview Depression Module (MINI*16) at baseline. A total of 720 participants will be recruited; 360 per study arm. Assessed outcomes will include levels of distress (SRQ-2018*17), functioning (WHOQoL-BREF*18), social capital (SASCAT*19), wellbeing (WHO-5*20), daily stressors (CDES*21), and Trauma Events Inventory*21. Participants will be assessed at baseline, 16- and 32-weeks post-baseline. A TSC/DMC will monitor the trial. The cost-effectiveness of aCBS will be evaluated. A 'process evaluation'*22 based on Normalisation Process Theory (www.normalizationprocess.org) will be undertaken to explore factors that facilitate and impede engagement with aCBS. A project webpage, Twitter account, briefings, knowledge exchange events, conference presentations and academic papers will disseminate project findings and influence decision makers.

The project team will work collaboratively with refugee communities to ensure that project activity is tailored to their needs and priorities. There is currently a limited range of psychometrically sound assessment scales for assessing mental health in refugee populations. The adaptation and development of such tools in the proposed project will be beneficial for local NGOs, and international agencies that support the mental health and wellbeing of refugees. The project also offers promise for identifying an efficacious, cost-effective and scalable intervention for reducing depressive symptoms, which is a cause of considerable health, social, and economic burden in refugee populations.

Importantly, the project will place great emphasis on building research capacity for evaluating complex interventions in Rwanda and Uganda. This will include a focus on quantitative and qualitative research methods aimed at adapting assessment measures and interventions and conducting evaluations of complex interventions in the local context. Training on the rapid qualitative Design, Implementation, Monitoring and Evaluation (DIME)*14 approach will be delivered to 3 research assistants over 15 days, which includes conducting and analysing qualitative free-listing interviews and focus group discussions. This will be complemented later in the project by an additional focused training on process evaluation techniques for the Co-Is and RAs in Uganda and Rwanda. Similarly training on quantitative methods (including data collection/management of an cRCT/health economic analysis, and data analysis) will be provided. This training will be co-ordinated by the Clinical Trials Research Center (CTRC) at University of Liverpool. CTRC staff will offer mentorship to academic partners based at Makerere University and University of Rwanda to develop skills and competencies across the duration of the project.

The project will serve to generate impact that can be evidenced at the level of the individual, region and globe. Specific areas of impact will include efforts to: 1) globally disseminate evidence-based, cost-effective non-pharmacological interventions for mental health*31; 2) alleviate the considerable burden and disability caused by common mental disorders*32; 3) address the limited availability of evidence-based psychosocial interventions in humanitarian crises*33 by developing implementation guidance for aCBS in conjunction with Community-based Sociotherapy Rwanda and UNHCR to be adapted and delivered in diverse refugee contexts to help promote mental health and wellbeing; 4) build capacity to evaluate complex interventions in challenging contexts such as refugee sites.

In line with existing guidelines*34 the research team will engage in a variety of activities to maximise the impact of the research. There will be a dedicated project web-page and Twitter account to provide regular updates on progress with the research. Two large stakeholder meetings will be will take place - a project launch event at the beginning of the project in Kigali, and a project completion meeting at the end of the project in Kampala. Briefing papers will be developed to communicate research findings with decision-makers. Ten videos resources relating to project relevant themes (e.g. refugee mental health and wellbeing, social capital, daily stressors) will be developed with the UNHCR and local NGO partners will serve as educational resources. These will be freely available through the project webpage. Members of the project team will present at the 'Inter-Agency Standing Committee' Reference Group for mental health and psycho-social support, and academic conferences e.g. Society for Social Medicine; The World Congress on Migration, Ethnicity, Race and Health. Academic papers will be submitted to high impact peer reviewed journals including: World Psychiatry, The Lancet Psychiatry, The British Journal of Psychiatry, Global Mental Health, and Transcultural Psychiatry.