Effectiveness and cost-effectiveness of a transdiagnostic intervention for alcohol misuse and psychological distress in humanitarian settings: study protocol for a randomised controlled trial in Uganda.

BACKGROUND: The war in South Sudan has displaced more than four million people, with Uganda hosting the largest number of South Sudanese refugees. Research in Uganda has shown elevated levels of alcohol misuse and psychological distress among these refugees. The World Health Organization (WHO) has developed a trans-diagnostic scalable psychological intervention called Problem Management Plus (PM +) to reduce psychological distress among populations exposed to adversities. Our study aims to evaluate the effectiveness and cost-effectiveness of the CHANGE intervention, which builds on PM + , to also address alcohol misuse through problem-solving therapy and selected behavioural strategies for dealing with alcohol use disorders. We hypothesise that the CHANGE intervention together with enhanced usual care (EUC) will be superior to EUC alone in increasing the percentage of days abstinent. METHODS: A parallel-arm individually randomised controlled trial will be conducted in the Rhino Camp and Imvepi settlements in Uganda. Five hundred adult male South Sudanese refugees with (i) elevated levels of alcohol use (between 8 and 20 on the Alcohol Use Disorder Identification Test [AUDIT]); and (ii) psychological distress (> 16 on the Kessler Psychological Distress Scale) will be randomly assigned 1:1 to EUC or CHANGE and EUC. CHANGE will be delivered by lay healthcare providers over 6 weeks. Outcomes will be assessed at 3 and 12 months post-randomisation. The primary outcome is the percentage of days abstinent, measured by the timeline follow-back measure at 3 months. Secondary outcomes include percentage of days abstinent at 12 months and alcohol misuse (measured by the AUDIT), psychological distress (i.e. depression, anxiety, posttraumatic stress disorder), functional disability, perpetration of intimate partner violence, and health economic indicators at 3 and 12 months. A mixed-methods process evaluation will investigate competency, dose, fidelity, feasibility, and acceptability. Primary analyses will be intention-to-treat. DISCUSSION: CHANGE aims to address alcohol misuse and psychological distress with male refugees in a humanitarian setting. If it is proven to be effective, it can help fill an important under-researched gap in humanitarian service delivery. TRIAL REGISTRATION: ISRCTN ISRCTN10360385. Registered on 30 January 2023.

Using theory of change to plan for the implementation of a psychological intervention addressing alcohol use disorder and psychological distress in Uganda.

In conflict-affected settings, prevalence of alcohol use disorders (AUDs) can be high. However, limited practical information exists on AUD management in low-income settings. Using a theory of change (ToC) approach, we aimed to identify pathways influencing the implementation and maintenance of a new transdiagnostic psychological intervention ("CHANGE"), targeting both psychological distress and AUDs in humanitarian settings. Three half-day workshops in Uganda engaged 41 stakeholders to develop a ToC map. ToC is a participatory program theory approach aiming to create a visual representation of how and why an intervention leads to specific outcomes. Additionally, five semi-structured interviews were conducted to explore experiences of stakeholders that participated in the ToC workshops. Two necessary pathways influencing the implementation and maintenance of CHANGE were identified: policy impact, and mental health service delivery. Barriers identified included policy gaps, limited recognition of social determinants and the need for integrated follow-up care. Interviewed participants valued ToC's participatory approach and expressed concerns about its adaptability in continuously changing contexts (e.g., humanitarian settings). Our study underscores ToC's value in delineating context-specific outcomes and identifies areas requiring further attention. It emphasizes the importance of early planning and stakeholder engagement for sustainable implementation of psychological interventions in humanitarian settings.