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.

Autor: van der Boor CF; Faculty of Public Health and Policy, London School of Hygiene and Tropical Medicine, 15-17 Tavistock Place, London, WC1H 9SH, UK. catharina.van-der-boor@lshtm.ac.uk., Taban D; HealthRight International, Plot 855, Mawanda Road -Kamwokya, Kampala, Uganda., Tol WA; Department of Public Health, University of Copenhagen, Bartholinsgade 4, Bg. 9, 1356 København K, CSS, Bg. 9, Building: 9.2.16, Copenhagen, Denmark., Akellot J; HealthRight International, Plot 855, Mawanda Road -Kamwokya, Kampala, Uganda., Neuman M; MRC International Statistics and Epidemiology Group, Faculty of Epidemiology and Population Health, London School of Hygiene and Tropical Medicine, Keppel Street, London, WC1E 7HT, UK., Weiss HA; MRC International Statistics and Epidemiology Group, Faculty of Epidemiology and Population Health, London School of Hygiene and Tropical Medicine, Keppel Street, London, WC1E 7HT, UK., Greco G; Faculty of Public Health and Policy, London School of Hygiene and Tropical Medicine, 15-17 Tavistock Place, London, WC1H 9SH, UK., Vassall A; Faculty of Public Health and Policy, London School of Hygiene and Tropical Medicine, 15-17 Tavistock Place, London, WC1H 9SH, UK., May C; Faculty of Public Health and Policy, London School of Hygiene and Tropical Medicine, 15-17 Tavistock Place, London, WC1H 9SH, UK., Nadkarni A; Centre for Global Mental Health (CGMH), Department of Population Health, London School of Hygiene & Tropical Medicine, London, UK.; Addictions Research Group, Sangath, Goa, India., Kinyanda E; MRC/UVRI Uganda Research Unit, London School of Hygiene and Tropical Medicine, Plot 51-59 Nakiwogo Road, PO Box 49, Entebbe, Uganda., Roberts B; Faculty of Public Health and Policy, London School of Hygiene and Tropical Medicine, 15-17 Tavistock Place, London, WC1H 9SH, UK., Fuhr DC; Faculty of Public Health and Policy, London School of Hygiene and Tropical Medicine, 15-17 Tavistock Place, London, WC1H 9SH, UK.; Department of Prevention and Evaluation, Leibniz Institute for Prevention Research and Epidemiology, Achterstraße 30, 28359, Bremen, Germany.; Health Sciences, University of Bremen, Bremen, Germany.
Jazyk: angličtina
Zdroj: Trials [Trials] 2024 Feb 27; Vol. 25 (1), pp. 148. Date of Electronic Publication: 2024 Feb 27.
DOI: 10.1186/s13063-024-07980-7
Abstrakt: 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.
(© 2024. The Author(s).)
Databáze: MEDLINE
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