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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.

Titel:	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/in / Beteiligte Person:	van der Boor CF ; Taban, D ; Tol, WA ; Akellot, J ; Neuman, M ; Weiss, HA ; Greco, G ; Vassall, A ; May, C ; Nadkarni, A ; Kinyanda, E ; Roberts, B ; Fuhr, DC
Link:	Zum Volltext
Zeitschrift:	Trials, Jg. 25 (2024-02-27), Heft 1, S. 148
Veröffentlichung:	[London] : BioMed Central, 2006-, 2024
Medientyp:	academicJournal
ISSN:	1745-6215 (electronic)
DOI:	10.1186/s13063-024-07980-7
Schlagwort:	Adult Humans Male Cost-Benefit Analysis Uganda Psychotherapy methods Randomized Controlled Trials as Topic Alcoholism diagnosis Alcoholism therapy Alcoholism psychology Psychological Distress
Sonstiges:	Nachgewiesen in: MEDLINE Sprachen: English Publication Type: Clinical Trial Protocol; Journal Article Language: English [Trials] 2024 Feb 27; Vol. 25 (1), pp. 148. <i>Date of Electronic Publication: </i>2024 Feb 27. MeSH Terms: Alcoholism* / diagnosis ; Alcoholism* / therapy ; Alcoholism* / psychology ; Psychological Distress* ; Adult ; Humans ; Male ; Cost-Benefit Analysis ; Uganda ; Psychotherapy / methods ; Randomized Controlled Trials as Topic Comments: Erratum in: Trials. 2024 Mar 21;25(1):208. (PMID: 38515145) References: UNHCR. Situation South Sudan. In: Operational Data Portal United Nations High Commissioner for Refugees. 2023. https://data.unhcr.org/en/situations/southsudan#_ga=2.173714659.1123177029.1677146387-570935053.1673194603. ; Tol WA, Augustinavicius J, Carswell K, Brown FL, Adaku A, Leku MR, García-Moreno C, Ventevogel P, White RG, Van Ommeren M. 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Grant Information: United Kingdom WT_ Wellcome Trust; MC_UU_00033/3 United Kingdom MRC_ Medical Research Council Contributed Indexing: Keywords: Alcohol misuse; Mental distress; Randomised controlled trial; Refugees; Scalable interventions Entry Date(s): Date Created: 20240228 Date Completed: 20240229 Latest Revision: 20240403 Update Code: 20240403 PubMed Central ID: PMC10900822

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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.