Evidence map›Paper›PMID 38414078›Full record

ArticleTrials2024

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.

Catharina F van der Boor, Dalili Taban, Wietse A Tol, Josephine Akellot, Melissa Neuman, Helen A Weiss, Giulia Greco, Anna Vassall, Carl May, Abhijit Nadkarni and 3 more

Erratum issuedOpen access · goldAbstract readClinical Trial Protocol
In one paragraph

Article in Trials, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. An erratum has been issued. Cited by 7 papers.

0numbers the graph read from it
0cells of the map it votes in
7citing papers in PubMed
3.8field-weighted citation impact, top 8% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

7 citing papers in PubMed, 6 citations in OpenAlex.

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4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

13 authors at 4 institutions in 5 countries.

Catharina F van der BoorFaculty 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.ORCID http://orcid.org/0000-0003-2710-7601
Dalili TabanHealthRight International, Plot 855, Mawanda Road -Kamwokya, Kampala, Uganda.
Wietse A TolDepartment of Public Health, University of Copenhagen, Bartholinsgade 4, Bg. 9, 1356 København K, CSS, Bg. 9, Building: 9.2.16, Copenhagen, Denmark.
Josephine AkellotHealthRight International, Plot 855, Mawanda Road -Kamwokya, Kampala, Uganda.
Melissa NeumanMRC International Statistics and Epidemiology Group, Faculty of Epidemiology and Population Health, London School of Hygiene and Tropical Medicine, Keppel Street, London, WC1E 7HT, UK.
Helen A WeissMRC International Statistics and Epidemiology Group, Faculty of Epidemiology and Population Health, London School of Hygiene and Tropical Medicine, Keppel Street, London, WC1E 7HT, UK.
Giulia GrecoFaculty of Public Health and Policy, London School of Hygiene and Tropical Medicine, 15-17 Tavistock Place, London, WC1H 9SH, UK.
Anna VassallFaculty of Public Health and Policy, London School of Hygiene and Tropical Medicine, 15-17 Tavistock Place, London, WC1H 9SH, UK.
Carl MayFaculty of Public Health and Policy, London School of Hygiene and Tropical Medicine, 15-17 Tavistock Place, London, WC1H 9SH, UK.
Abhijit NadkarniCentre for Global Mental Health (CGMH), Department of Population Health, London School of Hygiene & Tropical Medicine, London, UK.
Eugene KinyandaMRC/UVRI Uganda Research Unit, London School of Hygiene and Tropical Medicine, Plot 51-59 Nakiwogo Road, PO Box 49, Entebbe, Uganda.
Bayard RobertsFaculty of Public Health and Policy, London School of Hygiene and Tropical Medicine, 15-17 Tavistock Place, London, WC1H 9SH, UK.
Daniela C FuhrFaculty of Public Health and Policy, London School of Hygiene and Tropical Medicine, 15-17 Tavistock Place, London, WC1H 9SH, UK.
London School of Hygiene & Tropical Medicine · GBUganda Virus Research Institute · UGUniversity of Bremen · DEUniversity of Copenhagen · DK

Funding

Medical Research Council MC_UU_00033/3Wellcome Trust
6 · The paper itself

Abstract

backgroundThe 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.

methodsA 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 registrationISRCTN ISRCTN10360385. Registered on 30 January 2023.

Indexed as

AlcoholismPsychological DistressAdultCost-Benefit AnalysisHumansMalePsychotherapyRandomized Controlled Trials as TopicUgandaAlcohol misuseMental distressRandomised controlled trialRefugeesScalable interventions

Identifiers

PMID38414078
PMCPMC10900822
OpenAlexW4392190179

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.