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Trials
Published in: Trials 1/2024

Open Access 01-12-2024 | Study protocol

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

Authors: 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, Eugene Kinyanda, Bayard Roberts, Daniela C. Fuhr

Published in: Trials | Issue 1/2024

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Abstract

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.
Literature
1.
2.
Tol WA, Augustinavicius J, Carswell K, Brown FL, Adaku A, Leku MR, García-Moreno C, Ventevogel P, White RG, Van Ommeren M. Translation, adaptation, and pilot of a guided self-help intervention to reduce psychological distress in South Sudanese refugees in Uganda. Global Mental Health. 2018;5: e25.PubMedPubMedCentralCrossRef
3.
4.
Adaku A, Okello J, Lowry B, Kane JC, Alderman S, Musisi S, Tol WA. Mental health and psychosocial support for South Sudanese refugees in northern Uganda: a needs and resource assessment. Conflict Health. 2016;10:1.CrossRef
5.
6.
Kohn R, Saxena S, Levav I, Saraceno B. The treatment gap in mental health care. Bull World Health Organ. 2004;82(11):858–66.PubMedPubMedCentral
7.
Kigozi F, Ssebunnya J, Kizza D, Cooper S, Ndyanabangi S, the Mental Health and Poverty Project. An overview of Uganda’s mental health care system: results from an assessment using the world health organization’s assessment instrument for mental health systems (WHO-AIMS). Int J Ment Health Syst. 2010;4(1):1.PubMedPubMedCentralCrossRef
8.
Tol WA, Ager A, Bizouerne C, Bryant R, El Chammay R, Colebunders R, et al. Improving mental health and psychosocial wellbeing in humanitarian settings: reflections on research funded through R2HC. Confl Health. 2020;14(1):71.PubMedPubMedCentralCrossRef
9.
Roberts B, Fuhr DC. Scaling up mental health interventions in conflict zones. Lancet Public Health. 2019;4(10):e489–90.PubMedCrossRef
10.
Dawson KS, Bryant RA, Harper M, Kuowei Tay A, Rahman A, Schafer A, et al. Problem Management Plus (PM+): a WHO transdiagnostic psychological intervention for common mental health problems. World Psychiatry. 2015;14(3):354–7.PubMedPubMedCentralCrossRef
11.
Rahman A, Riaz N, Dawson KS, Hamdani SU, Chiumento A, Sijbrandij M, et al. Problem Management Plus (PM+): pilot trial of a WHO transdiagnostic psychological intervention in conflict-affected Pakistan. World Psychiatry. 2016;15(2):182.PubMedPubMedCentralCrossRef
12.
Sangraula M, Turner EL, Luitel NP, Van’t Hof E, Shrestha P, Ghimire R, Bryant R, Marahatta K, Van Ommeren M, Kohrt BA, Jordans MJ. Feasibility of Group Problem Management Plus (PM+) to improve mental health and functioning of adults in earthquake-affected communities in Nepal. Epidemiol Psychiatr Sci. 2020;29:e130.PubMedPubMedCentralCrossRef
13.
Acarturk C, Uygun E, Ilkkursun Z, Yurtbakan T, Kurt G, Adam-Troian J, et al. Group problem management plus (PM+) to decrease psychological distress among Syrian refugees in Turkey: a pilot randomised controlled trial. BMC Psychiatry. 2022;22(1):8.PubMedPubMedCentralCrossRef
14.
Bryant RA, Bawaneh A, Awwad M, Al-Hayek H, Giardinelli L, Whitney C, Jordans MJ, Cuijpers P, Sijbrandij M, Ventevogel P, Dawson K. Effectiveness of a brief group behavioral intervention for common mental disorders in Syrian refugees in Jordan: a randomized controlled trial. PLoS Med. 2022;19(3):e1003949.PubMedPubMedCentralCrossRef
15.
De Graaff AM, Cuijpers P, Twisk JW, Kieft B, Hunaidy S, Elsawy M, Gorgis N, Bouman TK, Lommen MJ, Acarturk C, Bryant R. Peer-provided psychological intervention for Syrian refugees: results of a randomised controlled trial on the effectiveness of Problem Management Plus. BMJ Ment Health. 2023;26(1).
16.
Schäfer SK, Thomas LM, Lindner S, Lieb K. World Health Organization’s low-intensity psychosocial interventions: a systematic review and meta-analysis of the effects of Problem Management Plus and Step-by-Step. World Psychiatry Off J World Psychiatr Assoc WPA. 2023;22(3):449–62.
17.
Grant BF, Stinson FS, Dawson DA, Chou SP, Dufour MC, Compton W, et al. Prevalence and co-occurrence of substance use disorders and independentmood and anxiety disorders: Results from the national epidemiologic survey on alcohol and relatedconditions. Arch Gen Psychiatry. 2004;61(8):807–16.PubMedCrossRef
18.
Fuhr DC, Bogdanov S, Tol WA, Nadkarni A, Roberts B. Problem Management Plus and Alcohol (PM+ A): A new intervention to address alcohol misuse and psychological distress among conflict-affected populations. Interv J Ment Health Psychosoc Support Confl Affect Areas. 2021;19(1):141–3.
19.
Nadkarni A, Massazza A, Guda R, Fernandes LT, Garg A, Jolly M, et al. Common strategies in empirically supported psychological interventions for alcohol use disorders: a meta-review. Drug Alcohol Rev. 2023;42(1):94–104.PubMedCrossRef
20.
Massazza A, Fuhr DC, Bogdanov S, Tol WA, Roberts B, Nadkarni A, et al. A Complex intervention for alcohol misuse among conflict-affected populations in uganda and ukraine: study protocol for the qualitative components in the CHANGE trial. Int J Qual Methods. 2021;20:160940692110630.CrossRef
21.
22.
23.
Saunders JB, Aasland OG, Babor TF, de la Fuente JR, Grant M. Development of the alcohol use disorders identification test (AUDIT): WHO collaborative project on early detection of persons with harmful alcohol consumption–II. Addict Abingdon Engl. 1993;88(6):791–804.CrossRef
24.
Kessler RC, Andrews G, Colpe LJ, Hiripi E, Mroczek DK, Normand SLT, et al. Short screening scales to monitor population prevalences and trends in non-specific psychological distress. Psychol Med. 2002;32(6):959–76.PubMedCrossRef
25.
Stuart J, Nowosad J. The influence of premigration trauma exposure and early postmigration stressors on changes in mental health over time among refugees in Australia. J Trauma Stress. 2020;33(6):917–27.PubMedCrossRef
26.
27.
Durand M. The OECD Better Life Initiative: How’s Life? and the Measurement of Well-Being. Rev Income Wealth. 2015;61(1):4–17.CrossRef
28.
Sobell LC, Sobell MB. Timeline follow-back: A technique for assessing self-reported alcohol consumption. In Measuring alcohol consumption: Psychosocial and biochemical methods 1992 (pp. 41–72). Totowa, NJ: Humana Press.
29.
Humeniuk R, Ali R, Babor TF, Farrell M, Formigoni ML, Jittiwutikarn J, et al. Validation of the alcohol, smoking and substance involvement screening test (ASSIST). Addiction. 2008;103(6):1039–47.PubMedCrossRef
30.
Kroenke K, Spitzer RL. The PHQ-9: a new depression diagnostic and severity measure. Psychiatr Ann. 2002;32(9):509–15.CrossRef
31.
Derogatis LR, Lipman RS, Rickels K, Uhlenhuth EH, Covi L. The Hopkins Symptom Checklist (HSCL): a self-report symptom inventory. Behav Sci. 1974;19(1):1–15.PubMedCrossRef
32.
Lang AJ, Wilkins K, Roy-Byrne PP, Golinelli D, Chavira D, Sherbourne C, et al. Abbreviated PTSD Checklist (PCL) as a guide to clinical response. Gen Hosp Psychiatry. 2012;34(4):332–8.PubMedPubMedCentralCrossRef
33.
Ustun TB, Kostanjesek N, Chatterji S, Rehm J, World Health Organization. Measuring health and disability: manual for WHO Disability Assessment Schedule (WHODAS 2.0)/edited by TB Üstün, N. Kostanjsek, S. Chatterji, J. Rehm. In Measuring health and disability: manual for WHO Disability Assessment Schedule (WHODAS 2.0)/edited by TB Üstün, N. Kostanjsek, S. Chatterji, J. Rehm 2010.
34.
Fulu E, Jewkes R, Roselli T, García-Moreno C. UN Multi-Country Crosssectional Study on Men and Violence Research Team: Prevalence of and factors associated with male perpetration of intimate partner violence: findings from the UN Multi-country Cross-sectional Study on Men and Violence in Asia and the Pacific. Lancet Glob Health. 2013;1(4):e187-207.PubMedCrossRef
35.
Herdman M, Gudex C, Lloyd A, Janssen MF, Kind P, Parkin D, Bonsel G, Badia X. Development and preliminary testing of the new five-level version of EQ-5D (EQ-5D-5L). Qual Life Res. 2011;20:1727–36.PubMedPubMedCentralCrossRef
36.
37.
Simon J, Anand P, Gray A, Rugkåsa J, Yeeles K, Burns T. Operationalising the capability approach for outcome measurement in mental health research. Soc Sci Med. 2013;1(98):187–96.CrossRef
38.
Kuteesa MO, Cook S, Weiss HA, Kamali A, Weinmann W, Seeley J, et al. Comparing Alcohol Use Disorders Identification Test (AUDIT) with Timeline Follow Back (TLFB), DSM-5 and Phosphatidylethanol (PEth) for the assessment of alcohol misuse among young people in Ugandan fishing communities. Addict Behav Rep. 2019;1(10):100233.
39.
Francis JM, Weiss HA, Helander A, Kapiga SH, Changalucha J, Grosskurth H. Comparison of self-reported alcohol use with the alcohol biomarker phosphatidylethanol among young people in northern Tanzania. Drug Alcohol Depend. 2015;1(156):289–96.CrossRef
40.
Lien L, Hauff E, Martinez P, Eide AH, Swarts L, Ayazi T. Alcohol use in South Sudan in relation to social factors, mental distress and traumatic events. BMC Public Health. 2016;16(1):937.PubMedPubMedCentralCrossRef
41.
Bruck D, Atem Deng S, Kot B, Grossman M. Sleep difficulties among South Sudanese former refugees settled in Australia. Transcult Psychiatry. 2021;58(2):172–86.PubMedCrossRef
42.
Kaggwa MM, Najjuka SM, Ashaba S, Mamun MA. Psychometrics of the Patient Health Questionnaire (PHQ-9) in Uganda: A Systematic Review. Front Psychiatry [Internet]. 2022 [cited 2023 May 2];13. Available from: https://​www.​frontiersin.​org/​articles/​https://​doi.​org/​10.​3389/​fpsyt.​2022.​781095
43.
Mughal AY, Devadas J, Ardman E, Levis B, Go VF, Gaynes BN. A systematic review of validated screening tools for anxiety disorders and PTSD in low to middle income countries. BMC Psychiatry. 2020;20(1):338.PubMedPubMedCentralCrossRef
44.
Lang AJ, Stein MB. An abbreviated PTSD checklist for use as a screening instrument in primary care. Behav Res Ther. 2005;43(5):585–94.PubMedCrossRef
45.
Tol WA, Leku MR, Lakin DP, Carswell K, Augustinavicius J, Adaku A, et al. Guided self-help to reduce psychological distress in South Sudanese female refugees in Uganda: a cluster randomised trial. Lancet Glob Health. 2020;8(2):e254–63.PubMedPubMedCentralCrossRef
46.
EuroQoL. EuroQol - a new facility for the measurement of health-related quality of life. Health Policy. 1990;16(3):199–208.
47.
Buchholz I, Janssen MF, Kohlmann T, Feng YS. A systematic review of studies comparing the measurement properties of the three-level and five-level versions of the EQ-5D. Pharmacoeconomics. 2018;36:645–61.PubMedPubMedCentralCrossRef
48.
Welie AG, Stolk E, Mukuria C, Belay YB, Krahn MD, Sander B, et al. Reliability and validity of using EQ-5D-5L among healthy and adolescents with major mental health disorders in Ethiopia. Eur J Health Econ. 2022;23(7):1105–19.PubMedCrossRef
49.
Yang F, Katumba KR, Roudijk B, Yang Z, Revill P, Griffin S, et al. Developing the EQ-5D-5L Value Set for Uganda Using the ‘Lite’ Protocol. Pharmacoeconomics. 2022;40(3):309–21.PubMedCrossRef
50.
Bouwmans C, Krol M, Severens H, Koopmanschap M, Brouwer W, van Roijen LH. The iMTA productivity cost questionnaire: a standardized instrument for measuring and valuing health-related productivity losses. Value Health. 2015;18(6):753–8.PubMedCrossRef
51.
Kohrt BA, Ramaiya MK, Rai S, Bhardwaj A, Jordans MD. Development of a scoring system for non-specialist ratings of clinical competence in global mental health: a qualitative process evaluation of the Enhancing Assessment of Common Therapeutic Factors (ENACT) scale. Global Mental Health. 2015;2:e23.
52.
Norton EC, Miller MM, Kleinman LC. Computing adjusted risk ratios and risk differences in stata. Stata J Promot Commun Stat Stata. 2013;13(3):492–509.CrossRef
53.
Moher D, Hopewell S, Schulz KF, Montori V, Gøtzsche PC, Devereaux PJ, et al. CONSORT 2010 explanation and elaboration: updated guidelines for reporting parallel group randomised trials. BMJ. 2010;24(340):c869.CrossRef
54.
Husereau D, Drummond M, Augustovski F, de Bekker-Grob E, Briggs AH, Carswell C, Caulley L, Chaiyakunapruk N, Greenberg D, Loder E, Mauskopf J. Consolidated Health Economic Evaluation Reporting Standards 2022 (CHEERS 2022) statement: updated reporting guidance for health economic evaluations. Int J Technol Assess Health Care. 2022;38(1):e13.PubMedCrossRef
55.
May CR, Albers B, Bracher M, Finch TL, Gilbert A, Girling M, et al. Translational framework for implementation evaluation and research: a normalisation process theory coding manual for qualitative research and instrument development. Implement Sci. 2022;17(1):19.PubMedPubMedCentralCrossRef
56.
Metadata
Title
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
Authors
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
Eugene Kinyanda
Bayard Roberts
Daniela C. Fuhr
Publication date
01-12-2024
Publisher
BioMed Central
Published in
Trials / Issue 1/2024
Electronic ISSN: 1745-6215
DOI
https://doi.org/10.1186/s13063-024-07980-7

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