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
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 (WH...
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| Format: | Article |
| Language: | English |
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BMC
2024-02-01
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| Series: | Trials |
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| Online Access: | https://doi.org/10.1186/s13063-024-07980-7 |
| _version_ | 1797246978200961024 |
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| author | 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 |
| author_facet | 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 |
| author_sort | Catharina F. van der Boor |
| collection | DOAJ |
| description | 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. |
| first_indexed | 2024-03-07T14:42:25Z |
| format | Article |
| id | doaj.art-19f6bfd30e3d41b6ab9995305223bca6 |
| institution | Directory Open Access Journal |
| issn | 1745-6215 |
| language | English |
| last_indexed | 2024-04-24T19:51:23Z |
| publishDate | 2024-02-01 |
| publisher | BMC |
| record_format | Article |
| series | Trials |
| spelling | doaj.art-19f6bfd30e3d41b6ab9995305223bca62024-03-24T12:32:48ZengBMCTrials1745-62152024-02-0125111810.1186/s13063-024-07980-7Effectiveness and cost-effectiveness of a transdiagnostic intervention for alcohol misuse and psychological distress in humanitarian settings: study protocol for a randomised controlled trial in UgandaCatharina F. van der Boor0Dalili Taban1Wietse A. Tol2Josephine Akellot3Melissa Neuman4Helen A. Weiss5Giulia Greco6Anna Vassall7Carl May8Abhijit Nadkarni9Eugene Kinyanda10Bayard Roberts11Daniela C. Fuhr12Faculty of Public Health and Policy, London School of Hygiene and Tropical MedicineHealthRight InternationalDepartment of Public Health, University of CopenhagenHealthRight InternationalMRC International Statistics and Epidemiology Group, Faculty of Epidemiology and Population Health, London School of Hygiene and Tropical MedicineMRC International Statistics and Epidemiology Group, Faculty of Epidemiology and Population Health, London School of Hygiene and Tropical MedicineFaculty of Public Health and Policy, London School of Hygiene and Tropical MedicineFaculty of Public Health and Policy, London School of Hygiene and Tropical MedicineFaculty of Public Health and Policy, London School of Hygiene and Tropical MedicineCentre for Global Mental Health (CGMH), Department of Population Health, London School of Hygiene & Tropical MedicineMRC/UVRI Uganda Research Unit, London School of Hygiene and Tropical MedicineFaculty of Public Health and Policy, London School of Hygiene and Tropical MedicineFaculty of Public Health and Policy, London School of Hygiene and Tropical MedicineAbstract 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.https://doi.org/10.1186/s13063-024-07980-7RefugeesAlcohol misuseMental distressScalable interventionsRandomised controlled trial |
| spellingShingle | 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 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 Trials Refugees Alcohol misuse Mental distress Scalable interventions Randomised controlled trial |
| 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 |
| title_full | 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 |
| title_fullStr | 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 |
| title_full_unstemmed | 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 |
| title_short | 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 |
| title_sort | 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 |
| topic | Refugees Alcohol misuse Mental distress Scalable interventions Randomised controlled trial |
| url | https://doi.org/10.1186/s13063-024-07980-7 |
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