Faculty of Public Health and Policy, London School of Hygiene and Tropical Medicine, 15-17 Tavistock Place, London, WC1H 9SH, UK.
HealthRight International, Plot 855, Mawanda Road -Kamwokya, Kampala, Uganda.
Trials. 2024 Feb 27;25(1):148. doi: 10.1186/s13063-024-07980-7.
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.
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.
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.
ISRCTN ISRCTN10360385. Registered on 30 January 2023.
南苏丹战争导致超过 400 万人流离失所，其中乌干达接纳了数量最多的南苏丹难民。在乌干达的研究表明，这些难民中存在较高水平的酒精滥用和心理困扰。世界卫生组织（WHO）开发了一种跨诊断可扩展的心理干预措施，称为问题管理加（PM+），以减少遭受逆境人群的心理困扰。我们的研究旨在评估 CHANGE 干预措施的有效性和成本效益，该干预措施建立在 PM+的基础上，通过解决问题疗法和针对酒精使用障碍的选定行为策略来解决酒精滥用问题。我们假设，与仅增强常规护理（EUC）相比，CHANGE 干预措施联合 EUC 将更有效地增加戒酒天数的百分比。
这是一项在乌干达 Rhino 营地和 Imvepi 定居点进行的平行臂个体随机对照试验。将 500 名年龄在 18 岁及以上、（i）酒精使用量较高（酒精使用障碍识别测试 [AUDIT] 量表 8-20 分）；和（ii）心理困扰（Kessler 心理困扰量表 [K10] 得分>16 分）的成年南苏丹男性难民随机分配 1:1 至 EUC 或 CHANGE 和 EUC。CHANGE 将由非专业医疗保健提供者在 6 周内提供。将在随机分组后 3 个月和 12 个月评估结局。主要结局是通过 3 个月时的时间表随访测量得到的戒酒天数的百分比。次要结局包括 12 个月时的戒酒天数百分比以及酒精滥用（通过 AUDIT 测量）、心理困扰（即抑郁、焦虑、创伤后应激障碍）、功能残疾、亲密伴侣暴力行为以及 3 个月和 12 个月时的健康经济指标。一项混合方法的过程评估将调查能力、剂量、保真度、可行性和可接受性。主要分析将采用意向治疗。
CHANGE 的目的是在人道主义环境中解决男性难民的酒精滥用和心理困扰问题。如果被证明有效，它可以帮助填补人道主义服务提供方面一个重要的研究不足的空白。
ISRCTN ISRCTN83326567。于 2023 年 1 月 30 日注册。
