Division of Clinical Epidemiology, Department of Clinical Research, University Hospital Basel, Basel, Switzerland.
University of Basel, Basel, Switzerland.
Trials. 2024 Sep 2;25(1):575. doi: 10.1186/s13063-024-08411-3.
The World Health Organization's (WHO) Mental Health Gap Action Programme (mhGAP) is a validated intervention that can be provided by non-specialised healthcare workers to individuals with unhealthy alcohol use. However, it typically requires several in-person sessions at a health facility, which may limit its feasibility and effectiveness in remote settings. This trial compares mhGAP-Standard, a 4 to 6 in-person session intervention, to mhGAP-Remote, a 1 in-person session intervention followed by 8 week of short message service (SMS) in Lesotho. We hypothesise that mhGAP-Remote is superior to mhGAP-Standard in reducing alcohol use (as detailed by the primary and secondary outcomes below).
This is a two-arm randomised open-label multicentre superiority trial. Participants allocated to mhGAP-Standard receive 4 in-person sessions using motivational interviewing, identifying triggers, and alternative behaviours, with the option of two additional booster sessions. Participants in the mhGAP-Remote arm receive 1 in-person session covering the same content, followed by standardised SMSs over 8 weeks that reinforce intervention content. Non-specialist providers deliver the intervention and receive weekly supervision. Adults (N = 248) attending participating health facilities for any reason and who meet criteria for unhealthy alcohol use based on the Alcohol Use Disorders Identification Test ([AUDIT] score ≥ 6 for women, ≥ 8 for men) are individually randomised to the two arms (1:1 allocation, stratified by participant sex and age (≥ 50 vs < 50 years old). Follow-up assessments occur at 8, 20, and 32 weeks post-randomisation. The primary outcome is change in self-reported alcohol use (continuous AUDIT score), from baseline to 8 weeks follow-up. Change in the AUDIT from baseline to 20 and 32 weeks follow-up is a secondary outcome. Change in the biomarker phosphatidylethanol (secondary), liver enzyme values in serum (exploratory), and HIV viral load (for people with HIV only; exploratory) are also evaluated from baseline throughout the entire follow-up period. A linear regression model will be conducted for the primary analysis, adjusted for the stratification factors. Three a priori sensitivity analyses for the primary outcome are planned based on per protocol treatment attendance, recovery from unhealthy alcohol use, and clinically significant and reliable change.
This trial will provide insight into feasibility and effectiveness of a shortened and primarily SMS supported version of mhGAP, which is especially relevant for settings where regular clinic attendance is a major barrier.
clinicaltrials.gov NCT05925270 . Approved on June 29th, 2023.
世界卫生组织（WHO）的心理健康差距行动规划（mhGAP）是一种经过验证的干预措施，可由非专业医疗保健工作者提供给有不健康饮酒行为的个人。然而，它通常需要在医疗机构进行几次面对面的治疗，这可能限制了其在偏远地区的可行性和有效性。这项试验比较了 mhGAP-标准，即 4 到 6 次面对面治疗，和 mhGAP-远程，即 1 次面对面治疗后，再接受 8 周的短消息服务（SMS），在莱索托进行。我们假设 mhGAP-远程优于 mhGAP-标准，能降低饮酒量（如下面的主要和次要结果所示）。
这是一项两臂随机开放标签多中心优效性试验。分配到 mhGAP-标准组的参与者接受 4 次面对面的治疗，使用动机性访谈，确定触发因素和替代行为，并可选择再进行两次强化治疗。mhGAP-远程组的参与者接受 1 次面对面的治疗，涵盖相同的内容，然后在 8 周内接受标准化的 SMS，强化干预内容。非专业提供者提供干预措施，并接受每周监督。任何原因到参与卫生设施就诊的成年人（N=248），根据酒精使用障碍识别测试（AUDIT 评分[女性≥6，男性≥8]），符合不健康饮酒标准，被单独随机分配到两组（1:1 分配，按参与者性别和年龄（≥50 岁与<50 岁）分层）。在随机分组后的 8、20 和 32 周进行随访评估。主要结果是自我报告的饮酒量变化（连续 AUDIT 评分），从基线到 8 周随访。从基线到 20 和 32 周随访的 AUDIT 变化是次要结果。从基线到整个随访期间的生物标志物磷脂酰乙醇（次要）、血清中肝酶值（探索性）和 HIV 病毒载量（仅限 HIV 感染者；探索性）也进行评估。主要分析将进行线性回归模型，调整分层因素。根据方案治疗的参与度、不健康饮酒的恢复情况以及临床显著和可靠的变化，计划进行三次主要结果的预先设定敏感性分析。
这项试验将提供关于 mhGAP 的缩短版本和主要通过短信支持的版本的可行性和有效性的见解，这对于定期就诊是一个主要障碍的环境尤其重要。
clinicaltrials.gov NCT05925270。于 2023 年 6 月 29 日批准。
