Myers Bronwyn, Lund Crick, Lombard Carl, Joska John, Levitt Naomi, Butler Christopher, Cleary Susan, Naledi Tracey, Milligan Peter, Stein Dan J, Sorsdahl Katherine
Alcohol, Tobacco and Other Drug Research Unit, South African Medical Research Council, Francie van Zyl Drive, Tygerberg, Cape Town, 7505, South Africa.
Division of Addiction Psychiatry, Psychiatry and Mental Health, University of Cape Town, Cape Town, South Africa.
Trials. 2018 Mar 16;19(1):185. doi: 10.1186/s13063-018-2568-9.
In low- and middle-income countries (LMIC), it is uncertain whether a "dedicated" approach to integrating mental health care (wherein a community health worker (CHW) has the sole responsibility of delivering mental health care) or a "designated" approach (wherein a CHW provides this service in addition to usual responsibilities) is most effective and cost-effective. This study aims to compare the effectiveness and cost-effectiveness of these two models of service integration relative to treatment as usual (TAU) for improving mental health and chronic disease outcomes among patients with HIV or diabetes.
METHODS/DESIGN: This is a cluster randomised trial. We will randomise 24 primary health care facilities in the Western Cape Province of South Africa to one of three study arms. Within each cluster, we will recruit 25 patients from HIV and 25 from diabetes services for a total sample of 1200 participants. Eligible patients will be aged 18 years or older, take medication for HIV or diabetes, and screen positive on the Alcohol Use Disorder Identification Test for hazardous/harmful alcohol use or depression on the Centre for Epidemiology Scale on Depression. Participants recruited in clinics assigned to the designated or dedicated approach will receive three sessions of motivational interviewing and problem-solving therapy, while those recruited at TAU-assigned clinics will be referred for further assessment. Participants will complete an interviewer-administered questionnaire at baseline, and at 6 and 12 months post-enrolment to assess change in self-reported outcomes. At these end points, we will test HIV RNA viral load for participants with HIV and HbA1c levels for participants with diabetes. Primary outcomes are reductions in self-reported hazardous/harmful alcohol use and risk of depression. Secondary outcomes are improvements in adherence to chronic disease treatment, biomarkers of chronic disease outcomes, and health-related quality of life. Mixed-effect linear regression models will model the effect of the interventions on primary and secondary outcomes. The cost-effectiveness of each approach will be assessed using incremental cost-effectiveness ratios.
Study findings will guide decision-making around how best to integrate mental health counselling into chronic disease care in a LMIC setting.
Pan African Clinical Trials Registry, Trial registration number: ACTR201610001825403 . Registered 17 October 2016.
在低收入和中等收入国家（LMIC），尚不确定采用“专门”方式整合精神卫生保健（即由社区卫生工作者（CHW）单独负责提供精神卫生保健）还是“指定”方式（即CHW在履行日常职责之外还提供此项服务）最为有效且具有成本效益。本研究旨在比较这两种服务整合模式相对于常规治疗（TAU）在改善艾滋病毒或糖尿病患者心理健康和慢性病结局方面的有效性和成本效益。
方法/设计：这是一项整群随机试验。我们将把南非西开普省的24个初级卫生保健机构随机分配到三个研究组之一。在每个整群中，我们将从艾滋病毒服务机构招募25名患者，从糖尿病服务机构招募25名患者，共1200名参与者。符合条件的患者年龄在18岁及以上，正在接受艾滋病毒或糖尿病治疗，并且在酒精使用障碍识别测试中筛查出有害/危险饮酒呈阳性，或在流行病学抑郁量表上筛查出抑郁呈阳性。分配到指定或专门方式的诊所招募的参与者将接受三次动机访谈和解决问题疗法，而在TAU分配诊所招募的参与者将被转介进行进一步评估。参与者将在基线时以及入组后6个月和12个月完成一份由访谈员实施的问卷，以评估自我报告结局的变化。在这些终点，我们将检测艾滋病毒参与者的艾滋病毒RNA病毒载量和糖尿病参与者的糖化血红蛋白水平。主要结局是自我报告的有害/危险饮酒减少以及抑郁风险降低。次要结局是慢性病治疗依从性的改善、慢性病结局的生物标志物以及与健康相关的生活质量的改善。混合效应线性回归模型将模拟干预措施对主要和次要结局的影响。将使用增量成本效益比评估每种方法的成本效益。
研究结果将指导在低收入和中等收入国家背景下如何最好地将心理健康咨询纳入慢性病护理的决策。
泛非临床试验注册中心，试验注册号：ACTR201610001825403。于2016年10月17日注册。
