The effectiveness and cost-effectiveness of lay counsellor-delivered psychological treatments for harmful and dependent drinking and moderate to severe depression in primary care in India: PREMIUM study protocol for randomized controlled trials
The effectiveness and cost-effectiveness of lay counsellor-delivered psychological treatments for harmful and dependent drinking and moderate to severe depression in primary care in India: PREMIUM study protocol for randomized controlled trials
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DOI：
10.1186/1745-6215-15-101
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发表时间：
2014-04-02
期刊：
影响因子：
2.5
通讯作者：
Kirkwood, Betty
中科院分区：
文献类型：
--
作者：
Patel, Vikram;Weobong, Benedict;Kirkwood, Betty
背景：全球疾病负担的主要心理健康原因是女性的抑郁症和男性的酒精使用障碍。发展中国家在初级保健中实施循证心理治疗的主要障碍是缺乏熟练的人力资源。这些试验的目的是评估的有效性和成本效益的两种心理治疗开发的抑郁症和酒精使用障碍的治疗在印度的初级保健。方法/设计：本研究方案为平行组、随机对照试验在果阿的8个初级保健中心开展了“健康活动方案”（针对中度至重度抑郁症的健康活动方案，针对有害和依赖性饮酒的酒精问题提供咨询），印度成年初级保健参加者将接受抑郁症患者健康问卷调查，仅在男性中，接受饮酒问题酒精使用障碍识别测试。筛查阳性的参与者将被邀请参加;筛查阳性的男性将被邀请参加酒精问题咨询试验。同意的人将按照1：1的比例分配，接受相应的心理治疗加强化日常护理或仅强化日常护理，分配顺序由计算机生成，按初级保健中心分层，抑郁症按性别分层。加强的日常护理包括向初级保健中心的医生提供符合具体情况的世界卫生组织准则和筛查结果。心理治疗将由非专业顾问提供，最长期限为三个月。主要结果是在入组后三个月的疾病严重程度和缓解率，以及酒精问题咨询试验，饮酒和饮酒对日常生活的影响。次要结果包括12个月时疾病的严重程度和缓解率，残疾评分，自杀行为和经济影响，以及3个月和12个月时的成本效益。将招募500名患有抑郁症的参与者和400名患有有害饮酒的参与者。初步分析将意向treat.Discussion：这些试验可能提供一种新的方法，用于治疗中重度抑郁症和饮酒问题的初级保健，这是潜在的可扩展性，因为它依赖于交付由一个单一的池外行辅导员。
Background: The leading mental health causes of the global burden of disease are depression in women and alcohol use disorders in men. A major hurdle to the implementation of evidence-based psychological treatments in primary care in developing countries is the non-availability of skilled human resources. The aim of these trials is to evaluate the effectiveness and cost-effectiveness of two psychological treatments developed for the treatment of depression and alcohol use disorders in primary care in India.Methods/design: This study protocol is for parallel group, randomized controlled trials (Healthy Activity Program for moderate to severe depression, Counselling for Alcohol Problems for harmful and dependent drinking) in eight primary health centres in Goa, India. Adult primary care attendees will be screened with the Patient Health Questionnaire for depression and, in men only, the Alcohol Use Disorders Identification Test for drinking problems. Screen-positive attendees will be invited to participate; men who screen positive for both disorders will be invited to participate in the Counselling for Alcohol Problems trial. Those who consent will be allocated in a 1:1 ratio to receive either the respective psychological treatment plus enhanced usual care or enhanced usual care only using a computer generated allocation sequence, stratified by primary health centre and, for depression, by sex. The enhanced usual care comprises providing primary health centre doctors with contextualized World Health Organization guidelines and screening results. Psychological treatments will be delivered by lay counsellors, over a maximum period of three months. Primary outcomes are severity of disorder and remission rates at three months post-enrolment and, for the Counselling for Alcohol Problems trial, drinking and the impact of drinking on daily lives. Secondary outcomes include severity of disorder and remission rates at 12 months, disability scores, suicidal behaviour and economic impact, and cost-effectiveness at three and 12 months. 500 participants with depression and 400 participants with harmful drinking will be recruited. Primary analyses will be intention-to-treat.Discussion: These trials may offer a new approach for the treatment of moderate-severe depression and drinking problems in primary care that is potentially scalable as it relies on delivery by a single pool of lay counsellors.