The Effectiveness and Cost-effectiveness of a Collaborative Stepped Care Intervention for the Treatment of Common Mental Disorders in Primary Care Settings in Goa, India
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 2,796
- 试验地点
- 2
- 主要终点
- Recovery from Common Mental Disorder (defined by ICD10)
研究概览
简要总结
Depressive and anxiety disorders (termed as 'Common Mental Disorders') affect as many as one in four persons attending primary care; most patients do not receive effective treatments. Although the integration of mental health in primary care is accepted as the only feasible way of managing Common Mental Disorders in developing countries, there is no evidence demonstrating how this can be done in a manner which is effective and affordable. The hypothesis of this trial is that a Collaborative Stepped Care package will be both clinically and cost-effective for the treatment of Common Mental Disorders in primary care.
详细描述
The goal of the research is to evaluate the clinical and cost-effectiveness of a Collaborative Stepped Care intervention for the treatment of Common Mental Disorders (CMD) in primary care in Goa, India.
The Collaborative Stepped Care intervention will be compared with Enhanced Usual care in a cluster randomized controlled trial in 24 primary care facilities; the first phase of the trial will be located in 12 government run Primary Health Centres, while the second phase will be located in 12 private family physician/general practice facilities. Approximately 2400 participants who screen positive on a screening questionnaire for CMD will be recruited from the 24 facilities (a harmonic mean of 100 per cluster per arm) of whom 2/3 will be ICD10 cases confirmed by a diagnostic interview (the Revised Clinical Interview Schedule). Follow-up interviews at home will be conducted by an independent team at 2, 6 and 12 months post recruitment. Allowing for 25% attrition during follow-up gives 650 patients in each arm with a confirmed CMD, or a total of 960 in each arm, contributing to analyses of the primary outcomes (see below).
The Collaborative Stepped Care intervention is a complex intervention comprising the following components: screening for detection of cases; psycho-education; antidepressants; inter-personal therapy; yoga; specialist supervision & adherence management. The method of delivery will be based on the stepped-care model which provides treatments according to the patients' needs and incorporates strategies to overcome challenges to the integration of mental health in primary care in developing countries. This will be compared with Enhanced Usual Care which will comprise screening for detection of cases, provision of the diagnosis to the doctor, and making antidepressants available in the facility-all these components will be available in the Collaborative Stepped care facilities as well. The intervention will be delivered by two new, full-time, primary care human resources-the Health Assistant (in both arms) who will screen adult attenders; and in the Collaborative Stepped Care arms, the Health Counselor-who has been trained over 3 months, and a part-time Psychiatrist supporting the primary care team.
The primary analyses will be intention-to-treat, regardless of adherence to the intervention, and will be based on outcomes measured at 6 months. All analyses will take into account any within-facility clustering resulting from the cluster randomized design, and will include adjustment for any of the a-priori defined confounding factors for which randomization did not achieve balance between the two arms at baseline.
The primary research question being answered and the analysis outputs are:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age above 18;
- •Suffering from a Common Mental Disorder (as defined by an a priori cut-off score on the 12 item General Health Questionnaire)
- •Resident in the state (Goa) for the subsequent 12 months
- •Not requiring urgent medical/surgical attention (e.g hospital admission)
排除标准
- •Suffering from a cognitive or sensory impairment which makes participation in the evaluation difficult
- •Not speaking Konkani, Marathi, Hindi or English
结局指标
主要结局
Recovery from Common Mental Disorder (defined by ICD10)
时间窗: 6 months
次要结局
- Case of CMD among all sub-threshold cases(at 2, 6 and 12 months)
- Costs of illness(2, 6 and 12 months)
- Psychological morbidity (mean scores)(at 2, 6 and 12 months)
- Disability levels(at 2, 6 and 12 months)
- Case of CMD among all screen-positive participants at 2, 6 and 12 months(2, 6 and 12 months)
- Recovery from CMD (defined by ICD10) among the subgroup with ICD-10 Depression at baseline(at 2, 6 and 12 months)