Development of a Comprehensive Intervention Programme for Management of Depression at the level of a Primary Health Centre
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 162
- 试验地点
- 1
- 主要终点
- Remission of depression at 12 weeks as measured by
研究概览
简要总结
This was a randomised control trial conducted in the primary care setting to evaluate the effectiveness of Community based Depression Intervention Programme (ComDIP)( developed by the investigators) , compared to Treatment as Usual (TAU) in reducing the severity of depression in women with moderate to severe depression. ComDIP had two components. One administered by the Medical Officer, which included Sertraline also, and the other implemented by the Junior Public Nurse, which was a psycho-social intervention. The primary outcome was reduction in severity of depression measured by the Hamilton Depression (HAM-D) Rating Scale. The mean scores of HAM-D were significantly lower in the ComDIP arm, compared to the TAU arm . Research papers from this study are being published
研究设计
- 研究类型
- Interventional
- 分配方式
- Permuted block randomization, fixed
- 盲法
- Outcome Assessor Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- Female
入选标准
- •1.Age group 18-60 years 2.Permanent residents living in the area of MCH unit Pangappara for at least past 6 months 3.Diagnosis of moderate to severe depression 4.Informed consent to participate in the trial , to record examination findings and use the data in research and future publication 5.Literacy to read and write in Malayalam 6.Have an active phone number.
排除标准
- •Past or current diagnosis or history of treatment for bipolar disorder, dementia, psychosis 2.Currently being managed by a psychiatrist or psychologist 3.Taking any psychotropic drug 4.High risk of suicidality as measured by a suicidality score above 17 5.Pregnant, breastfeeding or planning to become pregnant in next 6 months 6.Seriously ill or bedridden patient 7.A woman who is not able to communicate with the health worker.
结局指标
主要结局
Remission of depression at 12 weeks as measured by
时间窗: 2 weeks, 4weeks, 8 weeks, 12 weeks | Interim analysis will be done at 8 weeks
50% reduction in score from baseline in Hamilton Rating Scale for Depression ( HAM-D) or
时间窗: 2 weeks, 4weeks, 8 weeks, 12 weeks | Interim analysis will be done at 8 weeks
Montgomery Asberg Depression Rating Scale ( MADRS) or
时间窗: 2 weeks, 4weeks, 8 weeks, 12 weeks | Interim analysis will be done at 8 weeks
remission as per Mini Neuropsychiatric Interview (MINI) for Depression
时间窗: 2 weeks, 4weeks, 8 weeks, 12 weeks | Interim analysis will be done at 8 weeks
次要结局
- Improvement in suicidality score(2 weeks, 6 weeks, 8 weeks, 12weeks)
- Clinical Global Impression for Severity (CGI-S) score(2, 6, 8 and 12 weeks)
- Clinical Global Impression for Change or Improvement ( CGI-C / CGI-I)(2,6,8,12 weeks)
- modified Global Assessment of Functioning (mGAF) score(2,6,8,12 weeks)
- treatment adherence(2,6,8,12 weeks)
- acceptability(2,6,8,12 weeks)