Randomized Controlled Trial to Assess the Feasibility of Delivering Psycho-Social Interventions and Effectiveness in Improving the Common Psychological Problems of the Non-Clinical Population: a multi-centric and multi-setting study from central India
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 170
- 试验地点
- 2
- 主要终点
- Change in the scores on the DASS-21 (anxiety, depression, and stress), SSS-8 (somatic symptoms), and WHO-QoL-BREF (total as well as domain-specific) from baseline to end-of-session, 1months, and 3months post-intervention.
研究概览
简要总结
The study is aimed at assessing the feasibility and effectiveness of delivering wellness intervention for the non-clinical population who harbour sub-syndromal anxiety or depression or stress-related problems and are availing services for other medical disorders in different departments of the tertiary care hospital setting or community setting. A comprehensive wellness intervention package (comprehensive wellness program for mental health-"COMeWELL with PRiMEHElp”) shall be delivered by a trained psychologist to the intervention group while a general health advice shall be provided to the control arm and their effectiveness would be assessed over a period of three months. It would be a multi-site study. The intervention would be developed first and then be validated before employing in the study as per the standard guidelines. At the end of the study, we would like to evaluate the effectiveness of the COMeWELL with PRiMEHElp interventions Vis-a-vis general education. We will also assess the feasibility of delivering such an intervention in different settings.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant and Outcome Assessor Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •Age: above 18years.
- •Resides in the catchment area of the Primary Health Centre OR able to follow-up in the hospital regularly III.
- •Individuals visiting: the Primary Health Centre OR screening out-screening out-patient dept (of its equivalent) in the tertiary care hospital OR family members (up to three-degree relatives)/acquaintances of the.
排除标准
- •Suffering from a severe medical illness (uncontrolled Diabetes, hypertension, COPD/asthma, etc.) Sub-syndromic psychotic or manic symptoms, or other severe mental illnesses.
- •Diagnosed to be a case of mental disorder (as assessed on structured instruments (Structured Clinical Interview for DSM-5 Disorders, Clinical Trials Version (SCID-CT).
- •Already receiving any kind of treatment (pharmacological or non-pharmacological) from the mental health professionals for their sub-syndromic mental health problems.
结局指标
主要结局
Change in the scores on the DASS-21 (anxiety, depression, and stress), SSS-8 (somatic symptoms), and WHO-QoL-BREF (total as well as domain-specific) from baseline to end-of-session, 1months, and 3months post-intervention.
时间窗: at baseline (0 month), to end-of-session (3wks+/-1wk), 1months (1month 3wks+/-1wk), and 3months (3 months 3wks+/-1wk) post-intervention.
次要结局
- feasibility (acceptibility, reproducibility, demand, limited efficacy testing)(0, 1, 3months)
研究者
Dr Snehil Gupta
All India Institute of Medical Sciences, Bhopal