Effectiveness of YES (Yoga-based Extension Services) Intervention for Person with Severe Mental Disorders in Rural India: A Cluster Randomized study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- ICMR
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- WHO Disability Assessment Schedule 2.0 (WHODAS 2.0), Brief Psychiatric Rating Scale (BPRS), WHO-5 Well-being Index, Social and Occupational Functioning Assessment Scale (SOFAS), Color Trials A & B and N-back 1/2
研究概览
简要总结
This is a cluster randomized study to assess the feasibility and effectiveness of the Yoga-based Extension Services (YES) intervention as an add-on to routine treatment for persons with Severe Mental Disorder (SMD) in rural India. The intervention includes six face-to-face monthly yoga sessions delivered by trained yoga therapists, with home-based practice supported by videos and printed materials. The study will compare outcomes, including symptom severity, disability, cognitive function, and well-being, between the intervention and waitlist control groups, and will be conducted over 36 months in two rural taluks in Karnataka state. Inclusion criteria are male and female participants aged 18 to 60 years diagnosed according to ICD-10 criteria with schizophrenia, schizotypal and delusional disorders (F20–F29), bipolar affective disorder (F31), recurrent depressive disorder (F33), or severe depression with or without psychotic symptoms (F32.3), having a Clinical Global Impression (CGI) score less than or equal to 4, and able to read, write, and have working knowledge of English. Exclusion criteria are individuals with comorbid Intellectual disability or developmental disorders, individuals with a primary diagnosis of substance use disorders (F10–F19) or obsessive-compulsive disorder (F42), and participants already practising yoga regularly for the past three months..
研究设计
- 研究类型
- Interventional
- 分配方式
- Coin toss, Lottery, toss of dice, shuffling cards etc
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •Diagnosis of severe Mental Disorders as per ICD-10 criteria, including Schizophrenia (F20.0-F29), Bipolar Affective Disorder (F31.0-F31.9), Recurrent Depressive Disorder (F33.0-F33.9) Clinical Global Impression (CGI) Score less than or equal to 4 Ability to read, write and speak Kannada or have working knowledge of Kannada or English.
排除标准
- •Individuals with comorbid mental retardation or any other developmental disorder.
- •Individuals with the primary diagnosis of Substance abuse disorders (F.10-19) and other disorders as mentioned in the inclusion criteria as co-morbid disorders.
- •Obsessive Compulsive Disorder (F 42) Participants who are already practicing Yoga Regularly for the past 3 months.
结局指标
主要结局
WHO Disability Assessment Schedule 2.0 (WHODAS 2.0), Brief Psychiatric Rating Scale (BPRS), WHO-5 Well-being Index, Social and Occupational Functioning Assessment Scale (SOFAS), Color Trials A & B and N-back 1/2
时间窗: Baseline, 3 months, 6 months
次要结局
- Symptom Severity- brief psychiatry rating scale (BPRS) and PHQ-SADS(Well-being- WHO- Five wellbeing Index)
研究者
Dr Aarti Jagannathan
National Institute of Mental Health and Neuro Sciences