Adaptation of the Validated Yoga Module forDepression: Standardizing delivery through aTherapist Training Manual with Fidelity,Competence, and Reliability Testing.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- NIMHANS
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- 2. Competences in Clinical Practices (RECOPC-FIS II)
研究概览
简要总结
A validated yoga module is currently being used for patients with depression. However, a systematic delivery approach for teaching the yoga practice to patients does not exist. The study involves development of a therapist manual module for conducting yoga therapy session for patients with depression. In this manual, detailed descriptions with visual aids, step-by-step instructions and expected outcomes for each practice will be given. This will ensure standardization of yoga practice, progressive overloading, personalization, effective supervision and quantifiable performance monitoring. Experts will be consulted to refine and validate the manual. The effectiveness of the manual will be tested on yoga therapists providing therapy to patients with depression. This manual will ensure uniform and standard yoga training to patients making it applicable for research work.
研究设计
- 研究类型
- Interventional
- 分配方式
- Not Applicable
- 盲法
- Not Applicable
入排标准
- 年龄范围
- 18.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •For therapists 1 PGDYT or Bachelors in yoga with a minimum of 2 years’ experience/ Masters in yoga -Freshers or Currently pursuing/ BNYS graduates.
- •Freshers or currently pursuing/ MD yoga.
- •Freshers or currently pursuing. 2 Currently located in Bengaluru 3 Willing to attend the workshop for delivery of yoga therapy using manual 4 Consenting to participate in the study For Patients with depression 1 Diagnosis of depression according to DSM-5 criteria 2 Severity of depression.
- •mild, moderate and severe 3 Treatment naive or on any standard antidepressant treatment and/or psychological counselling 4 Age group of 18 to 60 years 5 Both male and female 6 Inpatient and Outpatient 7 Yoga naive.
- •not more than 3 structured yoga therapy sessions in the past month. 8 Not involved in any structured yoga therapy in the past 6 months 9 Consenting to participate in the stud.
排除标准
- •For Therapists 1 Yoga instructors’ course/ any short-term certification courses/ yoga training programs/ not involved in yoga therapy for patients.
- •2 Located outside Bengaluru 3 Not consenting to participate in the study For patients with depression 1 Co-morbid substance abuse (excluding nicotine dependence), psychosis, suicidal and self-injurious behaviour, mental retardation, any other DSM IV-TR anxiety disorders, OCD, and related disorders.
- •(This is only for fidelity testing in objective 2) 2 Severe depression with catatonic symptoms, high suicidal risk, or severe psychomotor retardation, on electroconvulsive therapy (ECT).
- •3 Bipolar depression.
- •4 Currently pregnant or lactating.
- •5 Subjects with severe physical ailments like general medical conditions like coronary artery disease, fracture,seizure disorders, and autoimmune disorders, which is contraindicated for the depression module.
- •6 Already practicing structured yoga/ undergoing yoga therapy on a regular basis.
结局指标
主要结局
2. Competences in Clinical Practices (RECOPC-FIS II)
时间窗: 1. Yoga Trainer’s Assessment Checklist - Baseline, after 5 sessions and after 10 sessions | 2. Competences in Clinical Practices (RECOPC-FIS II) - Baseline, after 5 sessions and after 10 sessions | 3. Yoga performance assessment scale - baseline, after 5 sessions, and | after 10 sessions; | Time line for all above assessments is baseline, 1 week and 2 weeks
1. Yoga Trainer’s Assessment Checklist
时间窗: 1. Yoga Trainer’s Assessment Checklist - Baseline, after 5 sessions and after 10 sessions | 2. Competences in Clinical Practices (RECOPC-FIS II) - Baseline, after 5 sessions and after 10 sessions | 3. Yoga performance assessment scale - baseline, after 5 sessions, and | after 10 sessions; | Time line for all above assessments is baseline, 1 week and 2 weeks
3. Yoga performance assessment scale
时间窗: 1. Yoga Trainer’s Assessment Checklist - Baseline, after 5 sessions and after 10 sessions | 2. Competences in Clinical Practices (RECOPC-FIS II) - Baseline, after 5 sessions and after 10 sessions | 3. Yoga performance assessment scale - baseline, after 5 sessions, and | after 10 sessions; | Time line for all above assessments is baseline, 1 week and 2 weeks
次要结局
- 1. Qualitative feedback from patients, trainees, & experts observing the therapy for depression(2. Yoga Therapy for Depression Module Performance Checklist)
- Qualitative feedback of the trainee, independent observer & the patient(After 10 yoga sessions)