“Effect of virtual-yoga and in-person yoga for individuals with common mental health disorders in the community: a randomized controlled trialâ€
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Depressions and anxiety symptoms
研究概览
简要总结
The primary objective of project is to compare the effect of Virtual Yoga and in-person yoga sessions in reducing the depressions and anxiety symptoms in participants. The secondary objectives are to effect of Virtual Yoga and in-person yoga sessions in improving the well-being, quality of life in participants. The total (n=60) patients with Common mental health Disorders will recruited from OPD of NIMHANS Bangalore. This patient will be randomized through the computer generated numbers and assigned into any two groups each (Virtual yoga=30) and (In-person-Yoga), as per the code. The inclusion criteria of is both gender both male and female participants with age group of 18-60 years will taken for the study. Patient diagnosed with Common Mental disorders diagnosed according to ICD-10 (Categories F32.0, F40, F41, F43, F44 and F45) and with less clinical global inventory (CGI) Score <= 4. The patients should also able to read, write and working knowledge of English. The patient should have the availability of high-speed internet access (512 Mbps and above) and high definition powerful web-camera facility at the therapist site and subject’s house. The Exclusion Criteria is that patient should not have Obsessive Compulsive Disorder (F 42) or Severe Depression with or without psychotic symptoms (F 32.3 onwards, and the participants who are already practicing yoga regularly for the past 3 months. Post recruitment, the participants will be explained the purpose of the study and their written informed consent will be obtained. The SRF who is conducting the assessments would hence be unaware of the group status of the participants. The validated Yoga for Psychiatric Disorders’ Module will be provided for 10 supervised session for 30-40 minutes per day over a period of one month
The assessments would be conducted at Baseline (Day 0), Post Intervention (Day 30), Day 60 (1st Follow-up) and Day 90 (2nd Follow-up). At each follow-up apart from the assessments, the participants would be provided a booster yoga session and their adherence of yoga practice at home would be checked for the previous month. The clinical assessments included in the projects are socio-demographic details and Hamilton Anxiety Rating Scale (HAM-A) : 14 and Hamilton Depression Rating Scale (HDRS): 17 to measures the anxiety and depression. The other assessment such as Edinburgh Mental Wellbeing Scale: 14 items, Quality of Life: (WHOQOL Brief) 26 items, Virtual Yoga Trainers Assessment (VYTA) Qualitative Feedback form. The yoga assessment will be conducted by yoga therapist based on Yoga performance Assessment Scale (YPA): Visual analog scale (VAS). The socio-demographic characteristics will be analyzed using the chi-square and t test. Based on the normality of the data, the differences among groups across timeline from baseline to the end of three months will be analyzed using the RMANOVA. The group differences at a particular follow-up will be analyzed using Independent Sample t test. Manual Content Analysis will be used to analyze the qualitative feedback data.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Investigator 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
- •Inclusion criteria
- •Common mental health disorder diagnosed to ICD-10(Categories F32.0, F40,F41,F43,F44 and F45).
- •Clinical Global Inventory (CGI)score less than or equal to 4
- •Availability of high internet access (512 Mbps and above) and high definition powerful web-camera facility at the therapist site and subjects house
- •able to read, write and working knowledge of english.
排除标准
- •Exclusion Criteria: 1)Obsessive Compulsive Disorder (F 42) 2)Severe Depression with or without psychotic symptoms (F 32.3 onwards) 3)Participants who are already practicing yoga regularly for the past 3 months.
结局指标
主要结局
Depressions and anxiety symptoms
时间窗: Baseline, Day 30, Day 60 and Day 90
次要结局
- Well-being(Baseline, Day 30, Day 60 and Day 90)
- Improve quality of life(Baseline, Day 30, Day 60 and Day 90)
