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临床试验/CTRI/2024/02/062804
CTRI/2024/02/062804尚未招募1 期

Effectiveness of Yoga Intervention on Patients with Mild and Moderate Depression - A Randomized Controlled Study

Ayisha Siddeequa M A1 个研究点 分布在 1 个国家目标入组 90 人开始时间: 2024年2月26日最近更新:

试验速览

阶段
1 期
状态
尚未招募
发起方
入组人数
90
试验地点
1
主要终点
The physiological, psychological, and neuropsychological parameters of the mild and moderate depressive patients ranging between the age group of 18 - 45 years will be measured [pre- test & post test].

研究概览

简要总结

After screening, a sample size of 90 participants with mild and moderate levels of depression attending the outpatient service of the Psychiatry Department of Sri Ramachandra Institute of Medical College and Research Institute will be recruited with informed consent before beginning the study and will be equally divided into two groups namely; the control group (45) and the interventional group (45). As the meta-analysis of studies of yoga for depression suggests Cohen’s d within groups was 0.45 for aerobic exercise and 0.38 for yoga training. A power analysis in G power assuming two independent means indicated 38 people per arm are necessary to have 80% power to detect this magnitude of a difference between samples. The sample size has been statistically calculated as (n=90). Though 38 people per arm are needed, however, we are recruiting 45 people per arm by expecting a 20% of dropout rate. Therefore, depressive patients (n=90), with mild and moderate levels of depression ranging between the age group of 18 - 45 years will be recruited for the study, excluding the depressive patients with intellectual disability, substance abuse disorder (except nicotine and caffeine), dementia, epilepsy, or cerebrovascular accidents, history of psychosis or bipolar disorder, and patients with suicidal risks or catatonia. The physiological, psychological, and neuropsychological parameters will be measured and studied with their other psycho-socio-demographic details on both groups. The participants in the control group will be taking conventional treatment and the participants in the interventional group will be taking the conventional treatment&n

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
Outcome Assessor Blinded

入排标准

年龄范围
18.00 Year(s) 至 45.00 Year(s)(—)
性别
All

入选标准

  • Patients with mild and moderate level of depression ranging between the age group of 18 -45 years will be recruited for the study.

排除标准

  • The depressive patients with intellectual disability, substance abuse disorder (except nicotine and caffeine), dementia, epilepsy or cerebrovascular accidents, history of psychosis or bipolar disorder, patients with suicidal risks or catatonia will be excluded from the study.

结局指标

主要结局

The physiological, psychological, and neuropsychological parameters of the mild and moderate depressive patients ranging between the age group of 18 - 45 years will be measured [pre- test & post test].

时间窗: 6 months

次要结局

  • The participants in the intervention group will receive intervention for 12 weeks.(After the post-test, a follow-up for 6 months will be made on the subsamples of the total)

研究者

发起方
Ayisha Siddeequa M A
申办方类型
Other [Self Funding ]
责任方
Principal Investigator
主要研究者

Mrs. Ayisha Siddeequa M.A.

Sri Ramachandra Institute of Higher Education and Research (DU)

研究点 (1)

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