A Randomized Control Trial Involving Yoga Intervention for Cognitive Enhancement in Persons With Remitted Unipolar Depression
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 76
- 试验地点
- 1
- 主要终点
- Attention and processing speed(Trail A and B)
研究概览
简要总结
It is evident from recent studies that cognitive deficits persist even after remission of depressive episode. Hence, in this study, the investigators would like to see whether specific Yoga practice will help in enhancing cognitive abilities in this population.
详细描述
Depression is a common mental health condition affecting many people around the world. It affects the person's mood, thinking (cognition), behavior and also physical health causing difficulty in performing duties in efficient way. Most of these problems can be treated by medicines and/or talk therapies. But the research shows that even after the recovery from most of these problems, most individuals continue to have difficulties in capacity to think properly, they are specifically called as dysfunction in executive functions of our mind. The executive functions are a set of skills which make us possible to play with ideas, taking time to think before acting, meeting novel, unanticipated challenges, resisting temptations, staying focused., etc.
To overcome these problems currently there is no standard solution. However, the previous studies have shown that specific Yoga practices help in overcoming these challenges in general population. Hence it is planned of testing whether regular practice of a specific Yoga along with ongoing treatment for depression would benefit persons in enhancing their thinking capabilities.
Screening procedure:
The screening will be a verbal process where the patient will be verbally asked about the symptoms to check eligibility criteria of this study. If the patient is not eligible after completing this questionnaire, then the participation in this study will end.
(PS: Screening procedures for the study eligibility may involve the review and collection of information from patient's medical record.) This will be followed by obtaining written informed consent from the patient if the person considers participating in the study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age more than 18years and less than 60 years
- •H/o at least one depressive episode which is under remission and at the time of examination and throughout the study duration,
- •Informed Consent
排除标准
- •Comorbid Psychosis, OCD, Bipolar disorder
- •Comorbid ADHD, IDD
- •Comorbid substance dependence (except tobacco)
- •Comorbid major or minor cognitive impairment,
- •Bi temporal ECT within 6 months
- •Past yoga practice - regularly for 1 month within 3 months Pregnancy
研究组 & 干预措施
Adjuvant yoga intervention group
The yoga group will attend the yoga under the guidance of a therapist for 6 weeks (6 days a week).yoga group, the participant needs to attend Specific Yoga Practices of duration around 1 Hour every day under a trained therapist for about 6 days in a week for 6 weeks, along with your ongoing medications (online/offline).. It includes warme up exercises and asanas.
干预措施: Adjuvant yoga intervention (Behavioral)
Treatment as usual group
The treatment-as-usual group will continue with usual treatment.the treatment as usual group will continue the ongoing medications for next 6 weeks. But participants will be coming for cognitive assessments at the end of 6 weeks and 4 weeks later. After the final assessment they will be given an option for joining yoga sessions provided in the yoga center at NIMHANS. But this will not be the part of this study.
结局指标
主要结局
Attention and processing speed(Trail A and B)
时间窗: Baseline, after six weeks yoga and after four weeks of completion of yoga
To study the change in attention and processing speed in intervention group as measured by Trail A and B test in comparison to treatment as usual. The scoring is based on time taken to complete the test. Less the time taken, better the attention and processing speed.
Working memory (Digit Span)
时间窗: Baseline, after six weeks yoga and after four weeks of completion of yoga
To study the change in working memory in intervention group as measured by digit span test in comparison to treatment as usual. The range of the scale is 0 to 28 points and higher is better memory.
Cognitive flexibility
时间窗: Baseline,after six weeks yoga and after four weeks of completion of yoga
To study the change in cognitive flexibility in intervention group as measured by stroop test test in comparison to treatment as usual. Stroop test also measures time to complete the task and less the time, better the score is.
Cognitive inhibition
时间窗: Baseline,after six weeks yoga and after four weeks of completion of yoga
To study the change in cognitive inhibition in intervention group as measured by stroop test test in comparison to treatment as usual.
次要结局
- Sustainability of cognitive inhibition(four weeks of completion of yoga)
- Sustainability of working memory(four weeks of completion of yoga)
- Sustainability of attention and processing speed(four weeks of completion of yoga)
- Sustainability of cognitive flexibility(four weeks of completion of yoga)
研究者
Vishwajit Nimgaonkar, MD PhD
Professor
University of Pittsburgh