跳至主要内容
临床试验/CTRI/2023/05/052534
CTRI/2023/05/052534招募中不适用

A RANDOMIZED CONTROL TRIAL INVOLVING YOGA INTERVENTION FOR COGNITIVE ENHANCEMENT IN PERSONS WITH REMITTED UNIPOLAR DEPRESSION

St. Johns National Academy of Health Sciences1 个研究点 分布在 1 个国家目标入组 76 人开始时间: 2023年5月15日最近更新:

试验速览

阶段
不适用
状态
招募中
入组人数
76
试验地点
1
主要终点
Primary endpoint – cognitive performances as assessed by the above tests

研究概览

简要总结

Depression is the most common mental health problemthrough-out the world including India. It has significant burden on publichealth in India with prevalence of 4.4% and & 7.1% of total years livedwith disability. Although, more focus is on mood symptoms indepression, presence of cognitive deficits is a matter of concern, according tothe evidence. Research shows that, cognitive deficits areexclusively responsible for functional impairment and disabilities leading topoor quality of life and unemployment. Though the role ofpharmacotherapy in remitting mood and physical symptoms is well known,cognitive deficits do persist, even after remission; especially in the domainsof executive function, working memory and attention. This indicatesthat even the individuals are out of apparent depression, their ability toperform optimally in their roles in the society, is hindered. Since there is nostandard, evidence-based solution for this issue, we, in this randomizedcontrolled trial, aim at employing yoga as an adjuvant intervention inimproving cognitive deficits. In this study 76 patients with remitted unipolardepression will be randomly assigned to yoga intervention and treatment asusual group. Both the groups will be assessed for cognitive functions atbaseline, after intervention and 1 month later. The performance in cognitivetests will be compared across timeline and between two groups.  Previous studies have shown that yoga haspositive effect on cognition in healthy and across various psychiatricdisorders. Hence, if yoga is found to be effective in our currenttarget population, it can serve as an implicit cognitive training interventionfor cognitive deficits in remission phase of unipolar depression, which is wellaccepted, easily accessible and cost effective.

研究设计

研究类型
Interventional
分配方式
Permuted block randomization, fixed
盲法
Not Applicable

入排标准

年龄范围
18.00 Year(s) 至 59.00 Year(s)(—)
性别
All

入选标准

  • Age more than 18years and less than 60 years 2)H/o at least one depressive episode which is under remission and at the time of examination and throughout the study duration, 3)Ability provide valid consent.

排除标准

  • Comorbid Psychosis, OCD, Bipolar disorder 2)Comorbid ADHD, IDD 3)Comorbid substance dependence (except tobacco) 4)Comorbid major or minor cognitive impairment, 5)Bi temporal ECT within 6 months 6)Past yoga practice.
  • regularly for 1 month within 3 months 7)Pregnancy 8)Any serious medical illness.

结局指标

主要结局

Primary endpoint – cognitive performances as assessed by the above tests

时间窗: 6th week

(Digit span, Trail A and B, Stoop color test) are significantly better in yoga group than in treatment-as-usual group at the end of 6 weeks.

时间窗: 6th week

次要结局

  • Secondary endpoint – cognitive enhancement sustained further for 4 weeks after 6 weeks of supervised yoga intervention.(10th week)

研究者

申办方类型
Research institution and hospital

研究点 (1)

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