Development, Validation and Comparative Efficacy Testing of a Hatha yoga protocol with a Bhakti Yoga protocol for Clinical Management of Adults diagnosed with Attention Deficit Hyperactivity Disorders (ADHD): A Randomized Controlled Pilot Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- To check the feasibility and compare preliminary effectiveness of the developed Hatha yoga protocol with the Bhakti protocol in a pilot randomized controlled trial.
研究概览
简要总结
Title of study is Development, Validation and Comparative Efficacy Testing of a Hatha yoga protocol with a Bhakti Yoga protocol for Clinical Management of Adults diagnosed with Attention Deficit Hyperactivity Disorders a Randomized Controlled Pilot Trial .Very few studies have assessed effects of yoga intervention in Adult ADHD. Yoga is culturally accepted, cost-effective, self-administrable, and adaptable for long-term care. There is an absence of standardized and validated yoga protocol for adult ADHD which leads to inconsistency and challenges in comparing results. Application of Yoga practice for enhancing determination and willpower as Hatha Yoga and Yoga philosophy and practice for culturing of emotions (Bhakti Yoga) has not been compared before in this population. Primary outcome of study to check the feasibility and compare preliminary effectiveness of the developed Hatha yoga protocol with the Bhakti protocol in a pilot randomized controlled trial. To study the changes in the variables example quality of life, clinical symptoms in attention deficit hyperactive disorder in adult ,impulsivity anxiety and depression score as comorbidity when Hatha Yoga or Bhakti Yoga protocol is added along with conventional pharmacological management for adults with ADHD. This is prospective three-arm randomized controlled design. Total sample size is 60. Each group consisting of 20 participants, will engage in yoga interventions over an 8-week period. The first group will practice hatha yoga, the second group will participate in bhakti yoga. Third group will be an active control-arm (to match therapist patient interactions) and only health education will be given. The interventions will be conducted both offline and online,1-session offline under supervision, remaining session online for each group, total 24 session for each group.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Outcome Assessor Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 40.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Those diagnosed with adult ADHD by a psychiatrist according to DSM criteria.
- •2.Aged between 18 to 40 years.
- •Those with ability and fitness to practice prescribed yoga.
- •Ready to abstain from substances on the day of testing.
排除标准
- •Less than 14 on the Adult ADHD Self-Report Scale, screener items, ASRS-A .
- •Other physical or neurological condition and learning differences that make practice of yoga difficult.
- •Those with severe psychiatric comorbidities such as severe depression or anxiety with suicidal ideations, those with psychosis or severe substance use disorders or cognitive impairment due to other causes.
- •Those on conventional structured psychotherapy.
- •Those with a change in medications in the last 8 weeks or in whom the change would be required in the next 8 weeks
- •Patient with current participation in regular yoga practices.
- •Patients with inability or unwilling to attain regular raj yoga or bhakti yoga practices.
结局指标
主要结局
To check the feasibility and compare preliminary effectiveness of the developed Hatha yoga protocol with the Bhakti protocol in a pilot randomized controlled trial.
时间窗: Two time point Baseline and 8 weeks
次要结局
- • To study the changes in the following variables when Hatha Yoga or Bhakti Yoga protocol is added along with conventional pharmacological management for adults with ADHD. Both immediate effects as well as effect of 8-week protocol on selected variables:(•Clinical symptoms on ASRS scale at 0 and 8 weeks)