Real world effectiveness of add-on yoga for patients with opiod dependence stabilized on treatment
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 180
- 试验地点
- 1
- 主要终点
- To assess the effectiveness of add-on yoga for improvement in quality of life (as measured with WHOQOL Bref) in patients with opioid dependence
研究概览
简要总结
This study spanning eight weeks duration would be conducted at the National Drug Dependence Treatment Centre (NDDTC), Ghaziabad and Trilokpuri Community Clinic, Delhi. Adult patients with opioid dependence who are currently stabilized on medications and willing for meditation-based intervention would be recruited in the study after obtaining informed consent. They would be assessed on baseline socio-demographic and substance use parameters. Quality of life would be assessed using WHOQOL Bref. The current substance use pattern would be assessed using Maudsley Addiction Profile. Sleep quality would be assessed using Pittsburg Sleep Quality Index (PSQI). The reasons of non-inclusion would also be assessed for those who do not intend to take part in the study.
The patients would be subsequently randomized using a computer-generated sequence into dhyana meditation group and wait-list control. Both the group would also be read-out a leaflet on relaxation. The yoga group would be taught about process of yoga by a trained teacher, preferably on the same day of baseline assessment. The training would be conducted individually or in groups of up to 4 participants. The participants in the yoga group would be encouraged to practice yoga and meditation for at least 30 minutes, at least 5 days a week. The participants would be asked to keep a daily log of yoga, mentioning whether they were able to do the dhayana, how much time they spent, whether they were able to concentrate, and whether they had any problems. A booster session at 2 to 4 weeks would be conducted to reinforce the technique, and to clarify any doubts.
At 8 weeks, all the participants would be assessed for their quality of life using WHOQOL Bref. Other substance use would also be identified using Maudsley Addiction Profile. Sleep would be assessed using PSQI. Feedback would be taken from the participants at the end of 8 weeks. The participants would also be followed up at 6 months and 12 months to assess their substance intake.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Open Label
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Patient having a diagnosis of opioid dependence as per ICD 10 diagnostic criteria 2.Age more than 18 years 3.On stable treatment for opioid dependence defined by unchanged medication for last 30 days and adherence of more than 80% in last 30 days, and do not need an immediate change in medication regimen 4.Willing to do meditation at least 5 days a week for at least 1 month.
排除标准
- •1.Unwilling to participate in the study 2.Concurrently receiving psychotherapy or already practicing yoga (at least once a week) in last 1 month.
- •3.Currently in clinically significant substance intoxication or withdrawal that interferes with assessment 4.Presence of medical illness that interferes with assessment 5.Presence of psychotic illness or hypomania/ mania currently or in the past.
结局指标
主要结局
To assess the effectiveness of add-on yoga for improvement in quality of life (as measured with WHOQOL Bref) in patients with opioid dependence
时间窗: 4 weeks and 8 weeks
次要结局
- To assess the reduction of substance use with yoga practice in patients with opioid dependence who are enrolled into add-on yoga programme(4 weeks, 8 weeks, 6 months and 12 months)
- To assess the improvement in sleep quality with yoga practice in patients with opioid dependence who are enrolled into add-on yoga programme(4 weeks, 8 weeks)
- To assess the acceptability and of add-on yoga programme for patients with opioid dependence(0 weeks, 4 weeks, 8 weeks)
- To assess the adherence to meditation practice in patients with opioid dependence who are enrolled into add-on yoga programme(8 weeks)