Efficacy of an 8-week Pranayama-Based Yoga Intervention Versus Active Control in Patients with Anxiety Disorders: A Randomized Controlled Trial.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 60
- 试验地点
- 1
研究概览
简要总结
This study is a parallel-group, outcome assessor–blinded, randomized controlled trial designed to evaluate the efficacy of a pranayama-based yoga intervention in patients with anxiety disorders who have residual symptoms despite stable pharmacological treatment. Sixty participants will be randomized to receive either pranayama-based yoga with Treatment as Usual (TAU) or breath-watch practice with TAU.
The intervention will be delivered over 8 weeks, including a 1-week supervised training phase followed by 7 weeks of home-based practice using pre-recorded videos, with one weekly live online booster session. Booster sessions will include either yoga philosophy discussions or mental health education, depending on group allocation.
The primary outcomes are changes in self-reported anxiety measured using the PROMIS Anxiety questionnaire and affective states assessed using the Positive and Negative Affect Schedule (PANAS). Assessments will be conducted at baseline and at the end of Week 8, with additional weekly monitoring during the intervention period.
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 60.00 Year(s)（—）
- 性别
- All
入选标准
- •Diagnosed with Generalized Anxiety Disorder (GAD) or Other/Unspecified Anxiety Disorder according to DSM-5 criteria.
- •Participants with at least mild anxiety symptoms (GAD-7 score more than or equals to 5).
- •Participants with or without pharmacotherapy.
- •If on pharmacotherapy, then participants willing to keep dosage of medications stable during the trial period.
- •Able and willing to provide written informed consent.
排除标准
- •History of bipolar disorder, schizophrenia, substance use or dependence (excluding tobacco), obsessive-compulsive disorder (OCD), severe depression, psychosis, phobias, or panic disorder.
- •Any severe medical comorbidities.
- •Participation in structured yoga therapy or online/offline pranayama or any mind-body technique at least once per week in last 3 months.
- •Participation in structured cognitive behavioral therapy (CBT) for anxiety within the past 3 months.
- •Not on a stable pharmacological dose for at least 4 weeks prior to enrolment.
- •Nasal abnormalities (e.g., nasal septum deviation, polyps).
- •Contraindications for fMRI (e.g., metal implants, claustrophobia, inability to remain still) will be assessed using a fMRI safety checklist before the scan.
研究者
Ashish Kumar
Department of Integrative Medicine, NIMHANS