Online Yoga vs Acceptance and Commitment Therapy for Treating Chronic Musculoskeletal Pain
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 274
- 试验地点
- 2
- 主要终点
- Pain Interference (Brief Pain Inventory-Short Form)
研究概览
简要总结
This study will compare online yoga with Acceptance and Commitment Therapy (ACT), an established treatment for chronic pain. We will compare the efficacy of the two treatments for reducing chronic musculoskeletal pain in veterans.
详细描述
This study will test if online yoga is not inferior than ACT for treating chronic pain in veterans. Participants will be randomly assigned to receive either online yoga instruction or ACT, once a week for 12 weeks in an online group class. They will complete self-report questionnaires about their experience of chronic pain. There will be a 6-month follow up period, during which the research team will check in with the participant to record any adverse events and maintain study contact.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Veteran of the United States Armed Forces ≥ 18 years old
- •Chronic pain > 6 months related to at least one musculoskeletal pain-related diagnosis indicated by an ICD-9 or -10 code
- •Minimum pain intensity at screening ≥4 on a 0-10 using the Defense and Veterans Pain Rating Scale (DVPRS)
- •Not begun new pain treatments or medications in the past month
- •Stable medication regimen for at least 4 weeks prior to entry to the study
- •English literacy
- •Internet connection at home
排除标准
- •Participation in another clinical trial, unless given prior authorization from both our research team and that of the other study
- •Back surgery within the last 12 months
- •Back pain potentially attributed to a specific known condition
- •Baseline pain <4 or ≥9 on a 0-10 Numeric Rating Scale
- •Unstable, serious coexisting medical illness, mental illness or psychiatric conditions
- •Attended or practiced yoga ≥ 1 x in the past 12 months
- •Current suicidal intent or plan
- •Has received ACT in the past
研究组 & 干预措施
Online Yoga
Postures, meditation, breathing exercises
干预措施: Yoga (Behavioral)
Acceptance and Commitment Therapy
Behavioral medicine
干预措施: Acceptance and Commitment Therapy (ACT) (Behavioral)
结局指标
主要结局
Pain Interference (Brief Pain Inventory-Short Form)
时间窗: Baseline, End-of-treatment at 12 weeks, and 6 months after treatment
The degree to which pain impacts mood, walking and other daily activities, as measured by the Pain Interference Scale of the Brief Pain Inventory - Short Form (BPI-SF). The BPI-SF assesses intensity and impact of pain on functioning on a 0-10 rating scale, with higher scores indicating greater degree of interference.
次要结局
- Depression (BDI-II)(Baseline, End-of-treatment at 12 weeks, and 6 months after treatment)
- Sleep (Pittsburgh Sleep Quality Index)(Baseline, End-of-treatment at 12 weeks, and 6 months after treatment)
研究者
Peter Bayley
Principal Investigator
Palo Alto Veterans Institute for Research