Online Yoga vs Acceptance and Commitment Therapy for Treating Chronic Musculoskeletal Pain

Not Applicable

Not yet recruiting

• Conditions: Chronic Pain; Musculoskeletal Pain

• Registration Number: NCT06704061
• Lead Sponsor: Palo Alto Veterans Institute for Research

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Status Verified: 2024-11
• Study First Submitted: 2024-11-20
• Study First Submitted QC: 2024-11-21
• Last Update Submitted: 2024-11-21
• Study First Posted: 2024-11-25
• Last Update Posted: 2024-11-25
• Study Start: 2025-07
• Primary Completion: 2029-07
• Study Completion: 2029-07

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 274

Inclusion Criteria

• 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
• Wireless internet connection at home

Exclusion Criteria

• 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Pain Interference (Brief Pain Inventory-Short Form)	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.

Secondary Outcome Measures

Name	Time	Method
Depression (BDI-II)	Baseline, End-of-treatment at 12 weeks, and 6 months after treatment	Symptoms of depression as measured by the Beck Depression Inventory (BDI-II). The BDI-II is comprised of 21 self-report questions, scored on a 0-3 scale, with higher scores indicating more depressive symptoms.
Sleep (Pittsburgh Sleep Quality Index)	Baseline, End-of-treatment at 12 weeks, and 6 months after treatment	Sleep quality as measured by the Pittsburgh Sleep Quality Index (PSQI). The PSQI is a a self-rated questionnaire that assesses sleep quality and disturbances over a 1-month interval.

Trial Locations

Locations (1)

Palo Alto VA Medical Center; 🇺🇸 Palo Alto, California, United States