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

NCT06704061 | Recruiting DMC

• 1 other identifier: BAYNEW0004
• Study Type: interventional
• Target: 274
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Pain; Musculoskeletal Pain

Keywords

chronic pain; veteran; musculoskeletal pain; yoga

Outcome Measures

Primary Outcomes (1)

• Pain Interference (Brief Pain Inventory-Short Form)

  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.

  Baseline, End-of-treatment at 12 weeks, and 6 months after treatment

Secondary Outcomes (2)

• 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

Study Arms (2)

Online Yoga

EXPERIMENTAL

Postures, meditation, breathing exercises

Behavioral: Yoga

Acceptance and Commitment Therapy

ACTIVE COMPARATOR

Behavioral medicine

Behavioral: Acceptance and Commitment Therapy (ACT)

Interventions

Yoga BEHAVIORAL

A 12-week online yoga course designed to treat pain.

Online Yoga

Acceptance and Commitment Therapy (ACT) BEHAVIORAL

A 12-week behavioral therapy course designed to treat pain.

Acceptance and Commitment Therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Palo Alto Veterans Institute for Research: lead

Study Sites (1)

Palo Alto VA Medical Center

Palo Alto, California, 94304, United States

RECRUITING

MeSH Terms

Conditions

Chronic Pain; Musculoskeletal Pain

Interventions

Yoga; Acceptance and Commitment Therapy

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Muscular Diseases; Musculoskeletal Diseases

Intervention Hierarchy (Ancestors)

Mind-Body Therapies; Complementary Therapies; Therapeutics; Spiritual Therapies; Exercise Movement Techniques; Physical Therapy Modalities; Cognitive Behavioral Therapy; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Peter Bayley, PhD

  Palo Alto Veterans Institute for Research

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Peter Bayley, PhD

CONTACT

650-493-5000; peter.bayley@va.gov

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: November 20, 2024
• First Posted: November 25, 2024
• Study Start: January 7, 2026
• Primary Completion (Estimated): November 1, 2029
• Study Completion (Estimated): November 1, 2029
• Last Updated: January 29, 2026

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: IPD and supporting information will be available at the end of the funding period. The duration of preservation and sharing of the data will be a minimum of 10 years after the funding period.
• Access Criteria: Data and source materials will be posted on DRYAD, an open-source tool for data publication and digital preservation. DRYAD provides searchable study-level metadata for dataset discovery. Data will be indexed by Google Dataset Search and other tools to enhance discoverability and will be discoverable online through standard web search of the study-level metadata as well as the persistent pointer from the DOI to the dataset.

Locations

US (1)