- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06704061
Online Yoga vs Acceptance and Commitment Therapy for Treating Chronic Musculoskeletal Pain
January 27, 2026 updated by: Peter Bayley, Palo Alto Veterans Institute for Research
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.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Estimated)
274
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Peter Bayley, PhD
- Phone Number: 68653 650-493-5000
- Email: peter.bayley@va.gov
Study Locations
-
-
California
-
Palo Alto, California, United States, 94304
- Recruiting
- Palo Alto VA Medical Center
-
Contact:
- Peter Bayley, PhD
- Phone Number: 68653 650-493-5000
- Email: peter.bayley@va.gov
-
Contact:
- Annie Lau, BA
- Phone Number: 6503748516
- Email: annie.lau2@va.gov
-
Principal Investigator:
- Peter Bayley, PhD
-
Sub-Investigator:
- Louise Mahoney, MS
-
Sub-Investigator:
- Elizabeth Walker, MSPT
-
Sub-Investigator:
- Julie Wetherell, PhD
-
Sub-Investigator:
- Santiago Allende, PsyD
-
Sub-Investigator:
- Dave Clark, MD, PhD
-
Sub-Investigator:
- Jessica Lohnberg, PhD
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Description
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
- 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
- Has received ACT in the past
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Online Yoga
Postures, meditation, breathing exercises
|
A 12-week online yoga course designed to treat pain.
|
|
Active Comparator: Acceptance and Commitment Therapy
Behavioral medicine
|
A 12-week behavioral therapy course designed to treat pain.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Pain Interference (Brief Pain Inventory-Short Form)
Time Frame: 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.
|
Baseline, End-of-treatment at 12 weeks, and 6 months after treatment
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Depression (BDI-II)
Time Frame: 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.
|
Baseline, End-of-treatment at 12 weeks, and 6 months after treatment
|
|
Sleep (Pittsburgh Sleep Quality Index)
Time Frame: 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.
|
Baseline, End-of-treatment at 12 weeks, and 6 months after treatment
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Peter Bayley, PhD, Palo Alto Veterans Institute for Research
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 7, 2026
Primary Completion (Estimated)
November 1, 2029
Study Completion (Estimated)
November 1, 2029
Study Registration Dates
First Submitted
November 20, 2024
First Submitted That Met QC Criteria
November 21, 2024
First Posted (Actual)
November 25, 2024
Study Record Updates
Last Update Posted (Actual)
January 29, 2026
Last Update Submitted That Met QC Criteria
January 27, 2026
Last Verified
November 1, 2025
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Pain
- Neurologic Manifestations
- Musculoskeletal Diseases
- Muscular Diseases
- Pathological Conditions, Signs and Symptoms
- Signs and Symptoms
- Musculoskeletal Pain
- Chronic Pain
- Therapeutics
- Mind-Body Therapies
- Complementary Therapies
- Spiritual Therapies
- Exercise Movement Techniques
- Physical Therapy Modalities
- Behavior Therapy
- Psychotherapy
- Behavioral Disciplines and Activities
- Cognitive Behavioral Therapy
- Yoga
- Acceptance and Commitment Therapy
Other Study ID Numbers
- BAYNEW0004
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
YES
IPD Plan Description
All demographic, clinical observations, and clinical self-reports
IPD Sharing 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.
IPD Sharing 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.
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
- ICF
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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