Online Yoga vs Acceptance and Commitment Therapy for Treating Chronic Musculoskeletal Pain
Study Overview
Status
Status
Conditions
Conditions
Intervention / Treatment
Intervention / Treatment
Detailed Description
Study Type
Study Type
Enrollment (Estimated)
Enrollment
Phase
Phase
- Not Applicable
Contacts and Locations
Study Contact
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
Eligibility Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
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
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Number of Arms
Arms and Interventions
Participant Group / ArmParticipant Group / Arm |
Intervention / TreatmentIntervention / 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
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
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
Sponsor
Sponsor
Investigators
Investigators
- Principal Investigator: Peter Bayley, PhD, Palo Alto Veterans Institute for Research
Study record dates
Study Major Dates
Study Start (Actual)
Study Start
Primary Completion (Estimated)
Primary Completion
Study Completion (Estimated)
Study Completion
Study Registration Dates
First Submitted
First Submitted
First Submitted That Met QC Criteria
First Submitted That Met QC Criteria
First Posted (Actual)
First Posted
Study Record Updates
Last Update Posted (Actual)
Last Update Posted
Last Update Submitted That Met QC Criteria
Last Update Submitted That Met QC Criteria
Last Verified
Last Verified
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
Other Study ID Numbers
- BAYNEW0004
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
- ICF
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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