Ignite Creation Date:
2025-12-24 @ 12:15 PM
Ignite Modification Date:
2026-01-18 @ 12:45 PM
Study NCT ID:
NCT06704061
Status:
RECRUITING
Last Update Posted:
2025-11-25
First Post:
2024-11-20
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Online Yoga vs Acceptance and Commitment Therapy for Treating Chronic Musculoskeletal Pain
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D059350', 'term': 'Chronic Pain'}, {'id': 'D059352', 'term': 'Musculoskeletal Pain'}], 'ancestors': [{'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D009135', 'term': 'Muscular Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D015013', 'term': 'Yoga'}, {'id': 'D064869', 'term': 'Acceptance and Commitment Therapy'}], 'ancestors': [{'id': 'D026441', 'term': 'Mind-Body Therapies'}, {'id': 'D000529', 'term': 'Complementary Therapies'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D026443', 'term': 'Spiritual Therapies'}, {'id': 'D026241', 'term': 'Exercise Movement Techniques'}, {'id': 'D026741', 'term': 'Physical Therapy Modalities'}, {'id': 'D015928', 'term': 'Cognitive Behavioral Therapy'}, {'id': 'D001521', 'term': 'Behavior Therapy'}, {'id': 'D011613', 'term': 'Psychotherapy'}, {'id': 'D004191', 'term': 'Behavioral Disciplines and Activities'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 274}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2026-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-11', 'completionDateStruct': {'date': '2029-07', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-11-20', 'studyFirstSubmitDate': '2024-11-20', 'studyFirstSubmitQcDate': '2024-11-21', 'lastUpdatePostDateStruct': {'date': '2025-11-25', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2024-11-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2029-07', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pain Interference (Brief Pain Inventory-Short Form)', 'timeFrame': 'Baseline, End-of-treatment at 12 weeks, and 6 months after treatment', 'description': '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.'}], 'secondaryOutcomes': [{'measure': 'Depression (BDI-II)', 'timeFrame': 'Baseline, End-of-treatment at 12 weeks, and 6 months after treatment', 'description': '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.'}, {'measure': 'Sleep (Pittsburgh Sleep Quality Index)', 'timeFrame': 'Baseline, End-of-treatment at 12 weeks, and 6 months after treatment', 'description': '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.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['chronic pain', 'veteran', 'musculoskeletal pain', 'yoga'], 'conditions': ['Chronic Pain', 'Musculoskeletal Pain']}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Veteran of the United States Armed Forces ≥ 18 years old\n* Chronic pain \\> 6 months related to at least one musculoskeletal pain-related diagnosis indicated by an ICD-9 or -10 code\n* Minimum pain intensity at screening ≥4 on a 0-10 using the Defense and Veterans Pain Rating Scale (DVPRS)\n* Not begun new pain treatments or medications in the past month\n* Stable medication regimen for at least 4 weeks prior to entry to the study\n* English literacy\n* Internet connection at home\n\nExclusion Criteria:\n\n* Participation in another clinical trial, unless given prior authorization from both our research team and that of the other study\n* Back surgery within the last 12 months\n* Back pain potentially attributed to a specific known condition\n* Baseline pain \\<4 or ≥9 on a 0-10 Numeric Rating Scale\n* Unstable, serious coexisting medical illness, mental illness or psychiatric conditions\n* Attended or practiced yoga ≥ 1 x in the past 12 months\n* Current suicidal intent or plan\n* Has received ACT in the past'}, 'identificationModule': {'nctId': 'NCT06704061', 'briefTitle': 'Online Yoga vs Acceptance and Commitment Therapy for Treating Chronic Musculoskeletal Pain', 'organization': {'class': 'OTHER', 'fullName': 'Palo Alto Veterans Institute for Research'}, 'officialTitle': 'Online Yoga vs Acceptance and Commitment Therapy for Treating Chronic Musculoskeletal Pain', 'orgStudyIdInfo': {'id': 'BAYNEW0004'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Online Yoga', 'description': 'Postures, meditation, breathing exercises', 'interventionNames': ['Behavioral: Yoga']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Acceptance and Commitment Therapy', 'description': 'Behavioral medicine', 'interventionNames': ['Behavioral: Acceptance and Commitment Therapy (ACT)']}], 'interventions': [{'name': 'Yoga', 'type': 'BEHAVIORAL', 'description': 'A 12-week online yoga course designed to treat pain.', 'armGroupLabels': ['Online Yoga']}, {'name': 'Acceptance and Commitment Therapy (ACT)', 'type': 'BEHAVIORAL', 'description': 'A 12-week behavioral therapy course designed to treat pain.', 'armGroupLabels': ['Acceptance and Commitment Therapy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '94304', 'city': 'Palo Alto', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Peter Bayley, PhD', 'role': 'CONTACT', 'email': 'peter.bayley@va.gov', 'phone': '650-493-5000', 'phoneExt': '68653'}, {'name': 'Annie Lau, BA', 'role': 'CONTACT', 'email': 'annie.lau2@va.gov', 'phone': '6503748516'}, {'name': 'Peter Bayley, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Louise Mahoney, MS', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Elizabeth Walker, MSPT', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Julie Wetherell, PhD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Santiago Allende, PsyD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Dave Clark, MD, PhD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Jessica Lohnberg, PhD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Palo Alto VA Medical Center', 'geoPoint': {'lat': 37.44188, 'lon': -122.14302}}], 'centralContacts': [{'name': 'Peter Bayley, PhD', 'role': 'CONTACT', 'email': 'peter.bayley@va.gov', 'phone': '650-493-5000', 'phoneExt': '68653'}], 'overallOfficials': [{'name': 'Peter Bayley, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Palo Alto Veterans Institute for Research'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ICF'], 'timeFrame': '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.', 'ipdSharing': 'YES', 'description': 'All demographic, clinical observations, and clinical self-reports', 'accessCriteria': '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.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Palo Alto Veterans Institute for Research', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Peter Bayley', 'investigatorAffiliation': 'Palo Alto Veterans Institute for Research'}}}}