Ignite Creation Date:
2025-12-25 @ 1:47 AM
Ignite Modification Date:
2026-01-07 @ 1:20 AM
Study NCT ID:
NCT04724694
Status:
COMPLETED
Last Update Posted:
2025-02-13
First Post:
2021-01-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Brief Cognitive Behavioral Therapy for Chronic Pain to Improve Functioning Among Veterans
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D059352', 'term': 'Musculoskeletal Pain'}, {'id': 'D010146', 'term': 'Pain'}, {'id': 'D059350', 'term': 'Chronic Pain'}], 'ancestors': [{'id': 'D009135', 'term': 'Muscular Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D013812', 'term': 'Therapeutics'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2024-05-20', 'size': 189840, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_000.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2024-10-22T13:23', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR'], 'maskingDescription': 'Only the outcomes assessor will be masked'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Two arm parallel design: 1) primary care treatment as usual, or 2) primary care treatment as usual and Brief Cognitive Behavioral Therapy for Chronic Pain'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 184}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-10-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-02', 'completionDateStruct': {'date': '2025-01-27', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-02-10', 'studyFirstSubmitDate': '2021-01-14', 'studyFirstSubmitQcDate': '2021-01-22', 'lastUpdatePostDateStruct': {'date': '2025-02-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-01-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-01-27', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Pain Self-Efficacy Questionnaire (PSEQ) to assess role in mediation at 12 week follow up', 'timeFrame': '12-weeks', 'description': 'This validated measure includes 10-items related to pain-related self-efficacy, such as accomplishing goals and becoming more active. Total scores range from 0 to 60, with higher scores indicating greater pain-related self-efficacy.'}, {'measure': 'Pain Catastrophizing Scale (PCS) to assess role in mediation at 12 week follow up', 'timeFrame': '12-weeks', 'description': 'This validated 13-item measure assesses pain-related cognitions such as pain magnification and perceived helplessness. Total scores range from 0 to 52, with higher scores indicating higher levels of negative pain-related thoughts'}], 'primaryOutcomes': [{'measure': 'Brief Pain Inventory -- Interference subscale (BPI-I) to assess change at 12 week follow-up', 'timeFrame': 'Baseline, 12-weeks', 'description': 'This measure is a validated 7-item subscale that evaluates pain-related interference in daily activities and social and occupational functioning. Average scores range from 0 to 10, with higher scores indicating higher pain-related interference.'}], 'secondaryOutcomes': [{'measure': 'Brief Pain Inventory -- Pain Intensity subscale (BPI-P) to assess change at 12 week follow-up', 'timeFrame': 'Baseline, 12-weeks', 'description': 'This measure is a validated 4-item subscale that evaluates pain intensity. Average scores range from 0 to 10, with higher scores indicating worse pain intensity.'}, {'measure': 'Patient Health Questionnaire -- 9 (PHQ-9) to assess change at 12 week follow-up', 'timeFrame': 'Baseline, 12-weeks', 'description': 'This 9-item measure of depressive symptoms is validated for use in primary care. Total scores range from 0 to 27, with higher scores indicating more depression symptoms.'}, {'measure': 'Scale for Suicide Ideation (SSI) to assess change at 12 week follow-up', 'timeFrame': 'Baseline, 12-weeks', 'description': 'This measure is 21-items and rates current attitudes, behaviors, and plans to commit suicide. Average scores range from 0 to 38, with higher scores indicating higher intensity of suicidal ideation.'}, {'measure': 'World Health Organization Quality of Life - BREF (WHOQOL-BREF) to assess change at 12 week follow up', 'timeFrame': 'Baseline, 12-weeks', 'description': 'This 26-item abbreviated version of the full-length WHOQOL measure evaluates quality of life in several domains such as social relationships and satisfaction with person-environment interactions. Scoring is by subscales representing four domains (i.e., physical health, psychological, social relationship, and environment). Transformed mean scores for each domain range from four to 20, with higher scores indicating greater quality of life in the respective domain.'}, {'measure': 'Ability to Participate in Social Roles and Activities - short form (APSRA) to assess change at 12 week follow up', 'timeFrame': 'Baseline, 12-weeks', 'description': "This 8-item measure was developed to evaluate one's perceived ability to perform usual social roles and activities. Total scores range from eight to 40, with higher scores indicating better ability to participate in usual activities."}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['primary care', 'chronic pain', 'cognitive behavioral therapy', 'integrated primary care', 'musculoskeletal pain'], 'conditions': ['Musculoskeletal Pain', 'Pain']}, 'descriptionModule': {'briefSummary': 'Chronic pain is very common among primary care Veterans and can seriously impact overall patient functioning and well-being. Currently, behavioral treatments for pain management are not often provided in primary care because they are designed to be delivered in specialty care settings, such as chronic pain clinics. To address this gap in care, the proposed study will test if Brief Cognitive Behavioral Therapy for Chronic Pain (Brief CBT-CP) is an effective treatment. Therefore, the first objective of the proposed study is to conduct a randomized controlled trial of Brief CBT-CP compared to primary care treatment as usual to assess treatment effectiveness by examining changes in pain-related physical activity interference, psychological distress, pain intensity, and other related outcomes. 178 eligible participants will be randomized into either Brief CBT-CP and primary care treatment as usual or primary care treatment as usual only. Eligible Veterans will include those with chronic musculoskeletal pain and pain-related functional impairment identified from primary care. Participants assigned to Brief CBT-CP will receive six sessions of treatment in 30-minute appointments. This intervention will include education and goal setting, activities and pacing, relaxation skills, cognitive coping, and relapse prevention. Assessments will include validated self-report measures that will take place at pre-treatment (baseline), mid-treatment, post-treatment, and at 6-month follow-up. The second objective of this study is examine the mechanisms by which Brief CBT-CP leads to improvement in patient outcomes. Statistical analysis will reveal if changes pain self-efficacy (i.e., perceived ability to manage pain or engage in usual activities despite being in pain) and catastrophizing (i.e., unhelpful, negative though patterns about pain and pain management) lead to improvements in patient functioning. The third objective of this study will be to explore perceptions of Brief CBT-CP among patients who experience significant improvement in outcomes compared to those who did not experience improvement. Participants will include up to 40 patients who were treated with Brief CBT-CP. Participants will be interviewed about key components of the treatment and their perception of effectiveness. Interview data will be compared to the results of statistical analysis to help understand the mechanisms by which Brief CBT-CP is effective or identify areas for improvement. Results of this study will provide information needed to determine if Brief CBT-CP should be widely disseminated across VA primary care clinics.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '79 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Veterans age \\>=18 and \\<=79 years\n* Conversant in English\n* A diagnosis of musculoskeletal pain of \\>three months\n* PEG score of \\>= 4 on pain intensity item and both interference items at screening\n* BPI interference and pain intensity score of at least 4.0 at baseline\n* If currently prescribed pain medication (other than topicals or NSAIDS), a stable dose in the last two months\n* If currently prescribed psychiatric medicine, a stable dose in the last two months\n* Established history of VA primary care utilization (i.e., at least one primary care visit in the past year)\n\nExclusion Criteria:\n\n* Current or prior (past 12 months) engagement in psychotherapy or behavioral intervention provided by behavioral medicine services or specialty mental health for chronic pain.\n\n * Medication management through psychiatric services or an on-going course of mental health services for issues other than chronic pain are not excluded.\n* Endorsement of imminent suicide risk\n* Current significant substance use problems (i.e., alcohol, opioids, benzodiazepines, or other drugs)\n* Unstable psychiatric status (e.g., active psychosis, current mania)\n* Diagnosed with major or minor neurocognitive disorder\n* Unwilling to have treatment sessions audio recorded\n* Pending disability claim\n* Recent or planned surgical/interventional procedure for pain'}, 'identificationModule': {'nctId': 'NCT04724694', 'briefTitle': 'Brief Cognitive Behavioral Therapy for Chronic Pain to Improve Functioning Among Veterans', 'organization': {'class': 'FED', 'fullName': 'VA Office of Research and Development'}, 'officialTitle': 'Brief Cognitive Behavioral Therapy for Chronic Pain to Improve Functional Outcomes Among Primary Care Veterans', 'orgStudyIdInfo': {'id': 'D3485-R'}, 'secondaryIdInfos': [{'id': 'RX003485-01A1', 'type': 'OTHER_GRANT', 'domain': 'VA-ORD'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Brief CBT for Chronic Pain and treatment as usual', 'description': 'Participants will receive Brief CBT-CP in addition to usual primary care treatment. Brief CBT-CP is a manualized protocol that includes six, 30-minute sessions over the course of 6-12 weeks. Session one focuses on foundational pain education and the development of treatment goals. Session two emphasizes balanced engagement in physical activity and pleasurable events. Session three emphasizes skills training for easily implemented relaxation techniques. Sessions four and five focus on recognizing and modifying unhelpful thoughts that negatively impact pain. Session six focuses on relapse prevention and independent implementation of CBT-CP skills following treatment.', 'interventionNames': ['Behavioral: Brief CBT for Chronic Pain', 'Other: Treatment as usual']}, {'type': 'OTHER', 'label': 'Treatment as usual only', 'description': 'Participants assigned to treatment as usual will receive standard medical care from their primary care provider including pain medications, brief advice (e.g., use of relative rest, application of heat or ice, other self-care strategies), or referral to pain-related adjunctive interventions (e.g., physical therapy), as indicated.', 'interventionNames': ['Other: Treatment as usual']}], 'interventions': [{'name': 'Brief CBT for Chronic Pain', 'type': 'BEHAVIORAL', 'otherNames': ['Brief CBT-CP'], 'description': 'Brief CBT-CP is a manualized protocol that includes six, 30-minute sessions over the course of 6-12 weeks. Session one focuses on foundational pain education and the development of treatment goals. Session two emphasizes balanced engagement in physical activity and pleasurable events. Session three emphasizes skills training for easily implemented relaxation techniques. Sessions four and five focus on recognizing and modifying unhelpful thoughts that negatively impact pain. Session six focuses on relapse prevention and independent implementation of CBT-CP skills following treatment.', 'armGroupLabels': ['Brief CBT for Chronic Pain and treatment as usual']}, {'name': 'Treatment as usual', 'type': 'OTHER', 'otherNames': ['Primary care treatment as usual'], 'description': 'Participants assigned to TAU will receive standard medical care from their primary care provider including pain medications, brief advice (e.g., use of relative rest, application of heat or ice, other self-care strategies), or referral to pain-related adjunctive interventions (e.g., physical therapy), as indicated.', 'armGroupLabels': ['Brief CBT for Chronic Pain and treatment as usual', 'Treatment as usual only']}]}, 'contactsLocationsModule': {'locations': [{'zip': '14215-1129', 'city': 'Buffalo', 'state': 'New York', 'country': 'United States', 'facility': 'VA Western New York Healthcare System, Buffalo, NY', 'geoPoint': {'lat': 42.88645, 'lon': -78.87837}}], 'overallOfficials': [{'name': 'Gregory P. Beehler, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'VA Western New York Healthcare System, Buffalo, NY'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL'], 'timeFrame': 'IPD will be made available for up to three years starting six months after final publication.', 'ipdSharing': 'YES', 'description': 'A Limited Dataset (LDS) will be created and shared pursuant to a Data Use Agreement (DUA) appropriately limiting use of the dataset and prohibiting the recipient from identifying or re-identifying (or taking steps to identify or re-identify) any individual whose data are included in the dataset. The LDS will contain IPD that underlie results presented in publications.', 'accessCriteria': 'Data will be shared upon completion of a written request and within 90 days of a completed Data Use Agreement (DUA).'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'VA Office of Research and Development', 'class': 'FED'}, 'responsibleParty': {'type': 'SPONSOR'}}}}