Ignite Creation Date:
2025-12-25 @ 3:20 AM
Ignite Modification Date:
2025-12-26 @ 1:59 AM
Study NCT ID:
NCT03469505
Status:
COMPLETED
Last Update Posted:
2025-05-21
First Post:
2018-02-02
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Cooperative Pain Education and Self-management: Expanding Treatment for Real-world Access (COPES ExTRA)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D059350', 'term': 'Chronic 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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 764}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-12-27', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-05', 'completionDateStruct': {'date': '2025-02-20', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-05-19', 'studyFirstSubmitDate': '2018-02-02', 'studyFirstSubmitQcDate': '2018-03-15', 'lastUpdatePostDateStruct': {'date': '2025-05-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-03-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-02-20', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Brief Pain Inventory, Interference Subscale Score', 'timeFrame': '4 months', 'description': 'The Brief Pain Inventory Interference Score is patient-reported pain-related interference. Data will be collected through automated IVR calls.'}], 'secondaryOutcomes': [{'measure': 'The Brief Pain Inventory, Interference Score', 'timeFrame': '6 months, 12 months', 'description': 'The Brief Pain Inventory Interference Score is patient-reported pain-related interference. Data will be collected through automated IVR calls.'}, {'measure': 'Numeric Rating Score, Pain Intensity', 'timeFrame': '4 month', 'description': 'The single average pain intensity rating question from the self-reported, Brief Pain Inventory. Data will be collected through automated IVR calls.'}, {'measure': 'PEG-3', 'timeFrame': '4 month', 'description': 'A Three-Item Scale Assessing Pain Intensity and Interference. Data will be collected through automated IVR calls.'}, {'measure': 'Depression symptom severity', 'timeFrame': '4 months', 'description': 'Depression symptom severity will be assessed using the 8-item Patient Health Questionnaire (PHQ-8) a widely-used measure with excellent internal consistency and stability. Data will be collected through an automated IVR.'}, {'measure': 'Pain Catastrophizing Scale- Short Form', 'timeFrame': '4 months', 'description': 'The Pain Catastrophizing Scale (PCS)-Short Form is a validated, 3-item self-report scale that examines thoughts and feelings people may experience when they are in pain. Data will be collected through an automated IVR'}, {'measure': 'Sleep Quality', 'timeFrame': '4 months', 'description': 'Sleep quality will be measured using the Insomnia Severity Index and will assess subjective sleep quality. Data will be collected through automated IVR calls.'}, {'measure': 'Pain Self-Efficacy', 'timeFrame': '4 months', 'description': 'Self-Efficacy will be assessed using 1-Item of the Pain Self-Efficacy Questionnaire. Data will be collected through automated IVR calls.'}, {'measure': 'Patient Global Perception of Change', 'timeFrame': '4 months', 'description': 'The Patient Global Perception of Change scale is a single item measure that quantifies a participant\'s overall perception of improvement since beginning treatment and the clinical importance of that improvement. Participants indicate improvement on a 7 point "much worse" to "much better" scale. Data will be collected through automated IVR calls.'}, {'measure': 'Pain Satisfaction Questionnaire', 'timeFrame': '4 month', 'description': 'Pain satisfaction will be measured using an adapted Pain Satisfaction Questionnaire. This 5-item measure about patient self report of experience of treatment . Data will be collected through automated IVR calls.'}, {'measure': 'Treatment dose', 'timeFrame': 'Up to 12 months post baseline', 'description': 'Number of cognitive behavioral therapy for chronic pain sessions attended for this treatment.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Pain, Chronic']}, 'descriptionModule': {'briefSummary': 'To conduct a superiority trial of COPES versus standard Veterans Health Administration (VHA) Cognitive Behavioral Therapy Chronic Pain (CBT-CP)', 'detailedDescription': 'Our prior efficacy trial found that COPES was not inferior to in-person CBT-CP and that participants attended, on average, a little over two more treatment weeks in COPES than in-person treatment, presumably due to the ease of in-home treatment attendance relative to in-person treatment.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with chronic musculoskeletal pain receiving care in VHA.\n* A pain-related musculoskeletal diagnosis indicated by an EHR identified ICD-9 or -10 code.\n* The presence of chronic pain of at least moderate severity with EHR NRS pain scores ≥ 4 in three separate months for a period of 12 months.\n* Absence of mental illness serious enough to have resulted in an inpatient psychiatric hospitalization in the prior 3 months excluding detoxification of alcohol or drugs.\n* Absence of malignant cancer diagnosis or receipt of hospice or end-of-life palliative care.\n* Ability to participate safely in the walking portion of the intervention as evidenced by patient-reported ability to walk at least one block and absence of diabetic foot ulcers at the time of the enrollment.\n* Absence of significant cognitive impairment as identified by a dementia-related diagnosis.\n* Availability of a touch-tone land-line or cellular telephone and no vision or hearing deficits that would impair participation verified by patient report at the time of the enrollment call.\n\nExclusion Criteria:\n\n* Patients not fitting criteria for inclusion.'}, 'identificationModule': {'nctId': 'NCT03469505', 'acronym': 'COPES ExTRA', 'briefTitle': 'Cooperative Pain Education and Self-management: Expanding Treatment for Real-world Access (COPES ExTRA)', 'organization': {'class': 'OTHER', 'fullName': 'Yale University'}, 'officialTitle': 'Cooperative Pain Education and Self-management: Expanding Treatment for Real-world Access (COPES ExTRA)', 'orgStudyIdInfo': {'id': '2000024225'}, 'secondaryIdInfos': [{'id': '1UG3AT009767-01', 'link': 'https://reporter.nih.gov/quickSearch/1UG3AT009767-01', 'type': 'NIH'}, {'id': '4UH3AT009767-03', 'link': 'https://reporter.nih.gov/quickSearch/4UH3AT009767-03', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'data from veterans using COPES', 'description': 'Data from veterans using COPES for chronic pain', 'interventionNames': ['Behavioral: COPES']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'data from veterans using CBT-CP', 'description': 'Data from veterans using CBT-CP for chronic pain', 'interventionNames': ['Behavioral: CBT-CP']}], 'interventions': [{'name': 'COPES', 'type': 'BEHAVIORAL', 'description': 'Cooperative Pain Education and Self-Management for chronic pain therapy.', 'armGroupLabels': ['data from veterans using COPES']}, {'name': 'CBT-CP', 'type': 'BEHAVIORAL', 'description': 'Cognitive Behavioral Therapy for Chronic Pain', 'armGroupLabels': ['data from veterans using CBT-CP']}]}, 'contactsLocationsModule': {'locations': [{'zip': '60141', 'city': 'Hines', 'state': 'Illinois', 'country': 'United States', 'facility': 'Edward Hines, Jr. VA Hospital', 'geoPoint': {'lat': 41.85364, 'lon': -87.8395}}, {'zip': '01053', 'city': 'Leeds', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'VA Central Western Massachusetts', 'geoPoint': {'lat': 42.35148, 'lon': -72.69954}}, {'zip': '48105', 'city': 'Ann Arbor', 'state': 'Michigan', 'country': 'United States', 'facility': 'VA Ann Arbor Healthcare System', 'geoPoint': {'lat': 42.27756, 'lon': -83.74088}}, {'zip': '39216', 'city': 'Jackson', 'state': 'Mississippi', 'country': 'United States', 'facility': 'G.V. (Sonny) Montgomery VA Medical Center', 'geoPoint': {'lat': 32.29876, 'lon': -90.18481}}, {'zip': '73104', 'city': 'Oklahoma City', 'state': 'Oklahoma', 'country': 'United States', 'facility': 'Oklahoma City VA Health Care System', 'geoPoint': {'lat': 35.46756, 'lon': -97.51643}}, {'zip': '29401', 'city': 'Charleston', 'state': 'South Carolina', 'country': 'United States', 'facility': 'Ralph H. Johnson VA Medical Center', 'geoPoint': {'lat': 32.77632, 'lon': -79.93275}}, {'zip': '75216', 'city': 'Dallas', 'state': 'Texas', 'country': 'United States', 'facility': 'VA North Texas Healthcare System', 'geoPoint': {'lat': 32.78306, 'lon': -96.80667}}, {'zip': '76504', 'city': 'Temple', 'state': 'Texas', 'country': 'United States', 'facility': 'VA Central Texas Healthcare System', 'geoPoint': {'lat': 31.09823, 'lon': -97.34278}}, {'zip': '98108', 'city': 'Seattle', 'state': 'Washington', 'country': 'United States', 'facility': 'VA Puget Sound Healthcare System', 'geoPoint': {'lat': 47.60621, 'lon': -122.33207}}], 'overallOfficials': [{'name': 'Alicia Heapy, Phd', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'VA Office of Research and Development'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Yale University', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Center for Complementary and Integrative Health (NCCIH)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}