Ignite Creation Date:
2025-12-24 @ 6:29 PM
Ignite Modification Date:
2026-02-02 @ 11:42 AM
Study NCT ID:
NCT03692468
Status:
COMPLETED
Last Update Posted:
2022-12-07
First Post:
2018-09-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Brief Intervention for Chronic Pain in Primary Care
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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D011613', 'term': 'Psychotherapy'}], 'ancestors': [{'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': 'ACTUAL', 'count': 61}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-09-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-12', 'completionDateStruct': {'date': '2020-11-18', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-12-06', 'studyFirstSubmitDate': '2018-09-20', 'studyFirstSubmitQcDate': '2018-09-28', 'lastUpdatePostDateStruct': {'date': '2022-12-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-10-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-04-21', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Chronic Pain Acceptance Questionnaire', 'timeFrame': 'Administered at baseline, 5 weeks post-baseline, and 1 month and 6-month follow-ups', 'description': 'This measure assess acceptance of chronic pain. Total scores range from 0-120 with higher scores indicating greater acceptance. There are 2 subscales: Activity Engagement (range= 0-66) and Pain Willingness (range= 0-54).'}, {'measure': 'Mindful Attention Awareness Scale', 'timeFrame': 'Administered at baseline, 5 weeks post-baseline, and 1 month and 6-month follow-ups', 'description': 'This measure assess the extent to which someone is using mindful awareness. Total scores range from 15-90 with greater scores indicating greater mindfulness.'}, {'measure': 'Montreal Cognitive Assessment', 'timeFrame': 'Administered at baseline', 'description': 'Brief screen of cognitive functioning; scores range from 0-30'}, {'measure': 'Brief Medical Numbers Test', 'timeFrame': 'Administered at baseline', 'description': 'Brief screen of health numeracy; scores range from 0-4'}, {'measure': 'Rapid Estimate of Adult Learning in Medicine', 'timeFrame': 'Administered at baseline', 'description': 'Brief screen of health literacy; patients are categorized into a reading level: at least 9th grade, 7th-8th grade, 4th-6th grade, and 3rd grade or less'}], 'primaryOutcomes': [{'measure': 'Brief Pain Inventory', 'timeFrame': '5 weeks post-baseline', 'description': "The Brief Pain Inventory measures pain severity and pain functioning. Pain severity is comprised of 4 questions on a 0-10 scale for pain at it's worst in the past week, the least in the past week, on average, and then currently. Each item is scored separately and higher scores indicate greater pain severity. There are then 12 daily activities in which the participants rates on a scale of 0-10 regarding how much the pain interferes with the activity (10 being the highest interference). These are all scored separately."}, {'measure': 'Hospital Anxiety and Depression Scale', 'timeFrame': '5 weeks post-baseline', 'description': 'This measure assesses the severity of depression and anxiety. Scores on each of the subscale (e.g., depression and anxiety) range from 0-21 with higher scores indicating greater severity.'}], 'secondaryOutcomes': [{'measure': 'Insomnia Severity Index', 'timeFrame': 'Administered at baseline, 5 weeks post-baseline, and 1 month and 6-month follow-ups', 'description': 'This measure assess difficulty with sleep. Total scores range from 0-28, with greater numbers indicating greater sleep difficulty.'}, {'measure': 'Pain Catastrophizing Scale', 'timeFrame': 'Administered at baseline, 5 weeks post-baseline, and 1 month and 6-month follow-ups', 'description': 'This measure assesses catastrophizing thoughts about pain. Total scores range from 0-52 with higher scores indicating greater catastrophizing. The three subscales are rumination (range= 0-16), magnification (range= 0-12), and helplessness (range= 0-24).'}, {'measure': 'Satisfaction with Life Scale', 'timeFrame': 'Administered at baseline, 5 weeks post-baseline, and 1 month and 6-month follow-ups', 'description': 'This measure assesses how satisfied a patient is with their life. Total scores range from 7-35 with higher scores indicating greater satisfaction.'}, {'measure': 'Health care utilization', 'timeFrame': 'Measured 6 months before and 6 months after study enrollment', 'description': 'The number of primary and specialty care visits, prescriptions written, emergency room visits, and hospital admissions'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Chronic Pain']}, 'referencesModule': {'references': [{'pmid': '35665994', 'type': 'DERIVED', 'citation': 'Miller-Matero LR, Gavrilova L, Hecht LM, Autio K, Tobin ET, Braciszewski JM, Maye M, Felton JW, Ahmedani BK. A brief psychological intervention for chronic pain in primary care: Examining long-term effects from a pilot randomized clinical trial. Pain Pract. 2022 Jul;22(6):564-570. doi: 10.1111/papr.13134. Epub 2022 Jun 14.'}, {'pmid': '33616190', 'type': 'DERIVED', 'citation': 'Miller-Matero LR, Hecht LM, Miller MK, Autio K, Pester BD, Tobin ET, Patel S, Braciszewski JM, Maye M, Ahmedani BK. A Brief Psychological Intervention for Chronic Pain in Primary Care: A Pilot Randomized Controlled Trial. Pain Med. 2021 Jul 25;22(7):1603-1611. doi: 10.1093/pm/pnaa444.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this research study is to investigate potential benefits of a behavioral intervention for co-occurring chronic pain and distress that is delivered in a primary care clinic.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Chronic pain condition\n* A current patient within the Henry Ford Health System Academic Internal Medicine Clinic in Detroit\n* Has been within the Henry Ford Health System for at least 6 months\n\nExclusion Criteria:\n\n* Current behavioral health treatment'}, 'identificationModule': {'nctId': 'NCT03692468', 'briefTitle': 'A Brief Intervention for Chronic Pain in Primary Care', 'organization': {'class': 'OTHER', 'fullName': 'Henry Ford Health System'}, 'officialTitle': 'A Brief Intervention for Co-occurring Pain and Distress in Primary Care', 'orgStudyIdInfo': {'id': 'Pain in Primary Care'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Intervention Group', 'description': 'Participants will engage in a 5 session psychotherapy intervention focused on improving pain and mood.', 'interventionNames': ['Behavioral: Psychotherapy']}, {'type': 'NO_INTERVENTION', 'label': 'Control Group', 'description': 'Patients will receive treatment as usual from their care providers.'}], 'interventions': [{'name': 'Psychotherapy', 'type': 'BEHAVIORAL', 'description': "Participants will complete 5, 60 minutes sessions. At each session, participants will learn strategies that have been shown to improve pain functioning and/or mood for patients who have chronic pain. The intervention will be delivered in the patient's primary care clinic.", 'armGroupLabels': ['Intervention Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '48202', 'city': 'Detroit', 'state': 'Michigan', 'country': 'United States', 'facility': 'Henry Ford Health System', 'geoPoint': {'lat': 42.33143, 'lon': -83.04575}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Henry Ford Health System', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Senior Staff Psychologist', 'investigatorFullName': 'Lisa Matero', 'investigatorAffiliation': 'Henry Ford Health System'}}}}