Ignite Creation Date:
2025-12-24 @ 8:03 PM
Ignite Modification Date:
2026-02-24 @ 2:06 PM
Study NCT ID:
NCT01530204
Status:
COMPLETED
Last Update Posted:
2018-07-03
First Post:
2012-02-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
RAPID: Reducing Pain; Preventing Depression
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020370', 'term': 'Osteoarthritis, Knee'}], 'ancestors': [{'id': 'D010003', 'term': 'Osteoarthritis'}, {'id': 'D001168', 'term': 'Arthritis'}, {'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D012216', 'term': 'Rheumatic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D026741', 'term': 'Physical Therapy Modalities'}, {'id': 'D015928', 'term': 'Cognitive Behavioral Therapy'}], 'ancestors': [{'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D012046', 'term': 'Rehabilitation'}, {'id': 'D001521', 'term': 'Behavior Therapy'}, {'id': 'D011613', 'term': 'Psychotherapy'}, {'id': 'D004191', 'term': 'Behavioral Disciplines and Activities'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 135}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-07', 'completionDateStruct': {'date': '2016-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-07-02', 'studyFirstSubmitDate': '2012-02-01', 'studyFirstSubmitQcDate': '2012-02-08', 'lastUpdatePostDateStruct': {'date': '2018-07-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2012-02-09', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Patient Global Impression of Change for Knee Pain', 'timeFrame': 'Assessed after the 8-16 week intervention'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['knee arthritis', 'knee osteoarthritis', 'knee pain', 'cognitive behavioral therapy', 'physical therapy', 'depression prevention'], 'conditions': ['Knee Osteoarthritis']}, 'referencesModule': {'references': [{'pmid': '17466815', 'type': 'BACKGROUND', 'citation': 'Collins LM, Murphy SA, Strecher V. The multiphase optimization strategy (MOST) and the sequential multiple assignment randomized trial (SMART): new methods for more potent eHealth interventions. Am J Prev Med. 2007 May;32(5 Suppl):S112-8. doi: 10.1016/j.amepre.2007.01.022.'}, {'pmid': '19270046', 'type': 'BACKGROUND', 'citation': "Beissner K, Henderson CR Jr, Papaleontiou M, Olkhovskaya Y, Wigglesworth J, Reid MC. Physical therapists' use of cognitive-behavioral therapy for older adults with chronic pain: a nationwide survey. Phys Ther. 2009 May;89(5):456-69. doi: 10.2522/ptj.20080163. Epub 2009 Mar 6."}, {'pmid': '31047790', 'type': 'DERIVED', 'citation': 'Karp JF, Zhang J, Wahed AS, Anderson S, Dew MA, Fitzgerald GK, Weiner DK, Albert S, Gildengers A, Butters M, Reynolds CF 3rd. Improving Patient Reported Outcomes and Preventing Depression and Anxiety in Older Adults With Knee Osteoarthritis: Results of a Sequenced Multiple Assignment Randomized Trial (SMART) Study. Am J Geriatr Psychiatry. 2019 Oct;27(10):1035-1045. doi: 10.1016/j.jagp.2019.03.011. Epub 2019 Mar 21.'}], 'seeAlsoLinks': [{'url': 'http://www.aging.pitt.edu/', 'label': 'University of Pittsburgh Institute on Aging'}, {'url': 'http://www.wpic.pitt.edu/research/depr/', 'label': 'Late-Life Depression Treatment and Prevention Center at the University of Pittsburgh'}, {'url': 'http://www.ADAPTstudy.com', 'label': 'Description of clinical trial for older adults with low back pain and depression'}]}, 'descriptionModule': {'briefSummary': 'The primary question addressed by this prevention study is to explore if improving pain and disability reduces episodes of Major Depression among seniors with knee osteoarthritis (OA) and mild depressive symptoms.', 'detailedDescription': 'In this Sequential Multiple Assignment Randomized (SMART) Trial, the investigators care comparing Cognitive Behavioral Therapy for Pain (CBT-P) with EXERCISE (knee-specific Physical Therapy) delivered individually and sequentially. A subset of participants will receive enhanced care as usual in which their primary care physicians will receive information about pharmacological management of knee osteoarthritis. The active phase of the study may be up to 16 weeks, and the follow-up period lasts 12 months.\n\nStage 1, Specific Aim 1: To test if Cognitive Behavioral Therapy for Pain (CBT-P) results in more improvement in pain and disability than those receiving knee-specific Physical Therapy (EXERCISE).\n\nStage 1, Hypothesis 1: At week 8, subjects randomized to CBT-P will have more improvement in pain and disability than those randomized to EXERCISE.\n\nStage 2, Specific Aim 2: For non-responders to Stage 1, to explore which sequence of interventions leads to greater improvement in pain and disability.\n\nStage 2, Hypothesis 2: Compared to the other sequenced interventions (see Figure), subjects randomized to CBT-P and then EXERCISE will have the most improvement in pain and disability.\n\nFollow-up, Specific Aim 3: To explore if improvement in pain and disability is associated with incident major depressive episode (MDE) over 12 months.\n\nFollow-up, Hypothesis 3: More pain and disability improvement will be associated with lower rates of incident (MDE) over 12 months.\n\nExploratory AIM 1: To compare "legacy" assessments of functioning and psychological health with Computer Adaptive Testing (CAT) assessments of these domains for level of agreement.\n\nExploratory AIM 2: To assess candidate genetic polymorphisms, peripheral mRNA biosignatures, and candidate cytokine and growth factor levels using both multiplex assays and individual ELISAs. The investigators are exploring if these biomarkers are associated with pain improvement and risk for developing MDE.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '60 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. \\>/= age 60\n2. meets accepted clinical criteria for knee OA based on the American College of Rheumatology 1986 clinical criteria guidelines.\n3. Western Ontario and McMaster University Arthritis Index (WOMAC) pain subscale score in the range of 7-15 (to minimize including subjects with knee OA so severe they may be better served by arthroplasty)\n4. PHQ-9 scores 1-9, with at least one of the cardinal symptoms of depression (low mood or anhedonia) endorsed.\n5. Modified Mini Mental State (3MS) Examination \\>/= 80.\n6. Has or is willing to establish care with a personal physician prior to any experimental procedures.\n\nExclusion Criteria:\n\n1. Major Depressive Episode or anxiety disorder within the past 1 year\n2. Currently taking an antidepressant\n3. History of bipolar or schizophrenia\n4. Drug or alcohol use disorder within the past 12 months\n5. Receiving knee-related workers compensation or involved in knee pain-related litigation.\n6. Currently taking an anti-anxiety medicine \\> 4 times/week for the past 4 weeks.'}, 'identificationModule': {'nctId': 'NCT01530204', 'acronym': 'RAPID', 'briefTitle': 'RAPID: Reducing Pain; Preventing Depression', 'organization': {'class': 'OTHER', 'fullName': 'University of Pittsburgh'}, 'officialTitle': 'RAPID: Reducing Pain; Preventing Depression', 'orgStudyIdInfo': {'id': 'MH090333 Sub-Project ID: 8317'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Physical Therapy', 'description': '8-12 sessions of knee-focused physical therapy and a home-based conditioning program.', 'interventionNames': ['Procedure: Physical Therapy for knee OA']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Cognitive Behavioral Therapy for Pain', 'description': '8-12 session pain-focused Cognitive Behavioral Therapy', 'interventionNames': ['Behavioral: Cognitive Behavioral Therapy for Pain CBT-P']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Enhanced Treatment as Usual', 'description': 'Information about state-of-the-art pharmacotherapy for osteoarthritis is communicated to the primary care physicians of participants.', 'interventionNames': ['Other: Enhanced Treatment as Usual']}], 'interventions': [{'name': 'Physical Therapy for knee OA', 'type': 'PROCEDURE', 'description': '8-12 sessions of knee-focused physical therapy and a home-based conditioning program.', 'armGroupLabels': ['Physical Therapy']}, {'name': 'Cognitive Behavioral Therapy for Pain CBT-P', 'type': 'BEHAVIORAL', 'description': '8-12 session pain-focused Cognitive Behavioral Therapy', 'armGroupLabels': ['Cognitive Behavioral Therapy for Pain']}, {'name': 'Enhanced Treatment as Usual', 'type': 'OTHER', 'description': 'Information about state-of-the-art pharmacotherapy for osteoarthritis is communicated to the primary care physicians of participants.', 'armGroupLabels': ['Enhanced Treatment as Usual']}]}, 'contactsLocationsModule': {'locations': [{'zip': '15213', 'city': 'Pittsburgh', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'University of Pittsburgh Late Life Depression Program', 'geoPoint': {'lat': 40.44062, 'lon': -79.99589}}], 'overallOfficials': [{'name': 'Jordan F Karp, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Pittsburgh'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Pittsburgh', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Jordan F. Karp', 'investigatorAffiliation': 'University of Pittsburgh'}}}}