Ignite Creation Date:
2025-12-25 @ 12:45 AM
Ignite Modification Date:
2025-12-25 @ 10:58 PM
Study NCT ID:
NCT00371267
Status:
COMPLETED
Last Update Posted:
2014-11-06
First Post:
2006-08-31
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Telephone-Delivered Cognitive Behavior Therapy for Chronic Pain
Sponsor:
Organization:
Raw JSON
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Carmody, Ph.D.', 'phoneExt': '6344', 'organization': 'San Francisco VA Medical Center'}, 'certainAgreement': {'piSponsorEmployee': True}, 'limitationsAndCaveats': {'description': 'The fact that the study was conducted in California may have posed some threat to external validity when applying these findings to the nationwide VA system.'}}, 'adverseEventsModule': {'timeFrame': '46 weeks', 'eventGroups': [{'id': 'EG000', 'title': 'Arm 1', 'description': 'Telephone-delivered cognitive behavior therapy for pain management\n\nCognitive Behavior Therapy: Telephone-delivered cognitive behavior therapy for pain management', 'otherNumAtRisk': 48, 'otherNumAffected': 0, 'seriousNumAtRisk': 48, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Arm 2', 'description': 'Telephone-delivered patient education regarding management of chronic pain\n\nPain Education: Telephone-delivered education regarding chronic pain', 'otherNumAtRisk': 50, 'otherNumAffected': 0, 'seriousNumAtRisk': 50, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Short Form-12 Physical Health', 'denoms': [{'units': 'Participants', 'counts': [{'value': '48', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm 1: Telephone CBT', 'description': 'Telephone-delivered cognitive behavior therapy for pain management\n\nCognitive Behavior Therapy: Telephone-delivered cognitive behavior therapy for pain management'}, {'id': 'OG001', 'title': 'Arm 2: Telephone Patient Education', 'description': 'Telephone-delivered patient education regarding management of chronic pain\n\nPain Education: Telephone-delivered education regarding chronic pain'}], 'classes': [{'categories': [{'measurements': [{'value': '44', 'spread': '9', 'groupId': 'OG000'}, {'value': '41', 'spread': '9', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.27', 'groupIds': ['OG000', 'OG001'], 'ciNumSides': 'TWO_SIDED', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': '46 weeks', 'description': 'Level of physical functioning in daily living, health-related quality of life Range: 0-100; higher score = higher functioning Score: Sum of weighted subscale scores', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Veterans with chronic pain'}, {'type': 'SECONDARY', 'title': 'Beck Depression Inventory (BDI)-2 Total Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '48', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm 1: Telephone CBT', 'description': 'Telephone-delivered cognitive behavior therapy for pain management\n\nCognitive Behavior Therapy: Telephone-delivered cognitive behavior therapy for pain management'}, {'id': 'OG001', 'title': 'Arm 2: Telephone Patient Education', 'description': 'Telephone-delivered patient education regarding management of chronic pain\n\nPain Education: Telephone-delivered education regarding chronic pain'}], 'classes': [{'categories': [{'measurements': [{'value': '16', 'spread': '11', 'groupId': 'OG000'}, {'value': '17', 'spread': '10', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.35', 'groupIds': ['OG000', 'OG001'], 'ciNumSides': 'TWO_SIDED', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': '46 weeks', 'description': 'Measure of symptoms of depression indicating severity of depression Total Score = sum of item scores Range: 0-63; higher scores = greater severity of depression', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Veterans with chronic pain'}, {'type': 'PRIMARY', 'title': 'Short Form-12 Mental Health', 'denoms': [{'units': 'Participants', 'counts': [{'value': '48', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm 1: Telephone CBT', 'description': 'Telephone-delivered cognitive behavior therapy for pain management\n\nCognitive Behavior Therapy: Telephone-delivered cognitive behavior therapy for pain management'}, {'id': 'OG001', 'title': 'Arm 2: Telephone Patient Education', 'description': 'Telephone-delivered patient education regarding management of chronic pain\n\nPain Education: Telephone-delivered education regarding chronic pain'}], 'classes': [{'categories': [{'measurements': [{'value': '45', 'spread': '9', 'groupId': 'OG000'}, {'value': '46', 'spread': '10', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.74', 'groupIds': ['OG000', 'OG001'], 'ciNumSides': 'TWO_SIDED', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': '46 weeks', 'description': 'Daily functioning, quality of life Range: 0-100; higher scores = higher level of functioning Score: sum of weighted subscale scores', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Veterans with chronic pain'}, {'type': 'SECONDARY', 'title': 'Pain Behavior Checklist Total Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '48', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm 1: Telephone CBT', 'description': 'Telephone-delivered cognitive behavior therapy for pain management\n\nCognitive Behavior Therapy: Telephone-delivered cognitive behavior therapy for pain management'}, {'id': 'OG001', 'title': 'Arm 2: Telephone Patient Education', 'description': 'Telephone-delivered patient education regarding management of chronic pain\n\nPain Education: Telephone-delivered education regarding chronic pain'}], 'classes': [{'categories': [{'measurements': [{'value': '2.3', 'spread': '1.3', 'groupId': 'OG000'}, {'value': '2.4', 'spread': '1.3', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.39', 'groupIds': ['OG000', 'OG001'], 'ciNumSides': 'TWO_SIDED', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': '46 weeks', 'description': 'Assessment of behavioral expression of pain Total Score = mean of item scores Range: 0-6; higher = more pain behavior', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Veterans with chronic pain'}, {'type': 'SECONDARY', 'title': 'Pain Intensity Rating', 'denoms': [{'units': 'Participants', 'counts': [{'value': '48', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm 1: Telephone CBT', 'description': 'Telephone-delivered cognitive behavior therapy for pain management\n\nCognitive Behavior Therapy: Telephone-delivered cognitive behavior therapy for pain management'}, {'id': 'OG001', 'title': 'Arm 2: Telephone Patient Education', 'description': 'Telephone-delivered patient education regarding management of chronic pain\n\nPain Education: Telephone-delivered education regarding chronic pain'}], 'classes': [{'categories': [{'measurements': [{'value': '3.6', 'spread': '1.3', 'groupId': 'OG000'}, {'value': '3.4', 'spread': '1.3', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.67', 'groupIds': ['OG000', 'OG001'], 'ciNumSides': 'TWO_SIDED', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': '46 weeks', 'description': 'Measure of rated pain intensity Score = mean Range: 0-5; higher scores = more intense pain', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Veterans with chronic pain'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Arm 1', 'description': 'Telephone-delivered cognitive behavior therapy for pain management\n\nCognitive Behavior Therapy: Telephone-delivered cognitive behavior therapy for pain management'}, {'id': 'FG001', 'title': 'Arm 2', 'description': 'Telephone-delivered patient education regarding management of chronic pain\n\nPain Education: Telephone-delivered education regarding chronic pain'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '48'}, {'groupId': 'FG001', 'numSubjects': '50'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '39'}, {'groupId': 'FG001', 'numSubjects': '32'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '9'}, {'groupId': 'FG001', 'numSubjects': '18'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '48', 'groupId': 'BG000'}, {'value': '50', 'groupId': 'BG001'}, {'value': '98', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Arm 1', 'description': 'Telephone-delivered cognitive behavior therapy for pain management\n\nCognitive Behavior Therapy: Telephone-delivered cognitive behavior therapy for pain management'}, {'id': 'BG001', 'title': 'Arm 2', 'description': 'Telephone-delivered patient education regarding management of chronic pain\n\nPain Education: Telephone-delivered education regarding chronic pain'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '66', 'spread': '9', 'groupId': 'BG000'}, {'value': '69', 'spread': '10', 'groupId': 'BG001'}, {'value': '67.5', 'spread': '9.5', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '46', 'groupId': 'BG000'}, {'value': '48', 'groupId': 'BG001'}, {'value': '94', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '47', 'groupId': 'BG000'}, {'value': '49', 'groupId': 'BG001'}, {'value': '96', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 101}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-10', 'completionDateStruct': {'date': '2010-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-10-29', 'studyFirstSubmitDate': '2006-08-31', 'resultsFirstSubmitDate': '2014-10-24', 'studyFirstSubmitQcDate': '2006-08-31', 'lastUpdatePostDateStruct': {'date': '2014-11-06', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2014-10-29', 'studyFirstPostDateStruct': {'date': '2006-09-04', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2014-11-06', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Short Form-12 Physical Health', 'timeFrame': '46 weeks', 'description': 'Level of physical functioning in daily living, health-related quality of life Range: 0-100; higher score = higher functioning Score: Sum of weighted subscale scores'}, {'measure': 'Short Form-12 Mental Health', 'timeFrame': '46 weeks', 'description': 'Daily functioning, quality of life Range: 0-100; higher scores = higher level of functioning Score: sum of weighted subscale scores'}], 'secondaryOutcomes': [{'measure': 'Beck Depression Inventory (BDI)-2 Total Score', 'timeFrame': '46 weeks', 'description': 'Measure of symptoms of depression indicating severity of depression Total Score = sum of item scores Range: 0-63; higher scores = greater severity of depression'}, {'measure': 'Pain Behavior Checklist Total Score', 'timeFrame': '46 weeks', 'description': 'Assessment of behavioral expression of pain Total Score = mean of item scores Range: 0-6; higher = more pain behavior'}, {'measure': 'Pain Intensity Rating', 'timeFrame': '46 weeks', 'description': 'Measure of rated pain intensity Score = mean Range: 0-5; higher scores = more intense pain'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['cognitive behavioral therapy', 'pain'], 'conditions': ['Pain']}, 'referencesModule': {'references': [{'pmid': '23244028', 'type': 'RESULT', 'citation': 'Carmody TP, Duncan CL, Huggins J, Solkowitz SN, Lee SK, Reyes N, Mozgai S, Simon JA. Telephone-delivered cognitive-behavioral therapy for pain management among older military veterans: a randomized trial. Psychol Serv. 2013 Aug;10(3):265-275. doi: 10.1037/a0030944. Epub 2012 Dec 17.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine whether telephone-delivered cognitive behavior therapy is effective in the treatment of chronic pain. To examine the effectiveness of this approach, a two-arm randomized clinical trial was conducted with 98 individuals, 55 years of age and older, who suffered from chronic pain, recruited from a primary care clinic at the VA Medical Center in San Francisco and affiliated VA Community-based Outpatient Clinics (CBOCs) in Santa Rosa, San Bruno, Ukiah, and Eureka.', 'detailedDescription': 'Chronic pain represents an epidemic in the United States and a serious public health problem, particularly among adults over the age of 55. In the Veterans Health Administration (VHA), nearly 50% of patients seen in primary care settings report disabling pain symptoms. Persistent pain in older adults is often associated with disability, emotional distress, and increased health care utilization and cost. Since an increase in the number of older adults is anticipated over the next two decades, the problem of chronic pain in this age group will take on increased importance.\n\nAlthough cognitive behavior therapy (CBT) aimed at improving coping skills is now commonly employed within interdisciplinary pain management programs, access to these interventions is often limited due to the distance from clinical care and disabling impact of pain. In addition, the dropout rate in studies of face-to-face CBT for chronic pain further detracts from its impact in pain management. A telephone-delivered version of CBT for chronic pain overcomes these barriers to access.\n\nTo examine the effectiveness of this approach, a two-arm randomized clinical trial was conducted with 98 individuals, 55 years of age and older, who suffered from chronic pain, recruited from a primary care clinic at the VA Medical Center in San Francisco and affiliated VA Community-based Outpatient Clinics (CBOCs) in Santa Rosa, San Bruno, Ukiah, and Eureka. In Study Arm 1, patients received telephone-based cognitive behavior therapy (T-CBT); and in Study Arm 2, patients received pain education (T-ED) matched with Study Arm 1 for amount of contact time. Patients in both groups received 12 sessions of telephone-based individual therapy over a 20-week period. Pain management outcomes were measured at mid-treatment (10 weeks), post-treatment (20 weeks), and at 3-month (32 weeks) and 6-month (46 weeks) follow-up. Outcome variables included measures of pain symptoms, physical limitations, coping, emotional distress, and health-related quality of life. The study hypothesis, assessment methodology, and intervention procedures were based on the cognitive-behavioral model of chronic pain'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '55 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nPotential subjects must be:\n\n* veterans enrolled in a VA primary care clinic\n* at least 55 years of age\n* have access to a telephone\n* have documented pain for at least the past year\n* a pain disorder involving muscle strain and inflammation, trauma to nerves, or central nervous system dysfunction\n* Their pain condition must be stable and participants must have no clear indication for specific medical/surgical intervention.\n\nExclusion Criteria:\n\nPatients were excluded who were:\n\n* psychotic\n* cognitively impaired\n* show significant suicidal risk (history of multiple suicide attempts or actively suicidal)\n* currently abusing alcohol or other drugs, including prescribed opioid pain medications\n* voice impairment that would prevent participation in telephone counseling\n* visual impairment that would prevent use of the workbook and completion of assessment materials.\n* Patients will also be excluded who have an unstable medical condition and clear indication for specific medical/surgical intervention in the near future.'}, 'identificationModule': {'nctId': 'NCT00371267', 'briefTitle': 'Telephone-Delivered Cognitive Behavior Therapy for Chronic Pain', 'organization': {'class': 'FED', 'fullName': 'VA Office of Research and Development'}, 'officialTitle': 'Telephone-Delivered Cognitive Behavior Therapy for Chronic Pain', 'orgStudyIdInfo': {'id': 'F4281-I'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Arm 1: Telephone-delivered CBT', 'description': 'Telephone-delivered cognitive behavior therapy for pain management', 'interventionNames': ['Behavioral: Telephone-delivered Cognitive Behavior Therapy']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Arm 2: Telephone patient education', 'description': 'Telephone-delivered patient education regarding management of chronic pain', 'interventionNames': ['Other: Telephone-delivered Patient Education']}], 'interventions': [{'name': 'Telephone-delivered Cognitive Behavior Therapy', 'type': 'BEHAVIORAL', 'description': 'Telephone-delivered cognitive behavior therapy for pain management', 'armGroupLabels': ['Arm 1: Telephone-delivered CBT']}, {'name': 'Telephone-delivered Patient Education', 'type': 'OTHER', 'otherNames': ['Patient education regarding pain management'], 'description': 'Telephone-delivered patient education regarding chronic pain', 'armGroupLabels': ['Arm 2: Telephone patient education']}]}, 'contactsLocationsModule': {'locations': [{'zip': '94121', 'city': 'San Francisco', 'state': 'California', 'country': 'United States', 'facility': 'VA Medical Center, San Francisco', 'geoPoint': {'lat': 37.77493, 'lon': -122.41942}}], 'overallOfficials': [{'name': 'Timothy Carmody, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'VA Medical Center, San Francisco'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'US Department of Veterans Affairs', 'class': 'FED'}, 'responsibleParty': {'type': 'SPONSOR'}}}}