Ignite Creation Date:
2025-12-24 @ 3:01 PM
Ignite Modification Date:
2026-03-12 @ 7:31 AM
Study NCT ID:
NCT00117559
Status:
COMPLETED
Last Update Posted:
2014-12-11
First Post:
2005-06-30
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Improving Quality of Life for Veterans Undergoing Interferon Treatment
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003863', 'term': 'Depression'}, {'id': 'D006526', 'term': 'Hepatitis C'}], 'ancestors': [{'id': 'D001526', 'term': 'Behavioral Symptoms'}, {'id': 'D001519', 'term': 'Behavior'}, {'id': 'D000086982', 'term': 'Blood-Borne Infections'}, {'id': 'D003141', 'term': 'Communicable Diseases'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D006525', 'term': 'Hepatitis, Viral, Human'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D018178', 'term': 'Flaviviridae Infections'}, {'id': 'D012327', 'term': 'RNA Virus Infections'}, {'id': 'D006505', 'term': 'Hepatitis'}, {'id': 'D008107', 'term': 'Liver Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'amy.silberbogen@va.gov', 'phone': '857-364-4797', 'title': 'Amy Silberbogen, Ph.D.', 'organization': 'VA Boston Healthcare System'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}, 'limitationsAndCaveats': {'description': 'Small sample size, all male, no in-person comparison group, reporting bias in self-report measures.'}}, 'adverseEventsModule': {'timeFrame': 'During recruitment and when running subjects', 'eventGroups': [{'id': 'EG000', 'title': 'TEL-CBT', 'description': 'Telehealth, problem solving based treatment\n\nTelehealth Treatment: Participants receive a 15-minute telephone call for 8 weeks', 'otherNumAtRisk': 9, 'otherNumAffected': 0, 'seriousNumAtRisk': 9, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Treatment as Ususal', 'description': 'Control group', 'otherNumAtRisk': 10, 'otherNumAffected': 0, 'seriousNumAtRisk': 10, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'BDI', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'TEL-CBT', 'description': 'Telehealth, problem solving based treatment\n\nTelehealth Treatment: Participants receive a 15-minute telephone call for 8 weeks'}, {'id': 'OG001', 'title': 'Treatment as Usual', 'description': 'Control group'}], 'classes': [{'title': 'Pre-Treatment', 'categories': [{'measurements': [{'value': '12.93', 'spread': '8.17', 'groupId': 'OG000'}, {'value': '12.29', 'spread': '10.10', 'groupId': 'OG001'}]}]}, {'title': 'Post-Treatment', 'categories': [{'measurements': [{'value': '10.45', 'spread': '6.03', 'groupId': 'OG000'}, {'value': '16.67', 'spread': '9.80', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<.05', 'groupIds': ['OG000', 'OG001'], 'ciNumSides': 'TWO_SIDED', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': '8 weeks', 'description': 'Beck Depression Inventory - measures depression. Range for Total score = 0 to 63 Higher scores are indicative of increased depression\n\nThe Beck Depression Inventory (BDI; Beck \\& Steer, 1988) is a widely used 21-item self-report instrument designed to assess depressive mood and symptoms. Each item is rated on a 4-point scale ranging from 0 to 3, with higher scores reflecting greater severity of depressive symptoms for the past two weeks. A sample item is "I do not feel sad." The BDI has demonstrated reliability (split-half reliability coefficient of .93) and validity (correlations with clinician ratings of depression range from .62 to .75; Beck, Steer, \\& Garbing, 1988). Cronbach\'s alpha was high for the present sample at both time points (a = .91 and .90).', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'TEL-CBT', 'description': 'Telehealth, problem solving based treatment\n\nTelehealth Treatment: Participants receive a 15-minute telephone call for 8 weeks'}, {'id': 'FG001', 'title': 'Treatment as Usual', 'description': 'Control group'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '9'}, {'groupId': 'FG001', 'numSubjects': '10'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '8'}, {'groupId': 'FG001', 'numSubjects': '9'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '19', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'TEL-CBT', 'description': 'Telehealth, problem solving based treatment\n\nTelehealth Treatment: Participants receive a 15-minute telephone call for 8 weeks'}, {'id': 'BG001', 'title': 'Treatment as Usual', 'description': 'Control group'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '53.78', 'spread': '4.35', 'groupId': 'BG000'}, {'value': '54.50', 'spread': '6.38', 'groupId': 'BG001'}, {'value': '54.16', 'spread': '5.38', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '19', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '19', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'BDI', 'classes': [{'categories': [{'measurements': [{'value': '12.93', 'spread': '8.17', 'groupId': 'BG000'}, {'value': '12.29', 'spread': '10.10', 'groupId': 'BG001'}, {'value': '12.61', 'spread': '9.14', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'STANDARD_DEVIATION'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 19}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2005-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-12', 'completionDateStruct': {'date': '2008-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-12-09', 'studyFirstSubmitDate': '2005-06-30', 'resultsFirstSubmitDate': '2014-11-17', 'studyFirstSubmitQcDate': '2005-07-06', 'lastUpdatePostDateStruct': {'date': '2014-12-11', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2014-12-09', 'studyFirstPostDateStruct': {'date': '2005-07-07', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2014-12-11', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'BDI', 'timeFrame': '8 weeks', 'description': 'Beck Depression Inventory - measures depression. Range for Total score = 0 to 63 Higher scores are indicative of increased depression\n\nThe Beck Depression Inventory (BDI; Beck \\& Steer, 1988) is a widely used 21-item self-report instrument designed to assess depressive mood and symptoms. Each item is rated on a 4-point scale ranging from 0 to 3, with higher scores reflecting greater severity of depressive symptoms for the past two weeks. A sample item is "I do not feel sad." The BDI has demonstrated reliability (split-half reliability coefficient of .93) and validity (correlations with clinician ratings of depression range from .62 to .75; Beck, Steer, \\& Garbing, 1988). Cronbach\'s alpha was high for the present sample at both time points (a = .91 and .90).'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Psychotherapy,group', 'Rehabilitation', 'Telecommunications'], 'conditions': ['Depression', 'Hepatitis C']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate a group psychotherapy intervention and a telehealth intervention for veterans undergoing interferon treatment for the hepatitis C virus. It is hypothesized that the cognitive behavioral therapy (CBT) condition and the telehealth condition will result in significantly improved outcomes, including enhanced adherence, quality of life, and psychological status.', 'detailedDescription': 'The purpose of the proposed pilot study is to evaluate a rehabilitative cognitive-behavioral group psychotherapy intervention and a telehealth intervention for veterans undergoing interferon treatment for the hepatitis C virus (HCV). The specific objectives of the proposed pilot study are: 1) develop study methods and materials; 2) evaluate study feasibility; and 3) assess the efficacy of a cognitive-behavioral group therapy approach and a telehealth approach as compared to care as usual in a randomized design. Participants will be 45 patients (15 participants in each condition) from the VA Boston Healthcare System who are undergoing interferon treatment for HCV. Assessment will occur at pre-treatment, post-treatment, and 3-month follow-up. Assessments will measure key areas, including adherence, quality of life, and psychological distress. Analyses will examine study feasibility and the effects of the treatment condition. It is hypothesized that the CBT condition and the telehealth condition will result in significantly improved outcomes, including enhanced adherence, quality of life, and psychological status. This treatment approach addresses initiatives by the National VHA Hepatitis C Program by optimizing the care of veterans experiencing the devastating side effects of interferon treatment.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Clinical diagnosis of hepatitis C.\n* Must be on the interferon treatment\n* Need to have access to telephone.\n\nExclusion Criteria:\n\n* Life threatening or acute illness\n* Current alcohol or substance abuse or dependence\n* Individuals already receiving psychological interventions specifically to manage the side effects of the IFN treatment.'}, 'identificationModule': {'nctId': 'NCT00117559', 'briefTitle': 'Improving Quality of Life for Veterans Undergoing Interferon Treatment', 'organization': {'class': 'FED', 'fullName': 'VA Office of Research and Development'}, 'officialTitle': 'Improving Quality of Life for Veterans Undergoing Interferon Treatment', 'orgStudyIdInfo': {'id': 'F3332-P'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'TEL-CBT', 'description': 'Telehealth, problem solving based treatment provided over the telephone', 'interventionNames': ['Behavioral: Telehealth Treatment']}, {'type': 'NO_INTERVENTION', 'label': 'Treatment as Ususal', 'description': 'Control group, no treatment provided'}], 'interventions': [{'name': 'Telehealth Treatment', 'type': 'BEHAVIORAL', 'description': 'Participants receive a 15-minute telephone call for 8 weeks', 'armGroupLabels': ['TEL-CBT']}]}, 'contactsLocationsModule': {'locations': [{'zip': '02130', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'VA Medical Center, Jamaica Plain Campus', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}], 'overallOfficials': [{'name': 'Amy Silberbogen, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'VA Medical Center, Jamaica Plain Campus'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'US Department of Veterans Affairs', 'class': 'FED'}, 'responsibleParty': {'type': 'SPONSOR'}}}}