Ignite Creation Date:
2025-12-24 @ 1:38 PM
Ignite Modification Date:
2026-01-01 @ 5:12 AM
Study NCT ID:
NCT00132795
Status:
COMPLETED
Last Update Posted:
2012-06-21
First Post:
2005-08-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Using Telephone Technology to Prevent Relapse After Alcoholism Treatment
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000437', 'term': 'Alcoholism'}, {'id': 'D012008', 'term': 'Recurrence'}], 'ancestors': [{'id': 'D019973', 'term': 'Alcohol-Related Disorders'}, {'id': 'D019966', 'term': 'Substance-Related Disorders'}, {'id': 'D064419', 'term': 'Chemically-Induced Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000431', 'term': 'Ethanol'}, {'id': 'D055502', 'term': 'Secondary Prevention'}, {'id': 'D035061', 'term': 'Control Groups'}], 'ancestors': [{'id': 'D000438', 'term': 'Alcohols'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D011314', 'term': 'Preventive Health Services'}, {'id': 'D006296', 'term': 'Health Services'}, {'id': 'D005159', 'term': 'Health Care Facilities Workforce and Services'}, {'id': 'D015980', 'term': 'Public Health Practice'}, {'id': 'D011634', 'term': 'Public Health'}, {'id': 'D004778', 'term': 'Environment and Public Health'}, {'id': 'D015340', 'term': 'Epidemiologic Research Design'}, {'id': 'D004812', 'term': 'Epidemiologic Methods'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D012107', 'term': 'Research Design'}, {'id': 'D008722', 'term': 'Methods'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 158}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2005-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-06', 'completionDateStruct': {'date': '2010-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-06-20', 'studyFirstSubmitDate': '2005-08-19', 'studyFirstSubmitQcDate': '2005-08-19', 'lastUpdatePostDateStruct': {'date': '2012-06-21', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2005-08-22', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Amount of alcohol and use', 'timeFrame': '4 months and one year', 'description': 'drinks per day, drinks per drinking day, percent days abstinent, heavy drinking days'}], 'secondaryOutcomes': [{'measure': 'Utilization of the telephone system components during the study', 'timeFrame': '4 months and one year', 'description': 'call rate, access of coping skills reviews and practices, access of monthly messages.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Cognitive Therapy', 'Recurrence', 'Prevention', 'Educational Technology'], 'conditions': ['Alcoholism']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.med.uvm.edu/hbrc/', 'label': "Investigator's home page"}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine whether a telephone based self-help program will prevent relapse among individuals undergoing standard substance abuse treatment.', 'detailedDescription': 'Relapse rates in the first few months following substance abuse treatment are as high as 50%, in spite of the immediate effectiveness of treatments such as Cognitive Behavioral Therapy (CBT). Continuing use of therapy skills following treatment is associated with maintenance of treatment gains. We have programmed a telephone to deliver pre-recorded summaries and rehearsal sessions of skills learned in therapy. The system also includes monthly feedback messages from therapists. We expect that this ad-lib access to therapy skills would allow patients to generalize skills to their personal post-treatment lives. It would also allow individuals in remote or rural areas to obtain access to assistance without travel barriers.\n\nComparison(s): patients completing group CBT for substance abuse will be randomly assigned to two conditions. In one condition, patients will have unlimited access to the therapeutic telephone system for 4 months. The other condition is standard care (i.e., no formal relapse prevention).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '19 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Meets current DSM-IV criteria for alcohol dependence\n* Active drinking during the three months prior to entry into treatment\n* Minimum age of 19\n* Minimum sixth grade reading level.\n\nExclusion Criteria:\n\n* Meets criteria for a current psychotic illness\n* Imminent plans to move or be incarcerated\n* Presence of such severe hearing, visual, or cognitive deficit(s) that participation in CBT or use of an Interactive Voice Response (IVR) system are not possible\n* Inability to identify at least one "locator" person to assist in tracking for follow-up assessments\n* Does not have telephone service within the home\n* Incarceration while in active protocol in the study\n* Attendance of less than 8 of 12 CBT sessions'}, 'identificationModule': {'nctId': 'NCT00132795', 'acronym': 'ATIVR', 'briefTitle': 'Using Telephone Technology to Prevent Relapse After Alcoholism Treatment', 'organization': {'class': 'OTHER', 'fullName': 'University of Vermont'}, 'officialTitle': 'Therapeutic IVR to Augment CBT in Alcohol Dependence', 'orgStudyIdInfo': {'id': 'NIAAAHEL014270'}, 'secondaryIdInfos': [{'id': 'R01AA014270', 'link': 'https://reporter.nih.gov/quickSearch/R01AA014270', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1 Therapeutic Phone System', 'description': 'patients assigned to this condition will have unlimited access to the therapeutic telephone system for 4 months.', 'interventionNames': ['Behavioral: Daily monitoring of alcohol & drug use, & therapy skills']}, {'type': 'ACTIVE_COMPARATOR', 'label': '2 Standard care', 'description': 'Standard post-CBT care (i.e., no formal relapse prevention or professional treatment).', 'interventionNames': ['Behavioral: control group']}], 'interventions': [{'name': 'Daily monitoring of alcohol & drug use, & therapy skills', 'type': 'BEHAVIORAL', 'otherNames': ['relapse prevention'], 'description': 'Comparison(s): patients completing group CBT for substance abuse will be randomly assigned to two conditions. In one condition, patients will have unlimited access to the therapeutic telephone system for 4 months. The other condition is standard care (i.e., no formal relapse prevention).', 'armGroupLabels': ['1 Therapeutic Phone System']}, {'name': 'control group', 'type': 'BEHAVIORAL', 'description': 'standard care (no added treatment)', 'armGroupLabels': ['2 Standard care']}]}, 'contactsLocationsModule': {'locations': [{'zip': '05403', 'city': 'Burlington', 'state': 'Vermont', 'country': 'United States', 'facility': 'UVM Health Behavior Research Center', 'geoPoint': {'lat': 44.47588, 'lon': -73.21207}}], 'overallOfficials': [{'name': 'John E. Helzer, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Vermont'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Vermont', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institute on Alcohol Abuse and Alcoholism (NIAAA)', 'class': 'NIH'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor of Psychiatry', 'investigatorFullName': 'John E. Helzer, MD', 'investigatorAffiliation': 'University of Vermont'}}}}