Ignite Creation Date:
2025-12-24 @ 3:44 PM
Ignite Modification Date:
2025-12-25 @ 4:41 PM
Study NCT ID:
NCT00298792
Status:
COMPLETED
Last Update Posted:
2009-04-15
First Post:
2006-03-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Individualized Treatment Program for Alcohol Problems
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000437', 'term': 'Alcoholism'}], 'ancestors': [{'id': 'D019973', 'term': 'Alcohol-Related Disorders'}, {'id': 'D019966', 'term': 'Substance-Related Disorders'}, {'id': 'D064419', 'term': 'Chemically-Induced Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 110}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-04', 'completionDateStruct': {'date': '2008-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2009-04-14', 'studyFirstSubmitDate': '2006-03-01', 'studyFirstSubmitQcDate': '2006-03-01', 'lastUpdatePostDateStruct': {'date': '2009-04-15', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2006-03-03', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Alcohol consumption', 'timeFrame': 'Pre - Post'}], 'secondaryOutcomes': [{'measure': 'Alcohol-related life problems', 'timeFrame': 'Pre - Post'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Cognitive Behavioral Treatment', 'Alcohol Dependence', 'Functional Analysis', 'Experience Sampling', 'Interactive Voice Response'], 'conditions': ['Alcohol Dependence']}, 'descriptionModule': {'briefSummary': "The purpose of this study is to determine if a treatment for alcohol dependence that is specifically tailored to patients' patterns of drinking and coping strategies can result in better outcomes than more standardized treatments.", 'detailedDescription': "Despite the popularity of Cognitive-Behavioral Treatment (CBT) in substance use disorders, recent findings have indicated that CBT may be no more effective than other, less theoretically driven, treatments, and that CBT treatments often fail to result in coping skills acquisition. In order to explore the possibility that current manual-driven modes of CBT delivery may not be adequate to successfully teach coping skills, we are proposing a pilot project for the development of an individualized assessment and cognitive-behavioral treatment program (IATP) for alcohol-dependent persons, in which experience sampling conducted via random calls to cell-phones is used to provide data to create individualized treatment plans. Data collected during experience sampling will include momentary assessments of patients' cognitions, affects, and coping behaviors with respect to drinking.\n\nParticipants will be 112 men and women meeting criteria for alcohol dependence, who will be randomly assigned to either a standard packaged manual-driven cognitive-behavioral treatment program (PCBT) like that used in Project MATCH, or to IATP. Patients in both treatments will be asked to engage in experience sampling for two weeks prior to treatment, and for another two weeks after treatment has ended, in order to compare in-vivo measures of coping skills utilization, pre- and posttreatment, between the two groups. Therapy will be conducted over 12 sessions in both treatments. In IATP, the information gathered from experience sampling will form the basis of a functional analysis of patients' drinking and drinking urges during the monitoring period. Cognitive appraisals, moods and coping responses will be evaluated as antecedents and consequences of drinking behavior. Therapists will use the information to address specific cognitions, affects, and behaviors that are adaptive and maladaptive, and will work with the patient to substitute adaptive coping tactics instead. In PCBT the experience sampling data will not be specifically used in therapy, but will still provide in-vivo measures of drinking and coping skills. It is hypothesized that IATP will yield significantly better coping skills acquisition than will PCBT, and that change in coping skills will predict better posttreatment outcomes for IATP. These results would have implications for our delivery of treatment, and for the validity of coping skills training for alcohol addiction."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male and female outpatients 18 years of age or older.\n* Participants will have a current DSM-IV diagnosis of alcohol dependence.\n* Participants will have signed a witnessed informed consent.\n\nExclusion Criteria:\n\n* Participants who meet current DSM-IV criteria for bipolar disorder, schizophrenia, dementia, or a psychological disorder requiring medication.\n* Participants who have had more than seven days of inpatient treatment for substance use disorders in the 30 days previous to randomization.'}, 'identificationModule': {'nctId': 'NCT00298792', 'acronym': 'IATP', 'briefTitle': 'Individualized Treatment Program for Alcohol Problems', 'organization': {'class': 'NIH', 'fullName': 'National Institute on Alcohol Abuse and Alcoholism (NIAAA)'}, 'officialTitle': 'Individualized Treatment Program for Alcohol Problems', 'orgStudyIdInfo': {'id': 'NIAAALIT014202-02'}, 'secondaryIdInfos': [{'id': 'NIH grant 1 R21 AA14202'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Individualized Assessment & treatment', 'description': 'Individualized treatment for alcohol dependent persons, based on momentary assessment of high-risk situations and recorded coping abilities.', 'interventionNames': ['Behavioral: Cognitive Behavioral Treatment', 'Behavioral: Cognitive-behavioral treatment']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Packaged Cognitive-Behavioral Treatment', 'description': 'Manualized cognitive-behavioral treatment for alcohol dependent persons.', 'interventionNames': ['Behavioral: Cognitive Behavioral Treatment', 'Behavioral: Cognitive-behavioral treatment']}], 'interventions': [{'name': 'Cognitive Behavioral Treatment', 'type': 'BEHAVIORAL', 'description': 'Psychosocial treatment emphasizing teaching of coping skills to maintain sobriety.', 'armGroupLabels': ['Individualized Assessment & treatment', 'Packaged Cognitive-Behavioral Treatment']}, {'name': 'Cognitive-behavioral treatment', 'type': 'BEHAVIORAL', 'description': 'Psychosocial treatment emphasizing teaching of coping skills to maintain sobriety', 'armGroupLabels': ['Individualized Assessment & treatment', 'Packaged Cognitive-Behavioral Treatment']}]}, 'contactsLocationsModule': {'locations': [{'zip': '06030', 'city': 'Farmington', 'state': 'Connecticut', 'country': 'United States', 'facility': 'University of Connecticut Health Center', 'geoPoint': {'lat': 41.71982, 'lon': -72.83204}}], 'overallOfficials': [{'name': 'Mark D. Litt, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'UConn Health'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'National Institute on Alcohol Abuse and Alcoholism (NIAAA)', 'class': 'NIH'}, 'responsibleParty': {'oldNameTitle': 'Mark D. Litt, Ph.D., Principal Investigator', 'oldOrganization': 'University of Connecticut Health Center'}}}}