Ignite Creation Date:
2025-12-24 @ 9:09 PM
Ignite Modification Date:
2025-12-29 @ 11:16 AM
Study NCT ID:
NCT01129804
Status:
COMPLETED
Last Update Posted:
2021-11-02
First Post:
2010-05-21
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Network Support for Alcohol Treatment 2
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000428', 'term': 'Alcohol Drinking'}, {'id': 'D000437', 'term': 'Alcoholism'}], 'ancestors': [{'id': 'D004327', 'term': 'Drinking Behavior'}, {'id': 'D001519', 'term': 'Behavior'}, {'id': 'D019973', 'term': 'Alcohol-Related Disorders'}, {'id': 'D019966', 'term': 'Substance-Related Disorders'}, {'id': 'D064419', 'term': 'Chemically-Induced Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'litt@uchc.edu', 'phone': '860-679-4680', 'title': 'Mark D. Litt, PhD; Principal Investigator', 'organization': 'UConn Health'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': '27 months', 'eventGroups': [{'id': 'EG000', 'title': 'Network Support', 'description': 'Network Support treatment is aimed at helping patients change their social support network so that it supports abstinence. In this treatment patients will be encouraged to attend AA meetings and engage in other activities that would involve non-drinkers. These activities would be determined by the patient, with help from the therapist. Patients would learn about methods of avoiding drinking, making new friends, and getting enjoyment from activities other than drinking. In addition patients will learn specific skills intended to help them make new acquaintances and change their circle of friends.\n\nCoping Skills Training: Patients in both treatments will be taught skills to help them keep from drinking.', 'otherNumAtRisk': 96, 'deathsNumAtRisk': 96, 'otherNumAffected': 5, 'seriousNumAtRisk': 96, 'deathsNumAffected': 2, 'seriousNumAffected': 30}, {'id': 'EG001', 'title': 'Packaged Cognitive-Behavioral Treatment', 'description': 'The purpose of Packaged Cognitive-Behavioral Treatment (PCBT) is to train patients in a variety of skills that they can use to keep themselves from drinking.\n\nCoping Skills Training: Patients in both treatments will be taught skills to help them keep from drinking.', 'otherNumAtRisk': 97, 'deathsNumAtRisk': 97, 'otherNumAffected': 5, 'seriousNumAtRisk': 97, 'deathsNumAffected': 2, 'seriousNumAffected': 35}], 'otherEvents': [{'term': 'Suicidal Ideation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 96, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 97, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'seriousEvents': [{'term': 'Increased drinking from baseline', 'stats': [{'groupId': 'EG000', 'numAtRisk': 96, 'numEvents': 30, 'numAffected': 30}, {'groupId': 'EG001', 'numAtRisk': 97, 'numEvents': 35, 'numAffected': 35}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Proportion Days Abstinent (PDA)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '96', 'groupId': 'OG000'}, {'value': '97', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Network Support', 'description': 'Network Support treatment is aimed at helping patients change their social support network so that it supports abstinence. In this treatment patients will be encouraged to attend AA meetings and engage in other activities that would involve non-drinkers. These activities would be determined by the patient, with help from the therapist. Patients would learn about methods of avoiding drinking, making new friends, and getting enjoyment from activities other than drinking. In addition patients will learn specific skills intended to help them make new acquaintances and change their circle of friends.\n\nCoping Skills Training: Patients in both treatments will be taught skills to help them keep from drinking.'}, {'id': 'OG001', 'title': 'Packaged Cognitive-Behavioral Treatment', 'description': 'The purpose of Packaged Cognitive-Behavioral Treatment (PCBT) is to train patients in a variety of skills that they can use to keep themselves from drinking.\n\nCoping Skills Training: Patients in both treatments will be taught skills to help them keep from drinking.'}], 'classes': [{'categories': [{'measurements': [{'value': '.67', 'spread': '.33', 'groupId': 'OG000'}, {'value': '.73', 'spread': '.33', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<.04', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Slope', 'ciNumSides': 'TWO_SIDED', 'paramValue': '0.1', 'pValueComment': 'Tested the null hypothesis that slopes of PDA over time would not differ between treatment conditions, as indicated by the significance of the Treatment main effect and Treatment X Time interaction effect, at the level of p \\< .05.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY', 'nonInferiorityComment': 'Longitudinal Linear mixed modeling', 'otherAnalysisDescription': 'Multilevel longitudinal modeling (MLM) with random effects and maximum likelihood estimation (Proc MIXED; SAS Institute, 1999) was used to evaluate the effects of treatment over time for each of the continuously scaled outcome variables described above. The MLM approach was used because it employs maximum likelihood estimation of covariance matrices rather than raw data, allowing us to take advantage of all data collected for anyone randomized to treatment. Each repeated dependent variable was analyzed as a unction of treatment condition, time since intake (in months), and the interaction of treatment condition by time.'}], 'paramType': 'MEAN', 'timeFrame': 'Every 3 months out to 2 years', 'description': 'PDA is based on data collected in each 90-day timeline follow-back assessment of daily drinking. PDA is calculated as the number of days out of 90 in which the patient reported 0 drinks.', 'unitOfMeasure': 'proportion of days abstinent', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Men and women aged 18-65 diagnosed with alcohol use disorder, moderate to severe.'}, {'type': 'SECONDARY', 'title': 'Social Network Change', 'denoms': [{'units': 'Participants', 'counts': [{'value': '96', 'groupId': 'OG000'}, {'value': '97', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Network Support', 'description': 'Network Support treatment is aimed at helping patients change their social support network so that it supports abstinence. In this treatment patients will be encouraged to attend AA meetings and engage in other activities that would involve non-drinkers. These activities would be determined by the patient, with help from the therapist. Patients would learn about methods of avoiding drinking, making new friends, and getting enjoyment from activities other than drinking. In addition patients will learn specific skills intended to help them make new acquaintances and change their circle of friends.\n\nCoping Skills Training: Patients in both treatments will be taught skills to help them keep from drinking.'}, {'id': 'OG001', 'title': 'Packaged Cognitive-Behavioral Treatment', 'description': 'The purpose of Packaged Cognitive-Behavioral Treatment (PCBT) is to train patients in a variety of skills that they can use to keep themselves from drinking.\n\nCoping Skills Training: Patients in both treatments will be taught skills to help them keep from drinking.'}], 'classes': [{'categories': [{'measurements': [{'value': '.35', 'spread': '.05', 'groupId': 'OG000'}, {'value': '.30', 'spread': '.05', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'assessed every 6 months out to 2 years, mean change over 2 years reported', 'description': 'Network Support for Abstinence. Minimum score=0; Maximum score =1. Higher scores indicate greater support for abstinence.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Network Support', 'description': 'Network Support treatment is aimed at helping patients change their social support network so that it supports abstinence. In this treatment patients will be encouraged to attend AA meetings and engage in other activities that would involve non-drinkers. These activities would be determined by the patient, with help from the therapist. Patients would learn about methods of avoiding drinking, making new friends, and getting enjoyment from activities other than drinking. In addition patients will learn specific skills intended to help them make new acquaintances and change their circle of friends.\n\nCoping Skills Training: Patients in both treatments will be taught skills to help them keep from drinking.'}, {'id': 'FG001', 'title': 'Packaged Cognitive-Behavioral Treatment', 'description': 'The purpose of Packaged Cognitive-Behavioral Treatment (PCBT) is to train patients in a variety of skills that they can use to keep themselves from drinking.\n\nCoping Skills Training: Patients in both treatments will be taught skills to help them keep from drinking.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '96'}, {'groupId': 'FG001', 'numSubjects': '97'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '64'}, {'groupId': 'FG001', 'numSubjects': '66'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '32'}, {'groupId': 'FG001', 'numSubjects': '31'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '96', 'groupId': 'BG000'}, {'value': '97', 'groupId': 'BG001'}, {'value': '193', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Network Support', 'description': 'Network Support treatment is aimed at helping patients change their social support network so that it supports abstinence. In this treatment patients will be encouraged to attend AA meetings and engage in other activities that would involve non-drinkers. These activities would be determined by the patient, with help from the therapist. Patients would learn about methods of avoiding drinking, making new friends, and getting enjoyment from activities other than drinking. In addition patients will learn specific skills intended to help them make new acquaintances and change their circle of friends.\n\nCoping Skills Training: Patients in both treatments will be taught skills to help them keep from drinking.'}, {'id': 'BG001', 'title': 'Packaged Cognitive-Behavioral Treatment', 'description': 'The purpose of Packaged Cognitive-Behavioral Treatment (PCBT) is to train patients in a variety of skills that they can use to keep themselves from drinking.\n\nCoping Skills Training: Patients in both treatments will be taught skills to help them keep from drinking.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '96', 'groupId': 'BG000'}, {'value': '97', 'groupId': 'BG001'}, {'value': '193', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '47.2', 'spread': '11.2', 'groupId': 'BG000'}, {'value': '45.1', 'spread': '9.8', 'groupId': 'BG001'}, {'value': '46.01', 'spread': '10.5', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '37', 'groupId': 'BG000'}, {'value': '29', 'groupId': 'BG001'}, {'value': '66', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '59', 'groupId': 'BG000'}, {'value': '68', 'groupId': 'BG001'}, {'value': '127', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '93', 'groupId': 'BG000'}, {'value': '94', 'groupId': 'BG001'}, {'value': '187', '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'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '92', 'groupId': 'BG000'}, {'value': '93', 'groupId': 'BG001'}, {'value': '185', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', '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'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '96', 'groupId': 'BG000'}, {'value': '97', 'groupId': 'BG001'}, {'value': '193', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 193}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-10', 'completionDateStruct': {'date': '2016-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-10-04', 'studyFirstSubmitDate': '2010-05-21', 'resultsFirstSubmitDate': '2021-09-08', 'studyFirstSubmitQcDate': '2010-05-24', 'lastUpdatePostDateStruct': {'date': '2021-11-02', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2021-10-04', 'studyFirstPostDateStruct': {'date': '2010-05-25', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2021-11-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2015-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Proportion Days Abstinent (PDA)', 'timeFrame': 'Every 3 months out to 2 years', 'description': 'PDA is based on data collected in each 90-day timeline follow-back assessment of daily drinking. PDA is calculated as the number of days out of 90 in which the patient reported 0 drinks.'}], 'secondaryOutcomes': [{'measure': 'Social Network Change', 'timeFrame': 'assessed every 6 months out to 2 years, mean change over 2 years reported', 'description': 'Network Support for Abstinence. Minimum score=0; Maximum score =1. Higher scores indicate greater support for abstinence.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Alcohol dependence', 'Network Support', 'Cognitive-behavioral treatment', 'Relapse prevention', 'Consequences of drinking', 'Social network development'], 'conditions': ['Alcohol Consumption']}, 'referencesModule': {'references': [{'pmid': '17663609', 'type': 'RESULT', 'citation': 'Litt MD, Kadden RM, Kabela-Cormier E, Petry N. Changing network support for drinking: initial findings from the network support project. J Consult Clin Psychol. 2007 Aug;75(4):542-55. doi: 10.1037/0022-006X.75.4.542.'}, {'pmid': '19309183', 'type': 'RESULT', 'citation': 'Litt MD, Kadden RM, Kabela-Cormier E, Petry NM. Changing network support for drinking: network support project 2-year follow-up. J Consult Clin Psychol. 2009 Apr;77(2):229-42. doi: 10.1037/a0015252.'}, {'pmid': '29575339', 'type': 'DERIVED', 'citation': 'Litt MD, Kadden RM, Tennen H. Treatment response and non-response in CBT and Network Support for alcohol disorders: targeted mechanisms and common factors. Addiction. 2018 Aug;113(8):1407-1417. doi: 10.1111/add.14224. Epub 2018 Apr 20.'}, {'pmid': '27354234', 'type': 'DERIVED', 'citation': 'Litt MD, Kadden RM, Tennen H, Kabela-Cormier E. Network Support II: Randomized controlled trial of Network Support treatment and cognitive behavioral therapy for alcohol use disorder. Drug Alcohol Depend. 2016 Aug 1;165:203-12. doi: 10.1016/j.drugalcdep.2016.06.010. Epub 2016 Jun 18.'}]}, 'descriptionModule': {'briefSummary': "The Network Support project is part of an ongoing effort to improve treatment for alcohol dependent patients. The Network Support Project is designed to help patients change their social network from one that reinforces drinking behavior to one that reinforces sobriety.\n\n160 patients will be assigned to one of two treatments. Each of the treatments will last 12 weeks. The first is a Network Support (NS) treatment designed to help patients develop new acquaintances and social networks. It is expected that alcohol dependent patients will benefit from increasing their contact with non-drinking people. This NS condition will be compared to a packaged CBT program for alcoholics (PCBT) that is designed to teach a number of skills to help people stop drinking, but does not address social networks per se.\n\nIn order to better understand what is happening to the investigators patients, the investigators will be using daily computerized telephone calls to ask about people's experiences. This will be done both before and after treatment. Patients will also be asked to participate in follow-up interviews every 3 months for 2 years following the end of treatment."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 18 yo\n* meets Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV) criteria for alcohol dependence\n\nExclusion Criteria:\n\n* acute medical or psychiatric problems that require inpatient treatment (e.g., acute psychosis, or suicide/homicide risk)\n* reading ability below the fifth grade level\n* lack of reliable transportation to the treatment site, or excessive commuting distance\n* inability to understand English'}, 'identificationModule': {'nctId': 'NCT01129804', 'briefTitle': 'Network Support for Alcohol Treatment 2', 'organization': {'class': 'OTHER', 'fullName': 'UConn Health'}, 'officialTitle': 'Network Support for Alcohol Treatment: Mechanisms and Effectiveness', 'orgStudyIdInfo': {'id': '09-050'}, 'secondaryIdInfos': [{'id': 'R01AA012827', 'link': 'https://reporter.nih.gov/quickSearch/R01AA012827', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Network Support', 'description': 'Network Support treatment is aimed at helping patients change their social support network so that it supports abstinence. In this treatment patients will be encouraged to attend AA meetings and engage in other activities that would involve non-drinkers. These activities would be determined by the patient, with help from the therapist. Patients would learn about methods of avoiding drinking, making new friends, and getting enjoyment from activities other than drinking. In addition patients will learn specific skills intended to help them make new acquaintances and change their circle of friends.', 'interventionNames': ['Behavioral: Coping Skills Training']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Packaged Cognitive-Behavioral Treatment', 'description': 'The purpose of Packaged Cognitive-Behavioral Treatment (PCBT) is to train patients in a variety of skills that they can use to keep themselves from drinking.', 'interventionNames': ['Behavioral: Coping Skills Training']}], 'interventions': [{'name': 'Coping Skills Training', 'type': 'BEHAVIORAL', 'description': 'Patients in both treatments will be taught skills to help them keep from drinking.', 'armGroupLabels': ['Network Support', '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, Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'UConn Health'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'UConn Health', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institute on Alcohol Abuse and Alcoholism (NIAAA)', 'class': 'NIH'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Mark Litt', 'investigatorAffiliation': 'UConn Health'}}}}