Ignite Creation Date:
2025-12-25 @ 4:02 AM
Ignite Modification Date:
2026-03-02 @ 3:44 PM
Study NCT ID:
NCT02888002
Status:
COMPLETED
Last Update Posted:
2020-09-02
First Post:
2016-01-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Internet-based vs Face-to-face Treatment for Alcohol Dependence
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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000431', 'term': 'Ethanol'}, {'id': 'D062405', 'term': 'Motivational Interviewing'}, {'id': 'D015928', 'term': 'Cognitive Behavioral Therapy'}], 'ancestors': [{'id': 'D000438', 'term': 'Alcohols'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D037001', 'term': 'Directive Counseling'}, {'id': 'D003376', 'term': 'Counseling'}, {'id': 'D008605', 'term': 'Mental Health Services'}, {'id': 'D004191', 'term': 'Behavioral Disciplines and Activities'}, {'id': 'D006296', 'term': 'Health Services'}, {'id': 'D005159', 'term': 'Health Care Facilities Workforce and Services'}, {'id': 'D001521', 'term': 'Behavior Therapy'}, {'id': 'D011613', 'term': 'Psychotherapy'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 310}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-12-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-09', 'completionDateStruct': {'date': '2020-03-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-09-01', 'studyFirstSubmitDate': '2016-01-17', 'studyFirstSubmitQcDate': '2016-08-29', 'lastUpdatePostDateStruct': {'date': '2020-09-02', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-09-02', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2020-03-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'The Readiness Ruler', 'timeFrame': '3, 6, 12 and 24 month', 'description': 'Scores between 0 and 100. In this study, "How ready to change reduce my drinking" and "How ready to quit drinking".'}, {'measure': 'Use of Internet-based program and website', 'timeFrame': 'From baseline to 3 months', 'description': 'Number of visits and number of completed exercises in the Internet-based program and website'}, {'measure': 'Session rating scale (SRS)', 'timeFrame': '2 and 5 weeks in to treatment', 'description': "4 scale questions on the user's alliance with the counselor"}, {'measure': 'Working Alliance Inventory-Short Revised (WAI-SR)', 'timeFrame': '2 and 5 weeks in to treatment', 'description': '12 questions on working alliance adapted for Internet-based programs'}], 'primaryOutcomes': [{'measure': 'Time Line Follow Back (TLFB)', 'timeFrame': '3, 6, 12 and 24 months', 'description': 'Change in number of standard drinks per day during last 7 days'}], 'secondaryOutcomes': [{'measure': 'Time Line Follow Back (TLFB) Change in number of consumption days', 'timeFrame': '3, 6, 12 and 24 months', 'description': 'Change in number of drinking days during last 7 days'}, {'measure': 'Time Line Follow Back (TLFB) Change in number of days binge-drinking days', 'timeFrame': '3, 6, 12 and 24 months', 'description': 'Change in number of binge-drinking days during last 7 days'}, {'measure': 'Alcohol Use Disorders Identification Test Consumption (AUDIT-C)', 'timeFrame': '3, 6, 12 and 24 months', 'description': 'Change in Quantity, Frequency and Binge-drinking scores during the time since last reported'}, {'measure': 'Alcohol Use Disorders Identification Test (AUDIT)', 'timeFrame': '3, 6, 12 and 24 months', 'description': 'Change in total AUDIT score, as a summarized measure of alcohol use since last reported'}, {'measure': 'Montgomery Asberg Depression Rating Scale - Self report (MADRS-S)', 'timeFrame': '3, 6, 12 and 24 months', 'description': 'Change in total MADRS-S score, as a summarized measure of depression'}, {'measure': 'Generalised Anxiety Disorder Assessment (GAD-7)', 'timeFrame': '3, 6, 12 and 24 months', 'description': 'Change in total GAD-7 score, as a summarized measure of anxiety'}, {'measure': 'Questions about help-seeking behavior from family and friends', 'timeFrame': '3, 6, 12 and 24 months', 'description': 'Change in help-seeking for alcohol related problems from family and friends. The questions about "other forms of support and treatment for problematic alcohol use during the trial period" were developed by our research group and used in a previous study of ours: Berman, A. H., Wennberg, P., \\& Sinadinovic, K. (2015). Changes in Mental and Physical Well-Being Among Problematic Alcohol and Drug Users in 12-Month Internet-Based Intervention Trials. Psychology of Addictive Behaviors, 29(1), 97-105. doi:10.1037/a0038420.PMID:25664387'}, {'measure': 'Questions about help-seeking behavior from professionals', 'timeFrame': '3, 6, 12 and 24 months', 'description': 'Change in help-seeking for alcohol related problems from professionals. The questions about "other forms of support and treatment for problematic alcohol use during the trial period" were developed by our research group and used in a previous study of ours: Berman, A. H., Wennberg, P., \\& Sinadinovic, K. (2015). Changes in Mental and Physical Well-Being Among Problematic Alcohol and Drug Users in 12-Month Internet-Based Intervention Trials. Psychology of Addictive Behaviors, 29(1), 97-105. doi:10.1037/a0038420.PMID:25664387'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Alcohol Abuse', 'Alcohol Dependence', 'Harmful Alcohol Use', 'Alcohol Use Disorder']}, 'referencesModule': {'references': [{'pmid': '25300885', 'type': 'BACKGROUND', 'citation': 'Sinadinovic K, Wennberg P, Johansson M, Berman AH. Targeting individuals with problematic alcohol use via Web-based cognitive-behavioral self-help modules, personalized screening feedback or assessment only: a randomized controlled trial. Eur Addict Res. 2014;20(6):305-18. doi: 10.1159/000362406. Epub 2014 Oct 4.'}], 'seeAlsoLinks': [{'url': 'http://riddargatan1.se', 'label': 'Clinic website'}]}, 'descriptionModule': {'briefSummary': 'A brief treatment program (MI/CBT) via face-to-face or via internet is tested in association with an outpatient addictions clinic.', 'detailedDescription': "A 5-module program based on motivational interviewing (MI) and cognitive behavioral therapy (CBT) is tested among help-seekers at one outpatient clinic within the Stockholm Center for Dependency Disorders: Riddargatan 1.The design is a two-armed randomized controlled non-inferiority study, and outcomes are measured in terms of changes in alcohol consumption, problematic alcohol use, alcohol dependence alcohol use disorder, anxiety, as well as depression and quality of life. 600 participants are recruited online from the clinic's website. Consenting participants will complete baseline questionnaires online and participate in face-to-face assessment by a physician at the clinic. Eligible individuals will then be randomized into one of two groups: 1.Internet-based treatment program with online counselor support. 2. Face-to-face treatment with 5 individual counselor sessions at the clinic. Follow-up will be conducted online after 3, 6, 12 and 24 months in both groups."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* AUDIT-score ≥16 points and/or fulfilling at least 3 criteria of alcohol dependence (ICD-10)\n\nExclusion Criteria:\n\n* Risk of severe withdrawal symptoms.\n* Risk of suicide.\n* Other psychiatric diagnosis that requires current treatment.\n* Need for medication for alcohol dependence.\n* Inadequate Swedish language skills.\n* No Internet access'}, 'identificationModule': {'nctId': 'NCT02888002', 'acronym': 'IMS', 'briefTitle': 'Internet-based vs Face-to-face Treatment for Alcohol Dependence', 'organization': {'class': 'OTHER', 'fullName': 'Karolinska Institutet'}, 'officialTitle': 'Internet-based vs Face-to-face Treatment for Alcohol Dependence: A Randomised, Controlled Non-inferiority Trial', 'orgStudyIdInfo': {'id': '2014/1758-31/2-2'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Internet-based treatment', 'description': '"Guide to better alcohol habits online". An Internet-based treatment program with online counselor support.', 'interventionNames': ['Behavioral: Guide to better alcohol habits']}, {'type': 'EXPERIMENTAL', 'label': 'Face-to-face treatment', 'description': '"Guide to better alcohol habits F2F": Face-to-face treatment with 5 individual counselor sessions at the clinic.', 'interventionNames': ['Behavioral: Guide to better alcohol habits']}], 'interventions': [{'name': 'Guide to better alcohol habits', 'type': 'BEHAVIORAL', 'otherNames': ['Motivational Interviewing (MI)', 'Cognitive Behavioral Therapy (CBT)', 'Behavioral Self-Control Training', 'eChange'], 'description': 'A 5-module therapeutic program wich includes self-help material in printed or web-based form with interactive exercises. The program includes instructions for the therapist.', 'armGroupLabels': ['Face-to-face treatment', 'Internet-based treatment']}]}, 'contactsLocationsModule': {'locations': [{'zip': '17176', 'city': 'Stockholm', 'country': 'Sweden', 'facility': 'Karolinska Institutet, Department of Public Health Sciences', 'geoPoint': {'lat': 59.32938, 'lon': 18.06871}}], 'overallOfficials': [{'name': 'Sven Andreasson, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Karolinska Institutet'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Karolinska Institutet', 'class': 'OTHER'}, 'collaborators': [{'name': 'Region Stockholm', 'class': 'OTHER_GOV'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Anne H Berman', 'investigatorAffiliation': 'Karolinska Institutet'}}}}