Ignite Creation Date:
2025-12-25 @ 1:20 AM
Ignite Modification Date:
2026-01-04 @ 3:50 AM
Study NCT ID:
NCT02283593
Status:
COMPLETED
Last Update Posted:
2015-09-01
First Post:
2014-11-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Self-help Internet-based Relapse Prevention for Problematic Alcohol Use
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'ECOLOGIC_OR_COMMUNITY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 4165}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-08', 'completionDateStruct': {'date': '2015-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-08-31', 'studyFirstSubmitDate': '2014-11-02', 'studyFirstSubmitQcDate': '2014-11-04', 'lastUpdatePostDateStruct': {'date': '2015-09-01', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-11-05', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Timeline Follow Back (TLFB)', 'timeFrame': '10 weeks', 'description': 'Quantity/frequency measure of alcohol consumption'}, {'measure': 'The Alcohol Use Disorders Identification Test (AUDIT)', 'timeFrame': '10 weeks', 'description': '3 consumption questions and 7 problem-related questions regarding alcohol consumption'}], 'secondaryOutcomes': [{'measure': 'The Drug Use Disorders Identification Test (DUDIT)', 'timeFrame': '10 weeks', 'description': '3 consumption questions and 7 problem-related questions regarding drug consumption'}, {'measure': 'The Hospital Anxiety and Depression Scale (HADS)', 'timeFrame': '10 weeks', 'description': '14 questions, 7 on anxiety symptoms and 7 on depression symptoms'}, {'measure': 'The Readiness to Change Questionnaire (RTCQ)', 'timeFrame': '10 weeks', 'description': '12 questions rated from -2 to +2 and divided into 3 dimensions: precontemplation, contemplation and action'}, {'measure': 'The Readiness Ruler', 'timeFrame': '10 weeks', 'description': 'Scores between 0 and 100. In this study, "I am not ready to change my drinking habits" and "I am very much ready to change my drinking habits".'}, {'measure': 'The World Health Quality of Life - shorter version (WHOQOL - BREF)', 'timeFrame': '10 weeks', 'description': '26 questions measuring four domains of quality of life: physical, psychological, social and environment.'}, {'measure': 'EQ-5D-5L', 'timeFrame': '10 weeks', 'description': '5 questions on the following dimensions: mobility, self-care, usual activity, pain/discomfort and anxiety/discomfort'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Problematic Alcohol Use']}, '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.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to observe and evaluate the use of a relapse prevention program over time among internet help-seekers. Participants are recruited via a nationally known portal for assisting anonymous individuals with changing their problematic alcohol use in a healthier direction (alkoholhjalpen.se). The intervention offered lasts 10 weeks and includes 7 relapse prevention modules, with a three-week pause between the 6th and 7th modules. Baseline data are collected regarding substance use and psychosocial health and follow-up takes place 10 weeks after recruitment. The study is observational.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '15 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Internet help-seekers with problematic alcohol use.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* AUDIT \\>5 points for women\n* AUDIT \\>7 points for men\n\nExclusion Criteria:\n\n* AUDIT \\<6 points for women\n* AUDIT \\<8 points for men'}, 'identificationModule': {'nctId': 'NCT02283593', 'acronym': 'eChangeNAT', 'briefTitle': 'Self-help Internet-based Relapse Prevention for Problematic Alcohol Use', 'organization': {'class': 'OTHER', 'fullName': 'Karolinska Institutet'}, 'officialTitle': 'Self-help Internet-based Relapse Prevention for Problematic Alcohol Use: A Naturalistic Study Among Internet Help-seekers', 'orgStudyIdInfo': {'id': '2013/686-31/5'}, 'secondaryIdInfos': [{'id': 'KI 2-1341/2014', 'type': 'OTHER', 'domain': 'Karolinska Institutet, Personal data act registrar'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'eChange.se', 'type': 'BEHAVIORAL', 'otherNames': ['SO (Self-help online, see Blankers et al., 2011)'], 'description': '7 modules: 1. Making a decisional balance 2. Setting a goal for alcohol consumption 3. Learning self control skills 4. Identifying risk situations 5. Dealing with urges 6. Dealing with emotions and with social pressure 7. Developing a crisis plan'}]}, 'contactsLocationsModule': {'locations': [{'zip': '17176', 'city': 'Stockholm', 'country': 'Sweden', 'facility': 'Karolinska Institutet, Department of Clinical Neuroscience', 'geoPoint': {'lat': 59.32938, 'lon': 18.06871}}], 'overallOfficials': [{'name': 'Anne H Berman, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Karolinska Institutet'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Karolinska Institutet', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Anne H Berman', 'investigatorAffiliation': 'Karolinska Institutet'}}}}