Ignite Creation Date:
2025-12-24 @ 9:19 PM
Ignite Modification Date:
2026-03-28 @ 7:14 AM
Study NCT ID:
NCT02384304
Status:
COMPLETED
Last Update Posted:
2015-09-02
First Post:
2015-02-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Guided and Unguided Internet Treatment for Problematic Alcohol Use
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': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 80}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-08', 'completionDateStruct': {'date': '2013-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-08-31', 'studyFirstSubmitDate': '2015-02-26', 'studyFirstSubmitQcDate': '2015-03-03', 'lastUpdatePostDateStruct': {'date': '2015-09-02', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-03-10', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Time Line Follow Back (TLFB)', 'timeFrame': 'Baseline and 10 weeks', 'description': 'Change in total TLFB score (consumption during preceding week), as a summarized measure of alcohol consumption'}], 'secondaryOutcomes': [{'measure': 'Alcohol Use Disorders Identification Test (AUDIT)', 'timeFrame': 'Baseline and 10 weeks', 'description': 'Change in total AUDIT score, as a summarized measure of alcohol use (including alcohol consumption and alcohol-related problems)'}, {'measure': 'Hamilton Anxiety and Depression Scale (HADS)', 'timeFrame': 'Baseline and 10 weeks', 'description': 'Change in total HADS score, as a summarized measure of depression and anxiety, respectively'}, {'measure': 'EQ5', 'timeFrame': 'Baseline and 10 weeks', 'description': 'Change in total EQ5 score, as a summarized measure of quality of life'}, {'measure': 'WHOQOL-BREF', 'timeFrame': 'Baseline and 10 weeks', 'description': 'Change in total WHOQOL-BREF score, as a summarized measure of quality of life'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['randomized controlled trial', 'alcohol', 'internet', 'internet based therapy', 'cognitive behavior therapy'], 'conditions': ['Alcohol Abuse', 'Alcohol Addiction']}, 'referencesModule': {'references': [{'type': 'BACKGROUND', 'citation': 'Sundström, C., Berman, A. H., Sinadinovic, K., & Johansson, M. (2013). Internet-based relapse prevention with therapist support for help-seeking problematic alcohol users: a randomized pilot study. Addiction science & clinical practice, 8(1), 1-1.'}, {'pmid': '27383389', 'type': 'DERIVED', 'citation': 'Sundstrom C, Gajecki M, Johansson M, Blankers M, Sinadinovic K, Stenlund-Gens E, Berman AH. Guided and Unguided Internet-Based Treatment for Problematic Alcohol Use - A Randomized Controlled Pilot Trial. PLoS One. 2016 Jul 6;11(7):e0157817. doi: 10.1371/journal.pone.0157817. eCollection 2016.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study was to determine whether a 10-week internet-based program based on cognitive behavioral therapy (CBT) is effective in the treatment of alcohol problems, and if having therapist guidance leads to greater effects.', 'detailedDescription': 'Objectives: An 10 week Internet-based self-help program based on cognitive behavioral therapy (CBT) was tested among Internet help seekers.The design was a three-armed randomized controlled design, and outcomes were measured in terms of changes in problematic alcohol use, as well as depression, anxiety and quality of life. 80 participants were recruited entirely online from an open access website and randomized into three different groups. All participants had access to the same self-help program. However, one group was given a choice between two forms of therapist guidance (messages or weekly chat sessions), one group received therapist guidance in the form of secure messages, and one group received no therapist guidance.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* ≥ 18 years\n* access to the Internet\n* problematic alcohol use defined as ≥ 8 p or more for men and ≥ 6 p or more for women in the Alcohol Use Identification Scale\n\nExclusion Criteria:\n\n• not adequately fluent in Swedish'}, 'identificationModule': {'nctId': 'NCT02384304', 'briefTitle': 'Guided and Unguided Internet Treatment for Problematic Alcohol Use', 'organization': {'class': 'OTHER', 'fullName': 'Karolinska Institutet'}, 'officialTitle': 'Guided and Unguided Internet Treatment for Problematic Alcohol Use: A Randomized Pilot Study', 'orgStudyIdInfo': {'id': '2012/1761-31/5'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Choice', 'description': 'A self help program consisting of 8 modules. Patients will have access to therapist support through either messages or chat sessions', 'interventionNames': ['Behavioral: Choice']}, {'type': 'EXPERIMENTAL', 'label': 'Messages', 'description': 'A self help program consisting of 8 modules. Patients will have access to therapist support through messages', 'interventionNames': ['Behavioral: Messages']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Self help', 'description': 'A relapse intervention program consisting of 8 modules. Patients will have no access to therapist support', 'interventionNames': ['Behavioral: Self help']}], 'interventions': [{'name': 'Choice', 'type': 'BEHAVIORAL', 'description': 'A self help program consisting of 8 modules and access to therapist guidance either through messages or through chat sessions', 'armGroupLabels': ['Choice']}, {'name': 'Messages', 'type': 'BEHAVIORAL', 'description': 'A self help program consisting of 8 modules and access to therapist guidance through messages', 'armGroupLabels': ['Messages']}, {'name': 'Self help', 'type': 'BEHAVIORAL', 'description': 'A self help program consisting of 8 modules', 'armGroupLabels': ['Self help']}]}, 'contactsLocationsModule': {'locations': [{'zip': '11364', 'city': 'Stockholm', 'state': 'Stockholm County', 'country': 'Sweden', 'facility': 'Karolinska institutet, Department of Clinical Neuroscience, Center for Psychiatric Research', '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'}}}}