Ignite Creation Date:
2025-12-24 @ 2:55 PM
Ignite Modification Date:
2026-01-22 @ 2:36 PM
Study NCT ID:
NCT01958359
Status:
COMPLETED
Last Update Posted:
2014-11-04
First Post:
2013-10-06
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Screening and Brief Intervention Via IVR for Problematic Use of Alcohol: A Randomized Controlled Trial
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': ['INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 260}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-11', 'completionDateStruct': {'date': '2014-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-11-02', 'studyFirstSubmitDate': '2013-10-06', 'studyFirstSubmitQcDate': '2013-10-08', 'lastUpdatePostDateStruct': {'date': '2014-11-04', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-10-09', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'AUDIT', 'timeFrame': '6 months', 'description': 'Change in total AUDIT score, as a summarized measure of alcohol use (including alcohol consumption and alcohol-related problems).'}], 'secondaryOutcomes': [{'measure': 'User satisfaction', 'timeFrame': '6 months', 'description': 'Change in total AUDIT score, as a summarized measure of alcohol use (including alcohol consumption and alcohol-related problems).'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Randomized Controlled Trial', 'Alcohol', 'Telephone', 'Mobile phone', 'Screening', 'Brief intervention', 'IVR-based conversation menu with exercises and vignettes'], 'conditions': ['Problem Drinking']}, 'referencesModule': {'references': [{'pmid': '29183357', 'type': 'DERIVED', 'citation': 'Andersson C, Gajecki M, Ojehagen A, Berman AH. Automated telephone interventions for problematic alcohol use in clinical and population samples: a randomized controlled trial. BMC Res Notes. 2017 Nov 28;10(1):624. doi: 10.1186/s13104-017-2955-4.'}], 'seeAlsoLinks': [{'url': 'http://www.telecoach.eu', 'label': 'Study information site.'}]}, 'descriptionModule': {'briefSummary': "Objectives: The study evaluates the efficacy of two automated telephony, also known as, Interactive Voice Recognition (IVR) interventions, Short IVR and Therapeutic IVR. The Short IVR works as an interactive alcohol diary where the user is contacted once a week for four weeks to register their alcohol consumption during the preceding week. The user is given feedback on changes in alcohol consumption compared to last week. The Therapeutic IVR contacts the user once a week for four weeks and is also available for user-initiated calls 24/7 during this four-week period. The Therapeutic IVR allows the user to traverse a menu where the user chooses among listening to vignettes and doing exercises with the purpose of looking at alcohol consumption and exploring ways of coping with it.\n\nMethod: The design is a three-armed randomized controlled design, and outcomes are measured in terms of changes in problematic alcohol use at follow up six months after study initiation and baseline data gathering. Participants with problematic alcohol use (AUDIT \\>7 for men and \\>5 for women) are randomized into one of three groups: 1. Short IVR, 2. Therapeutic IVR and 3. Control group. Outcomes on alcohol use as well as information on the users' satisfaction with the intervention are assessed after 6 months.\n\nThe primary hypothesis for this study is that having access to one of the two IVR interventions will lead to a greater reduction of problematic alcohol use compared to controls who undergo only screening and follow-up assessment. The secondary hypothesis is that having access to either Short IVR or Therapeutic IVR leads to comparable reductions in risky drinking."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* AUDIT \\>7 for men or AUDIT \\>5 for women.\n\nExclusion Criteria:\n\n* AUDIT \\<8 (men) or \\<6 (women)'}, 'identificationModule': {'nctId': 'NCT01958359', 'briefTitle': 'Screening and Brief Intervention Via IVR for Problematic Use of Alcohol: A Randomized Controlled Trial', 'organization': {'class': 'OTHER', 'fullName': 'Karolinska Institutet'}, 'officialTitle': 'Screening and Brief Intervention Via IVR for Problematic Use of Alcohol: A Randomized Controlled Trial', 'orgStudyIdInfo': {'id': '2010/1437-31/4'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Short IVR', 'description': 'IVR-based alcohol diary with feedback', 'interventionNames': ['Behavioral: Short IVR']}, {'type': 'EXPERIMENTAL', 'label': 'Therapeutic IVR', 'description': 'IVR-based conversation offering a menu of exercises and vignettes.', 'interventionNames': ['Behavioral: Therapeutic IVR']}, {'type': 'NO_INTERVENTION', 'label': 'Control', 'description': 'Untreated control group'}], 'interventions': [{'name': 'Short IVR', 'type': 'BEHAVIORAL', 'description': 'IVR-based alcohol diary with feedback', 'armGroupLabels': ['Short IVR']}, {'name': 'Therapeutic IVR', 'type': 'BEHAVIORAL', 'description': 'IVR-based conversation offering a menu of exercises and vignettes.', 'armGroupLabels': ['Therapeutic IVR']}]}, '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'}}}}