Ignite Creation Date:
2025-12-25 @ 4:36 AM
Ignite Modification Date:
2026-03-06 @ 2:06 AM
Study NCT ID:
NCT01931618
Status:
COMPLETED
Last Update Posted:
2017-09-08
First Post:
2013-08-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Testing the Efficacy of an Online Alcohol Intervention in a Workplace Setting
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 85}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-09', 'completionDateStruct': {'date': '2012-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-09-07', 'studyFirstSubmitDate': '2013-08-26', 'studyFirstSubmitQcDate': '2013-08-26', 'lastUpdatePostDateStruct': {'date': '2017-09-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2013-08-29', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The number of standard alcohol units consumed during the previous seven days', 'timeFrame': 'Measured six months after enrollment/baseline', 'description': 'Subjects are asked to indicate (through online questionnaires) how many standard alcohol units they consumed on each of the previous seven days, on a scale from zero to ten. Then a sum-score for weekly consumption is calculated, ranging from zero to 70.'}], 'secondaryOutcomes': [{'measure': 'Sick leave during last week', 'timeFrame': 'Assessed at six months post baseline', 'description': 'Sick leave was assessed with a "yes" or "no" response for each of the past seven days, and then accumulated, resulting in a score of zero to seven. Participants were instructed to report any sick leave regardless of reason.'}, {'measure': 'Negative consequences of alcohol consumption', 'timeFrame': 'Assessed at six months post baseline', 'description': 'Perceived negative consequences of own alcohol consumption, during the seven previous days, was assessed by a 13 item index, resulting in a sum score with a theoretical range from zero to 13. The items comprised: headache, nausea, anxiety, worn out, depressed, breaking a plan, breaking a date, sick leave, memory problems, bad conscience, conflict, destroyed something and injuries.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['alcohol', 'online intervention', 'hazardous drinking', 'harmful drinking', 'early intervention', 'behavior change intervention'], 'conditions': ['Hazardous Drinking', 'Harmful Drinking']}, 'referencesModule': {'references': [{'pmid': '23612478', 'type': 'BACKGROUND', 'citation': 'Brendryen H, Johansen A, Nesvag S, Kok G, Duckert F. Constructing a Theory- and Evidence-Based Treatment Rationale for Complex eHealth Interventions: Development of an Online Alcohol Intervention Using an Intervention Mapping Approach. JMIR Res Protoc. 2013 Jan 23;2(1):e6. doi: 10.2196/resprot.2371.'}, {'pmid': '28755326', 'type': 'DERIVED', 'citation': 'Brendryen H, Johansen A, Duckert F, Nesvag S. A Pilot Randomized Controlled Trial of an Internet-Based Alcohol Intervention in a Workplace Setting. Int J Behav Med. 2017 Oct;24(5):768-777. doi: 10.1007/s12529-017-9665-0.'}], 'seeAlsoLinks': [{'url': 'http://www.researchprotocols.org/2013/1/e6/', 'label': 'The detailed treatment rationale and description of intervention used in the current trial'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to test - in a workplace setting - if an online multi-session alcohol intervention improves treatment effect over and above a single session screening with feedback.\n\nHypothesis: automated online multi-session follow-up improves the effect on alcohol consumption over and above a single session screening', 'detailedDescription': 'Setting: Online study among Norwegian employees.\n\nParticipants: At-risk drinkers among employees in a select group of norwegian workplaces is recruited through an e-mail to their job e-mail account, and advertisements on the intranet of their organization.\n\nDesign: Randomized controlled trial (RCT). Subjects in both conditions receives a single session screening procedure including individualized normative feedback. The control group receives an online booklet about the effects of alcohol. The treatment group receives the multi session follow up program "Balance".'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* hazardous or harmful drinking (i.e., a FAST-score of 3 or more)\n\nExclusion Criteria:\n\n* underage (\\<18)\n* not provided a valid e-mail address\n* not provided a valid (Norwegian) mobile phone number'}, 'identificationModule': {'nctId': 'NCT01931618', 'briefTitle': 'Testing the Efficacy of an Online Alcohol Intervention in a Workplace Setting', 'organization': {'class': 'OTHER', 'fullName': 'University of Oslo'}, 'officialTitle': 'Digital Therapy: Evaluation of the Fully Automated Alcohol Intervention "Balance".', 'orgStudyIdInfo': {'id': 'SERAF-BALANCE-2'}, 'secondaryIdInfos': [{'id': '142956', 'type': 'OTHER_GRANT', 'domain': 'Norwegian Centre for Addiction Research, University of Oslo'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Usual care', 'description': 'Receives two interventions:\n\n1. Online screening and feedback.\n2. Online booklet.', 'interventionNames': ['Behavioral: Online screening and feedback', 'Behavioral: Online booklet.']}, {'type': 'EXPERIMENTAL', 'label': 'Extended follow-up', 'description': 'Receives two interventions:\n\n1. Online screening and feedback.\n2. Online multi session follow-up.', 'interventionNames': ['Behavioral: Online screening and feedback', 'Behavioral: Online multi session follow-up']}], 'interventions': [{'name': 'Online screening and feedback', 'type': 'BEHAVIORAL', 'description': 'An online single session screening procedure including individualized normative feedback.', 'armGroupLabels': ['Extended follow-up', 'Usual care']}, {'name': 'Online booklet.', 'type': 'BEHAVIORAL', 'description': 'An online booklet that covers general information about alcohol, its effect on the brain and the body, potential risks and harms of drinking, and an account of the threshold values of sensible drinking', 'armGroupLabels': ['Usual care']}, {'name': 'Online multi session follow-up', 'type': 'BEHAVIORAL', 'description': 'An online multi session follow-up program (i.e., "Balance"). The central concept of Balance is to support continued self-regulation throughout the behavior change process. There are four key aspects of the program, the first is focus on goal setting and tracking of alcohol consumption on a day-to-day basis. The second on relapse prevention - for example, when clients report drinking more than their target, they receive individualized content aimed at preventing a full blown relapse. The third is emotion regulation, where content and assignments from positive psychology and from cognitive behavioral therapy are used. Finally, intervention covers alcohol education (i.e. the same topics as in the booklet provided to the control group).', 'armGroupLabels': ['Extended follow-up']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Oslo', 'country': 'Norway', 'facility': 'The Norwegian Centre for Addiction Research, University of Oslo', 'geoPoint': {'lat': 59.91273, 'lon': 10.74609}}], 'overallOfficials': [{'name': 'Håvar Brendryen, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'The Norwegian Centre for Addiction Research, University of Oslo'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Oslo', 'class': 'OTHER'}, 'collaborators': [{'name': 'The Research Council of Norway', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Senior researcher', 'investigatorFullName': 'Håvar Brendryen', 'investigatorAffiliation': 'University of Oslo'}}}}