Ignite Creation Date:
2025-12-24 @ 7:51 PM
Ignite Modification Date:
2026-07-13 @ 11:17 AM
Study NCT ID:
NCT00423904
Status:
COMPLETED
Last Update Posted:
2007-01-18
First Post:
2007-01-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Brief Alcohol Intervention in General Hospitals
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': 'D003419', 'term': 'Crisis Intervention'}], 'ancestors': [{'id': 'D011613', 'term': 'Psychotherapy'}, {'id': 'D004191', 'term': 'Behavioral Disciplines and Activities'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE'}, 'primaryPurpose': 'ECT', 'interventionModel': 'FACTORIAL'}, 'enrollmentInfo': {'count': 1035}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2001-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2007-01', 'completionDateStruct': {'date': '2005-08'}, 'lastUpdateSubmitDate': '2007-01-17', 'studyFirstSubmitDate': '2007-01-17', 'studyFirstSubmitQcDate': '2007-01-17', 'lastUpdatePostDateStruct': {'date': '2007-01-18', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2007-01-18', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Reduced alcohol consumption'}, {'measure': 'Increased alcohol-specific help-seeking'}], 'secondaryOutcomes': [{'measure': 'Increased readiness to change drinking behaviour'}, {'measure': 'Increased well-being'}]}, 'conditionsModule': {'keywords': ['Early intervention', 'Brief intervention', 'alcohol', 'general hospital'], 'conditions': ['Alcohol Dependence', 'Alcohol Abuse', 'At-Risk-Drinking', 'Heavy Episodic Drinking']}, 'referencesModule': {'references': [{'pmid': '15993545', 'type': 'BACKGROUND', 'citation': "Freyer J, Bott K, Riedel J, Wedler B, Meyer C, Rumpf HJ, John U, Hapke U. Psychometric properties of the 'Processes of Change' scale for alcohol misuse and its short form (POC-20). Addict Behav. 2006 May;31(5):821-32. doi: 10.1016/j.addbeh.2005.06.007. Epub 2005 Jul 1."}, {'pmid': '16979304', 'type': 'BACKGROUND', 'citation': 'Freyer J, Coder B, Bischof G, Baumeister SE, Rumpf HJ, John U, Hapke U. Intention to utilize formal help in a sample with alcohol problems: a prospective study. Drug Alcohol Depend. 2007 Mar 16;87(2-3):210-6. doi: 10.1016/j.drugalcdep.2006.08.018. Epub 2006 Sep 18.'}, {'pmid': '16868869', 'type': 'BACKGROUND', 'citation': 'Freyer J, Coder B, Pockrandt C, Hartmann B, Rumpf HJ, John U, Hapke U. [General hospital patients with alcohol problems welcome counselling]. Gesundheitswesen. 2006 Jul;68(7):429-35. doi: 10.1055/s-2006-926908. German.'}, {'pmid': '15700519', 'type': 'BACKGROUND', 'citation': 'Freyer J, Tonigan JS, Keller S, John U, Rumpf HJ, Hapke U. Readiness to change versus readiness to seek help for alcohol problems: the development of the Treatment Readiness Tool (TReaT). J Stud Alcohol. 2004 Nov;65(6):801-9. doi: 10.15288/jsa.2004.65.801.'}, {'pmid': '16186144', 'type': 'BACKGROUND', 'citation': 'Freyer J, Tonigan JS, Keller S, Rumpf HJ, John U, Hapke U. Readiness for change and readiness for help-seeking: a composite assessment of client motivation. Alcohol Alcohol. 2005 Nov-Dec;40(6):540-4. doi: 10.1093/alcalc/agh195. Epub 2005 Sep 26.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of the study is to reveal the most promising procedure for implementing alcohol screening and intervention in general hospitals and to find out, if and to which extent non-specialist health professionals can be qualified to carry out motivational intervention on their own or if there is a need for a specialized counseling services. In a randomized controlled trial, patients recruited in general hospitals and fulfilling criteria for alcohol dependence, alcohol abuse, at-risk drinking or heavy episodic drinking will be allocated to three conditions: (1) Intervention by a liaison service (LC): Counselling based on the Transtheoretical Model of behaviour change (TTM) which will be provided by staff of the study (psychologists/ social worker) trained in Motivational Interviewing (MI), (2) Intervention by hospital physicians (PC): Counselling will be provided by hospital physicians trained in MI, and (3) Control group (CC): Treatment as usual, assessment only. Outcome assessment will be conducted after 12 months and includes abstinent point prevalence rates, drinks per day, help-seeking, stage progress and cost-effectiveness analysis.', 'detailedDescription': 'Background: High prevalence rates (10 - 25 %) and a promising setting for proactive intervention strategies make the general hospital a first choice setting for secondary prevention of alcohol-related disorders. Efficient screening instruments have been developed for early detection. With regard to the severity of alcohol problem (e.g. alcohol dependence vs. heavy episodic drinking) and the motivation to change, the target group is very heterogeneous. Although there are counseling strategies that take into account this heterogeneity, there is still a lack of implementation and poor knowledge about different implementation strategies in routine care. Objectives: To evaluate the effectiveness of a proactive secondary preventive intervention based on the TTM and on MI in a representative sample of general hospital patients carried out by a liaison service versus non-specialist physicians trained in counseling techniques by staff of the study. Methods: A sample of 1,479 alcohol at-risk-drinking, alcohol abusing or alcohol dependent patients from four general hospitals detected by screening questionnaires will be assigned to (1) a group counseled by an addiction liaison service, (2) a group counseled by the physicians of the ward, and (3) to an assessment-only condition with treatment as usual. Outcome will be measured one year later and will include abstinence point prevalence rates, stage progress, help seeking, and cost-effectiveness analysis. Expected impact: The project will yield new scientific knowledge on how to implement early intervention for alcohol at-risk-drinking and alcohol use disorders in the general hospital. Results of the study shall be transferred to nationwide practice guideline proposals. The study will contribute to the improvement of the health care system as well as the education of medical students. The study is designed to reveal empirical evidence for proactive TTM-based interventions for individuals suffering from a prevalent substance use disorder.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '64 Years', 'minimumAge': '18 Years', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Alcohol dependence\n* Alcohol abuse\n* At-risk drinking\n* Heavy episodic drinking\n\nExclusion Criteria:\n\n* Persons physically and mentally not capable of participating in study\n* Persons with a hospital stay of less than 24 hours'}, 'identificationModule': {'nctId': 'NCT00423904', 'briefTitle': 'Brief Alcohol Intervention in General Hospitals', 'organization': {'class': 'OTHER', 'fullName': 'University Medicine Greifswald'}, 'officialTitle': 'Implementing Early Intervention for Alcohol Use Disorders in the General Hospital', 'orgStudyIdInfo': {'id': 'E1_P1'}, 'secondaryIdInfos': [{'id': '01EB0120'}, {'id': '01EB0420'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'Brief intervention', 'type': 'BEHAVIORAL'}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Jennis Freyer-Adam, Dr', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Medicine Greifswald'}, {'name': 'Ulfert Hapke, Dr', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Applied Sciences Muenster'}, {'name': 'Ulrich John, Prof Dr', 'role': 'STUDY_DIRECTOR', 'affiliation': 'University Medicine Greifswald'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Medicine Greifswald', 'class': 'OTHER'}, 'collaborators': [{'name': 'German Federal Ministry of Education and Research', 'class': 'OTHER_GOV'}]}}}