Ignite Creation Date:
2025-12-25 @ 2:28 AM
Ignite Modification Date:
2026-02-21 @ 9:43 PM
Study NCT ID:
NCT01003834
Status:
COMPLETED
Last Update Posted:
2015-12-08
First Post:
2009-10-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Computerized Screening, Brief Intervention, and Referral to Treatment in Primary Care
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D019966', 'term': 'Substance-Related Disorders'}], 'ancestors': [{'id': 'D064419', 'term': 'Chemically-Induced Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 713}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-12', 'completionDateStruct': {'date': '2014-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-12-07', 'studyFirstSubmitDate': '2009-10-27', 'studyFirstSubmitQcDate': '2009-10-28', 'lastUpdatePostDateStruct': {'date': '2015-12-08', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-10-29', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Substance use', 'timeFrame': '3 months'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['substance use', 'drug use', 'drug abuse'], 'conditions': ['Substance Use Disorder']}, 'descriptionModule': {'briefSummary': 'This is a randomized, controlled clinical trial to evaluate the effect of a computerized screening, assessment, and brief intervention on substance use in patients recruited from a primary care clinic. Study participants will be assigned to one of the following 4 study groups: computerized health screening alone (standard care) (SC); computerized assessment-only intervention (CA); computerized assessment followed by a computer-directed motivational intervention (CACI); or computerized assessment followed by a therapist-delivered motivational intervention (CATI). Data regarding substance use, medical and psychosocial functioning, and economic outcomes will be collected.\n\nThe investigators hypothesize that patients randomized to CACI and CATI will be more likely to report drug abstinence at the 3-month follow-up visit and will show greater reductions in drug use at 1, 3 and 6 months follow-up than patients assigned to CA or SC. Similarly, patients in the CACI and CATI groups will report greater reductions in HIV risk behaviors, lower rates of medical and psychosocial problems, and increased economic gains at the 6-month follow-up. In addition, patients in the assessment only intervention (CA) will have outcomes superior to those found for SC patients. A cost-effectiveness analysis will also be done comparing economic costs associated with CA, CACI and CATI and their relationship to substance use reductions and related improvements in medical and psychosocial outcomes at the 6 month follow-up.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 18 - 65 years\n* Primary care clinic patient\n\nExclusion Criteria:\n\n* Pregnant'}, 'identificationModule': {'nctId': 'NCT01003834', 'acronym': 'SBIRT', 'briefTitle': 'Computerized Screening, Brief Intervention, and Referral to Treatment in Primary Care', 'organization': {'class': 'OTHER', 'fullName': 'Virginia Commonwealth University'}, 'officialTitle': 'Computer vs Therapist-Delivered Brief Interventions for Substance Use in Primary Care', 'orgStudyIdInfo': {'id': 'SBIRTVCU'}, 'secondaryIdInfos': [{'id': 'R01DA026091', 'link': 'https://reporter.nih.gov/quickSearch/R01DA026091', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Control', 'description': 'Screening only', 'interventionNames': ['Behavioral: Computerized health screening']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Assessment', 'description': 'Screening plus assessment', 'interventionNames': ['Behavioral: Computerized health screening', 'Behavioral: Computerized assessment']}, {'type': 'EXPERIMENTAL', 'label': 'Computer Intervention', 'description': 'Screening, assessment, and computer-delivered intervention', 'interventionNames': ['Behavioral: Computerized brief intervention', 'Behavioral: Computerized health screening', 'Behavioral: Computerized assessment']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Therapist Intervention', 'description': 'Screening, Assessment, and therapist-delivered intervention', 'interventionNames': ['Behavioral: Computerized health screening', 'Behavioral: Computerized assessment', 'Behavioral: Therapist-delivered motivational intervention']}], 'interventions': [{'name': 'Computerized brief intervention', 'type': 'BEHAVIORAL', 'description': 'Intervention based on Motivational Interviewing technique', 'armGroupLabels': ['Computer Intervention']}, {'name': 'Computerized health screening', 'type': 'BEHAVIORAL', 'description': 'Behavioral intervention', 'armGroupLabels': ['Assessment', 'Computer Intervention', 'Control', 'Therapist Intervention']}, {'name': 'Computerized assessment', 'type': 'BEHAVIORAL', 'description': 'Behavioral intervention', 'armGroupLabels': ['Assessment', 'Computer Intervention', 'Therapist Intervention']}, {'name': 'Therapist-delivered motivational intervention', 'type': 'BEHAVIORAL', 'description': 'Behavioral intervention', 'armGroupLabels': ['Therapist Intervention']}]}, 'contactsLocationsModule': {'locations': [{'zip': '23298', 'city': 'Richmond', 'state': 'Virginia', 'country': 'United States', 'facility': 'Virginia Commonwealth University', 'geoPoint': {'lat': 37.55376, 'lon': -77.46026}}], 'overallOfficials': [{'name': 'Dace Svikis, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Virginia Commonwealth University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Virginia Commonwealth University', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institute on Drug Abuse (NIDA)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}