Ignite Creation Date:
2025-12-25 @ 4:42 AM
Ignite Modification Date:
2025-12-26 @ 3:43 AM
Study NCT ID:
NCT01501318
Status:
COMPLETED
Last Update Posted:
2016-09-30
First Post:
2011-12-23
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Impact of Personalized Feedback Alone on Substance Use Behaviors
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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D004522', 'term': 'Educational Status'}], 'ancestors': [{'id': 'D012959', 'term': 'Socioeconomic Factors'}, {'id': 'D011154', 'term': 'Population Characteristics'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 40}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-09', 'completionDateStruct': {'date': '2012-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-09-29', 'studyFirstSubmitDate': '2011-12-23', 'studyFirstSubmitQcDate': '2011-12-23', 'lastUpdatePostDateStruct': {'date': '2016-09-30', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-12-29', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Substance use behaviors and consequences', 'timeFrame': '1 month follow-up', 'description': "Interview questionnaire includes items concerning substance use behaviors (e.g., the number of drinks in the last 7 days) and consequences {e.g., ''During the past month, how often have you failed to do what was normally expected of you because of your use of alcohol?'"}], 'secondaryOutcomes': [{'measure': 'Substance use behavioral intentions', 'timeFrame': '1 month follow-up', 'description': 'Interview questionnaire that asks participants about their memory of the materials provided in the intervention, their motivation toward change, and their self-reported change efforts.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['SBIRT', 'brief intervention', 'alcohol', 'drug abuse'], 'conditions': ['Substance Abuse']}, 'descriptionModule': {'briefSummary': 'The investigators seek to develop a more efficient and effective approach to providing brief behavioral health interventions for risky substance use behaviors by comparing a brief coach directed intervention to a tailored report only group.', 'detailedDescription': 'Screening and brief intervention (SBIRT) generally involves universal screening for risky substance use behaviors in medical settings and the immediate provision of a 3-15 minute intervention to those found to be at risk. In this pilot study, the investigators seek to develop a more efficient and effective approach to providing brief behavioral health interventions in the field by comparing a brief coach directed intervention to a tailored report only group. The goal is to create a cost-effective and sustainable system that provides consumers with tailored information that will help them both initiate and sustain the lifestyle changes necessary for improving their overall health.\n\nHypothesis 1: In a medical setting, personalized feedback alone will be associated with a reduction in risky substance use behaviors.\n\nHypothesis 2: In a medical setting, personalized feedback alone will have the same impact on behavior as that information plus a brief coach education session on risky substance use behaviors..'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '105 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Low level risky substance use\n\nExclusion Criteria:\n\n* high substance use risk levels\n* potential alcohol or drug addiction or dependence'}, 'identificationModule': {'nctId': 'NCT01501318', 'briefTitle': 'Impact of Personalized Feedback Alone on Substance Use Behaviors', 'organization': {'class': 'OTHER', 'fullName': 'University of Missouri-Columbia'}, 'officialTitle': "Brief Education to Reduce Health Care Consumers' Risky Substance Use Behaviors: How Brief is Brief?", 'orgStudyIdInfo': {'id': '1200450'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Personalized feedback plus education', 'description': 'Participants receive the personalized feedback report plus education. This is the currently implemented service approach.Treatment as usual with participants receiving a personalized feedback report about the risks associated with their current substance use behaviors and a brief (5-15 minute) motivational interviewing based education session provided by a trained health coach.', 'interventionNames': ['Behavioral: Personalized feedback report plus education']}, {'type': 'EXPERIMENTAL', 'label': 'Personalized feedback report alone', 'description': 'Provision of the personalized feedback report alone.', 'interventionNames': ['Behavioral: Personalized feedback report']}], 'interventions': [{'name': 'Personalized feedback report', 'type': 'BEHAVIORAL', 'description': 'Participants receive the personalized feedback report but no additional education.', 'armGroupLabels': ['Personalized feedback report alone']}, {'name': 'Personalized feedback report plus education', 'type': 'BEHAVIORAL', 'description': 'Participants receive the personalized feedback report plus education. This is the currently implemented service approach.', 'armGroupLabels': ['Personalized feedback plus education']}]}, 'contactsLocationsModule': {'locations': [{'zip': '65212', 'city': 'Columbia', 'state': 'Missouri', 'country': 'United States', 'facility': 'University of Missouri Hospital ER', 'geoPoint': {'lat': 38.95171, 'lon': -92.33407}}], 'overallOfficials': [{'name': 'Matthew G Hile, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Missouri Institute of Mental Health'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Missouri-Columbia', 'class': 'OTHER'}, 'collaborators': [{'name': 'University of Missouri, St. Louis', 'class': 'OTHER'}, {'name': 'Institute of Mental Health, Singapore', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}