Ignite Creation Date:
2025-12-24 @ 11:55 AM
Ignite Modification Date:
2026-01-08 @ 12:08 PM
Study NCT ID:
NCT02129361
Status:
COMPLETED
Last Update Posted:
2021-10-21
First Post:
2014-04-28
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Screening and Brief Intervention for Substance Misuse Following Traumatic Brain Injury
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000070642', 'term': 'Brain Injuries, Traumatic'}], 'ancestors': [{'id': 'D001930', 'term': 'Brain Injuries'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D006259', 'term': 'Craniocerebral Trauma'}, {'id': 'D020196', 'term': 'Trauma, Nervous System'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D003419', 'term': 'Crisis Intervention'}, {'id': 'D008403', 'term': 'Mass Screening'}], 'ancestors': [{'id': 'D011613', 'term': 'Psychotherapy'}, {'id': 'D004191', 'term': 'Behavioral Disciplines and Activities'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D006306', 'term': 'Health Surveys'}, {'id': 'D011795', 'term': 'Surveys and Questionnaires'}, {'id': 'D003625', 'term': 'Data Collection'}, {'id': 'D004812', 'term': 'Epidemiologic Methods'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D003954', 'term': 'Diagnostic Services'}, {'id': 'D011314', 'term': 'Preventive Health Services'}, {'id': 'D006296', 'term': 'Health Services'}, {'id': 'D005159', 'term': 'Health Care Facilities Workforce and Services'}, {'id': 'D017531', 'term': 'Health Care Evaluation Mechanisms'}, {'id': 'D011787', 'term': 'Quality of Health Care'}, {'id': 'D017530', 'term': 'Health Care Quality, Access, and Evaluation'}, {'id': 'D011634', 'term': 'Public Health'}, {'id': 'D004778', 'term': 'Environment and Public Health'}, {'id': 'D015980', 'term': 'Public Health Practice'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 139}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-10', 'completionDateStruct': {'date': '2018-10-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-10-20', 'studyFirstSubmitDate': '2014-04-28', 'studyFirstSubmitQcDate': '2014-04-30', 'lastUpdatePostDateStruct': {'date': '2021-10-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2014-05-02', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-10-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of alcoholic drinks consumed per week in past month', 'timeFrame': 'Change from baseline to 12 months post-discharge', 'description': 'Number of drinks will be recorded at baseline, 6, 9, and 12 months. We will be measuring change in the number of drinks consumed of the course of the year, with the primary outcome being measured at the 12 month assessment.'}], 'secondaryOutcomes': [{'measure': 'Frequency of alcohol binges in past month', 'timeFrame': 'Change in the number of alcohol binges baseline to 12 months post-discharge', 'description': 'Binge is defined as 4 or more drinks in a day for women, 5 or more drinks in a day for men'}, {'measure': 'Alcohol expectancies', 'timeFrame': '12 months post-discharge', 'description': 'Measured by the shortened Alcohol Expectancies Questionnaire-III'}, {'measure': 'Number of facts retained about negative consequences of substance misuse', 'timeFrame': '12 months post-discharge', 'description': 'Count of number of facts, maximum=8'}, {'measure': 'Number of alcoholic drinks consumed per week during the past month', 'timeFrame': 'Change from baseline to 3 months post-discharge', 'description': 'Count of number of facts, maximum=8'}, {'measure': 'Number of alcoholic drinks consumed per week in the past month', 'timeFrame': 'Change from baseline to 6 months post-discharge'}, {'measure': 'Frequency of alcohol binges in past month', 'timeFrame': 'Change from baseline to 6 months post-discharge', 'description': 'Binge is defined as 4 or more drinks in a day for women, 5 or more drinks in a day for men'}, {'measure': 'Number of alcohol binges in past month', 'timeFrame': 'Change from baseline to 3 months post-discharge', 'description': 'Binge is defined as 4 or more drinks in a day for women, 5 or more drinks in a day for men'}, {'measure': 'Alcohol expectancies', 'timeFrame': '6 months post-discharge', 'description': 'Measured by the shortened Alcohol Expectancies Questionnaire-III'}, {'measure': 'Alcohol expectancies', 'timeFrame': '3 months post-discharge', 'description': 'Measured by the shortened Alcohol Expectancies Questionnaire-III'}, {'measure': 'Number of facts retained about negative consequences of alcohol use', 'timeFrame': '3 months post-discharge', 'description': 'Count of number of facts, maximum=8'}, {'measure': 'Number of facts retained about negative consequences of alcohol use', 'timeFrame': '6 months post-discharge', 'description': 'Count of number of facts, maximum=8'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['traumatic brain injury'], 'conditions': ['Traumatic Brain Injury']}, 'referencesModule': {'references': [{'pmid': '34618511', 'type': 'DERIVED', 'citation': 'Bogner J, Corrigan JD, Peng J, Kane C, Coxe K. Comparative effectiveness of a brief intervention for alcohol misuse following traumatic brain injury: A randomized controlled trial. Rehabil Psychol. 2021 Nov;66(4):345-355. doi: 10.1037/rep0000405. Epub 2021 Oct 7.'}]}, 'descriptionModule': {'briefSummary': 'This study is investigating one way to improve health and healthy habits after traumatic brain injury (TBI). The primary goal of this study is to determine if a brief intervention accommodated for persons with moderate or severe TBI is effective in reducing alcohol misuse during the year following injury. It is hypothesized that an adapted Screening, Education and Brief Intervention (adapted SBI) will reduce the number of alcoholic drinks consumed per week over the year following discharge from inpatient rehabilitation, in comparison to a Screening and Education Attention Control condition (SEA control).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Sustained a TBI, defined as damage to brain tissue caused by external force and evidenced by loss of consciousness, post-traumatic amnesia, skull fracture, or objective neurological findings\n* History of alcohol misuse within the year prior to injury\n* Be at least 18 years old\n* English-speaking\n* Have cleared post-traumatic amnesia\n* Able and willing to provide informed consent\n\nExclusion Criteria:\n\n* Language impairments that would preclude participation in interview\n* Has not cleared post-traumatic amnesia before discharge'}, 'identificationModule': {'nctId': 'NCT02129361', 'briefTitle': 'Screening and Brief Intervention for Substance Misuse Following Traumatic Brain Injury', 'organization': {'class': 'OTHER', 'fullName': 'Ohio State University'}, 'officialTitle': 'Brief Intervention for Substance Misuse Following Moderate or Severe Traumatic Brain Injury (TBI): A Randomized Controlled Trial', 'orgStudyIdInfo': {'id': '2012H0424'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Adapted Screening and Brief Intervention', 'description': 'Adapted Screening and Brief Intervention: Participants will be screened for substance use, receive education regarding the effects of substance misuse, participate in a motivation interview, and participate in a booster session one month later', 'interventionNames': ['Behavioral: Adapted Screening and Brief Intervention (Adapted SBI)']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Screening & Education Attention Control', 'description': 'Screening \\& Education Attention Control: Participants will be screened for substance use, receive education regarding the effects of substance misuse, and participate in a booster session one month later', 'interventionNames': ['Behavioral: Screening & Education Attention Control']}], 'interventions': [{'name': 'Adapted Screening and Brief Intervention (Adapted SBI)', 'type': 'BEHAVIORAL', 'armGroupLabels': ['Adapted Screening and Brief Intervention']}, {'name': 'Screening & Education Attention Control', 'type': 'BEHAVIORAL', 'armGroupLabels': ['Screening & Education Attention Control']}]}, 'contactsLocationsModule': {'locations': [{'zip': '43210', 'city': 'Columbus', 'state': 'Ohio', 'country': 'United States', 'facility': 'Ohio State University Wexner Medical Center', 'geoPoint': {'lat': 39.96118, 'lon': -82.99879}}], 'overallOfficials': [{'name': 'Jennifer A Bogner, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Ohio State University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Jennifer Bogner, PhD, ABPP', 'class': 'OTHER'}, 'collaborators': [{'name': 'U.S. Department of Education', 'class': 'FED'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Jennifer Bogner, PhD, ABPP', 'investigatorAffiliation': 'Ohio State University'}}}}