Screening and Brief Intervention for Substance Misuse Following Traumatic Brain Injury
Brief Intervention for Substance Misuse Following Moderate or Severe Traumatic Brain Injury (TBI): A Randomized Controlled Trial
1 other identifier
interventional
139
1 country
1
Brief Summary
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Mar 2014
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2014
CompletedFirst Submitted
Initial submission to the registry
April 28, 2014
CompletedFirst Posted
Study publicly available on registry
May 2, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 31, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
October 31, 2018
CompletedOctober 21, 2021
October 1, 2021
4.7 years
April 28, 2014
October 20, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Number of alcoholic drinks consumed per week in past month
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.
Change from baseline to 12 months post-discharge
Secondary Outcomes (11)
Frequency of alcohol binges in past month
Change in the number of alcohol binges baseline to 12 months post-discharge
Alcohol expectancies
12 months post-discharge
Number of facts retained about negative consequences of substance misuse
12 months post-discharge
Number of alcoholic drinks consumed per week during the past month
Change from baseline to 3 months post-discharge
Number of alcoholic drinks consumed per week in the past month
Change from baseline to 6 months post-discharge
- +6 more secondary outcomes
Study Arms (2)
Adapted Screening and Brief Intervention
EXPERIMENTALAdapted 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
Screening & Education Attention Control
ACTIVE COMPARATORScreening \& 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
Interventions
Eligibility Criteria
You may qualify if:
- 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
- History of alcohol misuse within the year prior to injury
- Be at least 18 years old
- English-speaking
- Have cleared post-traumatic amnesia
- Able and willing to provide informed consent
You may not qualify if:
- Language impairments that would preclude participation in interview
- Has not cleared post-traumatic amnesia before discharge
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Jennifer Bogner, PhD, ABPPlead
- U.S. Department of Educationcollaborator
Study Sites (1)
Ohio State University Wexner Medical Center
Columbus, Ohio, 43210, United States
Related Publications (1)
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.
PMID: 34618511DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jennifer A Bogner, PhD
Ohio State University
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Associate Professor
Study Record Dates
First Submitted
April 28, 2014
First Posted
May 2, 2014
Study Start
March 1, 2014
Primary Completion
October 31, 2018
Study Completion
October 31, 2018
Last Updated
October 21, 2021
Record last verified: 2021-10