Clinical trial NCT02129361: Screening and Brief Intervention for Substance Misuse Following Traumatic Brain Injury
Official title: Brief Intervention for Substance Misuse Following Moderate or Severe Traumatic Brain Injury (TBI): A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Traumatic Brain Injury
Keywords: traumatic brain injury
Lead sponsor: Ohio State University
Sponsor class: OTHER
Collaborators: name: U.S. Department of Education
First posted: 2014-05-02
Enrollment: 139
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).


Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* Language impairments that would preclude participation in interview
* Has not cleared post-traumatic amnesia before discharge

Primary outcomes:
measure: Number of alcoholic drinks consumed per week in past month
timeFrame: Change from baseline to 12 months post-discharge
Secondary outcomes:
measure: Frequency of alcohol binges in past month
timeFrame: Change in the number of alcohol binges baseline to 12 months post-discharge
measure: Alcohol expectancies
timeFrame: 12 months post-discharge
measure: Number of facts retained about negative consequences of substance misuse
timeFrame: 12 months post-discharge
measure: Number of alcoholic drinks consumed per week during the past month
timeFrame: Change from baseline to 3 months post-discharge
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
measure: Number of alcohol binges in past month
timeFrame: Change from baseline to 3 months post-discharge
measure: Alcohol expectancies
timeFrame: 6 months post-discharge
measure: Alcohol expectancies
timeFrame: 3 months post-discharge
measure: Number of facts retained about negative consequences of alcohol use
timeFrame: 3 months post-discharge
measure: Number of facts retained about negative consequences of alcohol use
timeFrame: 6 months post-discharge
Other outcomes:
Locations:
city: Columbus
country: United States
facility: Ohio State University Wexner Medical Center
state: Ohio
Study officials:
affiliation: Ohio State University
name: Jennifer A Bogner, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.