Skip to content

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02129361
Enrollment
139
Registered
2014-05-02
Start date
2014-03-31
Completion date
2018-10-31
Last updated
2021-10-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Traumatic Brain Injury

Keywords

traumatic brain injury

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).

Interventions

BEHAVIORALAdapted Screening and Brief Intervention (Adapted SBI)
BEHAVIORALScreening & Education Attention Control

Sponsors

U.S. Department of Education
CollaboratorFED
Jennifer Bogner, PhD, ABPP
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Number of alcoholic drinks consumed per week in past monthChange from baseline to 12 months post-dischargeNumber 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.

Secondary

MeasureTime frameDescription
Alcohol expectancies12 months post-dischargeMeasured by the shortened Alcohol Expectancies Questionnaire-III
Number of facts retained about negative consequences of substance misuse12 months post-dischargeCount of number of facts, maximum=8
Number of alcoholic drinks consumed per week during the past monthChange from baseline to 3 months post-dischargeCount of number of facts, maximum=8
Frequency of alcohol binges in past monthChange in the number of alcohol binges baseline to 12 months post-dischargeBinge is defined as 4 or more drinks in a day for women, 5 or more drinks in a day for men
Number of alcohol binges in past monthChange from baseline to 3 months post-dischargeBinge is defined as 4 or more drinks in a day for women, 5 or more drinks in a day for men
Number of facts retained about negative consequences of alcohol use3 months post-dischargeCount of number of facts, maximum=8
Number of alcoholic drinks consumed per week in the past monthChange from baseline to 6 months post-discharge

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026