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CompletedNCT02129361Updated Oct 21, 2021

Screening and Brief Intervention for Substance Misuse Following Traumatic Brain Injury

An interventional study of Adapted Screening and Brief Intervention (Adapted SBI) and Screening & Education Attention Control in Traumatic Brain Injury, sponsored by Jennifer Bogner, PhD, ABPP. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-10-21.

Sponsored by Jennifer Bogner, PhD, ABPP · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
139
Allocation
Randomized
Ages
18 Years and older
Sex
All
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Study 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).

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Conditions studied

  • Traumatic Brain Injury

Keywords

  • traumatic brain injury
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In context

Brain Injuries

2,113 studies on the registry are indexed under Brain Injuries; 385 are open to participants now.

This study's enrollment of 139 is above the median of 48 across 1,331 interventional studies indexed under Brain Injuries.

Browse Brain Injuries studies →

Lead sponsor

Jennifer Bogner, PhD, ABPP is the lead sponsor of 2 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts 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

Exclusion Criteria:

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

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
139 participants (actual)

Study arms

  • Experimental
    Adapted Screening and Brief Intervention

    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

    Behavioral: Adapted Screening and Brief Intervention (Adapted SBI)

  • Active comparator
    Screening & Education Attention Control

    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

    Behavioral: Screening & Education Attention Control

Interventions

  • BehavioralAdapted Screening and Brief Intervention (Adapted SBI)
  • BehavioralScreening & Education Attention Control
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What researchers measure

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.

    Time frame: Change from baseline to 12 months post-discharge

Secondary outcomes

  1. Frequency of alcohol binges in past month

    Binge is defined as 4 or more drinks in a day for women, 5 or more drinks in a day for men

    Time frame: Change in the number of alcohol binges baseline to 12 months post-discharge

  2. Alcohol expectancies

    Measured by the shortened Alcohol Expectancies Questionnaire-III

    Time frame: 12 months post-discharge

  3. Number of facts retained about negative consequences of substance misuse

    Count of number of facts, maximum=8

    Time frame: 12 months post-discharge

  4. Number of alcoholic drinks consumed per week during the past month

    Count of number of facts, maximum=8

    Time frame: Change from baseline to 3 months post-discharge

  5. Number of alcoholic drinks consumed per week in the past month

    Time frame: Change from baseline to 6 months post-discharge

  6. Frequency of alcohol binges in past month

    Binge is defined as 4 or more drinks in a day for women, 5 or more drinks in a day for men

    Time frame: Change from baseline to 6 months post-discharge

  7. Number of alcohol binges in past month

    Binge is defined as 4 or more drinks in a day for women, 5 or more drinks in a day for men

    Time frame: Change from baseline to 3 months post-discharge

  8. Alcohol expectancies

    Measured by the shortened Alcohol Expectancies Questionnaire-III

    Time frame: 6 months post-discharge

  9. Alcohol expectancies

    Measured by the shortened Alcohol Expectancies Questionnaire-III

    Time frame: 3 months post-discharge

  10. Number of facts retained about negative consequences of alcohol use

    Count of number of facts, maximum=8

    Time frame: 3 months post-discharge

  11. Number of facts retained about negative consequences of alcohol use

    Count of number of facts, maximum=8

    Time frame: 6 months post-discharge

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Study locations

1 site
  • Ohio State University Wexner Medical Center
    Columbus, Ohio 43210, United States
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References and documents

Publications

  • 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. PubMed 34618511 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 21, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02129361
Lead sponsor
Jennifer Bogner, PhD, ABPP
Collaborators
U.S. Department of Education
Responsible party
Jennifer Bogner, PhD, ABPP (Associate Professor, Ohio State University) — Sponsor-investigator
First posted
May 2, 2014
Start date
Mar 2014
Primary completion
Oct 31, 2018
Completion
Oct 31, 2018
Last update
Oct 21, 2021

Study contacts

Jennifer A Bogner, PhD
principal investigator · Ohio State University

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Oct 2021. You cannot join it, but the record below documents what was studied.

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