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Completed

NCT Number: NCT02129361

Screening and Brief Intervention for Substance Misuse Following Traumatic Brain Injury

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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Key information

Conditions

Traumatic Brain Injury Brain Diseases Brain Injuries Brain Injuries, Traumatic Central Nervous System Diseases Craniocerebral Trauma Nervous System Diseases Trauma, Nervous System Wounds and Injuries

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ohio State University Wexner Medical Center

Columbus, Ohio, 43210, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Adapted Screening and Brief Intervention (Adapted SBI)

Behavioral

Screening & Education Attention Control

Behavioral

Primary outcomes

  1. Number of alcoholic drinks consumed per week in past month

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

    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.

Secondary outcomes

  1. Frequency of alcohol binges in past month

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

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

  2. Alcohol expectancies

    Time frame: 12 months post-discharge

    Measured by the shortened Alcohol Expectancies Questionnaire-III

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

    Time frame: 12 months post-discharge

    Count of number of facts, maximum=8

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

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

    Count of number of facts, maximum=8

  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

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

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

  7. Number of alcohol binges in past month

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

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

  8. Alcohol expectancies

    Time frame: 6 months post-discharge

    Measured by the shortened Alcohol Expectancies Questionnaire-III

  9. Alcohol expectancies

    Time frame: 3 months post-discharge

    Measured by the shortened Alcohol Expectancies Questionnaire-III

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

    Time frame: 3 months post-discharge

    Count of number of facts, maximum=8

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

    Time frame: 6 months post-discharge

    Count of number of facts, maximum=8

Sponsors and collaborators

Lead sponsor

Jennifer Bogner, PhD, ABPP

Other

Collaborators

  • U.S. Department of Education

Registry information

Official study title

Brief Intervention for Substance Misuse Following Moderate or Severe Traumatic Brain Injury (TBI): A Randomized Controlled Trial

Important dates

Study start
2014
Primary completion
2018
Study completion
2018
First posted
May 2, 2014
Registry last updated
Oct 21, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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