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Screening and Brief Intervention for Substance Misuse Following Traumatic Brain Injury

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ClinicalTrials.gov Identifier: NCT02129361
Recruitment Status : Enrolling by invitation
First Posted : May 2, 2014
Last Update Posted : December 19, 2017
Sponsor:
Collaborator:
U.S. Department of Education
Information provided by (Responsible Party):
Jennifer Bogner, PhD, ABPP, Ohio State University

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).

Condition or disease Intervention/treatment Phase
Traumatic Brain Injury Behavioral: Adapted Screening and Brief Intervention (Adapted SBI) Behavioral: Screening & Education Attention Control Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Brief Intervention for Substance Misuse Following Moderate or Severe Traumatic Brain Injury (TBI): A Randomized Controlled Trial
Study Start Date : March 2014
Estimated Primary Completion Date : October 2018
Estimated Study Completion Date : December 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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



Primary Outcome Measures :
  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 Outcome Measures :
  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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02129361


Locations
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United States, Ohio
Ohio State University Wexner Medical Center
Columbus, Ohio, United States, 43210
Sponsors and Collaborators
Jennifer Bogner, PhD, ABPP
U.S. Department of Education
Investigators
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Principal Investigator: Jennifer A Bogner, PhD Ohio State University Wexner Medical Center

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Responsible Party: Jennifer Bogner, PhD, ABPP, Associate Professor, Ohio State University
ClinicalTrials.gov Identifier: NCT02129361     History of Changes
Other Study ID Numbers: 2012H0424
First Posted: May 2, 2014    Key Record Dates
Last Update Posted: December 19, 2017
Last Verified: December 2017

Keywords provided by Jennifer Bogner, PhD, ABPP, Ohio State University:
traumatic brain injury

Additional relevant MeSH terms:
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Brain Injuries
Brain Injuries, Traumatic
Wounds and Injuries
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Craniocerebral Trauma
Trauma, Nervous System