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Screening and Brief Intervention for Substance Misuse Following Traumatic Brain Injury

Primary Purpose

Traumatic Brain Injury

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Adapted Screening and Brief Intervention (Adapted SBI)
Screening & Education Attention Control
Sponsored by
Jennifer Bogner, PhD, ABPP
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Traumatic Brain Injury focused on measuring traumatic brain injury

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Ohio State University Wexner Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Adapted Screening and Brief Intervention

Screening & Education Attention Control

Arm Description

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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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
Alcohol expectancies
Measured by the shortened Alcohol Expectancies Questionnaire-III
Number of facts retained about negative consequences of substance misuse
Count of number of facts, maximum=8
Number of alcoholic drinks consumed per week during the past month
Count of number of facts, maximum=8
Number of alcoholic drinks consumed per week in the past month
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
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
Alcohol expectancies
Measured by the shortened Alcohol Expectancies Questionnaire-III
Alcohol expectancies
Measured by the shortened Alcohol Expectancies Questionnaire-III
Number of facts retained about negative consequences of alcohol use
Count of number of facts, maximum=8
Number of facts retained about negative consequences of alcohol use
Count of number of facts, maximum=8

Full Information

First Posted
April 28, 2014
Last Updated
October 20, 2021
Sponsor
Jennifer Bogner, PhD, ABPP
Collaborators
U.S. Department of Education
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1. Study Identification

Unique Protocol Identification Number
NCT02129361
Brief Title
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

2. Study Status

Record Verification Date
October 2021
Overall Recruitment Status
Completed
Study Start Date
March 2014 (undefined)
Primary Completion Date
October 31, 2018 (Actual)
Study Completion Date
October 31, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Jennifer Bogner, PhD, ABPP
Collaborators
U.S. Department of Education

4. Oversight

Data Monitoring Committee
No

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Traumatic Brain Injury
Keywords
traumatic brain injury

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
139 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Adapted Screening and Brief Intervention
Arm Type
Experimental
Arm Description
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
Arm Title
Screening & Education Attention Control
Arm Type
Active Comparator
Arm Description
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
Intervention Type
Behavioral
Intervention Name(s)
Adapted Screening and Brief Intervention (Adapted SBI)
Intervention Type
Behavioral
Intervention Name(s)
Screening & Education Attention Control
Primary Outcome Measure Information:
Title
Number of alcoholic drinks consumed per week in past month
Description
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 Outcome Measure Information:
Title
Frequency of alcohol binges in past month
Description
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
Title
Alcohol expectancies
Description
Measured by the shortened Alcohol Expectancies Questionnaire-III
Time Frame
12 months post-discharge
Title
Number of facts retained about negative consequences of substance misuse
Description
Count of number of facts, maximum=8
Time Frame
12 months post-discharge
Title
Number of alcoholic drinks consumed per week during the past month
Description
Count of number of facts, maximum=8
Time Frame
Change from baseline to 3 months post-discharge
Title
Number of alcoholic drinks consumed per week in the past month
Time Frame
Change from baseline to 6 months post-discharge
Title
Frequency of alcohol binges in past month
Description
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
Title
Number of alcohol binges in past month
Description
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
Title
Alcohol expectancies
Description
Measured by the shortened Alcohol Expectancies Questionnaire-III
Time Frame
6 months post-discharge
Title
Alcohol expectancies
Description
Measured by the shortened Alcohol Expectancies Questionnaire-III
Time Frame
3 months post-discharge
Title
Number of facts retained about negative consequences of alcohol use
Description
Count of number of facts, maximum=8
Time Frame
3 months post-discharge
Title
Number of facts retained about negative consequences of alcohol use
Description
Count of number of facts, maximum=8
Time Frame
6 months post-discharge

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jennifer A Bogner, PhD
Organizational Affiliation
Ohio State University Wexner Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ohio State University Wexner Medical Center
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
34618511
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.
Results Reference
derived

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Screening and Brief Intervention for Substance Misuse Following Traumatic Brain Injury

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