Screening and Brief Intervention for Substance Misuse Following Traumatic Brain Injury

Traumatic Brain Injury Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02129361
• Other study ID #: 2012H0424
• Status: Completed
• Phase: N/A
• Start date: March 2014
• Est. completion date: October 31, 2018

Study information

• Verified date: October 2021
• Source: Ohio State University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 139
• Est. completion date: October 31, 2018
• Est. primary completion date: October 31, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Brain Injuries
• Brain Injuries, Traumatic
• Traumatic Brain Injury
• Wounds and Injuries

Intervention

Behavioral:
• Adapted Screening and Brief Intervention (Adapted SBI)

• Screening & Education Attention Control

Locations

Country	Name	City	State
United States	Ohio State University Wexner Medical Center	Columbus	Ohio

Sponsors (2)

Lead Sponsor	Collaborator
Jennifer Bogner, PhD, ABPP	U.S. Department of Education

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Change from baseline to 12 months post-discharge
Secondary	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	Change in the number of alcohol binges baseline to 12 months post-discharge
Secondary	Alcohol expectancies	Measured by the shortened Alcohol Expectancies Questionnaire-III	12 months post-discharge
Secondary	Number of facts retained about negative consequences of substance misuse	Count of number of facts, maximum=8	12 months post-discharge
Secondary	Number of alcoholic drinks consumed per week during the past month	Count of number of facts, maximum=8	Change from baseline to 3 months post-discharge
Secondary	Number of alcoholic drinks consumed per week in the past month		Change from baseline to 6 months post-discharge
Secondary	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	Change from baseline to 6 months post-discharge
Secondary	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	Change from baseline to 3 months post-discharge
Secondary	Alcohol expectancies	Measured by the shortened Alcohol Expectancies Questionnaire-III	6 months post-discharge
Secondary	Alcohol expectancies	Measured by the shortened Alcohol Expectancies Questionnaire-III	3 months post-discharge
Secondary	Number of facts retained about negative consequences of alcohol use	Count of number of facts, maximum=8	3 months post-discharge
Secondary	Number of facts retained about negative consequences of alcohol use	Count of number of facts, maximum=8	6 months post-discharge