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Screening and Brief Intervention for Substance Misuse Following Traumatic Brain Injury

NCT ID: NCT02129361

Last Updated: 2021-10-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

139 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-03-31

Study Completion Date

2018-10-31

Brief Summary

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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).

Detailed Description

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Conditions

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Traumatic Brain Injury

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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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

Group Type EXPERIMENTAL

Adapted Screening and Brief Intervention (Adapted SBI)

Intervention Type BEHAVIORAL

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

Group Type ACTIVE_COMPARATOR

Screening & Education Attention Control

Intervention Type BEHAVIORAL

Interventions

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Adapted Screening and Brief Intervention (Adapted SBI)

Intervention Type BEHAVIORAL

Screening & Education Attention Control

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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U.S. Department of Education

FED

Sponsor Role collaborator

Jennifer Bogner, PhD, ABPP

OTHER

Sponsor Role lead

Responsible Party

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Jennifer Bogner, PhD, ABPP

Associate Professor

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Jennifer A Bogner, PhD

Role: PRINCIPAL_INVESTIGATOR

Ohio State University

Locations

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Ohio State University Wexner Medical Center

Columbus, Ohio, United States

Site Status

Countries

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United States

References

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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.

Reference Type DERIVED
PMID: 34618511 (View on PubMed)

Other Identifiers

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2012H0424

Identifier Type: -

Identifier Source: org_study_id