NCT02129361

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
139

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2014

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2014

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

April 28, 2014

Completed
4 days until next milestone

First Posted

Study publicly available on registry

May 2, 2014

Completed
4.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 31, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 31, 2018

Completed
Last Updated

October 21, 2021

Status Verified

October 1, 2021

Enrollment Period

4.7 years

First QC Date

April 28, 2014

Last Update Submit

October 20, 2021

Conditions

Keywords

traumatic brain injury

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (11)

  • Frequency of alcohol binges in past month

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

  • Alcohol expectancies

    12 months post-discharge

  • Number of facts retained about negative consequences of substance misuse

    12 months post-discharge

  • Number of alcoholic drinks consumed per week during the past month

    Change from baseline to 3 months post-discharge

  • Number of alcoholic drinks consumed per week in the past month

    Change from baseline to 6 months post-discharge

  • +6 more secondary outcomes

Study Arms (2)

Adapted Screening and Brief Intervention

EXPERIMENTAL

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)

Screening & Education Attention Control

ACTIVE COMPARATOR

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

Interventions

Adapted Screening and Brief Intervention
Screening & Education Attention Control

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Language impairments that would preclude participation in interview
  • Has not cleared post-traumatic amnesia before discharge

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ohio State University Wexner Medical Center

Columbus, Ohio, 43210, United States

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Brain Injuries, Traumatic

Interventions

Crisis InterventionMass Screening

Condition Hierarchy (Ancestors)

Brain InjuriesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesCraniocerebral TraumaTrauma, Nervous SystemWounds and Injuries

Intervention Hierarchy (Ancestors)

PsychotherapyBehavioral Disciplines and ActivitiesDiagnostic Techniques and ProceduresDiagnosisHealth SurveysSurveys and QuestionnairesData CollectionEpidemiologic MethodsInvestigative TechniquesDiagnostic ServicesPreventive Health ServicesHealth ServicesHealth Care Facilities Workforce and ServicesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public HealthPublic Health Practice

Study Officials

  • Jennifer A Bogner, PhD

    Ohio State University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

April 28, 2014

First Posted

May 2, 2014

Study Start

March 1, 2014

Primary Completion

October 31, 2018

Study Completion

October 31, 2018

Last Updated

October 21, 2021

Record last verified: 2021-10

Locations