Recruiting

TBI-RECOVER

Sponsor:

Ohio State University

Code:

NCT07215221

Conditions

Traumatic Brain Injury

Substance Use Disorder (SUD)

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

TBI-RECOVER

Control

Study Details

Brief summary:

The goal of this hybrid type 2 pilot trial is to understand the implementation and effectiveness of the TBI-RECOVER intervention model (e.g., brain injury screening, cognitive and behavioral challenges screening, and neurocognitive accommodations) on patient retention in outpatient substance use disorder treatment. We will evaluate whether an implementation strategy bundle (e.g., training/education, champions, audit \& feedback, facilitation) improves provider use and sustainability of the TBI-RECOVER intervention, and also whether the TBI-RECOVER intervention improves patient symptoms and treatment retention.

Conditions

Traumatic Brain Injury

Substance Use Disorder (SUD)

Study ID

NCT07215221

Start date

Apr 28, 2026

Status verified date

Jul, 2026

Completion date

Mar 30, 2030

Anticipated

Primary completion date

Jan 30, 2030

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Patient Inclusion Criteria:

  • English-speaking; diagnosed with a substance use disorder; assigned to an outpatient provider for psychotherapy at the treatment clinic participating in the study.

Patient Exclusion Criteria:

  • None

Provider Inclusion Criteria:

\- All providers employed in the outpatient treatment clinic who deliver psychotherapy are eligible (e.g., social workers, counselors, psychologists).

Study Design

Enrollment

900 participants

Anticipated

Allocation

Non randomized

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: TBI-RECOVER treatment arm

Patients the treatment arm will be screened for brain injury, and those with a positive screen will receive the full TBI-RECOVER intervention model.

active comparator: Control arm

Patients in the control arm will be screened for brain injury, and those with a positive screen will receive a brief information and educational sheet.

Interventions

TBI-RECOVER

The TBI-RECOVER intervention model consists of three components: 1) a web-based brain injury and cognitive impairment screener using the Online Brain Injury Screening and Support System (OBISSS) of the National Association of State Head Injury Administrators, 2) brief education and information on traumatic brain injury and substance use disorders, and 3) neurocognitive accommodations, or compensatory strategies, for neurological impairment.

Control

The control condition includes a brief information and educational sheet on traumatic brain injury and substance use disorder, how these two conditions are connected with each other, and a list of suggested accommodations they can use in treatment.

Primary outcome measure

  • Treatment retention [ Time Frame: 1 year ]
  • BASIS-24 scores [ Time Frame: 1 year ]

Central Contacts and Locations

Locations

OSU Hospital System

Recruiting

Columbus, Ohio, United States, 43210

Contacts

Kathryn Hyzak, PhD

3802836683kathryn.hyzak@osumc.edu

More Information

Sponsor

Ohio State University

Last update posted

Jul 7, 2026

Last verified

Jul, 2026

Keywords

  • hybrid type 2 effectiveness-implementation
  • traumatic brain injury
  • RE-AIM
  • organizational theory
  • implementation strategies
  • implementation mechanisms
  • substance use disorder treatment
  • hybrid type 2 trial
  • cognitive impairment
  • treatment mechanisms
  • outpatient substance use treatment

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Ohio State University on 2026-07-07.