Implementation of TBI-RECOVER in Substance Use Treatment

NCT ID: NCT07215221

Last Updated: 2025-10-10

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

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

900 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-12-01

Study Completion Date

2030-07-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Traumatic Brain Injury Substance Use Disorder (SUD)

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

The study will use a quasi-experimental design with a control and treatment group recruited at separate phases of the trial.
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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.

Group Type EXPERIMENTAL

TBI-RECOVER

Intervention Type BEHAVIORAL

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 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.

Group Type ACTIVE_COMPARATOR

Control

Intervention Type BEHAVIORAL

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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type BEHAVIORAL

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.

Intervention Type BEHAVIORAL

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Neurologic Informed Care

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.


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

Exclusion Criteria

* None
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

National Institute on Drug Abuse (NIDA)

NIH

Sponsor Role collaborator

Ohio State University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Kathryn Hyzak

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

1K01DA060881-01A1

Identifier Type: NIH

Identifier Source: secondary_id

View Link

20251658

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.