NCT07215221 · Ohio State University
Implementation of TBI-RECOVER in Substance Use Treatment
(TBI-RECOVER)
What this study is about
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.
View original scientific description
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.
Interventions
BEHAVIORAL
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.
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.
Primary outcome measures
Treatment retention
Time frame: 1 year
The proportion of treatment sessions attended over one year.
BASIS-24 scores
Time frame: 1 year
The Behavior and Symptom Identification Scale (BASIS-24) measures six domains: (1) substance use, (2) impulsive/addictive behaviors, (3) relationships with self and others, (4) depression/anxiety, (5) daily living/role functioning, and (6) psychosis. Each item is rated on a 5-point Likert scale, where 0 = lowest symptom severity and 4 = highest symptom severity. Subscales and the overall score are summed and then divided by the number of non-missing items for a total score. There are no clinical cut-offs.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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).
Where
- Columbus, Ohio
Collaborators
National Institute on Drug Abuse (NIDA)
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jul 7, 2026 · Source of record for eligibility and locations