Implementation of TBI-RECOVER in Substance Use Treatment

NCT07215221 | Not Yet Recruiting

• 2 other identifiers: 202516581K01DA060881-01A1
• Study Type: interventional
• Target: 900
• Locations: 0 countries
• Sites: N/A

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)

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

Outcome Measures

Primary Outcomes (2)

• Treatment retention

  The proportion of treatment sessions attended over one year.

  1 year

• BASIS-24 scores

  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.

  1 year

Secondary Outcomes (3)

• Patient self-efficacy

  9 weeks

• Cognitive engagement in treatment

  9 weeks

• Satisfaction with treatment

  9 weeks

Other Outcomes (4)

• Adoption

  Up to 4 years

• Reach

  Up to 4 years.

• Implementation adherence using the Fidelity Verification Review Process

  1 year

Study Arms (2)

TBI-RECOVER treatment arm

EXPERIMENTAL

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

Behavioral: TBI-RECOVER

Control arm

ACTIVE COMPARATOR

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.

Behavioral: Control

Interventions

TBI-RECOVER 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.

Also known as: Neurologic Informed Care

TBI-RECOVER treatment arm

Control 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.

Control arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• None
• \- All providers employed in the outpatient treatment clinic who deliver psychotherapy are eligible (e.g., social workers, counselors, psychologists).

Sponsors & Collaborators

• Ohio State University: lead
• National Institute on Drug Abuse (NIDA): collaborator

MeSH Terms

Conditions

Brain Injuries, Traumatic; Substance-Related Disorders; Cognitive Dysfunction

Condition Hierarchy (Ancestors)

Brain Injuries; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries; Chemically-Induced Disorders; Mental Disorders; Cognition Disorders; Neurocognitive Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: The study will use a quasi-experimental design with a control and treatment group recruited at separate phases of the trial.

Study Record Dates

• First Submitted: October 7, 2025
• First Posted: October 10, 2025
• Study Start: April 28, 2026
• Primary Completion (Estimated): January 1, 2030
• Study Completion (Estimated): July 31, 2030
• Last Updated: April 16, 2026

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ANALYTIC CODE
• Time Frame: All de-identified data will be shared as soon as possible, and no later than the time of an associated publication or end of the performance period, whichever comes first. The study data will be stored in the repository for at least 5 years.
• Access Criteria: The study metadata and datasets will be submitted to ICPSR. Data will be findable and identifiable through a search of the name of the project PI (Dr. Kathryn Hyzak), project title, or key words associated with the study.