Implementation of TBI-RECOVER in Substance Use Treatment

Not Applicable

Not yet recruiting

• Conditions: Traumatic Brain Injury; Substance Use Disorder (SUD)

• Registration Number: NCT07215221
• Lead Sponsor: Ohio State University

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-08
• Study First Submitted: 2025-10-07
• Study First Submitted QC: 2025-10-08
• Last Update Submitted: 2025-10-08
• Study First Posted: 2025-10-10
• Last Update Posted: 2025-10-10
• Study Start: 2025-12-01
• Primary Completion: 2030-01-01
• Study Completion: 2030-07-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 900

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Treatment retention	1 year	The proportion of treatment sessions attended over one year.
BASIS-24 scores	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.

Secondary Outcome Measures

Name	Time	Method
Cognitive engagement in treatment	9 weeks	We will use the Patient Expectation Questionnaire (CEQ), as well as single-item questions. CEQ is a 6-item questionnaire, with items measured on a 1 to 9, where 1 = "not at all logical" and 9 = "very logical." Questions 4 and 6 are rated on a 0-100% scale. Higher scores equal higher cognitive engagement. We will also ask the following single-item questions to measure cognitive engagement: "I understand the goals of my treatment;" "My therapists' approach to providing care will help me reach my goals." Cognitive engagement will be measured at baseline (after informed consent), 3, 6, and 9 weeks.
Satisfaction with treatment	9 weeks	We will use the Treatment Perceptions Questionnaire (TPQ),(52) a 10-item measure of treatment satisfaction. Items measured on a 5-point Likert scale, where higher sum scores equal greater satisfaction with treatment. TPQ will be measured once at 9 weeks.
Patient self-efficacy	9 weeks	The General Self-Efficacy Scale (GSES) will be used to measure self-efficacy. GSES is a 10-item measure of self-efficacy used in research for patients in treatment for SUDs. Items are measured on a 4-point Likert scale, where 1 = "Not at all true" and 4 = "Exactly true." Items are summed for a total score, with higher scores equating to greater self-efficacy. GSES has strong psychometric properties (α = .76 - .90). GSES will be measured at baseline (after informed consent), 3, 6, and 9 weeks.