Substance Use Disorder (SUD), Traumatic Brain Injury
Conditions
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
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.
Interventions
BEHAVIORALTBI-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.
BEHAVIORALControl
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.
Sponsors
Ohio State University
National Institute on Drug Abuse (NIDA)
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
The study will use a quasi-experimental design with a control and treatment group recruited at separate phases of the trial.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
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).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
Countries
United States
Outcome results
None listed