Implementation of a neurological intervention to address traumatic brain injury in substance use treatment: protocol for a hybrid type 2 effectiveness-implementation pilot trial

Up to 4 in 5 adults seeking treatment for substance use disorders (SUDs) have sustained at least one traumatic brain injury (TBI) in their lifetime. TBIs can lead to cognitive impairments that can affect a person’s perceptions of their ability to attain goals, diminish self-efficacy, and reduce cognitive engagement in SUD treatment. Although screening for and accommodating the effects of TBI are widely recognized in the brain injury research and practice community, these interventions are not widely adopted in SUD treatment organizations. This study protocol describes a hybrid type 2 effectiveness-implementation pilot trial designed to investigate the effectiveness and implementation of the novel TBI-RECOVER intervention model (i.e., TBI screening, cognitive/behavioral challenges screening, and cognitive compensatory strategies) in a hospital-based outpatient SUD treatment program. Guided by the Theory of Implementation Effectiveness and Organizational Learning Theory, we will investigate multilevel mechanisms associated with the provider-focused implementation strategies on implementation outcomes, as well as intervention mechanisms associated with TBI-RECOVER on patient treatment outcomes. Aim 1 will evaluate the effectiveness of provider-focused implementation strategies (e.g., training/education, champions, external facilitation, and audit and feedback) on the adoption, reach, implementation fidelity, and maintenance of TBI-RECOVER. Hypothesized implementation strategy mechanisms are provider/facilitator working alliance, provider self-efficacy, implementation readiness, leadership support, and implementation climate. Aim 2 will enroll up to 300 patients in the Control/Pre-Implementation Phase to receive TBI screening and education, 300 patients in the Treatment/Implementation Phase to receive the TBI-RECOVER intervention, and 300 patients in the Sustainment Phase to receive TBI-RECOVER. Primary treatment effectiveness outcomes are treatment retention and symptom reduction. Hypothesized treatment mechanisms are patient self-efficacy, cognitive engagement, and treatment satisfaction. Aim 3 will qualitatively assess patient and provider acceptability and satisfaction with the TBI-RECOVER intervention, and provider perceptions of the utility of the implementation strategies in supporting implementation and sustainment of TBI-RECOVER. This pilot trial contributes to the implementation literature by examining potential multilevel mechanisms of provider-focused implementation strategies on implementation outcomes, as well as mechanisms through which TBI-RECOVER may improve patient treatment outcomes. Results will inform a subsequent multiphase optimization strategy to scale out TBI-RECOVER in a future cluster randomized controlled trial. Clinicaltrials.gov NCT07215221, registered October 9, 2025.