Hybrid 1 randomized controlled trial of an integrated stepped-care mental health intervention for traumatic injury patients.

Background: Annually, nearly 3 million individuals in the US are hospitalized after experiencing a traumatic injury (e.g., serious automobile crash, gunshot wound, stab injury). Many traumatically injured patients experience a trajectory of resilience. However, 20-40 % develop mental health problems such as posttraumatic stress disorder and depression; population estimates exceed 600,000 patients annually. Most trauma centers do not provide direct services to address mental health recovery, but the 2022 American College of Surgeons guidelines have established this as a priority. Cost-effective interventions are needed that meet the needs of patients at each stage of the recovery process while achieving sustainability at the level of implementation. This protocol paper describes a study that rigorously tests the Trauma Resilience and Recovery Program (TRRP), a scalable, sustainable technology-enhanced intervention to support the mental health recovery of patients who have experienced a traumatic injury.

Methods: We describe a randomized controlled trial with 1-year follow up of TRRP vs. enhanced usual care with 350 traumatically injured patients, including recruitment and retention procedures, assessment, implementation and fidelity monitoring, and statistical plans.

Conclusion: Novel components of our design include integration of technology-based elements, use of a stepped-care model, and implementation in a trauma center that did not previously have a mental health program. Data collected address the impact of TRRP and inform improvements to the model and its implementation in preparation for large-scale testing and implementation initiatives. This body of work is critical to informing the field as it continues to move toward national standards and recommendations.

Trial Registration: NCT05497115Clinicaltrials.gov.