Findings from a Randomized Controlled Trial of SMART: An EHealth Intervention for Mild Traumatic Brain Injury

Abstract

Objective: The aim of this study was to examine the efficacy of the SMART (Self-Management After Recent Traumatic brain injury) program and potential moderators.

Methods: Parallel randomized controlled trial (ClinicalTrials.gov Identifier: NCT03498495) was conducted. Eligibility criteria included treatment for mild traumatic brain injury in the emergency department and age 11-18 years. Participants were assigned equally to SMART (n = 35) or usual care (UC; n = 36). SMART included symptom monitoring and online modules supporting the return to activities and symptom management. Coping and quality of life (QoL) (primary outcomes) and post-concussive symptoms (secondary outcome) were assessed at baseline and weekly for 4 weeks.

Results: Groups did not differ in coping, QoL, or return to pre-injury symptom levels at any time point. Problem-focused engagement (PFE) moderated group differences over time (p = .02). At high PFE, UC participants reported lower QoL at time 1 (effect size [ES] = 0.60); SMART participants did not report a decline at any point. At low PFE, SMART participants reported declining QoL from pre-injury to time 1 (ES = 0.68), whereas UC participants reported an increase from time 1 to 3 (ES = 0.56). PFE also moderated group differences on the Health and Behavior Inventory (HBI) cognitive (p = .02) and somatic symptom scales (p = .05). At high PFE, SMART participants reported a more rapid return to pre-injury levels than UC participants (p = .05). Resilience also moderated group differences in QoL and HBI cognitive recovery.

Conclusion: Effectiveness of the SMART app varied based on preinjury coping styles and resilience, underscoring the potential need to tailor treatments to individual characteristics.

Keywords: coping skills and adjustment; eHealth/mHealth; randomized controlled trial; resilience; traumatic brain injury.