JMIR Publications

ABSTRACT

Background:

Concussion in children and adolescents is a significant public health concern, with 30-35% of patients at risk for prolonged emotional, cognitive, sleep, and/or physical symptoms. These symptoms negatively impact a child's quality of life while interfering with participation in important neurodevelopmental activities such as schoolwork, socializing, and sports. Early psychological intervention following a concussion may improve the ability to regulate emotions and adapt post-injury, resulting in greater acceptance of change, reduced stress, and recovery of somatic, emotional, and cognitive symptoms.

Objective:

This study’s primary objective is to assess the feasibility of conducting a parallel (1:1) group randomized controlled trial (RCT) to evaluate a digital therapeutic (DTx) mindfulness-based intervention (MBI) in adolescents aged 12 to 17.99 years. The attention-matched comparator intervention (a math game also employed in previous RCTs) will be delivered on the same DTx platform. Both groups will be provided with standard-of-care guidelines. The secondary objective is to examine intervention trends for quality of life; resilience; self-efficacy; cognition such as attention, working memory and executive functioning; symptom burden; and anxiety and depression scores at 4 weeks post-concussion, which will inform a more definitive RCT. A subsample will be used to examine whether those randomized to the experimental intervention have different brain-based imaging patterns compared with those randomized to the control group.

Methods:

This study is a double-blind Health Canada Regulated Trial. A total of 70 participants will be enrolled within 7 days of concussion and randomly assigned to receive the 4-week Dtx MBI (experimental group) or comparator intervention. Feasibility will be assessed based on the recruitment rate, treatment adherence to both interventions, and retention. All outcome measures will be evaluated before the intervention (within 7 days post-injury) and at 1, 2, and 4 weeks post-injury. A subset of 60 participants will undergo magnetic resonance imaging (MRI) within 72 hours and at 4 weeks post-recruitment to identify the neurophysiological mechanisms underlying potential benefits from MBI training in adolescents following a concussion.

Results:

NA - Research Protocol

Conclusions:

This trial will confirm feasibility and resolve uncertainties to inform a future definitive multicenter efficacy RCT. If proven effective, a smartphone-based MBI has the potential to be an accessible and low-risk preventive treatment for youths at risk of experiencing prolonged post-concussion symptoms and complications. Clinical Trial: NCT05105802