Smartphone App-Delivered Mindfulness-Based Intervention for Concussion in Adolescents (MBI-4-mTBI): Feasibility Randomized Controlled Trial.
Veronik Sicard, Molly Cairncross, Roger Zemek and 6 others
PMID 42114021WHAT IT FOUND
A mindfulness app for teens with concussion was feasible but had low adherence.
Only 60% of users met the minimum engagement target, dropping to 39% by week 4. The study was too small to prove the app reduces symptoms or improves recovery.
Key findings
01Four out of five feasibility targets (eligibility, recruitment, credibility, retention) were met, but adherence fell short at 60% versus the 70% target.
02Weekly adherence declined significantly over the 4 weeks, with the mindfulness group dropping from 50% to 39% meeting the minimum requirement.
03The study was not powered to detect efficacy, and descriptive results showed both groups had reductions in symptom burden without formal statistical testing between groups.
STILL TO COME
How it was doneWhat they found
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What it does not show
The study was a feasibility trial and was not powered to detect differences in clinical outcomes like symptom burden or quality of life. Adherence was low and declined sharply after week 1, with only about 40% of participants meeting the minimum engagement requirement by week 4. Participants in the sham group had lower treatment expectancy than those in the mindfulness group, which may indicate partial unblinding or differential perceived value. The app's engagement tracking may have under-reported actual usage by 10-20% because it only counted fully completed 'meaningful interactions'. All participants received standard-of-care concussion guidance, which supports natural recovery and makes it difficult to isolate the effect of the app-based interventions.
Declared interests
One author (BJS) is the CEO and a shareholder of the company that developed the app. Another author (RZ) is a founding partner and shareholder of the clinic where some participants were recruited. The study received funding from various grants, including those from the Ontario Neurotrauma Foundation and the National Football League.
The easy way to misread this
Do not interpret the reduction in symptoms in both groups as evidence that the mindfulness app works. The study was not powered to test efficacy, the differences between groups were not statistically tested, and natural recovery plus standard care likely drove the improvements seen in both the app and the puzzle game groups.
Summarised by AI from the full paper, without a clinician reviewing it. Check it against the source before it changes what you do. Read it on PubMed →