Accepted for/Published in: Journal of Medical Internet Research
Date Submitted: Jan 8, 2021
Date Accepted: Sep 29, 2021
Date Submitted to PubMed: Dec 3, 2021
Warning: This is an author submission that is not peer-reviewed or edited. Preprints - unless they show as "accepted" - should not be relied on to guide clinical practice or health-related behavior and should not be reported in news media as established information.
Clinical efficacy and psychological mechanisms of an app-based digital therapeutic for generalized anxiety disorder: a randomized controlled trial
ABSTRACT
Background:
Current treatments for Generalized Anxiety Disorder (GAD) yield suboptimal outcomes, partly because of insufficient targeting of underlying psychological mechanisms (e.g. avoidance reinforcement learning). Mindfulness training (MT), has shown efficacy for anxiety, yet widespread adoption has been limited, in part due to difficulty in scaling in-person-based delivery. Digital therapeutics are emerging as potential next-generation treatments, yet very few have been empirically validated.
Objective:
In this study, we tested the efficacy and mechanism of an app-delivered MT that was designed to target aberrant reinforcement learning.
Methods:
Individuals with GAD were randomized to receive Treatment as Usual (TAU, n=33) or TAU + app-delivered MT (n=28). Treatment-related changes in outcomes were assessed 1 and 2 months after treatment initiation.
Results:
In an intent-to-treat analysis, individuals in the MT group demonstrated a significant reduction in anxiety (GAD-7) relative to control (median (IQR) change in GAD-7: -8.5 (6.5) v. -1.0 (5.0), P<.001; 95% CI 6 to 10). Increases in mindfulness (non-reactivity subscale) mediated decreases in worry (PSWQ; P=.02), and decreases in worry mediated reductions in anxiety (P=.03).
Conclusions:
This is the first report studying the efficacy and mechanism of app-delivered MT for GAD. These findings demonstrate the clinical efficacy of MT delivered as a digital therapeutic for individuals with anxiety (Number Needed to Treat=1.6). These results also link recent advances in our mechanistic understanding of anxiety with treatment development, showing that app-delivered MT targets key reinforcement learning pathways resulting in tangible, clinically-meaningful reductions in worry and anxiety. Evidence-based, mechanistically-targeted digital therapeutics have the potential to improve health on a population level at low cost. Clinical Trial: Developing a Novel Digital Therapeutic for the Treatment of Generalized Anxiety Disorder (NCT03683472). URL - https://clinicaltrials.gov/ct2/show/NCT03683472?term=judson+brewer&draw=2&rank=1
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