Previously submitted to: Journal of Medical Internet Research (no longer under consideration since Aug 26, 2025)
Date Submitted: Feb 7, 2025
Warning: This is an author submission that is not peer-reviewed or edited.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.
Investigating the Unwinding Anxiety Mobile Application for Patients with Anxiety and Co-occurring Substance Use Disorders: A Single Arm Study Assessing Usability & Associated Changes in Anxiety and Substance Use
ABSTRACT
Background:
Patients with co-occurring anxiety and substance use disorders (A-SUD) have lower rates of treatment retention and are at increased risk for unwanted returns to substance use. App-based interventions (ABIs) offer accessible care that can overcome barriers to evidence-based treatment access. Despite growth in digital interventions for SUD, few studies have examined the role of anxiety-focused ABIs for patients with A-SUD.
Objective:
The objectives of this study were: (1) assess the usability of the Unwinding Anxiety® application, an anxiety treatment-focused, public-facing mobile app, as an adjunctive treatment for persons with A-SUD engaged in care; (2) conduct exploratory analyses of changes over time in A-SUD-associated specific outcomes (e.g., GAD-7, Penn State Worry Questionnaire, Brief Addiction Monitor) in a single-arm trial.
Methods:
We recruited 48 A-SUD patients engaged in substance use care (e.g., pharmacotherapy, peer support). Usability was assessed at 2-months via the Systems Usability Scale and the mHealth Satisfaction Questionnaire. Feasibility was assessed through module completion. Exploratory analyses investigated changes in A-SUD specific outcomes over 2 months.
Results:
Of the 48 enrolled participants, 20 (44%) completed follow-up assessments. Usability at 2-months was moderate via the Systems Usability Scale (M=70.4, 11.9) and high via subscales (e.g., positive experiences, negative experiences, life integration) on the mHealth Satisfaction Questionnaire. Participants completed an average of 13.2 of 28 (SD=8.65) modules. Engagement was also high with the features (M=51.3, SD=52.2); however, the meditations (M=6.47, SD=7.79) were minimally engaged with. Multivariate GLMs indicated unanticipated increases in the Brief Addiction Monitor SUD risk subscale, (β=0.99, SE=0.15, 95% CI [0.70, 1.29]) and expected changes for protective factors (β=0.75, SE=0.14, 95% CI [ 0.47, 1.03]), self-regulation (β= 0.65, SE=0.11, 95% CI [0.42, 0.87]), attention regulation (β= 0.72, SE=0.12, 95% CI [0.48, 0.96]), body-listening (β= 0.49, SE=0.13, 95% CI [0.24, 0.75]), emotional awareness (β= 0.70, SE=0.12, 95% CI [0.45, 0.94]) emotional regulation (β=0.36, SE=0.15, 95% CI [0.07, 0.64]) and worry (β= 0.86, SE=0.35, 95% CI [ 0.19, 1.54]) controlling for latency from 2-month follow up, baseline scores and relevant demographics.
Conclusions:
The Unwinding Anxiety mobile application is a promising, scalable adjunctive anxiety-focused ABI with the potential to enhance protective psychological resources as well as improving patients’ mental health and substance use outcomes. Clinical Trial: The study was funded by the National Institute of Drug Abuse (NIDA; F31DA055463; PI: William Nardi).
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