Accepted for/Published in: JMIR Formative Research
Date Submitted: Jan 9, 2025
Date Accepted: Jun 2, 2025
Development of a sham smartphone app for opioid use disorder: An acceptability and suitability study
ABSTRACT
Background:
Prescription digital therapeutics, which are app-based interventions prescribed by a healthcare professional, have the potential to increase adherence to medication for opioid use disorder and retention while overcoming treatment barriers, including provider capacity and patient access. Using a sham app as a control condition for a randomized clinical trial is an innovative method to establish true efficacy of these apps.
Objective:
The objective of this study was to develop and test a sham smartphone app for opioid use disorder.
Methods:
After the sham app was developed, participants were enrolled in a 4-week trial examining use and suitability of the sham app as a control condition. Criteria for determining suitability included 1) participants believe the sham app is an active intervention and 2) participants experience no clinical improvements in depression severity or quality of life after using the sham app. Self-reported depression severity and quality of life were captured before and after using the sham app. A user satisfaction survey and semi structured interviews were conducted at the end of the study. Quantitative analyses included paired two-tailed t-tests. The semi structured interviews were conducted with 20 of the 21 participants, and these interviews were analyzed using rapid qualitative analysis.
Results:
Overall, 21 participants (Mage=42.0 [SD=6.4], 9 [42.9%] female, and 12 [57.1%] male) were enrolled. No statistically significant differences were found in depression severity or quality of life after using the sham app, and 95% (19 out of 20) of study participants believed that they were using an active intervention. The user satisfaction survey revealed high overall satisfaction with the sham app with an average score of 91%. Participants found the app simple, educational, and user-friendly.
Conclusions:
The app we tested met our a priori criteria for suitability as a sham app. No clinical improvements from baseline were observed at end of the study period, and all but one participant believed that they were using an active intervention. Demonstrating that this sham app is suitable as a control condition elevates the rigor of randomized clinical trials and ensures the efficacy of prescription digital therapeutics.
Citation
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Copyright
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