Development of a mobile mindfulness smartphone app for post-traumatic stress disorder and alcohol use problems for veterans: Beta test results and study protocol for a pilot randomized controlled trial.
Jordan P Davis, Eric R Pedersen, Brian Borsari, Sarah Bowen, Jason E. Owen, Angeles Sedano, Reagan Fitzke, Joannalyn Delacruz, Denise D Tran, Keegan Buch, Shaddy K. Saba, Liv Canning, John Bunyi
Contemporary Clinical Trials April 12, 2023 DOI: 10.1016/j.cct.2023.107181 (opens in new tab)
Study at a glance
AI-extracted from the abstract| Characteristics | Pilot randomized controlled trial protocol with a completed beta test (Phase 2) and methods description Peer reviewed |
|---|---|
| Sample size | 16 |
| Population | Post-9/11 veterans who screened positive for PTSD and alcohol use disorder and were not currently receiving treatment |
| Duration | 30-day beta test; pilot RCT will follow participants for 3 months |
| Measures | PTSD Checklist, self-reported alcohol use, Perceived Stress Scale, Penn Alcohol Craving Scale, Emotion Regulation Questionnaire |
| Topics | Addiction Meditation PTSD |
| Keywords | Humans Alcoholism Pilot projects Stress disorders, post-traumatic Veterans Mobile applications Clinical trial Va Mobile health |
| Registration | NCT04769986 |
| Key findings | In a 16-veteran beta test, the Mind Guide app was associated with improvements over 30 days in PTSD symptoms, alcohol use frequency and problems, craving, perceived stress, and emotion regulation, with effect sizes ranging from d = -0.44 to d = -1.22. The authors describe these results as promising and are proceeding to a pilot randomized controlled trial of 200 veterans with three-month follow-up. |
Abstract
Background: Post-traumatic stress disorder (PTSD) and alcohol use disorder (AUD) are highly prevalent, and co-occurring among post-9/11 veterans. Mobile health (mHealth) applications, specifically those focused on mindfulness-based techniques, may be an effective avenue to intervene with veterans who cannot or will not seek care at traditional in-person settings. Thus, to address areas of improvement in mHealth for veterans, we developed Mind Guide and prepared it for testing in a pilot randomized controlled trial (RCT) with veterans.
Methods: We have completed phase 1 (treatment development) and Phase 2 (beta test) of our mobile mHealth app, Mind Guide. In this paper we describe the methods for Phase 1 as well as results for our beta test (n = 16; inclusion criteria included screen for PTSD, AUD, a post-9/11 veteran, and not currently receiving treatment) for Mind Guide as well as outline procedures for our pilot RCT of Mind Guide (Phase 3). The PTSD Checklist, self-reported alcohol use, the Perceived Stress Scale, Penn Alcohol Craving Scale, and the Emotion Regulation Questionnaire were used.
Results: Results of our beta test of Mind Guide show promising past 30 day effects on PTSD (d = -1.12), frequency of alcohol use (d = -0.54), and alcohol problems (d = -0.44), and related mechanisms of craving (d = -0.53), perceived stress (d = -0.88), and emotion regulation (d = -1.22).
Conclusion: Our initial beta-test of Mind Guide shows promise for reducing PTSD and alcohol related problems among veterans. Recruitment is ongoing for our pilot RCT in which 200 veterans will be recruited and followed up for 3 months. Clinicaltrials: gov Identifier: NCT04769986.
Comparable studies
Other randomized controlled trials on PTSD, most cited first.
Citations in the library
Cites 8
- Using Self-Report Assessment Methods to Explore Facets of Mindfulness Assessment January 27, 2006
- Mindfulness training for self-regulation and stress with incarcerated youth Probation Journal June 1, 2012
- Mindfulness-based treatments for posttraumatic stress disorder: a review of the treatment literature and neurobiological evidence. Journal of Psychiatry and Neuroscience October 2, 2017
- Mindful attention increases and mediates psychological outcomes following mantram repetition practice in veterans with posttraumatic stress disorder. Medical Care December 2014
- Reductions in cortisol associated with primary care brief mindfulness program for veterans with PTSD. Medical Care December 1, 2014
and 3 more in the library