A smartphone-based mindful breathing task with assessment of heart-rate variability for clinically relevant chronic pain, depression, and anxiety: Protocol for a randomized-controlled trial (Preprint)
A. Azam, V. Latman, J. Katz
March 23, 2019 DOI: 10.2196/preprints.14119 (opens in new tab)
Study at a glance
AI-extracted from the abstract| Characteristics | Randomized controlled trial |
|---|---|
| Sample size | 180 |
| Population | Adults self-reporting clinically significant chronic pain (CP), depression and/or anxiety (DA), and control participants without either condition, recruited at York University, Toronto |
| Intervention | Mindfulness meditation app (MMA+) |
| Duration | 5 minutes rest, 5 minutes stress induction, 12 minutes meditation condition |
| Topics | Anxiety Depression |
| Registration | NCT03296007 |
| Key findings | The protocol outlines a two-arm randomized trial testing whether practicing mindful breathing with a smartphone app, compared with meditation without the app, affects heart-rate variability (primary outcome) and self-reported pain, mood, mind-wandering, present awareness, and breath focus across chronic pain, depression/anxiety, and control groups. No results are reported; recruitment began in November 2017 and was expected to finish in July 2019. |
Abstract
Background: Mindfulness meditation is a commonly used psychological intervention for pain, mood, and anxiety conditions, but can be challenging to practice when dealing with severe symptoms without proper training experience. The Mindfulness Meditation App (MMA) is a supportive training tool specifically developed for the present study, to aid in the practice of mindful breathing using a smartphone.
Objective: The aim of the present study is to evaluate the psychophysiological effects of the MMA. Specifically, the study aims to assess parasympathetic functioning using heart-rate variability (HRV; primary outcome), pain and mood symptoms, mind-wandering and present awareness, and breath focus in groups of participants who self-report clinically significant symptoms of chronic pain (CP), depression and/or anxiety (DA), as well as control participants (C) who do not meet criteria for either.
Methods: The present study is a two-arm randomized-controlled trial (registration #NCT03296007), taking place at York University in Toronto, Canada. Sixty participants in each group of CP, DA, or C (N=180 total) will be pre-screened and randomly assigned by a 1:1 ratio to a mindfulness meditation app (MMA+) condition or a mindfulness meditation condition without the app (MMA-) after a brief stress-induction procedure. In MMA+, participants will practice mindful breathing with a smartphone and press “breath” or “other” buttons at the sound of audio tones if their awareness was on breathing or another experience, respectively. HRV and respiration data will be obtained during rest (5 minutes), stress-induction (5 minutes), and meditation condition (12 minutes). Participants will complete psychological self-report inventories before and after the stress-induction, and after the meditation condition.
Results: Recruitment for the study began in November 2017 and is expected to be completed in July of 2019.
Conclusions: This RCT will inform the design of mindfulness meditation training tools delivered by apps and web platforms for the treatment of chronic pain, depression, and anxiety conditions. CLINICALTRIAL ClinicalTrials.gov: NCT03296007
Comparable studies
Other randomized controlled trials on anxiety, most cited first.
Citations in the library
Cites 2
- Construct Validity of the Five Facet Mindfulness Questionnaire in Meditating and Nonmeditating Samples Assessment February 29, 2008
- Individuals with tension and migraine headaches exhibit increased heart rate variability during post-stress mindfulness meditation practice but a decrease during a post-stress control condition - A randomized, controlled experiment. International Journal of Psychophysiology December 2016