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)

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