Effects of a 12-Minute Smartphone-Based Mindful Breathing Task on Heart Rate Variability for Students With Clinically Relevant Chronic Pain, Depression, and Anxiety: Protocol for a Randomized Controlled Trial

Abstract

BackgroundMindfulness meditation (MM) is a commonly used psychological intervention for pain, mood, and anxiety conditions, but can be challenging to practice with severe symptoms without proper training. The Mindfulness Meditation app (MMA) is a supportive training tool specifically developed for this study to aid in the practice of mindful breathing using a smartphone.ObjectiveThis study aims to evaluate the psychophysiological effects of the MMA. Specifically, the study will assess parasympathetic functioning using heart rate variability (HRV; primary outcome), pain and mood symptoms, mind-wandering and present moment awareness, and breath focus in groups of undergraduate participants who self-report clinically-relevant symptoms of chronic pain (CP) and depression or anxiety (DA) and condition-free (CF) participants who do not meet either criteria. We hypothesize that use of the MMA by study groups will lead to improved HRV, pain, and mood symptoms compared with groups who do not use the app.MethodsThis study is a two-arm randomized controlled trial (RCT) recruiting through a Web-based research participation pool at York University in Toronto, Canada. We are aiming for minimum 60 participants in each of CP, DA, and CF groups. Upon arriving to the laboratory, participants will be prescreened for classification into groups of CP, DA, or CF. Groups will be randomly assigned by a 1:1 ratio to an MMA (MMA+) condition or MM 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 min), stress induction (5 min), and meditation conditions (12 min). Participants will complete psychological self-report inventories before and after the stress induction and after the meditation condition. Separate linear mixed models will be used to examine HRV and self-report inventories comparing groups and treatment conditions.ResultsRecruitment for the study began in November 2017 and is expected to be completed in winter of 2019-2020. As of July 2019, 189 participants have been recruited. The study’s main findings are expected to reveal a positive pattern of HRV responses in the CP, DA, and CF groups, such that a significant increase in HRV (P<.05) is detected in those randomized to the MMA+ condition in comparison with those randomized to the MMA− condition.ConclusionsThis RCT will contribute to the burgeoning health psychology literature regarding the clinical relevance of HRV in assessment and treatment of psychological and medical conditions. Furthermore, possible ways to inform designs of MM training tools delivered by apps and Web platforms for CP, depression, and anxiety conditions’ treatment will be discussed.Trial RegistrationClinicaltrials.gov NCT03296007; https://clinicaltrials.gov/ct2/show/NCT03296007.International Registered Report Identifier (I...

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“…Breathing, for example, has been evaluated as a fundamental element for the mindful meditation practices introduced by Kabat-Zinn, as it allows you to pay “non-judgmental attention to your cognitive, emotional and physical experiences, while reorienting your concentration. on respiratory sensations to promote cognitive and emotional regulation and progressively relaxed districts” ( Azam et al, 2019 ).…”

Classification of Anxiety Based on EDA and HR

“…Moreover, these biomedical sensors are often wireless and can stream to several and small devices, like smartphones, supporting the feasibility of the analysis of physiological signals and assisting with suggestions to deal with anxiety. Indeed, more recently, due to the increasing concern on mental disorders, namely anxiety, and to the technological advances which widespread the access and usage of mobile devices, there had been proposed mobile applications to help users dealing with anxiety [4,16,19,21].…”

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“…This is true for very serious mental health disorders, such as treatment-resistant depression, as it is for managing daily stress and anxiety that, if prolonged, could lead to more dramatic mental health issues. For example, determining which personal settings and emotional states are appropriate for different interventions, such as MMAs, are yet to be explored in full [ 21 ]. In fact, it is quite likely that there exists a great deal of intra- and interindividual variability in mood and feelings of stress and anxiety that might be necessary to understand and characterize so that guidelines and interventions, such as MMAs, can be tailored or personalized to individual users.…”