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Mindfulness 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.
This 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.
This 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.
Recruitment 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 (
This 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.
Clinicaltrials.gov NCT03296007; https://clinicaltrials.gov/ct2/show/NCT03296007.
DERR1-10.2196/14119
Mindfulness meditation (MM) is an element of the Buddhist traditions first introduced as a clinical intervention in western medicine by Kabat-Zinn [
One proposed mechanism for mindful breathing benefits is the state relaxation effect mediated by parasympathetic vagus nerve activation because of its process of bringing awareness to breathing sensations while practicing acceptance of stressors such as worrying thoughts, negative emotions, and pain [
Rigid and inflexible types of mind wandering, such as worry and rumination, are typically seen in individuals with psychiatric illnesses [
A potentially impeding factor for client populations in practicing mindful breathing is the demand characteristics of the silent, inwardly focused exercise that may naturally make them more saliently aware of their symptoms of depression (eg, rumination), anxiety (worry), and pain (sensations). Relatedly, a qualitative study has revealed experiential challenges to MM practice that must be addressed in clinical treatment contexts, including the fact that meditation is a difficult skill to learn and practice, and participants encounter difficult thoughts and feelings amidst practice [
Supportive training tools, such as smartphone apps, are widely used to receive audio guidance on MM, and evidence is emerging for their immediate and long-term effects on altering mood states [
A recent systematic review of mindfulness-related apps found over 500 apps in the marketplace, but only 23 were designed to provide mindfulness training, and they were largely focused on providing audiovisual guidance, timers, and reminders to practice [
The aim of this study is to overcome some of the aforementioned limitations by designing an app with input from clinical researchers and empirically testing the app’s effectiveness in a sample of young adults with CP, anxiety, and depression. To cultivate mindfulness, a mobile-based Mindfulness Meditation app (MMA) was developed based on Burg et al’s [
This study will evaluate the psychophysiological effects of a smartphone-based MMA (12 min;
Overall, 3 major hypotheses (1a, 1b, 2a, 2b, and 3) will be tested.
The Mindfulness Meditation App.
HRV change scores during MM will be significantly higher in the CP and DA groups receiving MMA+ compared with corresponding CP and DA groups receiving MMA−, and will not differ between CF groups receiving MMA+ or MMA−.
HRV will significantly increase from the stress to MM phases in CP and DA participants receiving MMA+ compared with corresponding CP and DA groups receiving MMA−, and will not differ between CF groups receiving MMA+ or MMA.
CP and DA participants randomized to MMA+ will report significant pre-post increases in levels of present moment awareness and state mindfulness compared with participants randomized to MMA−, and present moment awareness and state mindfulness will not differ between CF groups receiving MMA+ or MMA.
CP, DA, and CF participants receiving MMA+ will report significantly lower mind wandering than corresponding participants receiving MMA−, reflecting the potential for MMA+ to make participants more able to recover their attention from mind-wandering contents and processes during MM.
CP and DA participants randomized to the MMA+ condition will demonstrate significant reductions in mood symptoms (state depression and anxiety) after the MM task compared with CP and DA participants randomized to the MMA− condition, reflecting the potential for MMA+ to facilitate the emotion regulation effects of MM for clinical populations.
This RCT study was designed according to the 2010 Consolidated Standards of Reporting Trials statement (
Consolidated Standards of Reporting Trials 2010 flow diagram showing anticipated participant flow for enrolment, group classification, randomization to intervention, and analyses. MMA−: mindful breathing practice without using the Mindfulness Meditation app; MMA+: mindful breathing practice using the Mindfulness Meditation app; TBD: to be determined.
Sample size estimate for a repeated-measures linear mixed-effects analysis of variance (ANOVA) with 3 groups (CP, DA, and CF), 2 conditions (MMA+, MMA−), and 3 phases (baseline, stress induction, and MM) indicates that a total of 141 participants are needed to detect small-to-medium effect size (f=0.15) HRV changes with a type I error rate (alpha) of .05, a power of 0.95, and a 0.50 correlation between repeated measures (G*Power; Heinrich Heine University Düsseldorf). The small-to-medium effect size corresponds to previously published studies of HRV increases during brief mindfulness practice [
Participants will be eligible for the study if they are enrolled in a course at York University that provides course participation credit via study enrolment through the Undergraduate Research Participant Pool website. On the recruitment website as well as on the consent form, we have explained that the study may require use of a smartphone-based task. Participants with self-reported cardiac conditions (eg, cardiac arrhythmias, coronary artery disease, and pacemaker) will be excluded as they contravene the interpretation of vagal-mediated HRV [
Upon signing up for the study, participants will be instructed to arrive to the Human Pain Mechanisms Lab at York University, where the study procedures will be explained, and informed consent will be obtained from all participants. Participants will complete prescreening questionnaires for CP, depression, or anxiety symptoms. A research assistant will score the questionnaire once completed and check to see if the participant meets
A 3-block randomization schedule (CP, depression-anxiety, and condition free) with 2 treatment arm allocations (MMA+ and MMA−) was created by the study coinvestigator (study author MAA) using a randomization sequence generator [
Participants will undergo a 3-phase (baseline, stress induction, and MM) assessment during which electrocardiogram (ECG) and respiration rate data will be collected for later HRV analysis (
Study procedures. Physiological assessments are in red boxes, and questionnaire assessments are in gray boxes. BAI: Beck Anxiety Inventory; BPI: Brief Pain Inventory; CES-D: Center for Epidemiology Depression Scale; FFMS: Five-Factor Mindfulness Scale; HRV: heart rate variability; MWI: Mind-Wandering Inventory; PARS: Present Moment Awareness Rating Scale; POMS: Profile of Mood States; SDRS-5: Social Desirability Rating Scale-5; SUDS: Subjective Units of Distress Scale. TMS: Toronto Mindfulness Scale.
The first phase will comprise a 5-min baseline period during which participants will rest quietly with their eyes closed and not speak or make sudden movements.
Following the baseline phase, a 5-min stress induction procedure will be performed whereby the participant engages in a set of mental arithmetic tasks, with the instruction to work as quickly as possible for maximal performance. Mental arithmetic was chosen as a stressor task because of its superior properties in eliciting sympathetic responses compared with other laboratory-based stressors [
After the stress induction phase, a post-stress MM phase will involve either the MMA+ or MMA− task according to the randomization schedule.
After completing the prestudy set of questionnaires, participants will be randomized to either the smartphone-based MMA+ or a mindful breathing practice without use of a mobile app (MMA−). Mindful breathing instructions will involve paying attention to breathing sensations while seated with eyes closed for 12 min and reorienting attention back to breathing once aware of mind wandering [
The MMA was developed using JavaScript and installed on an iPhone 4s. As the app was designed with young adults in mind, the leading thought was to keep the intervention brief and the design simple and easy to use. Participants are asked to hover their thumbs on 2 buttons,
Participants in the MMA+ condition will use the MMA to practice mindful breathing with the following instructions: “For the duration of the task, pay attention to your breathing sensations, including (1) the feeling of the air passing through your nostrils, (2) the movement of your in-and-out breath at your chest and torso, (3) the sound of the air as you breathe in and out, (4) the temperature (coolness or warmth) of the in-and-out breath, and (5) returning your attention to your breath when you have noticed your attention has been elsewhere.” In addition, amidst mindful breathing practice, they will be asked to press a
Participants in the MMA− condition will engage in mindful breathing without use of the smartphone app for 12 min in a seated and eyes closed position.
There are several metrics that quantify HRV, the majority of which are either time based or frequency based. With the beat-to-beat interval series (also referred to as the R-R series), one can estimate the square root of the mean of squared successive differences between interbeat intervals (IBI), which has been found to be strongly correlated with respiration-based heart rate (HR) changes) [
ECG recordings will be collected using MindWare Impedance Cardiograph acquisition system and used to analyze HF-HRV as the primary HRV measure. The MindWare system utilizes 3 adhesive electrodes applied to the right collarbone (negative lead) and the lower left and right ribs (positive lead and ground lead) or alternatively the wrists (positive and negative leads) and ankle (ground lead) if necessary. MindWare BioLab and HRV software will be used to calculate time- and frequency-based HRV metrics. Patients will be measured during phases of (1) rest in a seated position with eyes closed (5 min), (2) a stress induction task requiring rapid completion of arithmetic problems (5 min), and (3) meditation conditions of MMA+ or MMA−.
A MindWare respiratory belt (below the sternum) will be used to monitor respiration rate during rest, stress induction, and meditation. Respiration is a potential confounding variable for HRV interpretation and will be used as a covariate in HRV analyses if it is found to differ between assessment phases or study groups [
Using data collected with the MMA+, breath focus will be measured using the ratio of
The following prescreening questionnaires will be administered to students to determine group classification by assessing for clinical CP (The Brief Pain Inventory), depression (The Center for Epidemiological Studies-Depression Scale), and anxiety symptoms (Beck Anxiety Inventory).
The Brief Pain Inventory is a 16-item, self-report questionnaire that measures pain intensity and pain interference. The test has good internal consistency (alpha=.85) and high test-retest reliability [
The Center for Epidemiological Studies Depression Scale (CES-D) is a screening test for depressive symptoms with good sensitivity and specificity and high internal consistency [
The Beck Anxiety Inventory is a 21-question multiple-choice self-report questionnaire that is used for measuring anxiety severity. Internal consistency (Cronbach alpha) ranges from .92 to .94 for adults and test-retest (1-week interval) reliability is 0.75 [
Participants will also be asked to complete the following questionnaires to assess mood (Profile of Mood States [POMS]), present moment awareness (Present Moment Awareness Ratings Scale [PMARS]), mind-wandering (Mind-Wandering Inventory [MWI]), state mindfulness (Toronto Mindfulness Scale [TMS]), trait mindfulness (Five Factor Mindfulness Scale), social desirability (Social Desirability Response Set 5-Item Survey), and subjective stress (Subjective Units of Distress Scale [SUDS]).
The POMS is a 37-item questionnaire designed to assess global distress as well as 6 mood states: fatigue, vigor-activity, tension-anxiety, depression, anger-hostility, and confusion-bewilderment. Participants are asked to indicate the degree to which they have experienced different mood states in the past week. The scale has good internal consistency (alpha=.91) and test-retest reliability (
The PMARS is a 5-item questionnaire developed specifically for use in this study. Participants will be asked to rate their level of awareness of different aspects of present moment experiences. The PMARS was used in a previous pilot study (VV Latman, MA, unpublished data, June 2017), and statistical analyses of its psychometric properties is underway [
The MWI is a 5-point Likert-based questionnaire developed by the authors with items retroactively assessing the frequency of different types of mind-wandering events the respondent experienced during the mindful breathing task. The MWI was used in a previous pilot study (VV Latman, MA, unpublished data, June 2017), and statistical analyses of its psychometric properties is underway [
The TMS is a state measure of mindfulness with 2 factors: curiosity and decentering. The TMS defines curiosity as an awareness of present moment experience with a curious attitude. Decentering is defined as an awareness qualified by distance and separation from current experience. The TMS has good internal consistency of alpha=.95. Current research demonstrates that the TMS is a reliable and valid measure of mindfulness that accurately measures curiosity and decentering [
The Five-Factor Mindfulness Scale (FFMS) is a 39-item Likert-based scale that assesses 5 aspects of mindfulness: nonreactivity to inner experience, acting with awareness, describing, nonjudging of inner experience, and observing. Research has demonstrated the FFMS to be valid in community and student samples with an internal consistency of alpha greater than .90 [
The Socially Desirable Response Set 5-Item Survey (SDRS-5) is a self-report measure designed to assess the tendency for individuals to provide socially desirable responses to self-reports of attitudes, behaviors, and feelings. Alpha reliability estimates for this instrument have been found to be between .66 and .68 [
The SUDS is a means of rating the severity of current distress (or anxiety), allowing for the monitoring of changes over time, where 0 is feeling perfectly relaxed and 100 is the worst anxiety and stress imaginable [
This study has 2 coprimary hypotheses based on published recommendations for HRV analyses [
To analyze HRV change in groups between the stress and MM phases, a linear mixed model will be used with group (CP, DA, and C) and condition (MMA+ and MMA−), with HRV change scores from stress to MM phases as the dependent variable. Planned comparisons will be computed comparing the MMA+ and MMA− conditions for each group (CP, DA, and C).
To analyze HRV differences between groups and across phases, a 3-way linear mixed-effects ANOVA will be used with group (CP, DA, and C), phase (baseline, stress, and MM), and condition (MMA− and MMA+), with HRV as the dependent variable. Significant interactions will be followed up with simple effects analyses comparing the stress and MM phases for each group (CP, DA, C) within the 2 conditions (MMA+ and MMA−).
To analyze pre-post increases in levels of present moment awareness, state mindfulness, and mind wandering, separate 3-way repeated-measures ANOVA with group (CP, DA, and C), time (pre and post), and condition (MMA− and MMA+) will be used with simple main effects to examine significant interactions.
To analyze pre-post changes in mood, a 3-way ANOVA with group (CP, DA, and C), time (pre and post), and condition (MMA− and MMA+) will be used with simple main effects to examine significant interactions.
Associations between HRV and psychometric measures will be explored with Pearson correlations and linear regression models using the following constructs: present moment awareness (PMARS), mind wandering (MWI), anxiety symptoms (Anxiety Sensitivity Index), depressive symptoms (CES-D), state mindfulness (TMS), and mindfulness skills (FFMS). Breath focus and reaction time will be examined for group differences (CP, DA, and C) using 1-way ANOVA. Given potential response biases in self-reported outcomes, we will examine group differences in socially desirable responding (SDRS-5) using 1-way ANOVA and use it as a control variable in applicable outcome analyses.
Recruitment for the study began in November 2017 and is expected to be completed in winter of 2019-2020. Data collection is currently underway. As of July 2019, we have recruited 189 total participants (C
The main findings of the study are expected to reveal a positive pattern of HRV responses across the different study groups, CP, DA, and C, such that they exhibit significantly increased HRV (
The MMA is designed as a supportive training tool to aid clinical populations with mindful breathing practice. Accordingly, our primary hypothesis is that HRV will increase from the stress to MM phases in DA and CP participants randomized to MMA+ compared with MMA−. Specifically, mindful breathing practice with the aid of the MMA is expected to yield additional relaxation effects for participants, by way of respiratory sinus arrhythmia, to be reflected in increased HRV measures. Examination of secondary hypotheses will help to further contextualize the role of key psychological processes, including present moment awareness, state mindfulness, mind wandering, and mood, as mediators and outcomes of mindfulness-based treatments.
A potential limitation of this study is the lack of blinding of research assistants with respect to group screening and treatment allocation procedures. Research assistants are required to remain in the room to address any technical or practical issues with the intervention, negating the possibility of blinding research assistants to treatment. However, both MMA+ and MMA− conditions entail app- or self-guided mindful breathing practice with no active involvement of research assistants; thus, risk of bias in intervention delivery is low. Another limitation is that the use of the MMA presents a demand characteristic requiring participants to reliably report
This RCT will contribute to the burgeoning health psychology literature about the clinical relevance of HRV measures in the assessment and treatment of psychiatric and health conditions. The findings may also contribute to the growing use of HRV as a biomarker and biofeedback tool within clinical and health psychology. Furthermore, there is an evolving need for an evidence basis related to supportive mindfulness training tools for the self-management of symptoms related to depression, anxiety, and chronic pain. The innovation of incorporating mindful breathing practice into a scalable app provides valuable information to allow for future iterative development of an app involving novel techniques for teaching mindfulness to clinical populations.
CONSORT-EHEALTH checklist (V 1.6.1).
analysis of variance
autonomic nervous system
condition-free
Center for Epidemiological Studies Depression Scale
chronic pain
depression or anxiety
electrocardiogram
Five-Factor Mindfulness Scale
high frequency
heart rate
heart rate variability
interbeat intervals
mindfulness meditation
Mindfulness Meditation app
mindful breathing practice without using the Mindfulness Meditation app
mindful breathing practice using the Mindfulness Meditation app
Mind-Wandering Inventory
Present Moment Awareness Ratings Scale
Profile of Mood States
randomized controlled trial
Socially Desirable Response Set 5-Item Survey
Subjective Units of Distress Scale
Toronto Mindfulness Scale
MMA is supported by the Canadian Institutes of Health Research Frederick Banting and Charles Best Doctoral Research Award. JK is supported by a Canadian Institutes of Health Research, Canada Research Chair in Health Psychology (Tier I).
The authors are the developers of the smartphone app examined in this study.