Evaluating the Psychophysiological Effects of a Smartphone-Based Mindfulness Task

Evaluating the Psychophysiological Effects of a Smartphone-Based Mindfulness Task on Individuals With Clinically Significant Symptoms of Chronic Pain, Depression and Anxiety

The aim of the present study is to evaluate the psychophysiological effects of a smart phone based mindfulness meditation app (MMA) for individuals with clinically significant symptoms of major depression and/or anxiety, or symptoms of chronic pain. Specifically, the study aims to examine parasympathetic tone using HRV (primary outcome), mind-wandering and present awareness, mood symptoms, and breath focus in groups of participants who self-report clinically significant symptoms of depression and/or anxiety (DA), chronic pain symptoms (CP), as well as control participants who do not meet our criteria for either (Controls (C). All study groups will be randomized to a mindfulness meditation app (MMA+) condition or a mindfulness meditation condition without the app (MMA-) after a brief stress-induction procedure.

Study Overview

• Status: Completed
• Conditions: Chronic Pain; Depression, Anxiety
• Intervention / Treatment: Behavioral: Mindfulness Meditation

• Study Type: Interventional
• Enrollment (Actual): 2016
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Toronto, Ontario, Canada, M3J 1P3
      • York University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• York University students

Exclusion Criteria:

• Individuals with diagnosed cardiac conditions (e.g. coronary artery disease, arrhythmias etc) will be excluded due to confounds with heart rate variability assessment

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Mindfulness Meditation App; Participants randomized to this arm will use a smartphone app to practice mindfulness meditation for 12 minutes.	Behavioral: Mindfulness Meditation; A meditative practice involving paying attention to present moment experiences and focusing on breathing sensations.
Active Comparator: Mindfulness Meditation No App; Participants randomized to this arm will not use a smartphone app, but will receive instructions to practice mindfulness meditation for 12 minutes.	Behavioral: Mindfulness Meditation; A meditative practice involving paying attention to present moment experiences and focusing on breathing sensations.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Heart Rate Variability	A stress biomarker derived from heart rate recordings that reflects parasympathetic control of cardiac output	22 minutes

Collaborators and Investigators

• Sponsor: York University
• Investigators: Principal Investigator: Joel Katz, PhD, York University

Publications and helpful links

General Publications

• Azam MA, Latman VV, Katz J. 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. JMIR Res Protoc. 2019 Dec 2;8(12):e14119. doi: 10.2196/14119.

Study record dates

Study Major Dates

• Study Start (Actual): November 10, 2017
• Primary Completion (Actual): May 1, 2020
• Study Completion (Actual): May 1, 2020

Study Registration Dates

• First Submitted: September 22, 2017
• First Submitted That Met QC Criteria: September 22, 2017
• First Posted (Actual): September 28, 2017

Study Record Updates

• Last Update Posted (Actual): June 9, 2022
• Last Update Submitted That Met QC Criteria: June 7, 2022
• Last Verified: June 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Behavioral Symptoms; Pain; Neurologic Manifestations; Depression; Chronic Pain
• Other Study ID Numbers: #e2017 - 303

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No