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Evaluating the Psychophysiological Effects of a Smartphone-Based Mindfulness Task

Primary Purpose

Chronic Pain, Depression, Anxiety

Status

Completed

Phase

Not Applicable

Locations

Canada

Study Type

Interventional

Intervention

Mindfulness Meditation

About this trial

This is an interventional treatment trial for Chronic Pain

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

York University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Mindfulness Meditation App

Mindfulness Meditation No App

Arm Description

Participants randomized to this arm will use a smartphone app to practice mindfulness meditation for 12 minutes.

Participants randomized to this arm will not use a smartphone app, but will receive instructions to practice mindfulness meditation for 12 minutes.

Outcomes

Primary Outcome Measures

Heart Rate Variability

A stress biomarker derived from heart rate recordings that reflects parasympathetic control of cardiac output

Secondary Outcome Measures

Full Information

NCT ID

NCT03296007

First Posted

September 22, 2017

Last Updated

June 7, 2022

Sponsor

York University

1. Study Identification

Unique Protocol Identification Number

NCT03296007

Brief Title

Evaluating the Psychophysiological Effects of a Smartphone-Based Mindfulness Task

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

June 2022

Overall Recruitment Status

Completed

Study Start Date

November 10, 2017 (Actual)

Primary Completion Date

May 1, 2020 (Actual)

Study Completion Date

May 1, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

York University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief Summary

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Chronic Pain, Depression, Anxiety

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

2016 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Mindfulness Meditation App

Arm Type

Experimental

Arm Description

Participants randomized to this arm will use a smartphone app to practice mindfulness meditation for 12 minutes.

Arm Title

Mindfulness Meditation No App

Arm Type

Active Comparator

Arm Description

Participants randomized to this arm will not use a smartphone app, but will receive instructions to practice mindfulness meditation for 12 minutes.

Intervention Type

Behavioral

Intervention Name(s)

Mindfulness Meditation

Intervention Description

A meditative practice involving paying attention to present moment experiences and focusing on breathing sensations.

Primary Outcome Measure Information:

Title

Heart Rate Variability

Description

A stress biomarker derived from heart rate recordings that reflects parasympathetic control of cardiac output

Time Frame

22 minutes

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Joel Katz, PhD

Organizational Affiliation

York University

Official's Role

Principal Investigator

Facility Information:

Facility Name

York University

City

Toronto

State/Province

Ontario

ZIP/Postal Code

M3J 1P3

Country

Canada

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

31789601

Citation

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.

Results Reference

derived

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Evaluating the Psychophysiological Effects of a Smartphone-Based Mindfulness Task

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