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CompletedNCT03296007Updated Jun 9, 2022

Evaluating the Psychophysiological Effects of a Smartphone-Based Mindfulness Task

An interventional study of Mindfulness Meditation in Chronic Pain and Depression, Anxiety, sponsored by York University. Completed at 1 site in Canada. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-06-09.

Sponsored by York University · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
2,016
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Chronic Pain
  • Depression, Anxiety
03

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • York University students

Exclusion criteria

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
04

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
2,016 participants (actual)

Study arms

  • Experimental
    Mindfulness Meditation App

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

    Behavioral: Mindfulness Meditation

  • 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

Interventions

  • BehavioralMindfulness Meditation

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

05

What researchers measure

Primary outcomes

  1. Heart Rate Variability

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

    Time frame: 22 minutes

06

Study locations

1 site
  • York University
    Toronto, Ontario M3J 1P3, Canada
07

References and documents

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. PubMed 31789601 ↗

Individual participant data

Plan to share: No

08

Registry details

Key details

Study ID
NCT03296007
Lead sponsor
York University
Responsible party
Joel Katz (Professor, York University) — Principal investigator
First posted
Sep 28, 2017
Start date
Nov 10, 2017
Primary completion
May 1, 2020
Completion
May 1, 2020
Last update
Jun 9, 2022

Study contacts

Joel Katz, PhD
principal investigator · York University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Jun 2022. You cannot join it, but the record below documents what was studied.

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