ClinicalTrials.gg
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

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

Where this study stands

Counted across the records on this site · 2026-11-13

Among 202 studies in Chronic Pain with a site in Canada — 52 open to participants now, 63 under way, 3 of them phase 3. Chronic Pain · Canada.

Enrollment
2nd of 162
2,016 · median 49
Started
2017
with 13 others
No phase
116 of 202
31 open now
Registered
66th of 202
by date

Among the 202 studies in Chronic Pain with a site in Canada, this one is the 2nd largest by enrollment of the 162 interventional ones that give a count, is one of 14 that started in 2017, is one of 116 with no phase, and was the 66th registered.

Chronic Pain

3,227 studies on the registry are indexed under Chronic Pain; 728 are open to participants now.

Browse Chronic Pain studies →

Open to participants now

52 of the 202 studies in Chronic Pain with a site in Canada are open now. Recruiting first, the newest first:

47 more — sign in →

All 52 open studies →

A study can be open while its sites in Canada have not opened yet or have stopped. Only those recruiting at a site in Canada →

Who these studies take

Of the 486 Chronic Pain studies recruiting now, 239 (49%) set no upper age limit and 173 (36%) stop at 75 or younger; 43 take children under 18; 64 take healthy volunteers.

This study: 18 Years to 65 Years · all sexes · healthy volunteers too.

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02

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.

03

Conditions studied

  • Chronic Pain
  • Depression, Anxiety
04

Who can participate

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

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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
05

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.

06

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

07

Study locations

1 site
  • York University
    Toronto, Ontario M3J 1P3, Canada
08

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

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Nov 2017 to primary completion in May 2020, 29 months.

Of 1,295 non-industry interventional studies with no phase under Chronic Pain, half reached primary completion within 20 months of starting (the median), counting those still running; a quarter within 9 and three quarters within 39. This study's 29 months is above that.

Counting every sponsor, half of 1,378 studies reached it within 20 months; a quarter within 9 and three quarters within 38.

How these figures are worked out, and which studies are left out of them.

Registered
Sep 22, 2017
First posted
Sep 28, 2017
StartActual
Nov 10, 2017
Primary completionActual
May 1, 2020
CompletionActual
May 1, 2020
Last update
Jun 9, 2022
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jun 9, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

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 ↗

Not currently enrolling

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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