Evaluating the Psychophysiological Effects of a Smartphone-Based Mindfulness Task

NCT ID: NCT03296007

Last Updated: 2022-06-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

2016 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-11-10

Study Completion Date

2020-05-01

Brief Summary

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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.

Detailed Description

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Conditions

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Chronic Pain Depression, Anxiety

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Mindfulness Meditation App

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

Group Type EXPERIMENTAL

Mindfulness Meditation

Intervention Type BEHAVIORAL

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

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.

Group Type ACTIVE_COMPARATOR

Mindfulness Meditation

Intervention Type BEHAVIORAL

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

Interventions

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Mindfulness Meditation

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

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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York University

OTHER

Sponsor Role lead

Responsible Party

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Joel Katz

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Joel Katz, PhD

Role: PRINCIPAL_INVESTIGATOR

York University

Locations

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York University

Toronto, Ontario, Canada

Site Status

Countries

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Canada

References

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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.

Reference Type DERIVED
PMID: 31789601 (View on PubMed)

Other Identifiers

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#e2017 - 303

Identifier Type: -

Identifier Source: org_study_id

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