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OpenTrials
Completed

NCT Number: NCT03296007

Evaluating the Psychophysiological Effects of a Smartphone-Based Mindfulness Task

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.

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Key information

Conditions

Chronic Pain Anxiety Disorders Behavior Behavioral Symptoms Depression Depression, Anxiety Mental Disorders Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

York University

Toronto, Ontario, M3J 1P3, Canada

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Mindfulness Meditation

Behavioral

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

Primary outcomes

  1. Heart Rate Variability

    Time frame: 22 minutes

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

Sponsors and collaborators

Lead sponsor

York University

Other

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2020
Study completion
2020
First posted
Sep 28, 2017
Registry last updated
Jun 9, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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