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NCT03296007 Clinical Trial

Evaluating the Psychophysiological Effects of a Smartphone-Based Mindfulness Task

Chronic Pain Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03296007
Other study ID # #e2017 - 303
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date November 10, 2017
Est. completion date May 1, 2020

Study information
Verified date June 2022
Source York University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 2016
Est. completion date May 1, 2020
Est. primary completion date May 1, 2020
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 65 Years
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Behavioral:
• Mindfulness Meditation
A meditative practice involving paying attention to present moment experiences and focusing on breathing sensations.

Locations
Country Name City State
Canada York University Toronto Ontario

Sponsors (1)
Lead Sponsor Collaborator
York University

Country where clinical trial is conducted

Canada, 

Outcome
Type Measure Description Time frame Safety issue
Primary Heart Rate Variability A stress biomarker derived from heart rate recordings that reflects parasympathetic control of cardiac output 22 minutes
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