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
• Status: Completed
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Chronic Pain
• Depression
• Depression, Anxiety

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