Evaluating the Psychophysiological Effects of a Smartphone-Based Mindfulness Task

Not Applicable

Completed

• Conditions: Depression, Anxiety; Chronic Pain
• Interventions: Behavioral: Mindfulness Meditation

• Registration Number: NCT03296007
• Lead Sponsor: York University

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-09-22
• Study First Submitted QC: 2017-09-22
• Study First Posted: 2017-09-28
• Study Start: 2017-11-10
• Primary Completion: 2020-05-01
• Study Completion: 2020-05-01
• Status Verified: 2022-06
• Last Update Submitted: 2022-06-07
• Last Update Posted: 2022-06-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 2016

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Mindfulness Meditation No App	Mindfulness Meditation	Participants randomized to this arm will not use a smartphone app, but will receive instructions to practice mindfulness meditation for 12 minutes.
Mindfulness Meditation App	Mindfulness Meditation	Participants randomized to this arm will use a smartphone app to practice mindfulness meditation for 12 minutes.

Primary Outcome Measures

Name	Time	Method
Heart Rate Variability	22 minutes	A stress biomarker derived from heart rate recordings that reflects parasympathetic control of cardiac output

Trial Locations

Locations (1)

York University; 🇨🇦 Toronto, Ontario, Canada