Evaluating the Psychophysiological Effects of a Smartphone-Based Mindfulness Task

• Sponsor: York University (Other)
• Overall Status: Completed
• CT.gov ID: NCT03296007
• Collaborator: (none)
• Enrollment: 2,016
• Location: 1
• Arms: 2
• Actual Duration (Months): 29.7
• Patients Per Site Per Month: 68

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Chronic Pain; Depression, Anxiety	Behavioral: Mindfulness Meditation	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 2016 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Evaluating the Psychophysiological Effects of a Smartphone-Based Mindfulness Task on Individuals With Clinically Significant Symptoms of Chronic Pain, Depression and Anxiety
• Actual Study Start Date: Nov 10, 2017
• Actual Primary Completion Date: May 1, 2020
• Actual Study Completion Date: May 1, 2020

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Mindfulness Meditation App Participants randomized to this arm will use a smartphone app to practice mindfulness meditation for 12 minutes.	Behavioral: Mindfulness Meditation; A meditative practice involving paying attention to present moment experiences and focusing on breathing sensations.
Active Comparator: 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.	Behavioral: Mindfulness Meditation; A meditative practice involving paying attention to present moment experiences and focusing on breathing sensations.

Outcome Measures

Primary Outcome Measures

1. Heart Rate Variability [22 minutes]

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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 65 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	York University	Toronto	Ontario	Canada	M3J 1P3

Sponsors and Collaborators

• York University

Investigators

• Principal Investigator: Joel Katz, PhD, York University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Joel Katz, Professor, York University
• ClinicalTrials.gov Identifier: NCT03296007
• Other Study ID Numbers: #e2017 - 303
• First Posted: Sep 28, 2017
• Last Update Posted: Jun 9, 2022
• Last Verified: Jun 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Chronic Pain; Depression

Study Results

No Results Posted as of Jun 9, 2022