Evaluating the Psychophysiological Effects of a Smartphone-Based Mindfulness Task
1 other identifier
interventional
2,016
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable chronic-pain
Started Nov 2017
Typical duration for not_applicable chronic-pain
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 22, 2017
CompletedFirst Posted
Study publicly available on registry
September 28, 2017
CompletedStudy Start
First participant enrolled
November 10, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2020
CompletedJune 9, 2022
June 1, 2022
2.5 years
September 22, 2017
June 7, 2022
Conditions
Outcome Measures
Primary Outcomes (1)
Heart Rate Variability
A stress biomarker derived from heart rate recordings that reflects parasympathetic control of cardiac output
22 minutes
Study Arms (2)
Mindfulness Meditation App
EXPERIMENTALParticipants randomized to this arm will use a smartphone app to practice mindfulness meditation for 12 minutes.
Mindfulness Meditation No App
ACTIVE COMPARATORParticipants randomized to this arm will not use a smartphone app, but will receive instructions to practice mindfulness meditation for 12 minutes.
Interventions
A meditative practice involving paying attention to present moment experiences and focusing on breathing sensations.
Eligibility Criteria
You may qualify if:
- York University students
You may not qualify if:
- Individuals with diagnosed cardiac conditions (e.g. coronary artery disease, arrhythmias etc) will be excluded due to confounds with heart rate variability assessment
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- York Universitylead
Study Sites (1)
York University
Toronto, Ontario, M3J 1P3, Canada
Related Publications (1)
Azam MA, Latman VV, Katz J. Effects of a 12-Minute Smartphone-Based Mindful Breathing Task on Heart Rate Variability for Students With Clinically Relevant Chronic Pain, Depression, and Anxiety: Protocol for a Randomized Controlled Trial. JMIR Res Protoc. 2019 Dec 2;8(12):e14119. doi: 10.2196/14119.
PMID: 31789601DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Joel Katz, PhD
York University
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
September 22, 2017
First Posted
September 28, 2017
Study Start
November 10, 2017
Primary Completion
May 1, 2020
Study Completion
May 1, 2020
Last Updated
June 9, 2022
Record last verified: 2022-06
Data Sharing
- IPD Sharing
- Will not share