Evaluating the Psychophysiological Effects of a Smartphone-Based Mindfulness Task

York University

Status: Completed

Conditions: Depression, Anxiety; Chronic Pain

Treatments: Behavioral: Mindfulness Meditation

Study type: Interventional

Funder types: Other

Identifiers

NCT03296007

#e2017 - 303

Details and patient eligibility

About

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.

Enrollment: 2,016 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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2,016 participants in 2 patient groups

Mindfulness Meditation App

Experimental group

Description:

Participants randomized to this arm will use a smartphone app to practice mindfulness meditation for 12 minutes.

Treatment:

Behavioral: Mindfulness Meditation

Mindfulness Meditation No App

Active Comparator group

Description:

Participants randomized to this arm will not use a smartphone app, but will receive instructions to practice mindfulness meditation for 12 minutes.

Treatment:

Behavioral: Mindfulness Meditation