A Brief App-based Mobile Health and Well-being Intervention Among Middle-aged Adults

Completed · Not applicable

Conditions studied: Meditation, Control Group

In brief

The purpose of this study is to determine the preliminary effects of using a mobile app (i.e., Calm) to decrease overall stress in middle-aged (i.e., 40-64 years) men and women who report high stress (greater than 15 on PSS). The study design is a randomized control trial with baseline, post-intervention (4 weeks from baseline), and follow-up phone interview (5 weeks from baseline) assessments. Middle-aged adults will be randomized to either a Calm meditation Intervention group or an attention control podcast group. Participants will be randomized after the completion of baseline and informed consent. Specific aim 1: Determine the feasibility (acceptability, demand) of using CALM app at least 10 min/day to reduce stress (greater than 15 on Perceived Stress Scale \[PSS\]) in middle-aged men and women. Benchmarks for feasibility: (acceptability) Recruitment greater than 40 percent men; greater than 75 percent satisfied with intervention; 75 percent perceive daily meditation and app components as appropriate and useful; (demand) Retention of men greater than 75 percent; greater than 80 percent adherence (minutes/week) to the meditation intervention. Specific aim 2: Explore the preliminary effect of meditation using Calm on overall perceived stress as compared to the health education group. Specific aim 3: Explore the preliminary effect of meditation using Calm on anxiety and depression. Specific aim 4: Explore gender as a moderator of the effect of meditation using Calm on stress. Specific aim 5: Explore the mediators of mindfulness, physical activity, eating, and coping behaviors on stress, anxiety and depression using Calm for meditation.

Key facts

Study ID

NCT04272138

Run by

Arizona State University

People needed

83

Starts

2020-02-03

Expected to finish

2020-06-16

Last updated by the study team

2022-02-28

Who can join

Age: 40 and older, up to 64. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Men or Women
• Age 40-64
• Able to read/understand English
• Have access to a smartphone on a daily basis
• A score of 15 or higher on the Perceived Stress Scale (PSS)
• Willing to be randomized
• Willing to download a mobile application

You may not qualify if…

• Have consistently practiced mindfulness meditation within the last 12 months
• Currently using the Calm app or another meditation app
• Currently prescribed mental health or mood medication
• Low levels of stress (i.e., less than a score of 15 assessed with the Perceived Stress Scale)
• Currently reside outside the United States

Where it is running

• Arizona Biomedical Collaborative — Phoenix, Arizona, United States

Full record on ClinicalTrials.gov

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