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

Summary

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.

Conditions

• Meditation
• Control Group

Interventions

BEHAVIORAL

Calm Meditation

The intervention will run for 4-weeks. Participants will complete the 30 day, "How to Meditate" meditation series that provides daily 10-minute meditations. Throughout the intervention, participants will be sent reminder emails via REDCap to participate in their assigned practice sessions participants and will complete online weekly participation logs via REDCap. Additionally, they will answer one, multiple-choice ecological momentary assessment question, randomly, 3x per day via test message assessing how one currently feels. Participants will complete baseline and post-intervention measures of the Perceived Stress Scale, Hospital Anxiety and Depression Scale, Mindfulness Attention Awareness Scale, International Physical Activity Questionnaire, Salzberg Stress Eating Scale, Brief Cope, and Brief Resilience Scale. Following these measures, participants will be asked to complete a satisfaction questionnaire (week 5) and have the opportunity to volunteer for a short phone interview.

BEHAVIORAL

Educational Podcast Control

The intervention will run for 4-weeks. Control group participants will listen to daily 10-minute health education podcasts. Throughout the intervention, participants will be sent reminder emails via REDCap to participate in their assigned practice sessions and participants will complete online weekly participation logs via REDCap. Additionally, they will answer one, multiple-choice EMA (ecological momentary assessment) question, randomly, 3x per day via test message assessing how one currently feels. Participants will complete baseline and post-intervention measures of the Perceived Stress Scale, Hospital Anxiety and Depression Scale, Mindfulness Attention Awareness Scale, International Physical Activity Questionnaire, Salzberg Stress Eating Scale, Brief Cope, and Brief Resilience Scale. Following these measures, participants will be asked to complete a satisfaction questionnaire (week 5) and have the opportunity to volunteer for a short phone interview.

Sponsors & Collaborators

• Arizona State University

  lead OTHER

Principal Investigators

• Jennifer Huberty, PhD · Arizona State University

Study Design

Allocation

RANDOMIZED

Purpose

OTHER

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

40 Years

Max Age

64 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2020-02-03

Primary Completion

2020-05-18

Completion

2020-06-16

Countries

• United States

Study Locations