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

NCT04272138 | Completed

• 1 other identifier: STUDY00011219
• Study Type: interventional
• Target: 83
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (2)

• Feasibility: Acceptability

  Acceptability will be measured using a satisfaction survey at the end of the study, following all other measures (satisfied with the intervention and perceive daily meditation and app components as appropriate and useful)

  Measured 1x at post-intervention about experience in study, about 4 weeks.

• Feasibility: Demand

  Demand will be measured using the subjective usage data (weekly participation logs measuring adherence (minutes/week) and the objective app usage data (data collected by the app measuring adherence (minutes/week) to the meditation intervention).

  1x at post-intervention about participation time in study (4 weeks total)

Secondary Outcomes (9)

• Stress

  Change from baseline (week 0) to post-intervention (week 4)

• Anxiety

  Change from baseline (week 0) to post-intervention (week 4)

• Depression

  Change from baseline (week 0) to post-intervention (week 4)

• Gender as moderator of stress

  Change from baseline (week 0) to post-intervention (week 4)

• Mindfulness as a mediator of stress

  Change from baseline (week 0) to post-intervention (week 4)

Study Arms (2)

Calm Meditation

EXPERIMENTAL

Participants in the intervention group will be exposed to 10 minutes per day of meditation via a smartphone application for 4 weeks. Participants will log their meditation participation in an online weekly log.

Behavioral: Calm Meditation

Educational Podcast Control

ACTIVE COMPARATOR

Participants in the control group will be exposed to 10 minutes per day of health education podcasts via a smartphone application for 4 weeks. Participants will log their podcast participation in an online weekly log.

Behavioral: Educational Podcast Control

Interventions

Calm Meditation BEHAVIORAL

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.

Calm Meditation

Educational Podcast Control BEHAVIORAL

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.

Educational Podcast Control

Eligibility Criteria

• Age: 40 Years - 64 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

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

Sponsors & Collaborators

• Arizona State University: lead

Study Sites (1)

Arizona Biomedical Collaborative

Phoenix, Arizona, 85004, United States

Location

Related Publications (1)

• Laird B, Puzia M, Larkey L, Ehlers D, Huberty J. A Mobile App for Stress Management in Middle-Aged Men and Women (Calm): Feasibility Randomized Controlled Trial. JMIR Form Res. 2022 May 24;6(5):e30294. doi: 10.2196/30294.

  PMID: 34989677 DERIVED

Study Officials

• Jennifer Huberty, PhD

  Arizona State University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 13, 2020
• First Posted: February 17, 2020
• Study Start: February 3, 2020
• Primary Completion: May 18, 2020
• Study Completion: June 16, 2020
• Last Updated: February 28, 2022

Record last verified: 2022-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)