Clinical trial NCT04272138: A Brief App-based Mobile Health and Well-being Intervention Among Middle-aged Adults
Official title: Feasibility 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 (>15 on PSS)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Meditation
Control Group
Lead sponsor: Arizona State University
Sponsor class: OTHER
First posted: 2020-02-17
Enrollment: 83
Sex: ALL
Minimum age (years): 40
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.

Detailed description: Recruitment: Participants will be recruited during winter/spring 2020. Interested participants will be directed to a REDCap link to complete an online eligibility screener. The screener will take approximately 10 minutes to complete (See Eligibility Survey). The survey will be free, voluntary, and available online. Participants will be allowed to skip questions in the survey.

Eligibility: Once eligibility is determined; participants will be sent an informed consent and baseline questionnaire via a REDCap link. This measure should take approximately 25 minutes to complete (See Informed Consent and Baseline Questionnaires). Once Informed Consent is signed and the Baseline Questionnaires are complete, participants will be randomized via an online randomizer (i.e., randomizer.com) to either an attention control podcast group or the Calm meditation group. Ineligible participants will be sent an email notifying their status and why.

Enrollment: The Research Team will email the intervention participants that will include instructions to download Calm (See Participant Scripts). The control participants will be emailed instructions to download the podcast app (See Participant Scripts).

Intervention: The intervention will run for 4-weeks. Intervention participants will complete the 30 day, "How to Meditate" meditation series that provides daily 10-minute meditations and the control group will listen to daily 10-minute health education podcasts. Throughout the intervention, both groups will be sent reminder emails via REDCap to participate in their assigned practice sessions (see Participant Scripts) 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 (between 8am and 8pm) via test message assessing how one currently feels (see Study Questionnaires).

Tracking: Participation in the Calm meditations will be tracked (meditation name, time of day, and time spent in meditation) by weekly REDCap participation logs and the Calm team.

Post-intervention: Post-intervention questionnaires and the satisfaction survey will be emailed to intervention and control participants via a link from REDCap (See Post-intervention questionnaires). The post-intervention survey will take about 25 minutes and the satisfaction survey will take about 10 minutes.

Post-intervention interview: Post-intervention phone interviews will be conducted the week following the end of the intervention (week 5) to no more than 20 participants in each group and take about 15-20 minutes.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Feasibility: Acceptability
timeFrame: Measured 1x at post-intervention about experience in study, about 4 weeks.
measure: Feasibility: Demand
timeFrame: 1x at post-intervention about participation time in study (4 weeks total)
Secondary outcomes:
measure: Stress
timeFrame: Change from baseline (week 0) to post-intervention (week 4)
measure: Anxiety
timeFrame: Change from baseline (week 0) to post-intervention (week 4)
measure: Depression
timeFrame: Change from baseline (week 0) to post-intervention (week 4)
measure: Gender as moderator of stress
timeFrame: Change from baseline (week 0) to post-intervention (week 4)
measure: Mindfulness as a mediator of stress
timeFrame: Change from baseline (week 0) to post-intervention (week 4)
measure: Physical Activity as a mediator on stress, anxiety, and depression
timeFrame: Change from baseline (week 0) to post-intervention (week 4)
measure: Eating as a mediator on stress, anxiety, and depression
timeFrame: Change from baseline (week 0) to post-intervention (week 4)
measure: Coping behaviors as a mediator on stress, anxiety, and depression
timeFrame: Change from baseline (week 0) to post-intervention (week 4)
measure: Resilience
timeFrame: Change from baseline (week 0) to post-intervention (week 4)
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Arizona Biomedical Collaborative
state: Arizona
Study officials:
affiliation: Arizona State University
name: Jennifer Huberty, PhD
role: STUDY_CHAIR
References:
citation: 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.