Clinical Trials Logo

Clinical Trial 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.


Clinical Trial 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. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT04272138
Study type Interventional
Source Arizona State University
Contact
Status Completed
Phase N/A
Start date February 3, 2020
Completion date June 16, 2020

See also
  Status Clinical Trial Phase
Completed NCT02157766 - Wisconsin Center for the Neuroscience and Psychophysiology of Meditation N/A
Recruiting NCT05020301 - Investigation of Functional Brain Network in Altered Meditation State With Multimodal Neuroimaging N/A
Completed NCT04917081 - 'Go With the Flow': Effects of Mindful Self-Compassion in Psychiatric Rehabilitation N/A
Recruiting NCT05645835 - Dynamic Neural Systems Underlying Social-emotional Functions in Older Adults N/A
Completed NCT03257007 - Mindfulness to Enhance Quality of Life and Support Advance Care Planning N/A
Completed NCT03459690 - EEG Changes With Guided Online Meditation N/A
Not yet recruiting NCT05314166 - Impact of Face-to-face Meditation on Non-attachment to Self and Identity Threat N/A
Recruiting NCT04968795 - Heartfulness Meditation and Corporate Burnout
Recruiting NCT05285488 - Impact of Distance Meditation on Non-attachment to the Self and Identity Threat N/A
Completed NCT05619419 - Study of Affect Induction for Lab Induced Pain in Healthy Undergraduates N/A
Completed NCT04302623 - Meditation and Yoga for Irritable Bowel Syndrome N/A
Completed NCT05669066 - Meditation and Opioid Consumption in Total Joint Replacement Patients Undergo Primary Total Hip and Knee Replacement N/A
Completed NCT04557033 - My Mindful Moments: A Mindfulness Meditation and Digital Art Activity N/A
Recruiting NCT05455814 - Brain Health With Inner Engineering Meditation N/A
Completed NCT06424951 - Kindness is Lesser Preferable Than Happiness: Investigating Interest in Different Effects of the Loving-kindness and Compassion Meditations N/A
Suspended NCT02104349 - Mindfulness Meditation for Spine Surgery Pain N/A
Completed NCT04632875 - Online Trial of Meditation and Behavior N/A
Completed NCT02578433 - Mindful Self Compassion in Rehabilitation Inpatients N/A
Completed NCT02313779 - Meditation and Decision Making Study III N/A
Completed NCT05154565 - Effect of a Daily Meditation Intervention in Student Pharmacists N/A