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NCT04272138 · ClinicalTrials.gov registry record · NA
A Brief App-based Mobile Health and Well-being Intervention Among Middle-aged Adults
A NA study, sponsored by Arizona State University.
- Completed
- Registry status
- NA
- Development phase
- 83
- Enrollment target
NCT04272138 is a NA study that has completed, run by Arizona State University. The registered enrollment target is 83 participants.
The verdict
NCT04272138, a NA study, has completed, sponsored by Arizona State University.
- COMPLETED
- Registry status
- NA
- Development phase
- 83 participants
- Enrollment target
Study 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.
Interventions
- BEHAVIORAL Calm Meditation
- BEHAVIORAL Educational Podcast Control
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 83 participants |
| Start Date | 2020-02-03 |
| Est. Completion | 2020-06-16 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04272138
The ClinicalTrials.gov registry entry for NCT04272138 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 83 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Arizona State University, which has 187 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Calm Meditation is the first listed.
NCT04272138 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT04272138 about?
NCT04272138 is a clinical study titled "A Brief App-based Mobile Health and Well-being Intervention Among Middle-aged Adults". 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-interv...
What is the current status of trial NCT04272138?
This trial is currently completed. It is a NA study. The enrollment target is 83 participants. The study started on 2020-02-03. Estimated completion is 2020-06-16.
What interventions are being tested in trial NCT04272138?
The interventions under investigation include: Calm Meditation (BEHAVIORAL), Educational Podcast Control (BEHAVIORAL).
Who is sponsoring clinical trial NCT04272138?
This trial is sponsored by Arizona State University, which has 187 total clinical trials registered on ClinicalTrials.gov.
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