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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: Completed NA study, sponsored by Arizona State University.
NCT04272138 is a NA study that has completed, run by Arizona State University. The registered enrollment target is 83 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (94% lower). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
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)
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 |
What the finished NCT04272138 record still lists
NCT04272138 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 83 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (94% lower).
The record links to 0 conditions, and to 2 interventions - of which Calm Meditation is the first listed.
NCT04272138 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04272138's enrollment target sits among peer trials
83 990th of 2000 higher than 1,011 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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