MeditationNCT04272138
A Brief App-based Mobile Health and Well-being Intervention Among Middle-aged Adults
A study testing Calm Meditation in people with Meditation and Control Group, run by Arizona State University at 1 site in United States.
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). Read more about this study
- Who is it for?
- Ages 40 to 64 yearsHealthy volunteers can take part
- Conditions the study is for
- Meditation, Control Group
- What is being tested?
- Calm Meditation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 83 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Feb 2020to 16 Jun 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 64 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Arizona Biomedical Collaborative
Phoenix, Arizona, 85004
About this study
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)
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.
Read more
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.
Read the 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.
- Conditions
- Meditation, Control Group
- Being tested
- Calm Meditation, Educational Podcast Control
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Calm MeditationBehavioural
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.
Educational Podcast ControlBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: Educational Podcast Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
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: 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).
Measured: 1x at post-intervention about participation time in study (4 weeks total)
Secondary outcomes (9)
Stress
Stress will be measured using the Perceived Stress Scale -10 item, with scores ranging from 10-40) and a higher score indicates a worse outcome.
Measured: Change from baseline (week 0) to post-intervention (week 4)
Anxiety
Anxiety will be measured using the Hospital Anxiety and Depression Scale, with scores ranging from 0-21, and a higher score indicates a worse outcome.
Measured: Change from baseline (week 0) to post-intervention (week 4)
Depression
Depression will be measured using the Hospital Anxiety and Depression Scale, with scores ranging from 0-21, and a higher score indicates a worse outcome.
Measured: Change from baseline (week 0) to post-intervention (week 4)
Gender as moderator of stress
Self-reported gender
Measured: Change from baseline (week 0) to post-intervention (week 4)
Mindfulness as a mediator of stress
Mindfulness will be measured using the Mindful Attention Awareness Scale, with scores ranging from 15-90, and a higher score indicates a better outcome.
Measured: Change from baseline (week 0) to post-intervention (week 4)
Physical Activity as a mediator on stress, anxiety, and depression
Physical activity will be measured using the International Physical Activity Questionnaire, when a higher score indicates a better outcome.
Measured: Change from baseline (week 0) to post-intervention (week 4)
Eating as a mediator on stress, anxiety, and depression
Eating will be measured using the Salzburg Stress Eating Scale, with scores ranging from 5-100, and a higher score indicates a worse outcome.
Measured: Change from baseline (week 0) to post-intervention (week 4)
Coping behaviors as a mediator on stress, anxiety, and depression
Coping behaviors will be measured using the Brief COPE Inventory, with scores ranging from 2-8, and a higher score indicates a better outcome.
Measured: Change from baseline (week 0) to post-intervention (week 4)
Resilience
Resilience will be measured using the Brief Resilience Scale, with scores ranging from 1-5, and a higher score indicates a better outcome.
Measured: Change from baseline (week 0) to post-intervention (week 4)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2020
- Study start3 Feb 2020
- Primary completion18 May 2020
- Study completion16 Jun 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for MeditationStudies of the same condition, open and under way.
- More trials run by Arizona State UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 83 participants (actual)
Sponsor and investigators
- Lead sponsor
- Arizona State University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jennifer Huberty, PhD, Study chair, Arizona State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04272138
- Sponsor's protocol ID
- STUDY00011219
- Status last verified
- Feb 2022
- First submitted
- 13 Jan 2020
- Last updated
- 28 Feb 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 34989677
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT04272138
- Acronym / sponsor ID
- STUDY00011219
- Conditions
- Meditation, Control Group
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 83 participants (actual)
- Lead sponsor
- Arizona State UniversityUniversity, hospital or other
- Study start
- 3 Feb 2020 (actual)
- Primary completion
- 18 May 2020 (actual)
- Study completion
- 16 Jun 2020 (actual)
- First posted
- 17 Feb 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Calm Meditation | Experimental | Behavioral: Calm MeditationParticipants 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. |
| Educational Podcast Control | Active comparator | Behavioral: Educational Podcast ControlParticipants 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. |
Who may qualify
- Ages
- 40 to 64 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- 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)
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Calm MeditationThe 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. | Behavioural | Calm Meditation |
| Educational Podcast ControlThe 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. | Behavioural | Educational Podcast Control |
Primary outcome
Feasibility: Acceptability
Time frame: Measured 1x at post-intervention about experience in study, about 4 weeks.
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)
Feasibility: Demand
Time frame: 1x at post-intervention about participation time in study (4 weeks total)
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).
9 secondary outcomes
Stress
Time frame: Change from baseline (week 0) to post-intervention (week 4)
Anxiety
Time frame: Change from baseline (week 0) to post-intervention (week 4)
Depression
Time frame: Change from baseline (week 0) to post-intervention (week 4)
Gender as moderator of stress
Time frame: Change from baseline (week 0) to post-intervention (week 4)
Mindfulness as a mediator of stress
Time frame: Change from baseline (week 0) to post-intervention (week 4)
Physical Activity as a mediator on stress, anxiety, and depression
Time frame: Change from baseline (week 0) to post-intervention (week 4)
Eating as a mediator on stress, anxiety, and depression
Time frame: Change from baseline (week 0) to post-intervention (week 4)
Coping behaviors as a mediator on stress, anxiety, and depression
Time frame: Change from baseline (week 0) to post-intervention (week 4)
Resilience
Time frame: Change from baseline (week 0) to post-intervention (week 4)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Feb 2022.
- Derived from this study: PubMed 34989677Laird 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jennifer Huberty, PhD study chair
Arizona State University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Calm Meditation in people with Meditation and Control Group, run by Arizona State University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility: Acceptability (time frame: Measured 1x at post-intervention about experience in study, about 4 weeks.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04272138, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Feb 2022.