StressNCT03891810
Calm College: A Brief Mobile App Meditation Intervention Among Stressed College Students
A study testing Calm in people with Stress, run by Arizona State University at 1 site in United States.
Trial summary
This research investigated the effects of a mindfulness meditation mobile application (i.e., Calm College) on reducing stress in undergraduate college students with moderate, high, or extreme levels of stress as compared to a delayed intervention group. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Stress
- What is being tested?
- Calm
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 88 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Sep 2017to 1 May 2018
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Current full-time undergraduate student at Arizona State University
- 18 years of age
- Able to read/understand English
- Own a smartphone
- A score of 14 or higher on the Perceived Stress Scale (PSS)
- Willingness to be randomized
- Willingness to download the Calm application
Who cannot join
- Participated in any mindfulness based practice within the last 6 months
- Currently utilize Calm or any other mindfulness based mobile application
- low levels of stress (i.e., less than a score of 14 assessed with the Perceived Stress Scale)
Trial locations and contacts
1 site in 1 country.
About this study
This research investigated the effects of a mindfulness meditation mobile application (i.e., Calm College) on reducing stress in undergraduate college students with moderate, high, or extreme levels of stress as compared to a delayed intervention group.
Read the detailed description
The purpose of this study is to investigate the effects of a mindfulness meditation mobile application (i.e., Calm College) on reducing stress in ASU undergraduate students with moderate, high, or extreme levels of stress as compared to a delayed response group.
The study design is a randomized control trial with baseline, post-intervention (8 wks from baseline), and follow-up (12 wks from baseline) assessments. College students will be randomized to either a Calm College Intervention group or a delayed response group. Participants will be randomized after the completion of baseline and informed consent.
Aim 1: Investigate the effects of an 8-wk mobile meditation application (i.e., Calm) to reduce self-reported stress in ASU undergraduate students with moderate, high or extreme levels of stress as compared to a wait-list control group.
Aim 2: Explore the relationship between stress and reported health risk behaviors (i.e., inadequate sleep, physical inactivity, dietary behaviors, and alcohol consumption) in college students who use a mobile meditation application (i.e, Calm).
Recruitment: Participants will be recruited during September 2017. Interested participants will be directed to a Qualtrics 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 Qualtrics link. This measure should take approximately 20 minutes to complete (See Informed Consent and Baseline Questionnaire). Once Informed Consent is signed and the Baseline Questionnaire is complete, participants will be randomized via an online randomizer (i.e., randomizer.com) to either a delayed response group or Calm College group. Ineligible participants will be sent an email notifying their status and given information on how to download Calm College (See Participant Scripts).
Enrollment: The Research Team will email the intervention participants that will include instructions to download Calm College (Participant Scripts). The control participants will be emailed and asked to not participate in any mindfulness based activities for 12-wks (See Participant Scrips). The intervention will run for 8-wks with a 4-wk follow-up period. Intervention participants will complete "7 days of Calm" during Week 1. For the remaining weeks (Week 2- Week 8) intervention participants will then be asked to meditate during the weekday from a 10-minute meditation of their choice. Throughout the intervention, the Calm College group will be sent reminder texts/emails via Google Voice to participate in the meditation sessions if participants are not meditating for more than 30 minutes a week (see Participant Scripts).
Tracking: Participation in the Calm College meditations will be tracked (meditation name, time of day, and time spent in meditation) by the Calm team.
Post-intervention: Post-intervention questionnaire will be emailed to intervention and control participants via a link from Qualtrics (See Post-intervention questionnaire delayed response, post-intervention questionnaire intervention). Intervention participants will have access to Calm College, but will not be asked to meditate.
Follow-up: Follow-up questionnaire will be emailed to intervention and control participants via a link from Qualtrics (See Follow-up questionnaire). Once follow-up measures have been completed, the control group will be emailed instructions on how to download Calm College.
- Conditions
- Stress
- Being tested
- Calm
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CalmBehavioural
The intervention ran for 8-wks with a 4-wk follow-up period. Intervention participants completed "7 days of Calm" during Week 1. For the remaining weeks (Week 2- Week 8) intervention participants were asked to meditate during the weekday from a 10-minute meditation of their choice. Throughout the intervention, the Calm College group were sent reminder texts/emails via Google Voice to participate in the meditation sessions if participants are not meditating for more than 30 minutes a week (see Participant Scripts).
| Study group | Role | What they receive |
|---|---|---|
| Calm | Experimental | The intervention ran for 8-wks with a 4-wk follow-up period. Intervention participants completed "7 days of Calm" during Week 1. For the remaining weeks (Week 2- Week 8) intervention participants were asked to meditate during the weekday from a 10-minute meditation of their choice. Throughout the intervention, the Calm College group were sent reminder texts/emails via Google Voice to participate in the meditation sessions if participants are not meditating for more than 30 minutes a week (see Participant Scripts). Receives: Behavioral: Calm |
| Control | No intervention | This group was a wait list control group who received the treatment following the intervention period. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Stress (Perceived Stress Scale (PSS) score)
The PSS is a 10-item inventory used for the assessment of perceived stress. The scale measures the degree to which situations are appraised as stressful. ?". The items are rated on a 5-point Likert scale ranging from 0 (never) to 4 (very often). Higher scores indicate higher levels of stress. Scores are computed via sum.
Measured: 8 weeks post baseline
Secondary outcomes (6)
Sleep (Self-reported sleep using the Patient-Reported Outcomes Measurement Information System Short Form (PROMIS 8a))
The PROMIS short-from is an 8-item inventory used to assess sleep disturbance in adults. The first seven questions follow the same pattern and are rated on a 5-point Likert scale ranging from 1 (Not at all) to 5 (Very much). The last question is rated on a reversed 5-point Likert scale ranging from 5 (Very poor) to 1 (Very good).
Measured: 8 weeks post baseline
Physical Activity (Aerobic and strength training, using the Youth Risk Behavior Survey (YRBS))
The YRBS is 99-item survey that assesses six categories of priority health-risk behaviors among youth and young adults, however only the sub-scale for physical activity was assessed for this outcome. Higher scores indicate higher levels of physical activity. There are 10 items in this sub scale, and scores range from 0-10. Scored are computed via sum of questions.
Measured: 8 weeks post baseline
Diet (Fruit and vegetable consumption, using the Youth Risk Behavior Survey (YRBS))
The YRBS is 99-item survey that assesses six categories of priority health-risk behaviors among youth and young adults, however only the sub-scale for diet was assessed for this outcome. Higher scores indicate higher levels of fruit and vegetable consumption. There are 20 items on this sub scale, and scores range from 0-20. Scored are computed via sum of questions.
Measured: 8 weeks post baseline
Alcohol Consumption (Alcohol consumption, using the Youth Risk Behavior Survey (YRBS))
The YRBS is 99-item survey that assesses six categories of priority health-risk behaviors among youth and young adults, however only the sub-scale for alcohol consumption was assessed for this outcome. Higher scores indicate higher levels of alcohol consumption. There are 6 items on this sub scale and scored range from 0-6. Scored are computed via sum of questions.
Measured: 8 weeks post baseline
Five Factor Mindfulness Questionnaire (FFMQ)
The FFMQ is a 39-item self-report inventory used for the assessment of multiple constructs of mindfulness skills. The inventory assesses five subscales: observing, describing, acting with awareness, non-judging of inner experience, and non-reactivity to inner experience. The response items are rated on a 5-point Likert scale ranging from 1 (never or very rarely true) to 5 (very often or always true). The facet scores range from 8-40 with the exception of non-reactivity to inner experience which ranges from 7-35. Higher scores indicate higher levels of mindfulness.
Measured: 8 weeks post baseline
Self-Compassion Survey Short-Form (SCS-SF)
The SCS-SF is a 12-item survey assessing three subscales: self-kindness versus self-judgment, common humanity versus isolation, and mindfulness versus over-identification. The response items are rated on a 5-point Likert scale ranging from 1 (almost never) to 5 (almost always). Higher scores indicate higher levels of self-compassion.
Measured: 8 weeks post baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2019
- Study start1 Sep 2017
- Primary completion1 May 2018
- Study completion1 May 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for StressStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The study design was a randomized control trial with baseline, post-intervention (8 wks from baseline), and follow-up (12 wks from baseline) assessments. College students were randomized to either a Calm College Intervention group or a delayed response group. Participants were randomized after the completion of baseline and informed consent.
- Masking
- None (open label)
- Enrolment
- 88 participants (actual)
Sponsor and investigators
- Lead sponsor
- Arizona State University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jennifer Huberty, Arizona State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03891810
- Sponsor's protocol ID
- STUDY00006896
- Status last verified
- Apr 2019
- First submitted
- 21 Mar 2019
- Last updated
- 1 May 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Baum A. Stress, intrusive imagery, and chronic distress. Health Psychol. 1990;9(6):653-75. doi: 10.1037//0278-6133.9.6.653.
PubMed 2286178Edenfield TM, Saeed SA. An update on mindfulness meditation as a self-help treatment for anxiety and depression. Psychol Res Behav Manag. 2012;5:131-41. doi: 10.2147/PRBM.S34937. Epub 2012 Nov 23.
PubMed 23175619Leppink EW, Odlaug BL, Lust K, Christenson G, Grant JE. The Young and the Stressed: Stress, Impulse Control, and Health in College Students. J Nerv Ment Dis. 2016 Dec;204(12):931-938. doi: 10.1097/NMD.0000000000000586.
PubMed 27575792McIndoo CC, File AA, Preddy T, Clark CG, Hopko DR. Mindfulness-based therapy and behavioral activation: A randomized controlled trial with depressed college students. Behav Res Ther. 2016 Feb;77:118-28. doi: 10.1016/j.brat.2015.12.012. Epub 2015 Dec 23.
PubMed 26745622Caldwell K, Harrison M, Adams M, Quin RH, Greeson J. Developing mindfulness in college students through movement-based courses: effects on self-regulatory self-efficacy, mood, stress, and sleep quality. J Am Coll Health. 2010 Mar-Apr;58(5):433-42. doi: 10.1080/07448480903540481.
PubMed 20304755Huberty J, Green J, Glissmann C, Larkey L, Puzia M, Lee C. Efficacy of the Mindfulness Meditation Mobile App "Calm" to Reduce Stress Among College Students: Randomized Controlled Trial. JMIR Mhealth Uhealth. 2019 Jun 25;7(6):e14273. doi: 10.2196/14273.
PubMed 31237569
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Calm College: A Brief Mobile App Meditation Intervention Among Stressed College Students
- ClinicalTrials.gov ID
- NCT03891810
- Acronym / sponsor ID
- STUDY00006896
- Conditions
- Stress
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 88 participants (actual)
- Lead sponsor
- Arizona State UniversityUniversity, hospital or other
- Study start
- 1 Sep 2017 (actual)
- Primary completion
- 1 May 2018 (actual)
- Study completion
- 1 May 2018 (actual)
- First posted
- 27 Mar 2019 (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.
This research investigated the effects of a mindfulness meditation mobile application (i.e., Calm College) on reducing stress in undergraduate college students with moderate, high, or extreme levels of stress as compared to a delayed intervention group.
Detailed description
The purpose of this study is to investigate the effects of a mindfulness meditation mobile application (i.e., Calm College) on reducing stress in ASU undergraduate students with moderate, high, or extreme levels of stress as compared to a delayed response group.
The study design is a randomized control trial with baseline, post-intervention (8 wks from baseline), and follow-up (12 wks from baseline) assessments. College students will be randomized to either a Calm College Intervention group or a delayed response group. Participants will be randomized after the completion of baseline and informed consent.
Aim 1: Investigate the effects of an 8-wk mobile meditation application (i.e., Calm) to reduce self-reported stress in ASU undergraduate students with moderate, high or extreme levels of stress as compared to a wait-list control group.
Aim 2: Explore the relationship between stress and reported health risk behaviors (i.e., inadequate sleep, physical inactivity, dietary behaviors, and alcohol consumption) in college students who use a mobile meditation application (i.e, Calm).
Recruitment: Participants will be recruited during September 2017. Interested participants will be directed to a Qualtrics 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 Qualtrics link. This measure should take approximately 20 minutes to complete (See Informed Consent and Baseline Questionnaire). Once Informed Consent is signed and the Baseline Questionnaire is complete, participants will be randomized via an online randomizer (i.e., randomizer.com) to either a delayed response group or Calm College group. Ineligible participants will be sent an email notifying their status and given information on how to download Calm College (See Participant Scripts).
Enrollment: The Research Team will email the intervention participants that will include instructions to download Calm College (Participant Scripts). The control participants will be emailed and asked to not participate in any mindfulness based activities for 12-wks (See Participant Scrips). The intervention will run for 8-wks with a 4-wk follow-up period. Intervention participants will complete "7 days of Calm" during Week 1. For the remaining weeks (Week 2- Week 8) intervention participants will then be asked to meditate during the weekday from a 10-minute meditation of their choice. Throughout the intervention, the Calm College group will be sent reminder texts/emails via Google Voice to participate in the meditation sessions if participants are not meditating for more than 30 minutes a week (see Participant Scripts).
Tracking: Participation in the Calm College meditations will be tracked (meditation name, time of day, and time spent in meditation) by the Calm team.
Post-intervention: Post-intervention questionnaire will be emailed to intervention and control participants via a link from Qualtrics (See Post-intervention questionnaire delayed response, post-intervention questionnaire intervention). Intervention participants will have access to Calm College, but will not be asked to meditate.
Follow-up: Follow-up questionnaire will be emailed to intervention and control participants via a link from Qualtrics (See Follow-up questionnaire). Once follow-up measures have been completed, the control group will be emailed instructions on how to download Calm College.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- The study design was a randomized control trial with baseline, post-intervention (8 wks from baseline), and follow-up (12 wks from baseline) assessments. College students were randomized to either a Calm College Intervention group or a delayed response group. Participants were randomized after the completion of baseline and informed consent.
| Arm | Type | Receives |
|---|---|---|
| Calm | Experimental | Behavioral: CalmThe intervention ran for 8-wks with a 4-wk follow-up period. Intervention participants completed "7 days of Calm" during Week 1. For the remaining weeks (Week 2- Week 8) intervention participants were asked to meditate during the weekday from a 10-minute meditation of their choice. Throughout the intervention, the Calm College group were sent reminder texts/emails via Google Voice to participate in the meditation sessions if participants are not meditating for more than 30 minutes a week (see Participant Scripts). |
| Control | No intervention | –This group was a wait list control group who received the treatment following the intervention period. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Current full-time undergraduate student at Arizona State University
- 18 years of age
- Able to read/understand English
- Own a smartphone
- A score of 14 or higher on the Perceived Stress Scale (PSS)
Key exclusion criteria (3 listed)
- Participated in any mindfulness based practice within the last 6 months
- Currently utilize Calm or any other mindfulness based mobile application
- low levels of stress (i.e., less than a score of 14 assessed with the Perceived Stress Scale)
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 |
|---|---|---|
| CalmThe intervention ran for 8-wks with a 4-wk follow-up period. Intervention participants completed "7 days of Calm" during Week 1. For the remaining weeks (Week 2- Week 8) intervention participants were asked to meditate during the weekday from a 10-minute meditation of their choice. Throughout the intervention, the Calm College group were sent reminder texts/emails via Google Voice to participate in the meditation sessions if participants are not meditating for more than 30 minutes a week (see Participant Scripts). | Behavioural | Calm |
Primary outcome
Stress (Perceived Stress Scale (PSS) score)
Time frame: 8 weeks post baseline
The PSS is a 10-item inventory used for the assessment of perceived stress. The scale measures the degree to which situations are appraised as stressful. ?". The items are rated on a 5-point Likert scale ranging from 0 (never) to 4 (very often). Higher scores indicate higher levels of stress. Scores are computed via sum.
6 secondary outcomes
Sleep (Self-reported sleep using the Patient-Reported Outcomes Measurement Information System Short Form (PROMIS 8a))
Time frame: 8 weeks post baseline
Physical Activity (Aerobic and strength training, using the Youth Risk Behavior Survey (YRBS))
Time frame: 8 weeks post baseline
Diet (Fruit and vegetable consumption, using the Youth Risk Behavior Survey (YRBS))
Time frame: 8 weeks post baseline
Alcohol Consumption (Alcohol consumption, using the Youth Risk Behavior Survey (YRBS))
Time frame: 8 weeks post baseline
Five Factor Mindfulness Questionnaire (FFMQ)
Time frame: 8 weeks post baseline
Self-Compassion Survey Short-Form (SCS-SF)
Time frame: 8 weeks post baseline
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 1 May 2019.
- Background: PubMed 2286178Baum A. Stress, intrusive imagery, and chronic distress. Health Psychol. 1990;9(6):653-75. doi: 10.1037//0278-6133.9.6.653.
- Background: PubMed 23175619Edenfield TM, Saeed SA. An update on mindfulness meditation as a self-help treatment for anxiety and depression. Psychol Res Behav Manag. 2012;5:131-41. doi: 10.2147/PRBM.S34937. Epub 2012 Nov 23.
- Background: PubMed 27575792Leppink EW, Odlaug BL, Lust K, Christenson G, Grant JE. The Young and the Stressed: Stress, Impulse Control, and Health in College Students. J Nerv Ment Dis. 2016 Dec;204(12):931-938. doi: 10.1097/NMD.0000000000000586.
- Background: PubMed 26745622McIndoo CC, File AA, Preddy T, Clark CG, Hopko DR. Mindfulness-based therapy and behavioral activation: A randomized controlled trial with depressed college students. Behav Res Ther. 2016 Feb;77:118-28. doi: 10.1016/j.brat.2015.12.012. Epub 2015 Dec 23.
- Background: PubMed 20304755Caldwell K, Harrison M, Adams M, Quin RH, Greeson J. Developing mindfulness in college students through movement-based courses: effects on self-regulatory self-efficacy, mood, stress, and sleep quality. J Am Coll Health. 2010 Mar-Apr;58(5):433-42. doi: 10.1080/07448480903540481.
- Derived from this study: PubMed 31237569Huberty J, Green J, Glissmann C, Larkey L, Puzia M, Lee C. Efficacy of the Mindfulness Meditation Mobile App "Calm" to Reduce Stress Among College Students: Randomized Controlled Trial. JMIR Mhealth Uhealth. 2019 Jun 25;7(6):e14273. doi: 10.2196/14273.
- Individual participant dataSharing planned: No
Related trials for Stress
Not yet recruiting
Effect of Stress Ball Use During Femoral Arterial Sheath Removal After Coronary Angiography
Femoral Arterial Sheath Removal, Stress Ball
Recruiting
Effect of a Brief Daily Digital Meditation on Well-Being in US Young Adults (BEGIN II)
Mental Health and General Well-being
Not yet recruitingObservational study
Periodontal Status and Biomarkers in MASLD
Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD)
Recruiting
NightWare and Cardiovascular Health in Women With PTSD
Post Traumatic Stress Disorder, Cardiovascular Diseases
Active, not recruiting
Intervention to Address Disparate Mental Health Consequences of COVID-19 Pandemic on Latinx and African Newcomers
Mental Health Issue, Mental Health Disorder
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.
The record lists no contact. Use the official record to reach the sponsor.
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 in people with Stress, 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 3 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 1 May 2019. 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?
Stress (Perceived Stress Scale (PSS) score) (time frame: 8 weeks post baseline). 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 NCT03891810, which also lists 6 linked publications.
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 1 May 2019.