Clinical trial NCT03891810: Calm College: A Brief Mobile App Meditation Intervention Among Stressed College Students
Official title: Calm College: A Brief Mobile App Meditation Intervention Among Stressed College Students
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stress
Lead sponsor: Arizona State University
Sponsor class: OTHER
First posted: 2019-03-27
Enrollment: 88
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: TREATMENT

Brief 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.

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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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)

Primary outcomes:
measure: Stress (Perceived Stress Scale (PSS) score)
timeFrame: 8 weeks post baseline
Secondary outcomes:
measure: Sleep (Self-reported sleep using the Patient-Reported Outcomes Measurement Information System Short Form (PROMIS 8a))
timeFrame: 8 weeks post baseline
measure: Physical Activity (Aerobic and strength training, using the Youth Risk Behavior Survey (YRBS))
timeFrame: 8 weeks post baseline
measure: Diet (Fruit and vegetable consumption, using the Youth Risk Behavior Survey (YRBS))
timeFrame: 8 weeks post baseline
measure: Alcohol Consumption (Alcohol consumption, using the Youth Risk Behavior Survey (YRBS))
timeFrame: 8 weeks post baseline
measure: Five Factor Mindfulness Questionnaire (FFMQ)
timeFrame: 8 weeks post baseline
measure: Self-Compassion Survey Short-Form (SCS-SF)
timeFrame: 8 weeks post baseline
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Arizona State University
state: Arizona
Study officials:
References:
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citation: Huberty 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.