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Calm College: A Brief Mobile App Meditation Intervention Among Stressed College Students

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ClinicalTrials.gov Identifier: NCT03891810
Recruitment Status : Completed
First Posted : March 27, 2019
Last Update Posted : May 1, 2019
Sponsor:
Information provided by (Responsible Party):
Jennifer Huberty, Arizona State University

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.

Condition or disease Intervention/treatment Phase
Stress Behavioral: Calm Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 88 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
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.
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Calm College: A Brief Mobile App Meditation Intervention Among Stressed College Students
Actual Study Start Date : September 1, 2017
Actual Primary Completion Date : May 1, 2018
Actual Study Completion Date : May 1, 2018

Arm Intervention/treatment
Experimental: Calm
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).
Behavioral: Calm
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).

No Intervention: Control
This group was a wait list control group who received the treatment following the intervention period.



Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Sleep (Self-reported sleep using the Patient-Reported Outcomes Measurement Information System Short Form (PROMIS 8a)) [ Time Frame: 8 weeks post baseline ]
    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).

  2. Physical Activity (Aerobic and strength training, using the Youth Risk Behavior Survey (YRBS)) [ Time Frame: 8 weeks post baseline ]
    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.

  3. Diet (Fruit and vegetable consumption, using the Youth Risk Behavior Survey (YRBS)) [ Time Frame: 8 weeks post baseline ]
    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.

  4. Alcohol Consumption (Alcohol consumption, using the Youth Risk Behavior Survey (YRBS)) [ Time Frame: 8 weeks post baseline ]
    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.

  5. Five Factor Mindfulness Questionnaire (FFMQ) [ Time Frame: 8 weeks post baseline ]
    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.

  6. Self-Compassion Survey Short-Form (SCS-SF) [ Time Frame: 8 weeks post baseline ]
    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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03891810


Locations
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United States, Arizona
Arizona State University
Phoenix, Arizona, United States, 85004
Sponsors and Collaborators
Arizona State University
Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Jennifer Huberty, Associate Professor, Arizona State University
ClinicalTrials.gov Identifier: NCT03891810    
Other Study ID Numbers: STUDY00006896
First Posted: March 27, 2019    Key Record Dates
Last Update Posted: May 1, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No