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

NCT03891810 | Completed

• 1 other identifier: STUDY00006896
• Study Type: interventional
• Target: 88
• Locations: 1 country
• Sites: 1

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.

Conditions

Stress

Outcome Measures

Primary Outcomes (1)

• 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.

  8 weeks post baseline

Secondary Outcomes (6)

• Sleep (Self-reported sleep using the Patient-Reported Outcomes Measurement Information System Short Form (PROMIS 8a))

  8 weeks post baseline

• Physical Activity (Aerobic and strength training, using the Youth Risk Behavior Survey (YRBS))

  8 weeks post baseline

• Diet (Fruit and vegetable consumption, using the Youth Risk Behavior Survey (YRBS))

  8 weeks post baseline

• Alcohol Consumption (Alcohol consumption, using the Youth Risk Behavior Survey (YRBS))

  8 weeks post baseline

• Five Factor Mindfulness Questionnaire (FFMQ)

  8 weeks post baseline

Study Arms (2)

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).

Behavioral: Calm

Control

NO INTERVENTION

This group was a wait list control group who received the treatment following the intervention period.

Interventions

Calm BEHAVIORAL

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).

Calm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Current full-time undergraduate student at Arizona State University
• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Arizona State University: lead

Study Sites (1)

Arizona State University

Phoenix, Arizona, 85004, United States

Location

Related Publications (6)

• Baum A. Stress, intrusive imagery, and chronic distress. Health Psychol. 1990;9(6):653-75. doi: 10.1037//0278-6133.9.6.653.

  PMID: 2286178 BACKGROUND

• Edenfield 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.

  PMID: 23175619 BACKGROUND

• Leppink 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.

  PMID: 27575792 BACKGROUND

• McIndoo 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.

  PMID: 26745622 BACKGROUND

• Caldwell 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.

  PMID: 20304755 BACKGROUND

• 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.

  PMID: 31237569 DERIVED

MeSH Terms

Interventions

Calmodulin

Intervention Hierarchy (Ancestors)

Intracellular Calcium-Sensing Proteins; Intracellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; Calcium-Binding Proteins; Carrier Proteins; Proteins

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: 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.

Study Record Dates

• First Submitted: March 21, 2019
• First Posted: March 27, 2019
• Study Start: September 1, 2017
• Primary Completion: May 1, 2018
• Study Completion: May 1, 2018
• Last Updated: May 1, 2019

Record last verified: 2019-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)