Calm Athlete: Feasibility of App-based Mindfulness Training on Collegiate Student-Athletes' Mental Wellbeing

The goal of this clinical trial is to evaluate the feasibility of a mobile app-based mindfulness training program in collegiate student-athletes. The main questions it aims to answer are:

• Is a app-based mindfulness program feasible for use with collegiate student athletes?
• What, if any, benefits are seen in the mental wellbeing of collegiate student athletes following mindfulness training?

Participants will use the Calm app to complete semi-structured program of 21 mindfulness sessions over 6 weeks. Participants will complete each 8-15 minute sessions at a location and time of their choosing.

Study Overview

• Status: Completed
• Conditions: Mental Health Wellness; Mindfulness
• Intervention / Treatment: Behavioral: Mindfulness Training

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Illinois
    • Urbana, Illinois, United States, 61801
      • University of Illinois at Urbana Champaign

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• 18-30 years old
• NCAA athlete academically eligible to practice and compete in sport, and physically cleared by university sports medicine staff for participation
• Not a regular user of mindfulness meditation in the last 6 months (<4 sessions/month)
• Willingness to create an account on the Calm app and share usage data with researchers
• Fluent in English

Exclusion Criteria:

• Regular mindfulness meditation practice (>4 sessions/month)
• Not currently an NCAA eligible athlete
• Hospitalization or intensive outpatient treatment for mental illness within the past 2 years
• Not cleared by sports medicine staff to participate in sport due to injury at time of enrollment
• Not willing to download the Calm app and/or create an account
• Not willing to share app usage data with researchers
• Not fluent in English

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Mindfulness Intervention; Participants will engage with a mobile application to complete 21 sessions lasting approximately 11 minutes of mindfulness training over 6 weeks.

Behavioral: Mindfulness Training; Participants will be asked to complete 21 mindfulness sessions within the Calm app on their own time and at a location of their choosing. They will be instructed to complete the '7 Days of Calm' program within the first two weeks of the intervention, the '7 Days of Managing Stress' program during weeks 3 & 4 of the intervention, and the 'Letting Go of Anxiety' program during the final two weeks of the intervention. The sessions have a mean run time of 11.76 minutes. Each 7-day program will be completed within a 2-week period, which equates to about one session every other day, but can be completed at any interval within those 2 weeks. All 21 sessions will be completed within a 6-week period.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Feasibility- Adherence	Proportion of prescribed sessions completed by enrolled participants	Measured at end of 6 week intervention
Feasibility- Participant Intervention Satisfaction	Self rating of satisfaction of the intervention measured with a 5 point Likert scale (1=very dissatisfied, 5=very satisfied.	Measured at end of 6 week intervention
Feasibility- Retention	Proportion of enrolled participants that complete intervention and all assessments	Measured at end of 6 week intervention and at 4 week follow up

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cognitive and Affective Mindfulness Scale-Revised (CAMS-R)	12-item scale measuring mindfulness across 4 subscales: attention, present focus, awareness & acceptance. Min. score = 12, Max Score = 48, higher score represents greater level of mindfulness	Measured at baseline, at end of 6 week intervention and at 4 week follow-up
College Student Athlete Life Stress Scale (CSALSS)	24-item questionnaire assessing stress specific to collegiate student-athlete's lives. 8 subscales are represented: academic requirements, sport injury, performance demand, coach relationships, training adaptation, family relationships, romantic relationships, interpersonal relationships. Min. score = 24, Max score = 144, higher score represents higher stress levels.	Measured at baseline, at end of 6 week intervention and at 4 week follow-up

Collaborators and Investigators

• Sponsor: University of Illinois at Urbana-Champaign

Study record dates

Study Major Dates

• Study Start (Actual): August 23, 2023
• Primary Completion (Actual): January 29, 2024
• Study Completion (Actual): January 29, 2024

Study Registration Dates

• First Submitted: August 24, 2023
• First Submitted That Met QC Criteria: September 18, 2023
• First Posted (Actual): September 22, 2023

Study Record Updates

• Last Update Posted (Actual): February 20, 2024
• Last Update Submitted That Met QC Criteria: February 16, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: Athlete
• Other Study ID Numbers: 24377

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No