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

Mindfulness Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06050681
• Other study ID #: 24377
• Status: Completed
• Phase: N/A
• Start date: August 23, 2023
• Est. completion date: January 29, 2024

Study information

• Verified date: February 2024
• Source: University of Illinois at Urbana-Champaign
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: January 29, 2024
• Est. primary completion date: January 29, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 30 Years

Eligibility

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

Related Conditions & MeSH terms

• Mental Health Wellness
• Mindfulness

Intervention

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.

Locations

Country	Name	City	State
United States	University of Illinois at Urbana Champaign	Urbana	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
University of Illinois at Urbana-Champaign

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Feasibility- Adherence	Proportion of prescribed sessions completed by enrolled participants	Measured at end of 6 week intervention
Primary	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
Primary	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	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
Secondary	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