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

Study Overview
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Brief Summary
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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.

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

Conditions
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Mindfulness, Mental Health Wellness

Intervention / Treatment
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* Behavioral: Mindfulness Training


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 30 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Intervention Model: Single Group Assignment
Interventional Model Description: Single group intervention feasibility
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Mindfulness Intervention<br>Participants will engage with a mobile application to complete 21 sessions lasting approximately 11 minutes of mindfulness training over 6 weeks. | Behavioral: Mindfulness Training<br>* 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.<br>|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Athlete