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Completed

NCT Number: NCT06050681

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.

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Key information

Age range

18 year–30 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Illinois at Urbana Champaign

Urbana, Illinois, 61801, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Mindfulness Training

Behavioral

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.

Primary outcomes

  1. Feasibility- Adherence

    Time frame: Measured at end of 6 week intervention

    Proportion of prescribed sessions completed by enrolled participants

  2. Feasibility- Participant Intervention Satisfaction

    Time frame: Measured at end of 6 week intervention

    Self rating of satisfaction of the intervention measured with a 5 point Likert scale (1=very dissatisfied, 5=very satisfied.

  3. Feasibility- Retention

    Time frame: Measured at end of 6 week intervention and at 4 week follow up

    Proportion of enrolled participants that complete intervention and all assessments

Secondary outcomes

  1. Cognitive and Affective Mindfulness Scale-Revised (CAMS-R)

    Time frame: Measured at baseline, at end of 6 week intervention and at 4 week follow-up

    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

  2. College Student Athlete Life Stress Scale (CSALSS)

    Time frame: Measured at baseline, at end of 6 week intervention and at 4 week follow-up

    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.

Sponsors and collaborators

Lead sponsor

University of Illinois at Urbana-Champaign

Other

Registry information

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Sep 22, 2023
Registry last updated
Feb 20, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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