NCT06050681

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Aug 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 23, 2023

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

August 24, 2023

Completed
29 days until next milestone

First Posted

Study publicly available on registry

September 22, 2023

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 29, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 29, 2024

Completed
Last Updated

February 20, 2024

Status Verified

February 1, 2024

Enrollment Period

5 months

First QC Date

August 24, 2023

Last Update Submit

February 16, 2024

Conditions

Keywords

Athlete

Outcome Measures

Primary Outcomes (3)

  • 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 Outcomes (2)

  • Cognitive and Affective Mindfulness Scale-Revised (CAMS-R)

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

  • College Student Athlete Life Stress Scale (CSALSS)

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

Study Arms (1)

Mindfulness Intervention

EXPERIMENTAL

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

Behavioral: Mindfulness Training

Interventions

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.

Mindfulness Intervention

Eligibility Criteria

Age18 Years - 30 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Illinois at Urbana Champaign

Urbana, Illinois, 61801, United States

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Model Details: Single group intervention feasibility
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 24, 2023

First Posted

September 22, 2023

Study Start

August 23, 2023

Primary Completion

January 29, 2024

Study Completion

January 29, 2024

Last Updated

February 20, 2024

Record last verified: 2024-02

Data Sharing

IPD Sharing
Will not share

Locations