MindfulnessNCT06050681
Calm Athlete: Feasibility of App-based Mindfulness Training on Collegiate Student-Athletes' Mental Wellbeing
A study testing Mindfulness Training in people with Mindfulness and Mental Health Wellness, run by University of Illinois at Urbana-Champaign at 1 site in United States.
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… Read more about this study
- Who is it for?
- Ages 18 to 30 yearsHealthy volunteers can take part
- Conditions the study is for
- Mindfulness, Mental Health Wellness
- What is being tested?
- Mindfulness Training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 23 Aug 2023to 29 Jan 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 30 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Illinois at Urbana Champaign
Urbana, Illinois, 61801
About this study
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.
- Conditions
- Mindfulness, Mental Health Wellness
- Being tested
- Mindfulness Training
- Keywords
- Athlete
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mindfulness TrainingBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Mindfulness Intervention | Experimental | Participants will engage with a mobile application to complete 21 sessions lasting approximately 11 minutes of mindfulness training over 6 weeks. Receives: Behavioral: Mindfulness Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility- Adherence
Proportion of prescribed sessions completed by enrolled participants
Measured: 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: Measured at end of 6 week intervention
Feasibility- Retention
Proportion of enrolled participants that complete intervention and all assessments
Measured: Measured at end of 6 week intervention and at 4 week follow up
Secondary outcomes (2)
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: 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: Measured at baseline, at end of 6 week intervention and at 4 week follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2023
- Study start23 Aug 2023
- Primary completion29 Jan 2024
- Study completion29 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MindfulnessStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Single group intervention feasibility
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Illinois at Urbana-Champaign
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06050681
- Sponsor's protocol ID
- 24377
- Status last verified
- Feb 2024
- First submitted
- 24 Aug 2023
- Last updated
- 20 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Calm Athlete: Feasibility of App-based Mindfulness Training on Collegiate Student-Athletes' Mental Wellbeing
- ClinicalTrials.gov ID
- NCT06050681
- Acronym / sponsor ID
- 24377
- Conditions
- Mindfulness, Mental Health Wellness
- Keywords
- Athlete
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- University of Illinois at Urbana-ChampaignUniversity, hospital or other
- Study start
- 23 Aug 2023 (actual)
- Primary completion
- 29 Jan 2024 (actual)
- Study completion
- 29 Jan 2024 (actual)
- First posted
- 22 Sep 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Single group intervention feasibility
| Arm | Type | Receives |
|---|---|---|
| Mindfulness Intervention | Experimental | Behavioral: Mindfulness TrainingParticipants will engage with a mobile application to complete 21 sessions lasting approximately 11 minutes of mindfulness training over 6 weeks. |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mindfulness TrainingParticipants 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. | Behavioural | Mindfulness Intervention |
Primary outcome
Feasibility- Adherence
Time frame: Measured at end of 6 week intervention
Proportion of prescribed sessions completed by enrolled participants
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.
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
2 secondary outcomes
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
College Student Athlete Life Stress Scale (CSALSS)
Time frame: Measured at baseline, at end of 6 week intervention and at 4 week follow-up
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Feb 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mindfulness Training in people with Mindfulness and Mental Health Wellness, run by University of Illinois at Urbana-Champaign at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility- Adherence (time frame: Measured at end of 6 week intervention). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Feb 2024.