DepressionNCT06182150
Mitigating Mental Health Issues Among Women's Sport Student-Athletes Through a Moderate-Intensity Exercise Intervention
A study testing Moderate-Intensity Indoor Cycling Exercise in people with Depression and Anxiety, run by University of North Carolina, Chapel Hill at 1 site in United States.
Trial summary
The goal of this clinical trial is to learn about moderate-intensity indoor cycling interventions in women's sport student-athletes transitioning into college and collegiate sport. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Depression, Anxiety, Stress, Psychological
- What is being tested?
- Moderate-Intensity Indoor Cycling Exercise
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 1 siteUnited States
- Study dates
- 29 Jan 2024to 25 Feb 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- first- or second-year undergraduate student
- current participation in women's intramural sport, club sport, varsity collegiate sport, or recreational sport
Who cannot join
- individuals who did not meet the inclusion criteria
- those incapable of providing informed consent
- did not complete surveys at T1 and T2
Trial locations and contacts
1 site in 1 country.
United States1 site
UNC Student Recreation Center
Chapel Hill, North Carolina, 27516
About this study
Official title: PAUSE-Cardio: Mitigating Depression, Anxiety, and Stress Among Women's Sport Student- Athletes Through a Moderate-Intensity Exercise Intervention
The goal of this clinical trial is to learn about moderate-intensity indoor cycling interventions in women's sport student-athletes transitioning into college and collegiate sport. The main question[s] it aims to answer are:
Aim 1: Establish preliminary feasibility for the intervention based on recruitment and retention rates.
Read more
Aim 2: Assess efficacy through comparison of pre- and post-intervention mental health outcomes scores between experimental and control groups.
Exploratory Aim 3: Explore associations between exercise, athletic, and academic identities and mental health issues post-intervention.
Participants will complete an online questionnaire. This online questionnaire will be given before the program begins and after the 4 weeks. The questionnaire will ask about the participants' basic information, the participants' experience with exercise, and the participants' transition experience including mental, physical, and social factors.
Participants will be asked to attend an in-person 45-minute exercise class once a week at the University of North Carolina at Chapel Hill (UNC) Student Recreation Center.
Participants enrolled in the program will be asked to complete a self-report form during each weekly practice including heart rate (before and after practice) and ratings of perceived exertion. Heart rate will be measured during practice, smart devices (i.e., Apple Watch, FitBit) are not required.
Read the detailed description
Purpose: The goal of this pilot study is to examine the relationship between mental health concerns (e.g., anxiety, depression, and stress) and PAUSE-Cardio, a 4-week moderate-intensity cardiovascular exercise intervention program for women's sport student-athletes transitioning into college and collegiate sport.
The investigators hypothesize that at least 70% of participants will be retained for the length of the intervention, including completion of the Qualtrics survey at T1 and T2. Additionally, the investigators hypothesize that symptoms of depression, anxiety, and stress will be significantly decreased post-intervention compared to pre-intervention following moderate-intensity exercise program completion.
Participants: Participants will consist of twenty-two women's sport student-athletes (N=22) ages 18 and older in the participants' first two years of undergraduate study. Participants must be actively practicing an intramural sport, club sport, varsity collegiate sport, or recreational sport.
Procedures: The study design will be a mixed-methods pilot study employing moderate-intensity cardiovascular exercise. Results will be assessed with a longitudinal self-report survey of valid and reliable psychometric measures and free response items. All measurements and questions will be compiled into one Qualtrics-based survey that will be administered two times (pre-program [T1] and post-program [T2]). Study-specific moderate-intensity exercise will be administered once weekly for four weeks in a group fitness setting for 45 minutes. The 45-minute class will consist of a 5-minute warm-up, a 35-minute conditioning segment, and a 5-minute cooldown. This multipart study is gathering data through a mixed-methods longitudinal design in conjunction with a prospective cohort design. Data collection is utilizing Qualtrics, an online survey platform, and administering PAUSE-Cardio, a 4-week moderate-intensity cardiovascular exercise intervention program. Individuals who are at least 18 years of age and self-identify as women's sport student-athletes within the participants' first two years of study in collegiate settings are invited to participate via social media, emails, flyers, and word of mouth. A self-report survey of valid and reliable psychometric quantitative measures and qualitative free-response items is being administered 4 weeks apart, pre-program (T1) and post-program (T2) to participants. The feasibility of the intervention program is being determined by examining recruitment and retention rates. To assess the preliminary efficacy of the intervention, within- and between-group comparisons are being conducted using aggregated data, including waitlist control data. In addition to the primary aims, an exploratory analysis is being conducted to investigate potential associations between exercise, athletic, and academic identities, and mental health issues.
- Conditions
- Depression, Anxiety, Stress, Psychological
- Being tested
- Moderate-Intensity Indoor Cycling Exercise
- Keywords
- Exercise Intervention
- Medical subject headings
- Depression, Anxiety Disorders, Stress, Psychological
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Moderate-Intensity Indoor Cycling ExerciseBehavioural
The 45-minute indoor cycling moderate-intensity cardiovascular exercise will take place once a week over four weeks. The group fitness-based class consists a 5-minute warm-up, a 35-minute conditioning segment, and a 5-minute cooldown.
| Study group | Role | What they receive |
|---|---|---|
| PAUSE-Cardio Moderate-Intensity Exercise Arm | Experimental | Arm receiving moderate-intensity indoor cycling exercise once weekly for 4 weeks. Receives: Behavioral: Moderate-Intensity Indoor Cycling Exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in combined depression, stress, and anxiety symptomatology scores
The Depression, Anxiety, and Stress Scale (DASS) utilizing 42 items on a 4-point Likert scale ranging from 0 to 3 (0=did not apply to me at all and 3=applied to me very much, or most of the time). Higher scores correlate with greater symptoms of depression, stress, and anxiety.
Measured: Baseline, Week 4
Secondary outcomes (3)
Change from baseline in academic identity scores
Academic Identity Measurement Scale, a 13-item measurement to investigate student identification with academics will be utilized. Each item will be scored on a 5-point Likert scale from 1 to 5 (1=strongly disagree and 5=strongly agree). Scores on the Academic Identity Measurement Scale were able to range from 13 to 65, with higher scores indicating greater identification with academics.
Measured: Baseline, Week 4
Change from baseline in athlete identity scores
The Athlete Identity Measurement Scale (AIMS) was utilized to understand varying degrees of athletic identity within participants. AIMS is a reliable 10-item measure at the forefront of athletic identity measurement. Participants will be asked to complete 7 items from the AIMS, representing participant goals, friendships, and thoughts surrounding the sport the participant plays. The measurement was scored on a 7-point Likert scale (1=strongly disagree and 7=strongly agree) and scores are able to range from 7 to 35. Higher scores on the AIMS are suggestive of greater sports identity.
Measured: Baseline, Week 4
Change from baseline in exercise identity scores
Participants responded to the full-form Exercise Identity Scale, a 9-item instrument used to measure one's identification with exercise as it related to the concept of self. Participants responded to the 9 items with a 7-point Likert scale (1=strongly disagree and 7=strongly agree) and scores were able to range from 9 to 45. Higher scores on the Exercise Identity Scale represented a greater identification with exercise in relation to one's concept of self.
Measured: Baseline, Week 4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Dec 2023
- Study start29 Jan 2024
- Primary completion25 Feb 2024
- Study completion25 Feb 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for DepressionStudies of the same condition, open and under way.
- More trials run by University of North Carolina, Chapel HillThe sponsor's other registered studies.
- 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
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of North Carolina, Chapel Hill
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Emily G Thomas, Principal investigator, University of North Carolina, Chapel Hill
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06182150
- Sponsor's protocol ID
- 23-0810
- Status last verified
- Feb 2024
- First submitted
- 11 Dec 2023
- Last updated
- 28 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Anderson DF, Cychosz CM. Development of an exercise identity scale. Percept Mot Skills. 1994 Jun;78(3 Pt 1):747-51. doi: 10.1177/003151259407800313.
PubMed 8084685Lochbaum M, Cooper S, Limp S. The Athletic Identity Measurement Scale: A Systematic Review with Meta-Analysis from 1993 to 2021. Eur J Investig Health Psychol Educ. 2022 Sep 14;12(9):1391-1414. doi: 10.3390/ejihpe12090097.
PubMed 36135235Lovibond PF, Lovibond SH. The structure of negative emotional states: comparison of the Depression Anxiety Stress Scales (DASS) with the Beck Depression and Anxiety Inventories. Behav Res Ther. 1995 Mar;33(3):335-43. doi: 10.1016/0005-7967(94)00075-u.
PubMed 7726811Osborne, J. W. (1997). Identification with Academics and Academic Success among Community College Students. Community College Review, 25(1), 59-67.
Qualtrics. (2013). Qualtrics (Version 37,892) [Computer software]. Provo, UT, USA
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PAUSE-Cardio: Mitigating Depression, Anxiety, and Stress Among Women's Sport Student- Athletes Through a Moderate-Intensity Exercise Intervention
- ClinicalTrials.gov ID
- NCT06182150
- Acronym / sponsor ID
- 23-0810
- Conditions
- Depression, Anxiety, Stress, Psychological
- Keywords
- Exercise Intervention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 5 participants (actual)
- Lead sponsor
- University of North Carolina, Chapel HillUniversity, hospital or other
- Study start
- 29 Jan 2024 (actual)
- Primary completion
- 25 Feb 2024 (actual)
- Study completion
- 25 Feb 2024 (actual)
- First posted
- 26 Dec 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 learn about moderate-intensity indoor cycling interventions in women's sport student-athletes transitioning into college and collegiate sport. The main question[s] it aims to answer are:
Aim 1: Establish preliminary feasibility for the intervention based on recruitment and retention rates.
Aim 2: Assess efficacy through comparison of pre- and post-intervention mental health outcomes scores between experimental and control groups.
Exploratory Aim 3: Explore associations between exercise, athletic, and academic identities and mental health issues post-intervention.
Participants will complete an online questionnaire. This online questionnaire will be given before the program begins and after the 4 weeks. The questionnaire will ask about the participants' basic information, the participants' experience with exercise, and the participants' transition experience including mental, physical, and social factors.
Participants will be asked to attend an in-person 45-minute exercise class once a week at the University of North Carolina at Chapel Hill (UNC) Student Recreation Center.
Participants enrolled in the program will be asked to complete a self-report form during each weekly practice including heart rate (before and after practice) and ratings of perceived exertion. Heart rate will be measured during practice, smart devices (i.e., Apple Watch, FitBit) are not required.
Detailed description
Purpose: The goal of this pilot study is to examine the relationship between mental health concerns (e.g., anxiety, depression, and stress) and PAUSE-Cardio, a 4-week moderate-intensity cardiovascular exercise intervention program for women's sport student-athletes transitioning into college and collegiate sport.
The investigators hypothesize that at least 70% of participants will be retained for the length of the intervention, including completion of the Qualtrics survey at T1 and T2. Additionally, the investigators hypothesize that symptoms of depression, anxiety, and stress will be significantly decreased post-intervention compared to pre-intervention following moderate-intensity exercise program completion.
Participants: Participants will consist of twenty-two women's sport student-athletes (N=22) ages 18 and older in the participants' first two years of undergraduate study. Participants must be actively practicing an intramural sport, club sport, varsity collegiate sport, or recreational sport.
Procedures: The study design will be a mixed-methods pilot study employing moderate-intensity cardiovascular exercise. Results will be assessed with a longitudinal self-report survey of valid and reliable psychometric measures and free response items. All measurements and questions will be compiled into one Qualtrics-based survey that will be administered two times (pre-program [T1] and post-program [T2]). Study-specific moderate-intensity exercise will be administered once weekly for four weeks in a group fitness setting for 45 minutes. The 45-minute class will consist of a 5-minute warm-up, a 35-minute conditioning segment, and a 5-minute cooldown. This multipart study is gathering data through a mixed-methods longitudinal design in conjunction with a prospective cohort design. Data collection is utilizing Qualtrics, an online survey platform, and administering PAUSE-Cardio, a 4-week moderate-intensity cardiovascular exercise intervention program. Individuals who are at least 18 years of age and self-identify as women's sport student-athletes within the participants' first two years of study in collegiate settings are invited to participate via social media, emails, flyers, and word of mouth. A self-report survey of valid and reliable psychometric quantitative measures and qualitative free-response items is being administered 4 weeks apart, pre-program (T1) and post-program (T2) to participants. The feasibility of the intervention program is being determined by examining recruitment and retention rates. To assess the preliminary efficacy of the intervention, within- and between-group comparisons are being conducted using aggregated data, including waitlist control data. In addition to the primary aims, an exploratory analysis is being conducted to investigate potential associations between exercise, athletic, and academic identities, and mental health issues.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| PAUSE-Cardio Moderate-Intensity Exercise Arm | Experimental | Behavioral: Moderate-Intensity Indoor Cycling ExerciseArm receiving moderate-intensity indoor cycling exercise once weekly for 4 weeks. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- first- or second-year undergraduate student
- current participation in women's intramural sport, club sport, varsity collegiate sport, or recreational sport
Key exclusion criteria (3 listed)
- individuals who did not meet the inclusion criteria
- those incapable of providing informed consent
- did not complete surveys at T1 and T2
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 |
|---|---|---|
| Moderate-Intensity Indoor Cycling ExerciseThe 45-minute indoor cycling moderate-intensity cardiovascular exercise will take place once a week over four weeks. The group fitness-based class consists a 5-minute warm-up, a 35-minute conditioning segment, and a 5-minute cooldown. | Behavioural | PAUSE-Cardio Moderate-Intensity Exercise Arm |
Primary outcome
Change from baseline in combined depression, stress, and anxiety symptomatology scores
Time frame: Baseline, Week 4
The Depression, Anxiety, and Stress Scale (DASS) utilizing 42 items on a 4-point Likert scale ranging from 0 to 3 (0=did not apply to me at all and 3=applied to me very much, or most of the time). Higher scores correlate with greater symptoms of depression, stress, and anxiety.
3 secondary outcomes
Change from baseline in academic identity scores
Time frame: Baseline, Week 4
Change from baseline in athlete identity scores
Time frame: Baseline, Week 4
Change from baseline in exercise identity scores
Time frame: Baseline, Week 4
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 28 Feb 2024.
- Background: PubMed 8084685Anderson DF, Cychosz CM. Development of an exercise identity scale. Percept Mot Skills. 1994 Jun;78(3 Pt 1):747-51. doi: 10.1177/003151259407800313.
- Background: PubMed 36135235Lochbaum M, Cooper S, Limp S. The Athletic Identity Measurement Scale: A Systematic Review with Meta-Analysis from 1993 to 2021. Eur J Investig Health Psychol Educ. 2022 Sep 14;12(9):1391-1414. doi: 10.3390/ejihpe12090097.
- Background: PubMed 7726811Lovibond PF, Lovibond SH. The structure of negative emotional states: comparison of the Depression Anxiety Stress Scales (DASS) with the Beck Depression and Anxiety Inventories. Behav Res Ther. 1995 Mar;33(3):335-43. doi: 10.1016/0005-7967(94)00075-u.
- BackgroundOsborne, J. W. (1997). Identification with Academics and Academic Success among Community College Students. Community College Review, 25(1), 59-67.
- BackgroundQualtrics. (2013). Qualtrics (Version 37,892) [Computer software]. Provo, UT, USA
- 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.
Emily G Thomas principal investigator
University of North Carolina, Chapel Hill
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Moderate-Intensity Indoor Cycling Exercise in people with Depression and Anxiety, run by University of North Carolina, Chapel Hill 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 2 inclusion and 3 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 28 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?
Change from baseline in combined depression, stress, and anxiety symptomatology scores (time frame: Baseline, Week 4). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06182150, which also lists 5 linked publications.
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 28 Feb 2024.