Mitigating Mental Health Issues Among Women's Sport Student-Athletes Through a Moderate-Intensity Exercise Intervention
PAUSE-Cardio: Mitigating Depression, Anxiety, and Stress Among Women's Sport Student- Athletes Through a Moderate-Intensity Exercise Intervention
1 other identifier
interventional
5
1 country
1
Brief 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. 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable depression
Started Jan 2024
Shorter than P25 for not_applicable depression
1 active site
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
First Submitted
Initial submission to the registry
December 11, 2023
CompletedFirst Posted
Study publicly available on registry
December 26, 2023
CompletedStudy Start
First participant enrolled
January 29, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 25, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
February 25, 2024
CompletedFebruary 28, 2024
February 1, 2024
27 days
December 11, 2023
February 26, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
Baseline, Week 4
Secondary Outcomes (3)
Change from baseline in academic identity scores
Baseline, Week 4
Change from baseline in athlete identity scores
Baseline, Week 4
Change from baseline in exercise identity scores
Baseline, Week 4
Study Arms (1)
PAUSE-Cardio Moderate-Intensity Exercise Arm
EXPERIMENTALArm receiving moderate-intensity indoor cycling exercise once weekly for 4 weeks.
Interventions
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.
Eligibility Criteria
You may qualify if:
- first- or second-year undergraduate student
- current participation in women's intramural sport, club sport, varsity collegiate sport, or recreational sport
You may not qualify if:
- those incapable of providing informed consent
- did not complete surveys at T1 and T2
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
UNC Student Recreation Center
Chapel Hill, North Carolina, 27516, United States
Related Publications (5)
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.
PMID: 8084685BACKGROUNDLochbaum 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.
PMID: 36135235BACKGROUNDLovibond 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.
PMID: 7726811BACKGROUNDOsborne, 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
BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Emily G Thomas
University of North Carolina, Chapel Hill
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 11, 2023
First Posted
December 26, 2023
Study Start
January 29, 2024
Primary Completion
February 25, 2024
Study Completion
February 25, 2024
Last Updated
February 28, 2024
Record last verified: 2024-02
Data Sharing
- IPD Sharing
- Will not share