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

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.

Study Overview

• Status: Completed
• Conditions: Depression; Stress, Psychological; Anxiety
• Intervention / Treatment: Behavioral: Moderate-Intensity Indoor Cycling Exercise

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 Type: Interventional
• Enrollment (Actual): 5
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • North Carolina
    • Chapel Hill, North Carolina, United States, 27516
      • UNC Student Recreation Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• first- or second-year undergraduate student
• current participation in women's intramural sport, club sport, varsity collegiate sport, or recreational sport

Exclusion Criteria:

• individuals who did not meet the inclusion criteria
• those incapable of providing informed consent
• did not complete surveys at T1 and T2

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: PAUSE-Cardio Moderate-Intensity Exercise Arm; Arm receiving moderate-intensity indoor cycling exercise once weekly for 4 weeks.	Behavioral: Moderate-Intensity Indoor Cycling Exercise; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	Baseline, Week 4

Collaborators and Investigators

• Sponsor: University of North Carolina, Chapel Hill
• Investigators: Principal Investigator: Emily G Thomas, University of North Carolina, Chapel Hill

Publications and helpful links

General Publications

• Lovibond 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.
• 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.
• Osborne, 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
• Lochbaum 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.

Study record dates

Study Major Dates

• Study Start (Actual): January 29, 2024
• Primary Completion (Actual): February 25, 2024
• Study Completion (Actual): February 25, 2024

Study Registration Dates

• First Submitted: December 11, 2023
• First Submitted That Met QC Criteria: December 12, 2023
• First Posted (Actual): December 26, 2023

Study Record Updates

• Last Update Posted (Estimated): February 28, 2024
• Last Update Submitted That Met QC Criteria: February 26, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: Exercise Intervention
• Additional Relevant MeSH Terms: Behavioral Symptoms; Depression; Stress, Psychological
• Other Study ID Numbers: 23-0810

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No