Mitigating Mental Health Issues Among Women's Sport Student-Athletes Through a Moderate-Intensity Exercise Intervention

Depression Clinical Trial

Official title:

PAUSE-Cardio: Mitigating Depression, Anxiety, and Stress Among Women's Sport Student- Athletes Through a Moderate-Intensity Exercise Intervention

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06182150
• Other study ID #: 23-0810
• Status: Completed
• Phase: N/A
• Start date: January 29, 2024
• Est. completion date: February 25, 2024

Study information

• Verified date: February 2024
• Source: University of North Carolina, Chapel Hill
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 5
• Est. completion date: February 25, 2024
• Est. primary completion date: February 25, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Anxiety
• Depression
• Stress, Psychological

Intervention

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.

Locations

Country	Name	City	State
United States	UNC Student Recreation Center	Chapel Hill	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
University of North Carolina, Chapel Hill

Country where clinical trial is conducted

United States, 

References & 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. — View Citation

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. — View Citation

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. — View Citation

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

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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