Ignite Creation Date:
2025-12-24 @ 7:32 PM
Ignite Modification Date:
2025-12-25 @ 5:14 PM
Study NCT ID:
NCT06652503
Status:
RECRUITING
Last Update Posted:
2025-12-12
First Post:
2024-10-14
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
The Student Wellness and Emotional Growth Resiliency (SWAG-R) Program
Sponsor:
Nova Southeastern University
Organization:
Study Overview
Official Title:
The Student Wellness and Emotional Growth Resiliency (SWAG-R) Program: A 6-week Coaching Program Designed For NSU Undergraduate Students to Decrease Anxiety, Depression, and Stress and Improve Mental Health, Quality of Life, and Resiliency
Status:
RECRUITING
Status Verified Date:
2025-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
SWAG-R
Brief Summary:
The purpose of this research study is to provide a free 6-week, online psychological coaching program to NSU undergraduate students to help with anxiety, depression, and stress, while improving quality of life and healthy coping skills.
Detailed Description:
* All study participants will first complete a study pre-screen over the phone with a study team member. This screening will take 10-15 minutes.
* If participants are eligible to participate in the study, participants will be verbally guided through the Informed Consent form to determine if participants have any questions. This phone call will take approximately 10 minutes.
* Participants will then be electronically sent the Informed Consent form for participant review and to complete and sign, if participants would like to participate in the study.
* Once investigators receive the signed Informed Consent document, participants will be assigned a unique Study Identification Number and first assessment measures will be sent to complete (Time Point 1). This assessment will be completed electronically at participant convenience.
* Participants will then be randomly assigned to either start the free 6-week online coaching program OR will be randomly assigned to the waitlist for 6 weeks. Participants have an equal chance of being offered the coaching program right away or being put on the waitlist.
* The coaching program will consist of (6) free, 60 minute online coaching sessions. Participants will be assigned the same coach for the 6 weeks. Participants can coordinate schedule day/time preferences as the sessions will be done through HIPAA Zoom. Everyone in the study will get the same coaching topics in the same order.
* 6 weeks later, participants will complete another assessment (Time Point 2). This assessment will be completed electronically at participant convenience.
* If participants were on the waitlist, these participants can now start the free 6 week online coaching program, if participants would like. Participants are not obligated to participate but will be offered the program.
* If participants already completed the 6 week online coaching program, participants will not have any other coaching sessions during this time.
* 6 weeks later, participants will complete another assessment (Time Point 3). This assessment will be completed electronically at participant convenience.
* 6 weeks later, participants will complete another assessment (Time Point 4). This assessment will be completed electronically at participant convenience.
* If participants are eligible to participate in the study, participants will be verbally guided through the Informed Consent form to determine if participants have any questions. This phone call will take approximately 10 minutes.
* Participants will then be electronically sent the Informed Consent form for participant review and to complete and sign, if participants would like to participate in the study.
* Once investigators receive the signed Informed Consent document, participants will be assigned a unique Study Identification Number and first assessment measures will be sent to complete (Time Point 1). This assessment will be completed electronically at participant convenience.
* Participants will then be randomly assigned to either start the free 6-week online coaching program OR will be randomly assigned to the waitlist for 6 weeks. Participants have an equal chance of being offered the coaching program right away or being put on the waitlist.
* The coaching program will consist of (6) free, 60 minute online coaching sessions. Participants will be assigned the same coach for the 6 weeks. Participants can coordinate schedule day/time preferences as the sessions will be done through HIPAA Zoom. Everyone in the study will get the same coaching topics in the same order.
* 6 weeks later, participants will complete another assessment (Time Point 2). This assessment will be completed electronically at participant convenience.
* If participants were on the waitlist, these participants can now start the free 6 week online coaching program, if participants would like. Participants are not obligated to participate but will be offered the program.
* If participants already completed the 6 week online coaching program, participants will not have any other coaching sessions during this time.
* 6 weeks later, participants will complete another assessment (Time Point 3). This assessment will be completed electronically at participant convenience.
* 6 weeks later, participants will complete another assessment (Time Point 4). This assessment will be completed electronically at participant convenience.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: