Ignite Creation Date:
2024-10-26 @ 3:43 PM
Last Modification Date:
2024-10-26 @ 3:43 PM
Study NCT ID:
NCT06652503
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-10-14
Brief Title:
The Student Wellness and Emotional Growth Resiliency SWAG-R Program
Sponsor:
None
Organization:
None
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:
NOT_YET_RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
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 daytime 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 daytime 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:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None