- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06652503
The Student Wellness and Emotional Growth Resiliency (SWAG-R) Program (SWAG-R)
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
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Principal Investigator
- Phone Number: 954-262-5880
- Email: kthayer@nova.edu
Study Locations
-
-
Florida
-
Fort Lauderdale, Florida, United States, 33301
- Recruiting
- Nova Southeastern University
-
Contact:
- Principal Investigator
- Phone Number: 954-262-5880
- Email: kthayer@nova.edu
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Currently matriculating NSU undergraduate students (ages 18+)
Exclusion Criteria:
- Students who are not current NSU undergrads, participants aged 17 and younger, students who are currently enrolled in psychotherapy or mental health services, or students with acute mental health needs (e.g., psychosis, active alcohol or substance use problems, suicidality)
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Intervention Group
The coaching program will consist of (6) free, 60 minute online coaching sessions.
You will be assigned the same coach for the 6 weeks.
You 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.
|
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
Other Names:
|
|
No Intervention: Waitlist Group
Waitlist, no intervention group
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Participant anxiety symptom severity
Time Frame: From enrollment up to 24 weeks
|
GAD-7 (Generalized Anxiety Disorder 7 scale): GAD-7 total score for the seven items ranges from 0 to 21. 0-4: minimal anxiety 5-9: mild anxiety 10-14: moderate anxiety 15-21: severe anxiety |
From enrollment up to 24 weeks
|
|
Participant depression symptoms severity
Time Frame: From enrollment up to 24 weeks
|
PHQ-9 (Patient Health Questionnaire 9): Interpretation of Total Score 1-4 Minimal depression 5-9 Mild depression 10-14 Moderate depression 15-19 Moderately severe depression 20-27 Severe depression
|
From enrollment up to 24 weeks
|
|
Participant difficulties with emotion regulation
Time Frame: From enrollment up to 24 weeks
|
Difficulties in Emotion Regulation Scale (DERS): a 36-item self-report measure of six facets of emotion regulation.
Items are rated on a scale of 1 ("almost never [0-10%]") to 5 ("almost always [91-100%]").
Higher scores indicate greater difficulties in emotion regulation (i.e., greater emotion dysregulation).
|
From enrollment up to 24 weeks
|
|
Participant Stress levels
Time Frame: From enrollment up to 24 weeks
|
Perceived Stress Scale: Individual scores on the PSS can range from 0 to 40 with higher scores indicating higher perceived stress. Scores ranging from 0-13 would be considered low stress. Scores ranging from 14-26 would be considered moderate stress. Scores ranging from 27-40 would be considered high perceived stress. |
From enrollment up to 24 weeks
|
|
Participant Resiliency
Time Frame: From enrollment up to 24 weeks
|
Brief Resiliency Scale: Scoring: Add the responses varying from 1-5 for all six items giving a range from 6-30.
Divide the total sum by the total number of questions answered.
Higher scores indicate greater resiliency.
|
From enrollment up to 24 weeks
|
|
Participant quality of life and life satisfaction
Time Frame: From enrollment up to 24 weeks
|
WHOQOL-BREF (World Health Organization Quality of Life Brief Inventory): contains 26 items and addresses 4 QOL domains: physical health (7 items), psychological health (6 items), social relationships (3 items) and environment (8 items). Two other items measure overall QOL and general health. Items are rated on a 5-point Likert scale (low score of 1 to high score of 5) to determine a raw item score. Subsequently, the mean score for each domain is calculated, resulting in a mean score per domain that is between 4 and 20. Finally, this mean domain score is then multiplied by 4 in order to transform the domain score into a scaled score, with a higher score indicating a higher QOL. |
From enrollment up to 24 weeks
|
|
Participant adaptive coping
Time Frame: From enrollment up to 24 weeks
|
Brief Cope Inventory: Scales are computed as follows (with no reversals of coding): Self-distraction, items 1 and 19 Active coping, items 2 and 7 Denial, items 3 and 8 Substance use, items 4 and 11 Use of emotional support, items 5 and 15 Use of instrumental support, items 10 and 23 Behavioral disengagement, items 6 and 16 Venting, items 9 and 21 Positive reframing, items 12 and 17 Planning, items 14 and 25 Humor, items 18 and 28 Acceptance, items 20 and 24 Religion, items 22 and 27 Self-blame, items 13 and 26 Minimum scores on sub scales =2, maximum scores = 8 with higher scores indicating greater reliance on that type of coping. |
From enrollment up to 24 weeks
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Kayla Thayer, Ph.D., ABPP, Nova Southeastern University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2024-197-NSU
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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