AnxietySWAG-RNCT06652503
The Student Wellness and Emotional Growth Resiliency (SWAG-R) Program
A study testing online mental health coaching in people with Anxiety and Depression, run by Nova Southeastern University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Anxiety, Depression, Stress
- What is being tested?
- online mental health coaching
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 160 participants
- Where
- 1 siteUnited States
- Study dates
- 13 Jan 2025to Sep 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Currently matriculating NSU undergraduate students (ages 18+)
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Nova Southeastern University
Fort Lauderdale, Florida, 33301
Principal Investigator, 954-262-5880, kthayer@nova.edu
About this study
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
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.
Read the 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.
- Conditions
- Anxiety, Depression, Stress, Wellbeing, Quality of Life
- Being tested
- online mental health coaching
- Keywords
- anxiety, depression, stress, wellbeing, quality of life
- Medical subject headings
- Anxiety Disorders, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
online mental health coachingBehavioural
Also called SWAG-R Coaching Program
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 group | Role | What they receive |
|---|---|---|
| Intervention Group | Experimental | 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. Receives: Behavioral: online mental health coaching |
| Waitlist Group | No intervention | Waitlist, no intervention group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Participant anxiety symptom severity
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
Measured: From enrollment up to 24 weeks
Participant depression symptoms severity
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
Measured: From enrollment up to 24 weeks
Participant difficulties with emotion regulation
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).
Measured: From enrollment up to 24 weeks
Participant Stress levels
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.
Measured: From enrollment up to 24 weeks
Participant Resiliency
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.
Measured: From enrollment up to 24 weeks
Participant quality of life and life satisfaction
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.
Measured: From enrollment up to 24 weeks
Participant adaptive coping
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.
Measured: From enrollment up to 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2024
- Study start13 Jan 2025
- Primary completionAug 2026 (estimated)
- Study completionSep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnxietyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 160 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nova Southeastern University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Kayla Thayer, Ph.D., ABPP, Principal investigator, Nova Southeastern University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06652503
- Sponsor's protocol ID
- 2024-197-NSU
- Acronym
- SWAG-R
- Status last verified
- Dec 2025
- First submitted
- 14 Oct 2024
- Last updated
- 12 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All collected IDP in aggregate with the exception of any identifying participant data (i.e., participant names).
Study at a glance
From the registry record, last updated by the sponsor on 12 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06652503
- Acronym / sponsor ID
- SWAG-R / 2024-197-NSU
- Conditions
- Anxiety, Depression, Stress, Wellbeing, Quality of Life
- Keywords
- anxiety, depression, stress, wellbeing, quality of life
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 160 participants (estimated)
- Lead sponsor
- Nova Southeastern UniversityUniversity, hospital or other
- Study start
- 13 Jan 2025 (actual)
- Primary completion
- Aug 2026 (estimated)
- Study completion
- Sep 2026 (estimated)
- First posted
- 22 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention Group | Experimental | Behavioral: online mental health coachingThe 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. |
| Waitlist Group | No intervention | –Waitlist, no intervention group |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Currently matriculating NSU undergraduate students (ages 18+)
Key exclusion criteria (1 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| online mental health coachingAlso: SWAG-R Coaching ProgramSWAG-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 | Behavioural | Intervention Group |
Primary outcome
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
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
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).
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.
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.
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.
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Dec 2025.
- Individual participant dataSharing planned: Yes. All collected IDP in aggregate with the exception of any identifying participant data (i.e., participant names).
Related trials for Anxiety
Not yet recruiting
Effect of Stress Ball Use During Femoral Arterial Sheath Removal After Coronary Angiography
Femoral Arterial Sheath Removal, Stress Ball
Recruiting
Unified Protocol in Penitentiary Facilities
Depression Disorders, Anxiety
Not yet recruiting
Preventive and Personalized Digital Emotion Regulation Skills Intervention to Reduce Depression and Anxiety in Youths With Adverse Childhood Experiences
Adverse Childhood Experience, Depression / Major Depressive Disorder
Recruiting
Effect of a Brief Daily Digital Meditation on Well-Being in US Young Adults (BEGIN II)
Mental Health and General Well-being
Not yet recruitingObservational study
Functional Impact of Psychological Symptoms in Patients With Superior Semicircular Canal Dehiscence Syndrome (SSCD): a National Cross-sectional Study
Superior Semicircular Canal Dehiscence
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Kayla Thayer, Ph.D., ABPP principal investigator
Nova Southeastern University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing online mental health coaching in people with Anxiety and Depression, run by Nova Southeastern University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 12 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Principal Investigator (954-262-5880, kthayer@nova.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Participant anxiety symptom severity (time frame: From enrollment up to 24 weeks). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Dec 2025.