Clinical trial NCT06652503: The Student Wellness and Emotional Growth Resiliency (SWAG-R) Program
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Anxiety
Depression
Stress
Wellbeing
Quality of Life
Keywords: anxiety
depression
stress
wellbeing
quality of life
Lead sponsor: Nova Southeastern University
Sponsor class: OTHER
First posted: 2024-10-22
Enrollment: 160
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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)

Primary outcomes:
measure: Participant anxiety symptom severity
timeFrame: From enrollment up to 24 weeks
measure: Participant depression symptoms severity
timeFrame: From enrollment up to 24 weeks
measure: Participant difficulties with emotion regulation
timeFrame: From enrollment up to 24 weeks
measure: Participant Stress levels
timeFrame: From enrollment up to 24 weeks
measure: Participant Resiliency
timeFrame: From enrollment up to 24 weeks
measure: Participant quality of life and life satisfaction
timeFrame: From enrollment up to 24 weeks
measure: Participant adaptive coping
timeFrame: From enrollment up to 24 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Fort Lauderdale
country: United States
facility: Nova Southeastern University
state: Florida
Study officials:
affiliation: Nova Southeastern University
name: Kayla Thayer, Ph.D., ABPP
role: PRINCIPAL_INVESTIGATOR
References: