NCT06652503

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
160

participants targeted

Target at P75+ for not_applicable anxiety

Timeline
4mo left

Started Jan 2025

Typical duration for not_applicable anxiety

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress80%
Jan 2025Sep 2026

First Submitted

Initial submission to the registry

October 14, 2024

Completed
8 days until next milestone

First Posted

Study publicly available on registry

October 22, 2024

Completed
3 months until next milestone

Study Start

First participant enrolled

January 13, 2025

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2026

Expected
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2026

Last Updated

December 12, 2025

Status Verified

December 1, 2025

Enrollment Period

1.5 years

First QC Date

October 14, 2024

Last Update Submit

December 5, 2025

Conditions

Keywords

anxietydepressionstresswellbeingquality of life

Outcome Measures

Primary Outcomes (7)

  • 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

    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

    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).

    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.

    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.

    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.

    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.

    From enrollment up to 24 weeks

Study Arms (2)

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.

Behavioral: online mental health coaching

Waitlist Group

NO INTERVENTION

Waitlist, no intervention group

Interventions

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

Also known as: SWAG-R Coaching Program
Intervention Group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Currently matriculating NSU undergraduate students (ages 18+)

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Nova Southeastern University

Fort Lauderdale, Florida, 33301, United States

RECRUITING

MeSH Terms

Conditions

Anxiety DisordersDepression

Condition Hierarchy (Ancestors)

Mental DisordersBehavioral SymptomsBehavior

Study Officials

  • Kayla Thayer, Ph.D., ABPP

    Nova Southeastern University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Principal Investigator

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 14, 2024

First Posted

October 22, 2024

Study Start

January 13, 2025

Primary Completion (Estimated)

August 1, 2026

Study Completion (Estimated)

September 1, 2026

Last Updated

December 12, 2025

Record last verified: 2025-12

Data Sharing

IPD Sharing
Will share

All collected IDP in aggregate with the exception of any identifying participant data (i.e., participant names).

Locations