Ignite Creation Date:
2025-12-25 @ 5:01 AM
Ignite Modification Date:
2025-12-26 @ 4:02 AM
Study NCT ID:
NCT07140718
Status:
RECRUITING
Last Update Posted:
2025-10-24
First Post:
2025-08-22
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
The Fundamental Adaptive Skills Training
Sponsor:
Florida State University
Organization:
Study Overview
Official Title:
Piloting and Evaluating the Fundamental Adaptive Skills Training (FAST): a New Digitally Augmented Single-Session Transdiagnostic Resilience Intervention
Status:
RECRUITING
Status Verified Date:
2025-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
FAST
Brief Summary:
The present study seeks to develop, refine, and test a novel psychological treatment for boosting mental health resilience among college students. This Fundamental Adaptive Skills Training (FAST) will be evaluated in a randomized controlled trial. We will seek to recruit 5 undergraduate students as participants for a pilot phase and 100 undergraduate students for a randomized controlled trial. The primary questions we are seeking to answer in this trial are:
Do participants rate the FAST intervention as acceptable? Does FAST improve sleep quality, physical activity, anxiety sensitivity, loneliness, and social isolation for college students?
Participants will:
Receive the active FAST or a placebo control Relaxation and Mindfulness Training (RMT) and will complete measures at baseline, week 2, and week 4.
Do participants rate the FAST intervention as acceptable? Does FAST improve sleep quality, physical activity, anxiety sensitivity, loneliness, and social isolation for college students?
Participants will:
Receive the active FAST or a placebo control Relaxation and Mindfulness Training (RMT) and will complete measures at baseline, week 2, and week 4.
Detailed Description:
The mental health crisis among college students has intensified in recent years, with rising rates of anxiety, depression, and stress. Despite increased institutional efforts, existing mental health services often remain inaccessible or insufficient. The present study proposes and evaluates the Fundamental Adaptive Skills Training (FAST), a novel, single-session intervention designed to promote mental health resilience in college students. FAST will be developed to target empirically supported mechanisms-sleep and physical activity, anxiety sensitivity, loneliness, and social isolation-each linked to a broad range of emotional disorders. Delivered in a digital, group-based format by trained undergraduate peer facilitators, FAST will be scalable, cost-effective, and engaging. This randomized controlled trial will assess the intervention's acceptability and efficacy in improving targeted mechanisms and reducing symptoms of anxiety, depression, and stress over a four-week follow-up period. 100 participants identified as at-risk based on elevated negative affectivity will be randomly assigned to FAST or an active control condition involving mindfulness and relaxation training (RMT). Primary outcomes include improvements in sleep quality, physical activity, anxiety sensitivity, loneliness, and social isolation from baseline through week two and week four follow-up. Similarly, clinical outcomes will include improvements in anxiety, depression, and stress levels as indicators of broader emotional resilience. Findings will advance the science of developing and implementing accessible, evidence-based mental health interventions and may contribute to a novel, scalable solution for addressing mental health issues in higher education settings.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: