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Recruiting NCT07140718

The Fundamental Adaptive Skills Training

No phase Interventional Fundamental Adaptive Skills Training Relaxation and Mindfulness Training

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Fundamental Adaptive Skills Training, Relaxation and Mindfulness Training.
Who it may be relevant to
Registry conditions: Fundamental Adaptive Skills Training, Relaxation and Mindfulness Training. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

Piloting and Evaluating the Fundamental Adaptive Skills Training (FAST): a New Digitally Augmented Single-Session Transdiagnostic Resilience Intervention

Overview

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.

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.

Interventions

  • Behavioral Fundamental Adaptive Skills Training
    The FAST intervention will be approximately 60 minutes in duration. The video component of FAST, animated using the Vyond software, will be presented via computer or projector. Pause points and brief interactive exercises will be added throughout the presentation to promote engagement and ensure comprehension of FAST material. The treatment will be sectioned into thirds: a physical health section focused on sleep hygiene and physical activity, an anxiety sensitivity section dispelling common AS
  • Behavioral Relaxation and Mindfulness Training
    The RMT intervention will be primarily psychoeducational and focused on explaining relaxation methods used in various psychological treatments such as progressive muscle relaxation, guided imagery, and mindfulness-focused breathing exercises. Interactive relaxation and mindfulness exercises and brief discussions following each relaxation component will be included to control for time spent on interactive exercises in the FAST condition. The intervention will take approximately 60 minutes. Tailor

Primary outcome measures

  • Acceptability Questionnaire [Time frame: Post-intervention through week 4 follow up]
  • Athens Insomnia Scale [Time frame: Baseline through week 4 follow up]
  • Brief Physical Activity Assessment Tool [Time frame: Baseline through week 4 follow up]
  • Anxiety Sensitivity Index 3 [Time frame: Baseline through week 4 follow up]
  • UCLA Loneliness 10 [Time frame: Baseline through week 4 follow up]
  • PROMIS Anxiety Scale 8a [Time frame: Baseline through week 4 follow up]
  • PROMIS Depression 8b [Time frame: Baseline through week 4 follow up]
  • Perceived Stress Scale [Time frame: Baseline through week 4 follow up]
Secondary outcome measures (1)
  • Short Form 12 [Time frame: Baseline through week 4 follow up]

Eligibility criteria

Inclusion criteria

  • Aged 18+
  • At-risk for emotional disorders as indicated by a PANAS-NA Score >= 20
  • Ability to use a computer or smartphone
  • Currently enrolled at college/university at the time of study enrollment

Exclusion criteria

  • Adults aged 17 and under
  • PANAS-NA Score <= 19
  • Inability to use a computer or smartphone
  • Not currently enrolled at college/university at the time of study enrollment

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Treatment

Study locations

United States · 1 center
  • FSU Anxiety and Behavioral Health Clinic — Tallahassee

Identifiers

NCT: NCT07140718 · STUDY00006276

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗