跳至主要内容
临床试验/NCT07140718
NCT07140718招募中不适用

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

Florida State University2 个研究点 分布在 1 个国家目标入组 105 人开始时间: 2025年9月20日最近更新:
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
105
试验地点
2
主要终点
Acceptability Questionnaire

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Participant)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • 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

研究组 & 干预措施

Fundamental Adaptive Skills Training

Experimental

干预措施: Fundamental Adaptive Skills Training (Behavioral)

Relaxation and Mindfulness Training

Active Comparator

干预措施: Relaxation and Mindfulness Training (Behavioral)

结局指标

主要结局

Acceptability Questionnaire

时间窗: Post-intervention through week 4 follow up

Self report measure indexing intervention acceptability. Scores range from 0 to 27 with higher scores indicating more favorable acceptability.

Athens Insomnia Scale

时间窗: Baseline through week 4 follow up

8 item self report measure of sleep quality. Scores range from 0 to 24 with higher scores indicating more severe sleep problems.

Brief Physical Activity Assessment Tool

时间窗: Baseline through week 4 follow up

2 item self report measure indexing physical activity. Scores range from 0 to 8 with higher scores indicating more frequent engagement in physical activity.

Anxiety Sensitivity Index 3

时间窗: Baseline through week 4 follow up

18 item self report measure indexing anxiety sensitivity. Scores range from 0 to 72 with higher scores indicating more severe anxiety sensitivity.

UCLA Loneliness 10

时间窗: Baseline through week 4 follow up

10 item self-report measure indexing loneliness. Scores range from 10 to 40 with higher scores indicating more severe loneliness symptoms.

PROMIS Anxiety Scale 8a

时间窗: Baseline through week 4 follow up

8 item self report measure of anxiety. Scores range from 8 to 40 with higher scores indicating more severe anxiety symptoms.

PROMIS Depression 8b

时间窗: Baseline through week 4 follow up

8 item self report measure indexing depression. Scores range from 8 to 40 with higher scores indicating more severe depression symptoms

Perceived Stress Scale

时间窗: Baseline through week 4 follow up

14 item self report measure indexing stress. Scores range from 0 to 56 with higher scores reflecting more severe stress symptoms.

Acceptability Questionnaire

时间窗: Post-intervention through week 4 follow up

Self report measure indexing intervention acceptability. Scores range from 0 to 27 with higher scores indicating more favorable acceptability.

Athens Insomnia Scale

时间窗: Baseline through week 4 follow up

8 item self report measure of sleep quality. Scores range from 0 to 24 with higher scores indicating more severe sleep problems.

Brief Physical Activity Assessment Tool

时间窗: Baseline through week 4 follow up

2 item self report measure indexing physical activity. Scores range from 0 to 8 with higher scores indicating more frequent engagement in physical activity.

Anxiety Sensitivity Index 3

时间窗: Baseline through week 4 follow up

18 item self report measure indexing anxiety sensitivity. Scores range from 0 to 72 with higher scores indicating more severe anxiety sensitivity.

UCLA Loneliness 10

时间窗: Baseline through week 4 follow up

10 item self-report measure indexing loneliness. Scores range from 10 to 40 with higher scores indicating more severe loneliness symptoms.

PROMIS Anxiety Scale 8a

时间窗: Baseline through week 4 follow up

8 item self report measure of anxiety. Scores range from 8 to 40 with higher scores indicating more severe anxiety symptoms.

PROMIS Depression 8b

时间窗: Baseline through week 4 follow up

8 item self report measure indexing depression. Scores range from 8 to 40 with higher scores indicating more severe depression symptoms

Perceived Stress Scale

时间窗: Baseline through week 4 follow up

14 item self report measure indexing stress. Scores range from 0 to 56 with higher scores reflecting more severe stress symptoms.

次要结局

  • Short Form 12(Baseline through week 4 follow up)
  • Short Form 12(Baseline through week 4 follow up)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Norman Schmidt

Distinguished Research Professor

Florida State University

研究点 (2)

Loading locations...

相似试验