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Идёт набор NCT07140718

The Fundamental Adaptive Skills Training

Без фазы С лечением Fundamental Adaptive Skills Training Relaxation and Mindfulness Training

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Fundamental Adaptive Skills Training, Relaxation and Mindfulness Training.
Кому может быть актуально
Состояния в реестре: Fundamental Adaptive Skills Training, Relaxation and Mindfulness Training. Базовые параметры: от 18 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
США
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

  • Поведенческое 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
  • Поведенческое 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

Первичные конечные точки

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

Критерии участия

Критерии включения

  • 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

Критерии исключения

  • 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Рандомизированное
Модель
Параллельные группы
Маскирование
Простое слепое
Основная цель
Лечение

Центры проведения

США · 1 центр
  • FSU Anxiety and Behavioral Health Clinic — Tallahassee

Идентификаторы

NCT: NCT07140718 · STUDY00006276

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗