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Набор скоро начнётся NCT07737821

Improv Comedy to Reduce Anxiety and Improve Mental Well-Being in Young Chinese Adults in Hong Kong

Без фазы С лечением Anxiety Mental Health

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: Improv Against Anxiety (IAA).
Кому может быть актуально
Состояния в реестре: Anxiety, Mental Health. Базовые параметры: 18 лет — 29 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
Гонконг
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
Официальное название

An Improv Comedy Intervention to Reduce Anxiety and Enhance Mental Well-Being in Chinese Emerging Adults in Hong Kong: A Randomized Controlled Trial

Обзор

The goal of this clinical trial is to learn if improv comedy helps reduce anxiety symptoms and improve mental well-being in Chinese young adults in Hong Kong. The main questions it aims to answer are: 1. Does improv comedy reduce anxiety symptoms? 2. Does improv comedy improve mental well-being? Researchers will compare participants who join the improv comedy workshops to participants who are placed on a waiting list to receive the workshops later, to see if improv comedy reduces anxiety and improves mental well-being. Participants will: 1. Attend weekly three-hour improv comedy workshops for 4 consecutive weeks 2. Complete four assessments and brief reflections during or around the workshop sessions 3. Take part in up to two individual interviews (optional)

Вмешательства

  • Поведенческое Improv Against Anxiety (IAA)
    Improv Against Anxiety (IAA) is a structured, group-based improv comedy program consisting of four weekly 3-hour sessions. Sessions use established improv games and exercises to reduce anxiety symptoms and enhance mental well-bein

Первичные конечные точки

  • Mean change from baseline in anxiety symptoms measured by the GAD-7 at Week 2, Week 4, and Week 6 [Срок оценки: Baseline (pre-intervention), Week 2 (mid-treatment), Week 4 (post-intervention), and Week 6 (2-week follow-up)]
  • Mean change from baseline in mental well-being measured by the WHO-5 at Week 2, Week 4, and Week 6 [Срок оценки: Baseline (pre-intervention), Week 2 (mid-treatment), Week 4 (post-intervention), and Week 6 (2-week follow-up)]
Вторичные конечные точки (12)
  • Mean change from baseline in depression symptoms measured by the PHQ-9 at Week 2, Week 4, and Week 6 [Срок оценки: Baseline (pre intervention), Week 2 (mid treatment), Week 4 (post intervention), and Week 6 (2 week follow up)]
  • Mean change from baseline in worry measured by the PSWQ-A at Week 2, Week 4, and Week 6 [Срок оценки: Baseline (pre intervention), Week 2 (mid treatment), Week 4 (post intervention), and Week 6 (2 week follow up)]
  • Mean change from baseline in sleep disturbance measured by the ISI at Week 2, Week 4, and Week 6 [Срок оценки: Baseline (pre intervention), Week 2 (mid treatment), Week 4 (post intervention), and Week 6 (2 week follow up)]
  • Mean change from baseline in perceived stress measured by the PSS-4 at Week 2, Week 4, and Week 6 [Срок оценки: Baseline (pre intervention), Week 2 (mid treatment), Week 4 (post intervention), and Week 6 (2 week follow up)]
  • Mean changes from baseline in positive and negative affect measured by the I-PANAS-SF at Week 2, Week 4, and Week 6 [Срок оценки: Baseline (pre intervention), Week 2 (mid treatment), Week 4 (post intervention), and Week 6 (2 week follow up)]
  • Mean change from baseline in loneliness measured by the ULS-6 at Week 2, Week 4, and Week 6 [Срок оценки: Baseline (pre intervention), Week 2 (mid treatment), Week 4 (post intervention), and Week 6 (2 week follow up)]
  • Mean change from baseline in self-esteem measured by the RSES at Week 2, Week 4, and Week 6 [Срок оценки: Baseline (pre intervention), Week 2 (mid treatment), Week 4 (post intervention), and Week 6 (2 week follow up)]
  • Mean change from baseline in intolerance of uncertainty measured by the IUS-12 at Week 2, Week 4, and Week 6 [Срок оценки: Baseline (pre intervention), Week 2 (mid treatment), Week 4 (post intervention), and Week 6 (2 week follow up)]
  • Mean change from baseline in maximization tendency measured by the MTS-7 at Week 2, Week 4, and Week 6 [Срок оценки: Baseline (pre intervention), Week 2 (mid treatment), Week 4 (post intervention), and Week 6 (2 week follow up)]
  • Mean change from baseline in fear of negative evaluation measured by the BFNE-S at Week 2, Week 4, and Week 6 [Срок оценки: Baseline (pre intervention), Week 2 (mid treatment), Week 4 (post intervention), and Week 6 (2 week follow up)]
  • Mean change from baseline in playfulness measured by the APTS-CN at Week 2, Week 4, and Week 6 [Срок оценки: Baseline (pre intervention), Week 2 (mid treatment), Week 4 (post intervention), and Week 6 (2 week follow up)]
  • Mean change from baseline in openness to experience measured by the CBF-PI-B at Week 2, Week 4, and Week 6 [Срок оценки: Baseline (pre intervention), Week 2 (mid treatment), Week 4 (post intervention), and Week 6 (2 week follow up)]

Критерии участия

Критерии включения

  • Ethnic Chinese, fluent in spoken Mandarin and able to read Chinese
  • Never married and without children
  • No current or past diagnosis of any mental disorder (e.g. anxiety disorders, depressive disorders, bipolar disorder, psychotic disorders)
  • Mild to moderate anxiety symptoms (defined as a GAD-7 total score between 5 and 14)
  • No prior experience of formal performance training in drama
  • Availability to attend at least 3 out of 4 weekly sessions over the 4-week intervention period upon enrolment

Критерии исключения

  • Unstable or severe chronic physical illness that would contraindicate participation in group activities or light-to-moderate physical movement (e.g., uncontrolled hypertension, severe asthma, acute cardiovascular events within the past 6 months)
  • Moderately severe to severe depression symptoms (defined as a PHQ-9 total score greater than 14)
  • Suicidal ideation (defined as a score greater than 0 on item 9 of the PHQ-9)
  • Potential risky drinking behavior (defined as AUDIT-C total score greater than 4)

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

Гонконг · 1 центр
  • Centre on Behavioral Health, The University of Hong Kong — Гонконг

Идентификаторы

NCT: NCT07737821 · EA260474

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗