Меню
Идёт набор NCT05319509

Pilot Study of Virtual Reality Therapy for Students With Anxiety

Без фазы С лечением Anxiety

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: gameChange.
Кому может быть актуально
Состояния в реестре: Anxiety. Базовые параметры: 18 лет — 30 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 →

Не всё понятно в терминах? Прочитайте наш гид для пациентов →

Обзор

The purpose of this study is to assess changes in self-reported anxiety over the course of six virtual reality (VR) sessions and to assess changes in academic self-efficacy, as well as examine the feasibility and acceptability of a relatively short and time intensive VR intervention (i.e.,six sessions over the course of three weeks) for reducing anxiety symptoms in college students.

Вмешательства

  • Устройство gameChange
    Staff will explain the rationale behind gameChange, and briefly explain the different scenarios: a doctor's office, a waiting room, a pub, a café, a grocery store, a public street and a bus. Each scenario contains five levels, each increasing with anxiety stimuli and certain tasks the participant must complete. The participant will put on the Oculus headset, and go through a preliminary orientation game. The headset will be casted to an external monitor. Once they start gameChange, it will take

Первичные конечные точки

  • Change in state anxiety as assessed by the Liebowitz Social Anxiety Scale-Self Report version (LSAS-SR) [Срок оценки: before first session in week 1, before third session in week 2 and before sixth session in week 3]
  • Change in depressive symptoms as assessed by score on the Patient Health Questionnaire-4 (PHQ-4) [Срок оценки: Baseline(before the first session in week 1)]
  • Change in anxiety related behaviors such as rate of speech [Срок оценки: Week 1(session1 and session 2), week 2( session 3 and session 4), week 3 (session 5 and session 6)]
  • Change in anxiety related behaviors such as volume of speech [Срок оценки: Week 1(session1 and session 2), week 2( session 3 and session 4), week 3 (session 5 and session 6)]
  • Change in anxiety related behaviors such as Negative self-talk [Срок оценки: Week 1(session1 and session 2), week 2( session 3 and session 4), week 3 (session 5 and session 6)]
  • Change in anxiety related behaviors such as Utterances about experience [Срок оценки: Week 1(session1 and session 2), week 2( session 3 and session 4), week 3 (session 5 and session 6)]
  • Change in anxiety related behaviors such as Laughter [Срок оценки: Week 1(session1 and session 2), week 2( session 3 and session 4), week 3 (session 5 and session 6)]
  • Change in Psychomotor agitation such as pacing [Срок оценки: Week 1(session1 and session 2), week 2( session 3 and session 4), week 3 (session 5 and session 6)]
  • Change in Psychomotor agitation such as Fidgeting [Срок оценки: Week 1(session1 and session 2), week 2( session 3 and session 4), week 3 (session 5 and session 6)]
  • Change in Psychomotor agitation such as Rubbing hands/neck/head [Срок оценки: Week 1(session1 and session 2), week 2( session 3 and session 4), week 3 (session 5 and session 6)]
Вторичные конечные точки (4)
  • Change in self-reported academic performance as assessed by the Motivated Strategies for Learning Questionnaire (MSLQ) [Срок оценки: before first session in week 1, before third session in week 2 and before sixth session in week 3]
  • change in feasibility as assessed by the rating on a short questionnaire [Срок оценки: after the third session in week 2 , after sixth session in week 3]
  • Change in acceptability as assessed by the rating on a short questionnaire [Срок оценки: after the third session in week 2 , after sixth session in week 3]
  • Change in perceived presence in the virtual environment (as indicated by continuous score on the Igroup Presence Questionnaire (IPQ) [Срок оценки: after the third session in week 2 and the sixth session in week 3]

Критерии участия

Критерии включения

  • enrolled in The University of Texas Health Science Center School of Public Health San Antonio regional campus
  • competent in English
  • total score of at least 3 on the Generalized Anxiety Disorder (GAD-2)

Критерии исключения

  • Currently receiving psychological treatment for anxiety symptoms, or has received treatment in the last year.
  • Report photosensitive epilepsy.
  • Report stereoscopic vision or balance problems

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Не применимо
Модель
Одна группа
Маскирование
Открытое
Основная цель
Лечение

Центры проведения

США · 1 центр
  • The University of Texas Health Science Center at Houston — Houston

Идентификаторы

NCT: NCT05319509 · HSC-SPH-21-0935

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗