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Набор скоро начнётся NCT07558824

A Randomized Controlled Efficacy Trial of a Telemedicine-based Virtual Reality Clinic for the Treatment of Phobias

Без фазы С лечением Specific Phobia, Animal

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: Telemedicine-Based Virtual Reality Exposure Therapy, Telemedicine-Based Exposure Therapy Using Photos and Videos.
Кому может быть актуально
Состояния в реестре: Specific Phobia, Animal. 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 →

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Официальное название

Doxy.me VR vs. Telemental Health-Based Exposure Therapy: Phase II

Обзор

The goal of this clinical trial is to learn if a telemedicine-based virtual reality clinic (Doxy.me VR) works to treat dog, spider, and snake phobias in adults. The main questions it aims to answer are: Does Doxy.me VR decrease the severity of phobias better than traditional telemedicine-based treatment? Does this work because it feels more realistic than telemedicine alone?

Вмешательства

  • Поведенческое Telemedicine-Based Virtual Reality Exposure Therapy
    Participants will complete 7 60-minute exposure therapy sessions in a Virtual Reality Clinic using Virtual Reality stimuli and progress to in vivo exposures. Other Name:
  • Поведенческое Telemedicine-Based Exposure Therapy Using Photos and Videos
    Participants will complete 7 60-minute exposure therapy sessions using photos/videos and progress to in vivo exposures.

Первичные конечные точки

  • Phobia symptom severity [Срок оценки: Baseline, 4 Weeks Post-Baseline (Mid-Treatment), 7 Weeks Post-Baseline (Post-Treatment), and 28 weeks Post-Baseline (3-Months Post-Treatment)]
  • Dog Phobia Severity [Срок оценки: Baseline, 4 Weeks Post-Baseline (Mid-Treatment), 7 Weeks Post-Baseline (Post-Treatment), and 28 weeks Post-Baseline (3-Months Post-Treatment)]
  • Snake Phobia Severity [Срок оценки: Baseline, 4 Weeks Post-Baseline (Mid-Treatment), 7 Weeks Post-Baseline (Post-Treatment), and 28 weeks Post-Baseline (3-Months Post-Treatment)]
  • Spider Phobia Severity [Срок оценки: Baseline, 4 Weeks Post-Baseline (Mid-Treatment), 7 Weeks Post-Baseline (Post-Treatment), and 28 weeks Post-Baseline (3-Months Post-Treatment)]
Вторичные конечные точки (9)
  • Specific Phobia Diagnosis [Срок оценки: Baseline, 4 Weeks Post-Baseline (Mid-Treatment), 7 Weeks Post-Baseline (Post-Treatment), and 28 weeks Post-Baseline (3-Months Post-Treatment)]
  • General Anxiety [Срок оценки: Baseline, 7 Weeks Post-Baseline (Post-Treatment), and 28 weeks Post-Baseline (3-Months Post-Treatment)]
  • Depression Severity [Срок оценки: Baseline, 7 Weeks Post-Baseline (Post-Treatment), and 28 weeks Post-Baseline (3-Months Post-Treatment)]
  • Quality of Life Level [Срок оценки: Baseline, 7 Weeks Post-Baseline (Post-Treatment), and 28 weeks Post-Baseline (3-Months Post-Treatment)]
  • Level of Telepresence [Срок оценки: Week 1, Week 2, Week 3, Week 4, Week 5, Week 6, Week 7; Averaged across weeks]
  • Cybersickness Severity [Срок оценки: Week 1, Week 2, Week 3, Week 4, Week 5, Week 6, Week 7; Averaged across weeks]
  • Level of Working (Therapeutic) Alliance [Срок оценки: 4 Weeks Post-Baseline (Mid-Treatment), 7 Weeks Post-Baseline (Post-Treatment)]
  • Satisfaction with Therapy [Срок оценки: 4 Weeks Post-Baseline (Mid-Treatment), 7 Weeks Post-Baseline (Post-Treatment)]
  • System Usability [Срок оценки: 4 Weeks Post-Baseline (Mid-Treatment), 7 Weeks Post-Baseline (Post-Treatment)]

Критерии участия

Критерии включения

Individuals will be eligible if they: (1) are an adult (≥18 years old); (2) have a self-reported fear of dogs, snakes, and/or spiders; (3) score 89 ≥ on the FSQ OR 24 ≥ on the SNAQ OR 147 ≥ on the DPQ; and (4) have access to the internet AND a computer OR smartphone with video conferencing capabilities.

Критерии исключения

Individuals will be ineligible to participate if they: (1) are participating in ongoing mental health therapy from a non-study therapist; (2) changed psychiatric medication use within the past 6 weeks; (3) report active auditory, visual, and/or tactile hallucinations via the DART Psychosis Module screening question; (4) report active health conditions requiring upcoming planned or likely hospitalization or intensive treatment that will prevent them from participating; (5) report active legal proceedings that might lead to incarceration during the study period that would prevent them from participating; (6) report an unstable housing situation (eg., eviction or homelessness); (7) have experienced photosensitive seizures within the prior 6 months; (8) endorse more than 20% of symptom validity questions.

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
Открытое
Основная цель
Лечение

Центры проведения

США · 1 центр
  • University of South Florida — Tampa

Идентификаторы

NCT: NCT07558824 · 008130 · R44MH129065

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗