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Набор скоро начнётся NCT06852183

Restructuring Body Experience in Anorexia Nervosa: Virtual Reality Functionality-Focused Mirror Exposure

Без фазы С лечением Anorexia Nervosa

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: VR -FME.
Кому может быть актуально
Состояния в реестре: Anorexia Nervosa. Базовые параметры: от 16 лет · Женщины.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Список центров уточняется — проверьте первичный протокол.
Следующий шаг
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Обзор

Background: Body image disturbance remains a core therapeutic challenge in Anorexia Nervosa (AN) treatment, necessitating innovative intervention approaches. This study protocol describes a randomized controlled trial investigating Virtual Reality Functionality-Focused Mirror Exposure (VR-FME), a novel intervention targeting the perceptual, affective, and cognitive dimensions of body image disturbance in AN patients. Methods: This single-blind, parallel-group randomized controlled trial will evaluate the efficacy of VR-FME as an adjunct to treatment as usual (TAU). Participants with AN will be randomly allocated to receive either VR-FME combined with TAU or TAU alone. The intervention specifically addresses altered body image through immersive virtual reality technology, providing controlled exposure and cognitive restructuring opportunities. Primary Outcome: The primary outcome measure will assess changes in body image disturbance severity and core eating disorder symptomatology. We hypothesize that the integration of VR-FME with TAU will demonstrate superior therapeutic outcomes compared to TAU alone. Significance: This protocol represents an innovative approach to addressing body image disturbance in AN, potentially enhancing current therapeutic strategies through the integration of immersive virtual reality technology. The findings will contribute to the evolving landscape of technology-enhanced interventions for eating disorders.

Вмешательства

  • Другое VR -FME
    The VR-FME intervention specifically focuses on improving body representation and the body-self relationship by working on multisensory integration processes and embodied cognition techniques. This is thanks to the combination of immersive virtual reality experiences of body illusion combined with traditional psychological techniques. The experimental group will receive this intervention in addition to the usual treatment, which will continue as usual for the control group. The intervention cons

Первичные конечные точки

  • Eating Disorder Inventory 3 [Срок оценки: Before the intervention, after the end of the intervention (at the end of the 4th week) and after one month after the intervention ended]
  • Physical Appearance State and Trait Anxiety Scale [Срок оценки: Before the intervention, after the end of the intervention (at the end of the 4th week) and after one month after the intervention ended]
  • Body Mass Index [Срок оценки: Before the intervention, after the end of the intervention (at the end of the 4th week) and after one month after the intervention ended]
  • Body Image Assessment Scale - Body Dimensions [Срок оценки: Before the intervention, after the end of the intervention (at the end of the 4th week) and after one month after the intervention ended]
  • Body Size Estimation Task [Срок оценки: Before the intervention, after the end of the intervention (at the end of the 4th week) and after one month after the intervention ended]
  • Body Appreciation Scale-2 [Срок оценки: Before the intervention, after the end of the intervention (at the end of the 4th week) and after one month after the intervention ended]
  • Objectified Body Consciousness Scale [Срок оценки: Before the intervention, after the end of the intervention (at the end of the 4th week) and after one month after the intervention ended]
  • Body Uneasiness Test [Срок оценки: Before the intervention, after the end of the intervention (at the end of the 4th week) and after one month after the intervention ended]
Вторичные конечные точки (1)
  • Qualitative feedback survey [Срок оценки: After the end of the intervention (week 4)]

Критерии участия

Критерии включения

  • Age: between 16-24.
  • Primary diagnosis of Anorexia Nervosa
  • BMI > 14.5
  • No current diagnosis or previous diagnosis for neurological disorders
  • Females
  • Fluency in Italian
  • Ability to provide informed consent (and parental consent for minors)

Критерии исключения

  • Anorexia Nervosa is not a primary diagnosis
  • Age < 16
  • BMI < 14.5
  • Conditions that could interfere with VR use (e.g., neurological conditions, severe visual impairments, vestibular disorders)
  • Males
  • Substance abuse, active suicidal ideation, severe psychiatric comorbidities
  • Pregrancy
  • Ongoing participation in other clinical trials
  • Inability to commit to the full duration of the study

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Не применимо
Модель
Параллельные группы
Маскирование
Открытое
Основная цель
Лечение

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT06852183 · CNR_08/2024

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗