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Набор скоро начнётся NCT07161570

Virtual Reality Digital Therapeutics for Seasonal Affective Disorder

Без фазы С лечением Seasonal Affective Disorder (SAD)

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: Virtual Reality (VR) Intervention, Light Box (LB) intervention.
Кому может быть актуально
Состояния в реестре: Seasonal Affective Disorder (SAD). 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
Список центров уточняется — проверьте первичный протокол.
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
Официальное название

Effectiveness of Virtual Reality Digital Therapeutics for Seasonal Affective Disorder.

Обзор

Seasonal Affective Disorder (SAD) is commonly treated with bright light therapy. Virtual reality (VR) is an immersive computer-generated environment, which has been used to treat mental health difficulties, such as depression, social anxiety and stress. This study aims to compare the use of VR with bright light therapy in treating SAD. Participants will be randomly allocated to either the VR condition or the light box condition and instructed to use the respective device every day for 14 days.

Подробное описание

Seasonal Affective Disorder (SAD) affects approximately 1 in 20 people in the UK during the winter months, with significant impacts on wellbeing and productivity. SAD is commonly treated with bright light treatment, alone or in combination with psychological therapy or antidepressants. Virtual reality (VR) is an immersive computer-generated environment. VR technology has been applied to treat a range of mental health conditions, including depression, anxiety, and stress. However, the possible contribution of this technology to the treatment of SAD has not been explored. This study aims to test the effectiveness of a VR intervention in alleviating symptoms of SAD compared to standard bright light treatment.

The investigators aim to recruit 60 participants who self-identify or have been diagnosed with SAD and who report moderate to severe symptoms. Participants are also required to be 18 years or older, a UK resident and able to access internet and attend the Anglia Ruskin University Cambridge campus. Participants will be excluded from the study if they declare suffering from epilepsy or having previously experienced adverse effects when using VR or light box devices. Participants will also be excluded if they are taking photosensitizing medications or have significant retinal pathology, or if they are currently receiving active treatment for SAD, including antidepressant medication, bright light treatment, or psychological treatment (such as Cognitive Behavioural Therapy). Recruitment will occur during the winter months, between November 2025 and March 2026.

After consenting, potential participants will be asked to complete some measures assessing their typical seasonal mood variation, to check eligibility to participate. If eligible, they will be asked to complete demographic questions and questionnaires measuring their current mood state and symptoms. Participants will then be randomly allocated to either the VR condition or the light box condition. Those allocated to the VR-condition, will be instructed to use the VR headset for 10 minutes within the first hour after waking, every day for 14 days. Those allocated to the light box intervention, will be instructed to use the light box for 30 minutes within the first hour after waking, every day for 14 days. Before and after each session, participants will be asked to record their current mood. At the end of the 14-day period, participants will return the headset or the light box and complete the final symptom and mood state questionnaires and questions regarding their experience. One week later, participants will be asked to complete a follow-up questionnaire about their mood and symptoms.

Вмешательства

  • Устройство Virtual Reality (VR) Intervention
    10-min VR intervention, once a day, everyday for 14 days.
  • Устройство Light Box (LB) intervention
    30-min LB intervention once a day, everyday for 14 days.

Первичные конечные точки

  • Change in levels of mood and depressive symptoms [Срок оценки: From baseline (day 1 to 7) to follow-up (day 28) of treatment]
Вторичные конечные точки (1)
  • Participant engagement, experience and satisfaction of the intervention [Срок оценки: From baseline (day 1 to 7) to end of follow-up (day 28) treatment]

Критерии участия

Критерии включения

  • fluent in English and capable of giving informed consent
  • 18 or older
  • resident in the United Kingdom and
  • able to access internet and attend Anglia Ruskin University's Cambridge campus
  • must self-identify or have been diagnosed with SAD, with moderate to severe symptoms

Критерии исключения

  • declared suffering from epilepsy (due to the risk that seizures may be triggered by VR use).
  • currently using photosensitizing medications or have significant retinal pathology, due to potentially detrimental effects of light box use. For other ophthalmologic conditions, consultation with an ophthalmologist will be recommended.
  • currently receiving active treatment for SAD, including antidepressant medication (less than 3 months), bright light treatment, or psychotherapy (e.g. CBT for seasonal affective disorder).

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
Двойное слепое
Основная цель
Лечение

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07161570 · 10149188

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗