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Идёт набор NCT05663489

Neurobiological Markers of Treatment Response for Anxiety and OCD

— Наблюдательное Obsessive-Compulsive Disorder Social Anxiety Disorder Panic Disorder

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: Bergen 4-Day Treatment (B4DT).
Кому может быть актуально
Состояния в реестре: Obsessive-Compulsive Disorder, Social Anxiety Disorder, Panic Disorder. Базовые параметры: от 16 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
Норвегия
Следующий шаг
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Обзор

Obsessive-compulsive disorder (OCD) and anxiety disorders are common and debilitating conditions which are often chronic when treatment is not provided. International guidelines recommend cognitive behavioral therapy (CBT) as the first-line treatment, and research has shown that CBT can be delivered over a concentrated period of time. The Bergen 4-Day Treatment (B4DT) is an exposure-based treatment which is delivered over four consecutive days. B4DT has been shown to induce rapid and long-lasting remission in around 70% of patients. This provides a platform for studying psychological and neurobiological changes associated with treatment response and non-response. The present study will investigate longitudinal changes in psychological measures and DNA methylation in patients who receive the B4DT, as well as a subset will also undergo multimodal brain imaging.

Подробное описание

The primary study will include 500 OCD patients who will receive the B4DT. Symptom severity will be prospectively measured before treatment, approximately 10 days after treatment and three months after treatment. Saliva samples will be collected for later extraction of DNA methylation during the first day of treatment, the last day of treatment, and three months after treatment. A substudy will use multimodal magnetic resonance imaging (MRI) before treatment, approximately 10 days after treatment and three months after treatment. The substudy will also 100 patients with social anxiety disorder or panic disorder for DNA methylation and MRI, as well as 50 healthy controls for MRI. Clinical data will be collected from a consent-based quality register ("Kvalitetsregister for konsentrerte behandlingsformat").

The aim of the study is to investigate changes in DNA methylation as well as functional and structural brain networks that occur in patients undergoing B4DT, and to correlate these changes with immediate and long-term response to treatment.

Вмешательства

  • Поведенческое Bergen 4-Day Treatment (B4DT)
    A concentrated and exposure-based psychological treatment over four consecutive days

Первичные конечные точки

  • Yale-Brown Obsessive Compulsive Scale (Y-BOCS) [Срок оценки: Before treatment]
  • Yale-Brown Obsessive Compulsive Scale (Y-BOCS) [Срок оценки: approximately 10 days after treatment]
  • Yale-Brown Obsessive Compulsive Scale (Y-BOCS) [Срок оценки: three months after treatment]
  • Panic Disorder Severity Scale (PDSS) [Срок оценки: Before treatment]
  • Panic Disorder Severity Scale (PDSS) [Срок оценки: approximately 10 days after treatment]
  • Panic Disorder Severity Scale (PDSS) [Срок оценки: three months after treatment]
  • Liebowitz Social Anxiety Scale (LSAS) [Срок оценки: Before treatment]
  • Liebowitz Social Anxiety Scale (LSAS) [Срок оценки: approximately 10 days after treatment]
  • Liebowitz Social Anxiety Scale (LSAS) [Срок оценки: three months after treatment]
Вторичные конечные точки (6)
  • DNA Methylation [Срок оценки: Before treatment]
  • DNA Methylation [Срок оценки: approximately 10 days after treatment]
  • DNA Methylation [Срок оценки: three months after treatment]
  • Magnetic Resonance Imaging [Срок оценки: Before treatment]
  • Magnetic Resonance Imaging [Срок оценки: approximately 10 days after treatment]
  • Magnetic Resonance Imaging [Срок оценки: three months after treatment]

Критерии участия

Критерии включения

  • Diagnosed with obsessive-compulsive disorder, panic disorder or social anxiety disorder using DSM-5 criteria
  • Referred to National Clinic for 4-Day Treatment, Haukeland University Hospital, Bergen, Norway
  • Consented to participate in the "Kvalitetsregister for konsentrerte behandlingsformat"

Критерии исключения

  • Suicidal, ongoing mania, primary eating disorder, intellectual disability, ongoing psychosis, ongoing substance abuse

For MRI substudy:

Критерии включения

\- For the healthy controls, no previous or current psychiatric disorders as detected by the Mini International Neuropsychiatric Interview (MINI)

Критерии исключения

\- MRI incompatibility (e.g. pregnancy, metal implants)

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

Здоровые добровольцы: Да

Дизайн исследования

Модель наблюдения
Когортное

Центры проведения

Норвегия · 1 центр
  • Bergen Center for Brain Plasticity — Bergen

Идентификаторы

NCT: NCT05663489 · BCBP-1

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗