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Идёт набор NCT07484750

Efficacy and Influencing Factors of Mindfulness-Based Exposure Group Therapy for OCD

Без фазы С лечением Obessive-Compulsive 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: mindfulness based exposure therapy, Treatment as Usual (TAU).
Кому может быть актуально
Состояния в реестре: Obessive-Compulsive Disorder. Базовые параметры: 16 лет — 55 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
Китай
Следующий шаг
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Официальное название

Mindfulness-Based Exposure Group Therapy for Obsessive-compulsive Disorder: A Randomized Controlled Trial

Обзор

Obessive-Compulsive Disorder (OCD) is frequently treatment-refractory and imposes a substantial burden on affected individuals. Although Exposure and Response Prevention (ERP) is widely regarded as the first-line intervention, its inherently distressing nature contributes to treatment refusal and premature dropout in a subset of patients. The present study aims to develop and validate a novel intervention, Mindfulness-Based Exposure Therapy (MBET). In contrast to existing protocols that incorporate mindfulness as an adjunct to ERP and have yielded mixed or limited benefits, this study seeks a theoretically grounded integration of mindfulness and exposure-based principles. We hypothesize that mindfulness training improves emotion regulation, thereby producing a synergistic effect that enhances patients' capacity to engage in and complete exposure tasks. From a clinical perspective, MBET is intended to offer a more tolerable and acceptable alternative to standard ERP, with the potential to improve treatment adherence and clinical outcomes among patients who experience traditional exposure procedures as excessively distressing.

Вмешательства

  • Поведенческое mindfulness based exposure therapy
    Mindfulness-Based Exposure Therapy (MBET) is a structured, 10-week group psychological intervention specifically designed for individuals with Obsessive-Compulsive Disorder (OCD). The program is delivered in weekly sessions, with each session lasting 3 hours. To ensure optimal group dynamics and personalized attention, each group consists of 6 to 8 patients and is facilitated by 1 to 2 trained therapists.To reinforce the skills acquired during the group meetings, participants are assigned daily
  • Другое Treatment as Usual (TAU)
    treatment as usual with stable medication

Первичные конечные точки

  • Obsessive-compulsive symptoms improvement [Срок оценки: Pre-treatment (Baseline), Mid-treatment (Week 5), and Post-treatment (Week 10).]

Критерии участия

Критерии включения

  • Have a primary diagnosis of Obsessive-Compulsive Disorder (OCD) according to DSM-5 criteria
  • Are between 16 and 55 years of age (inclusive)
  • Have a Yale-Brown Obsessive Compulsive Scale (Y-BOCS) total score ≥ 16
  • Have an education level of junior high school or above
  • Are medication-free or have been stabilized on psychotropic medication for at least 8 weeks
  • Have sufficient visual and auditory capabilities to complete study assessments
  • Are willing to participate and provide written informed consent

Критерии исключения

  • Meet DSM-5 criteria for any other psychiatric disorder besides OCD
  • Have severe OCD symptoms that prevent completion of assessments
  • Exhibit active suicidal ideation or high suicide risk
  • Have a serious somatic disease, central nervous system disease, or substance abuse history
  • Are pregnant, breastfeeding, or planning pregnancy
  • Have metal implants contraindicated for MRI (e.g., pacemakers, intracranial clips, metal dentures, arterial stents, joint fixations)

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

Китай · 1 центр
  • Shanghai mental health center — Шанхай

Идентификаторы

NCT: NCT07484750 · SMHC-OCD-019

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗