- ICH GCP
- Реестр клинических исследований США
- Клиническое испытание NCT07725926
Integrating Exposure and Response Prevention and Habit Reversal Techniques to Treat a Tourettic Subtype of Obsessive-Compulsive Disorder (Tourettic OCD) (TORCH)
Обзор исследования
Статус
Условия
Подробное описание
Тип исследования
Регистрация (Оцененный)
Фаза
- Непригодный
Контакты и местонахождение
Контакты исследования
- Имя: Dipesh Patel, MPhil / PhD
- Номер телефона: +44 (0)20 3456 7890
- Электронная почта: dipesh.patel.23@ucl.ac.uk
Места учебы
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London
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London, London, Соединенное Королевство, WC1N 3BG
- Рекрутинг
- University College London Queen Square Institute of Neurology
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Контакт:
- Dipesh Patel, MPhil / PhD
- Номер телефона: +44 (0)20 3456 7890
- Электронная почта: dipesh.patel.23@ucl.ac.uk
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Главный следователь:
- Himanshu Tyagi, PhD
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London, London, Соединенное Королевство, WC1N 3BG
- Рекрутинг
- University College London Hospitals NHS Foundation Trust
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Контакт:
- Dipesh Patel, MPhil / PhD
- Номер телефона: +44 (0)20 3456 7890
- Электронная почта: dipesh.patel.23@ucl.ac.uk
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Критерии участия
Критерии приемлемости
Возраст, подходящий для обучения
- Взрослый
- Пожилой взрослый
Принимает здоровых добровольцев
Описание
Inclusion Criteria:
- Age 18 years or older
- All genders
- Confirmation of a primary diagnosis of either:
a. Tourettes Disorder / Tourette Syndrome b. Persistent Motor or Vocal Tic Disorder / Chronic Motor or Vocal Tic Disorder c. Provisional Tic Disorder / Transient Motor Tics d. Other Specified Tic Disorder e. Unspecified Tic Disorder f. Obsessive-Compulsive Disorder [d] Participants taking psychotropic medication are eligible provided medication type and dose remain stable throughout the intervention period [e] Ability to provide sustained informed consent [f] A minimum score of 16 on YBOCS [g] A minimum score of 5 on the Premonitory Urge for Tics Scale (PUTS)
Exclusion Criteria:
- Substance misuse
- Current diagnosis of a personality disorder
- Schizophrenia
- Bipolar disorder
- Contraindications to participation in a trial (i.e., active suicidal ideations and/or requirement of an interpreter)
- Any psychiatric or neurological condition that, in the opinion of the investigators, would interfere with participation or interpretation of study outcomes.
Учебный план
Как устроено исследование?
Детали дизайна
- Основная цель: Уход
- Распределение: Рандомизированный
- Интервенционная модель: Параллельное назначение
- Маскировка: Одинокий
Оружие и интервенции
Группа участников / Армия |
Вмешательство/лечение |
|---|---|
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Экспериментальный: Combined Exposure and Response Prevention and Habit Reversal
Participants allocated to this arm will receive a 12-week individual psychological intervention integrating Exposure and Response Prevention (ERP) and Habit Reversal Training (HRT).
ERP will involve planned exposure to obsessional fears, distress, sensory discomfort, premonitory urges, and "not-just-right" experiences while reducing compulsions, avoidance, reassurance seeking, and other safety behaviours.
HRT will include awareness training, identification of premonitory urges and tic-related cues, development and practice of competing responses, and strategies to support generalisation.
Sessions will last approximately 50 minutes and will be delivered face-to-face or remotely.
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Exposure and Response Prevention (ERP) is a behavioural intervention that involves gradual and systematic exposure to obsessional fears, distress, sensory discomfort, premonitory urges, and "not-just-right" experiences while refraining from compulsions, avoidance, reassurance seeking, and other safety behaviours.
Treatment is delivered individually over 12 weekly 50-minute sessions, either face-to-face or remotely.
Habit Reversal Training (HbRT) is a behavioural intervention that includes awareness training, identification of premonitory urges and antecedents to tic expression, development and practice of competing responses, and strategies to generalise skills across settings.
Treatment is delivered individually over 12 weekly 50-minute sessions, either face-to-face or remotely.
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Активный компаратор: Psychoeducation / Supportive Intervention
Participants allocated to this arm will receive a 12-week individual psychological intervention consisting of psychoeducation and supportive therapy.
Sessions will provide information about obsessive-compulsive disorder, tic disorders, Tourettic obsessive-compulsive disorder, stress, and wellbeing, together with supportive discussion and general problem-solving.
This intervention will not include structured Exposure and Response Prevention, Habit Reversal Training, or other targeted behavioural techniques.
Sessions will last approximately 50 minutes and will be delivered face-to-face or remotely.
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Psychoeducation and Supportive Therapy consists of structured education about obsessive-compulsive disorder, tic disorders, Tourettic obsessive-compulsive disorder, stress, and wellbeing, together with supportive discussion and general problem-solving.
The intervention does not include Exposure and Response Prevention, Habit Reversal Training, or other targeted behavioural techniques.
Treatment is delivered individually over 12 weekly 50-minute sessions, either face-to-face or remotely.
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Активный компаратор: Standardised Exposure and Response Prevention
Participants allocated to this arm will receive a 12-week individual psychological intervention based on Exposure and Response Prevention (ERP).
Treatment will involve gradual and systematic exposure to obsessional fears, distress, sensory discomfort, premonitory urges, and "not-just-right" experiences while refraining from compulsions, avoidance, reassurance seeking, and other safety behaviours.
The intervention aims to reduce obsessive-compulsive symptoms by promoting inhibitory learning and increasing tolerance of uncertainty and internal experiences.
Sessions will last approximately 50 minutes and will be delivered face-to-face or remotely.
|
Exposure and Response Prevention (ERP) is a behavioural intervention that involves gradual and systematic exposure to obsessional fears, distress, sensory discomfort, premonitory urges, and "not-just-right" experiences while refraining from compulsions, avoidance, reassurance seeking, and other safety behaviours.
Treatment is delivered individually over 12 weekly 50-minute sessions, either face-to-face or remotely.
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Активный компаратор: Standardised Habit Reversal
Participants allocated to this arm will receive a 12-week individual psychological intervention based on Habit Reversal Training (HbRT).
Treatment will include awareness training to improve recognition of tics and premonitory urges, identification of antecedents and contextual triggers, development and practice of competing responses, and strategies to promote generalisation of skills to everyday settings.
The intervention aims to reduce tic severity and improve voluntary tic management.
Sessions will last approximately 50 minutes and will be delivered face-to-face or remotely.
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Habit Reversal Training (HbRT) is a behavioural intervention that includes awareness training, identification of premonitory urges and antecedents to tic expression, development and practice of competing responses, and strategies to generalise skills across settings.
Treatment is delivered individually over 12 weekly 50-minute sessions, either face-to-face or remotely.
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Что измеряет исследование?
Первичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
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Change From Baseline in Yale-Brown Obsessive Compulsive Scale Total Score
Временное ограничение: Baseline, Week 12 and Week 24
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Obsessive-compulsive symptom severity will be assessed using the Yale-Brown Obsessive Compulsive Scale (Y-BOCS).
Total scores range from 0 to 40, with higher scores indicating greater obsessive-compulsive symptom severity.
Change from baseline will be assessed at Week 12 and Week 24.
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Baseline, Week 12 and Week 24
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Change From Baseline in Yale Global Tic Severity Scale Total Tic Severity Score
Временное ограничение: Baseline, Week 12 and Week 24
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Tic symptom severity will be assessed using the Yale Global Tic Severity Scale (YGTSS) Total Tic Severity Score.
Scores range from 0 to 50, with higher scores indicating greater tic symptom severity.
Change from baseline will be assessed at Week 12 and Week 24.
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Baseline, Week 12 and Week 24
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Вторичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
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Change From Baseline in Yale Global Tic Severity Scale Global Severity Score
Временное ограничение: Baseline, Week 12 and Week 24
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Overall tic symptom severity and tic-related impairment will be assessed using the Yale Global Tic Severity Scale (YGTSS) Total Score.
The Global Score is calculated by summing the Total Tic Severity Score (0-50) and the Impairment Score (0-50), resulting in a global score ranging from 0 to 100.
Higher scores indicate greater overall tic severity and impairment.
Change from baseline will be assessed at Week 12 and Week 24.
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Baseline, Week 12 and Week 24
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Соавторы и исследователи
Соавторы
Даты записи исследования
Изучение основных дат
Начало исследования (Действительный)
Первичное завершение (Оцененный)
Завершение исследования (Оцененный)
Даты регистрации исследования
Первый отправленный
Впервые представлено, что соответствует критериям контроля качества
Первый опубликованный (Действительный)
Обновления учебных записей
Последнее опубликованное обновление (Действительный)
Последнее отправленное обновление, отвечающее критериям контроля качества
Последняя проверка
Дополнительная информация
Термины, связанные с этим исследованием
Ключевые слова
Дополнительные соответствующие термины MeSH
- Заболевания головного мозга
- Заболевания центральной нервной системы
- Заболевания нервной системы
- Психические расстройства
- Генетические заболевания, врожденные
- Нейродегенеративные заболевания
- Нарушения развития нервной системы
- Двигательные расстройства
- Наследственные дегенеративные заболевания, нервная система
- Заболевания базальных ганглиев
- Расстройства личности
- Тревожные расстройства
- Врожденные, наследственные и неонатальные заболевания и аномалии
- Компульсивное расстройство личности
- Обсессивно-компульсивное расстройство
- Тиковые расстройства
- Синдром Туретта
Другие идентификационные номера исследования
- ERP/HR TOCD RTC - 177187
Планирование данных отдельных участников (IPD)
Планируете делиться данными об отдельных участниках (IPD)?
Информация о лекарствах и устройствах, исследовательские документы
Изучает лекарственный продукт, регулируемый FDA США.
Изучает продукт устройства, регулируемый Управлением по санитарному надзору за качеством пищевых продуктов и медикаментов США.
Эта информация была получена непосредственно с веб-сайта clinicaltrials.gov без каких-либо изменений. Если у вас есть запросы на изменение, удаление или обновление сведений об исследовании, обращайтесь по адресу register@clinicaltrials.gov. Как только изменение будет реализовано на clinicaltrials.gov, оно будет автоматически обновлено и на нашем веб-сайте. .