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Идёт набор NCT07725926

Integrating Exposure and Response Prevention and Habit Reversal Techniques to Treat a Tourettic Subtype of Obsessive-Compulsive Disorder (Tourettic OCD)

Без фазы С лечением Obsessive - Compulsive Disorder Tic Disorder, Chronic Motor or Vocal Tic Disorders Tic Disorder, Combined Vocal and Multiple Motor

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: Exposure and Response Prevention (ERP), Habit Reversal Training (HbRT, Psychoeducation and Supportive Intervention.
Кому может быть актуально
Состояния в реестре: Obsessive - Compulsive Disorder, Tic Disorder, Chronic Motor or Vocal, Tic Disorders, Tic Disorder, Combined Vocal and Multiple Motor. Базовые параметры: 18 лет — 65 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
Великобритания
Следующий шаг
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Обзор

Obsessive-Compulsive Disorder and Tic Disorders frequently co-occur, and a subgroup of patients - those with a Tourettic Subtype of OCD (TOCD) - present with concurrent obsessive-compulsive and tic symptoms. Existing psychological interventions typically target one condition or the other, but rarely both together. This study aims to test whether a combined psychological therapy integrating Exposure and Response Prevention (ERP) and Habit Reversal (HbRT) is more effective at reducing symptoms than either therapy delivered alone, in adults with TOCD.

Подробное описание

Participants are randomly allocated to one of four groups: (1) combined ERP and HbRT, (2) ERP alone, (3) HbRT alone, or (4) a supportive psychoeducation control. All participants receive 12 weekly one-to-one sessions (either in-person or remotely) of approximately fifty minutes. Symptoms will be assessed using the Yale Global Tic Severity Scale (YGTSS) and Yale-Brown Obsessive Compulsive Scale (Y-BOCS) by an independent clinician at the start of treatment, at Week 12, and again at Week 24.

Вмешательства

  • Поведенческое Exposure and Response Prevention (ERP)
    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.
  • Поведенческое Habit Reversal Training (HbRT
    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.
  • Поведенческое Psychoeducation and Supportive Intervention
    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.

Первичные конечные точки

  • Change From Baseline in Yale-Brown Obsessive Compulsive Scale Total Score [Срок оценки: Baseline, Week 12 and Week 24]
  • Change From Baseline in Yale Global Tic Severity Scale Total Tic Severity Score [Срок оценки: Baseline, Week 12 and Week 24]
Вторичные конечные точки (1)
  • Change From Baseline in Yale Global Tic Severity Scale Global Severity Score [Срок оценки: Baseline, Week 12 and Week 24]

Критерии участия

Критерии включения

  • 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)

Критерии исключения

  • 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.

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
Простое слепое
Основная цель
Лечение

Центры проведения

Великобритания · 2 центра
  • University College London Hospitals NHS Foundation Trust — London
  • University College London Queen Square Institute of Neurology — London

Идентификаторы

NCT: NCT07725926 · ERP/HR TOCD RTC - 177187

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗