The Effect of Immersive Virtual Reality Treatment With Cognitive Behaviour Therapy for Obsessive-Compulsive Disorder

Официальное название

Effectiveness of the Immersive Virtual Reality (VR) Treatment With Cognitive Behaviour Therapy (CBT) for Obsessive-Compulsive Disorder (OCD) : A Randomized Controlled Study

Обзор

This study will evaluate the clinical effectiveness ofthe Immersive Virtual Reality alongside exprosure and response Prevention (ERP) Treatment in cognitive-Behavioral Therapy for Obsessive-compulsive Disorder, and the underlying neural mechanism by electroencephalography (EEG) and eye-tracking methodology .

Подробное описание

The current study aims to the clinical effectiveness of the Immersive Virtual Reality alongside exprosure and response Prevention (ERP) Treatment in cognitive-Behavioral Therapy for Obsessive-compulsive Disorder. 30 OCD patients whose symptom were mainly associated with "contamination/clean" , "Symmetry/precision", "Examination" and "Sex" will be randomized into two groups (i.e. VR ERP or ERP). The treatment will be performed twice a week for the first two weeks. And for the next 4 week, the treatment for OCD patients will be undertook once a week. There will be 8 times in total. The investigators will assess thhe OCD patients'symptom severity in the baseline, 2 weeks, 4weeks and after 8 weeks of the whole combined treatment. Through the study, Yale-Brown Obsessive Compulsive Scale（Y-BOCS）, the Obsessive Compulsive Inventory-Revised (OCI-R), the Beck Depression Inventory (BDI), the Beck Anxiety Inventory (BAI), Perceived Stress Scale (PSS), Pittsburgh sleep quality index (PSQI) and side-effect questionnaire will be obtained by a trained investigator. The patients will also get individual's data of EEG and eye-movement.

Вмешательства

• Комбинированный продукт The combination of exposure and response prevention (ERP) and VR
  The combination of exposure and response prevention (ERP) and VR aimed to investigate the combination of an immersive virtual reality environment (VRE) alongside therapist delivered CBT to reduce anxiety when the OCD patients were induced by virtual scene.Specially, patients will get the first CBT session in the first week for 90 minutes in order to gather detailed information of individual's symptom. Then the next 2 weeks, patients will get VR+ERP session twice a week. From the fourth week to t
• Поведенческое Traditional ERP
  Patients will achieve the exposure based CBT for total 10 times excluding 8 sessions of ERP. Structured protocol described by Foa et al., 2012. Specially, patients will get the first CBT session in the first week for 90 minutes in order to gather detailed information of individual's symptom. Then the next 2 weeks, patients will get ERP session twice a week. From the fourth week to the seventh week, patients weill get ERP session once a week. In the end of the eighth week, patients will get the l

Первичные конечные точки

• Change in Yale-Brown Obsessive Compulsive Scale(Y-BOCS) score [Срок оценки: from baseline to 8weeks]

Вторичные конечные точки (5)

• Change in Obsessive Compulsive Inventory-Revised(OCI-R) [Срок оценки: from baseline to 8weeks]
• Change in Beck Depression Inventory(BDI) [Срок оценки: from baseline to 8weeks]
• Change in Beck Anxiety Inventory (BAI) [Срок оценки: from baseline to 8weeks]
• Chinese version of Working Alliance Inventory-Short Form (WAI-SR) [Срок оценки: assessed only once after the entire treatment at the end of the eighth week. (at the end week 8 )]
• Simulator Sickness Questionnaire(SSQ) [Срок оценки: The SSQ should be assessed each time after the VR+ERP treating for OCD patients. (at week 2, 3, 4, 5, 6, 7)]

Критерии участия

Критерии включения

• age: 18-50 years old;
• Diagnostic and Statistical Manual of Mental Disorders (DSM-5) criteria for OCD;
• Y-BOCS total score > or = 16, discontinued medication for at least 8 weeks before
• the enrollment or the paitients' clinical medication is stable for at least a month (the dose and the types of drugs) .>or＝9 years education

Критерии исключения

• Any axis I psychiatric disorder comorbidity
• Participants who have received any forms of psychological therapy in the past.
• Patients cannot tolerate or adapt to the somatic discomfort caused by VR .
• Prior history of neurological disease (e.g., epilepsy) or brain surgery for traumatic brain injury
• Participants with claustrophobic, heart pacemaker, mechanical heart valve, mechanical implant such as an aneurysm clip, hip replacement, or any other pieces of metal that have accidentally entered their body.
• Any current significant medical condition.
• serious suicide risk

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

Китай · 1 центр

• Shanghai Mental Health Center — Шанхай

Идентификаторы

NCT: NCT04534907 · SMHC-OCD-009

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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