Virtual Reality Exposure Therapy in Patients With Obsessive-Compulsive Disorder: A Randomized Controlled Trial in Outpatients
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- The Yale-Brown Obsessive-Compulsive Scale (Y-BOCS) self report version
研究概览
简要总结
The aim of this study is to evaluate the efficacy of virtual reality exposure therapy (VRET) as a treatment for obsessive-compulsive disorder (OCD). This study focuses on patients receiving treatment in outpatient psychiatry or clinical psychology settings, utilizing a within-subject design for comparison. Patients first complete informed consent and baseline questionnaires and are placed on a waiting list for five weeks. After this period, they are reassigned to the active (experimental) group, which will receive five sessions of exposure therapy in virtual reality over a subsequent five-week period. The treatment effect will be evaluated using pre/post assessments, as well as monitoring adherence to exposure and response prevention assignments.
详细描述
The virtual environment of so called "OCD house" is used as a tool for the therapy. Immersive VR glasses Meta Quest 2 are used to visualize the environment.
During exposure therapy, relevant virtual stimuli can be freely combined involving common objects and situations in the home that may trigger OCD symptoms and hoarding. Target stimuli (VR elements) are divided into several sets corresponding to OCD subtypes. During the session, the therapist can modify the level of difficulty via four standardized levels according to the individual needs of clients.
The therapeutic application enables direct interaction with stimuli in the environment of the virtual house and garden, thanks to hand tracking. The hand tracking and hand gestures are used also to control the movement in the environment by the patients, but direct head and body rotations and small movements are enabled by the VR headset. The psychotherapist can follow the patient actions and control the settings of the environment (e.g.selection of relevant stimuli, level of difficulty) using a streaming app on the tablet or a mobile phone and advise the patient where necessary. The level of difficulty is gradually increased during the progress of the therapy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of OCD (F42) using currently valid DSM-V and ICD-11
- •Fluent in Czech
排除标准
- •Any other psychiatric, neurological and serious somatic illness
- •Substance abuse
- •Psychotropic medication (e.g. benzodiazepines) except antidepressants, antipsychotic medication and hypnotics.
- •Contradictions to using a virtual reality (e.g., epilepsy, balance problems)
- •Pregnancy
- •Cardiostimulator and mental implants
结局指标
主要结局
The Yale-Brown Obsessive-Compulsive Scale (Y-BOCS) self report version
时间窗: Applied repeatedly: 1) Before the assignment to the waitlist condition, 2) After the waitlist period = Before the start of the first VRET therapy session, 3) After the last VRET session and 4) Follow-up 3 months after the last therapy session.
The Y-BOCS is a 19-item scale assessing the severity of obsessive-compulsive symptoms. Raw score range from 0 to 40, where 0 = no symptoms and 40 = very severe symptoms with highly impaired daily functioning.
The Beck Depression Inventory
时间窗: Applied repeatedly: 1) Before the assignment to the waitlist condition, 2) After the waitlist period = Before the start of the first VRET therapy session, 3) After the last VRET session and 4) Follow-up 3 months after the last therapy session.
The Beck Depression Inventory (BDI) is a 21-item, self-report rating inventory that measures characteristic attitudes and symptoms of depression.
Beck Anxiety Inventory (BAI)
时间窗: Applied repeatedly: 1) Before the assignment to the waitlist condition, 2) After the waitlist period = Before the start of the first VRET therapy session, 3) After the last VRET session and 4) Follow-up 3 months after the last therapy session.
BAI is an inventory of anxiety symptoms with 18 items rated on a 5-point Likert scale (0-4). Score range from 0 to 72, with higher scores indicating more severe anxiety symptoms.
Hierarchy of fears
时间窗: Applied repeatedly: 1) Before the assignment to the waitlist condition, 2) After the waitlist period = Before the start of the first VRET therapy session, 3) After the last VRET session and 4) Follow-up 3 months after the last therapy session.
Patients describe and rate their most feared situations or stimuli on a 10-point scale (1-10).
The Spielberger State-Trait Anxiety Inventory-X2 (STAI-X2)
时间窗: Applied repeatedly: 1) Before the assignment to the waitlist, 2) After the waitlist period = Before the start of the first VRET therapy session, 3) After the last VRET session and 4) Follow-up 3 months after the last therapy session
The Spielberger State-Trait Anxiety Inventory-X2 (STAI-X2) is used to measure self-reported symptoms of trait anxiety with higher score indicating higher anxiety levels (score range 20-80).
次要结局
- Subjective Units of Distress Scale (SUDS)(During In-Sessions: week 1-5 of experimental VRET condition)
- Adherence to exposures(Before In-Sessions: week 1-5 of experimental VRET condition)
- The Igroup Presence Questionnaire (IPQ)(Immediately after the first session of VR exposure therapy.)
- Simulator Sickness Questionnaire (SSQ)(Immediately after the first session of VR exposure therapy.)
研究者
Iveta Fajnerová
Supervisor
National Institute of Mental Health, Czech Republic