Virtual Reality Exposure Therapy in Patients With Obsessive-Compulsive Disorder: A Randomized Controlled Trial in Inpatients
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 62
- 试验地点
- 1
- 主要终点
- The Yale-Brown Obsessive-Compulsive Scale (Y-BOCS)
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). Participants are randomly assigned to one of the following interventions: a) exposure condition - the group with a standard CBT program enriched with exposure therapy in VR (VRET), b) control condition 1 - the group with a standard CBT program enriched with VR cognitive training aimed at cognitive flexibility or c) control condition 2 - standard CBT program without any additional VR intervention. 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 intervention in the experimental group. Immersive VR glasses HTC Vive Pro are used to visualize the virtual 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 behavior. 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 the clients.
The therapeutic application enables movement and direct interaction with stimuli in the environment of the virtual house and garden, thanks to a set of handhold controllers. Direct head and body rotations and small body 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 the computer and screen connected to the headset, 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
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 17 Years 至 55 Years（Child, 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)
时间窗: Applied repeatedly: 1) At the baseline - Before the start of the first therapy session (S1), 2) Post-intervention - after the last session (S5) and 3) 2 months after the last session in the follow-up measurement (subjective Y-BOCS).
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 (BDI)
时间窗: Applied repeatedly for 5 weeks of the intervention (once per week) and 2 months after the last session in the follow-up measurement.
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 for 5 weeks of the intervention (once per week) and 2 months after the last session in the follow-up measurement.
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.
Adherence to exposures
时间窗: Immediately before each session (S1-S5) and 2 months after the last session in the follow-up measurement.
Four questions aimed at gathering information about how patients managed to perform exposures during the past week and to what extent the skills acquired during the VR exposure therapy were useful.
The Yale-Brown Obsessive-Compulsive Scale (Y-BOCS)
时间窗: Applied repeatedly: 1) At the baseline - Before the start of the first therapy session (S1), 2) Post-intervention - after the last session (S5) and 3) 2 months after the last session in the follow-up measurement (subjective Y-BOCS).
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 (BDI)
时间窗: Applied repeatedly for 5 weeks of the intervention (once per week) and 2 months after the last session in the follow-up measurement.
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 for 5 weeks of the intervention (once per week) and 2 months after the last session in the follow-up measurement.
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.
Adherence to exposures
时间窗: Immediately before each session (S1-S5) and 2 months after the last session in the follow-up measurement.
Four questions aimed at gathering information about how patients managed to perform exposures during the past week and to what extent the skills acquired during the VR exposure therapy were useful.
次要结局
- The Spielberger State-Trait Anxiety Inventory-X2 (STAI-X2)(1) At the baseline - Before the start of the first therapy session (S1), 2) Post-intervention - after the last session (S5) and 3) 2 months after the last session in the follow-up measurement.)
- Six-item State-Trait Anxiety Inventory (STAI-6)(Applied repeatedly during the intervention - twice during each of the 5 weekly sessions - Immediately Pre- and Post-Session (all sessions S1-S5))
- Cognitive Flexibility Inventory(Immediately before the first (S1), after the last (S5) session and 2 months after the last session in the follow-up measurement.)
- The Spielberger State-Trait Anxiety Inventory-X2 (STAI-X2)(1) At the baseline - Before the start of the first therapy session (S1), 2) Post-intervention - after the last session (S5) and 3) 2 months after the last session in the follow-up measurement.)
- Six-item State-Trait Anxiety Inventory (STAI-6)(Applied repeatedly during the intervention - twice during each of the 5 weekly sessions - Immediately Pre- and Post-Session (all sessions S1-S5))
- Subjective Units of Distress Scale (SUDS)(During In-Sessions: all sessions S1-S5)
- Anxiety Hierarchy(Baseline - Immediately before first (S1), posttreatment - after the last session (S5) + (Controlling for Baseline Score) and 2 months after the last session in the follow-up measurement.)
- Barratt Impusiveness Scale (BIS-11)(Immediately before the first (S1), after the last (S5) session and 2 months after the last session in the follow-up measurement.)
- Cognitive Flexibility Inventory(Immediately before the first (S1), after the last (S5) session and 2 months after the last session in the follow-up measurement.)
研究者
Iveta Fajnerová
Supervisor
National Institute of Mental Health, Czech Republic