跳至主要内容
临床试验/NCT05841017
NCT05841017进行中(未招募)不适用

Effectiveness of the Immersive Virtual Reality in the Psychological Treatment of Obsessive Compulsive Disorder

Consorci Hospitalari de Vic2 个研究点 分布在 1 个国家目标入组 98 人开始时间: 2023年2月13日最近更新:
适应症

试验速览

阶段
不适用
状态
进行中(未招募)
入组人数
98
试验地点
2
主要终点
Obsessive Compulsive Disorder symptomatology.

研究概览

简要总结

Immersive VR (IVR) is based on the generation and projection of images from different perspectives. Obsessive Compulsive Disorder (OCD) is considered one of the 5 most common mental disorders and one of the 20 most disabling diseases according to the World Health Organization (WHO). Its vital prevalence is about 2.5%. This study aims to establish the effectiveness of a cognitive-behavioral intervention - individual and group - using IVR in patients diagnosed with OCD compared to a group receiving standard treatment by the Mental Health Center. A sample will be obtained from the list of all patients registered in the Mental Health Service of the University Hospital of Vic (Vic, Catalonia) with the primary or secondary diagnosis of Obsessive Compulsive Disorder according to Diagnostic and Statistical Manual of Mental Disorders (DSM 5) and in active treatment status in the period between January 2021 and January 2023. Randomized controlled clinical trial. Variables: sociodemographic, clinical, OCD symptom follow-up and quality of life. Measurement instruments: Yale-Brown Obsessive Compulsive Scale (Y-BOCS), State-Trait Anxiety Inventory (STAI), Beck Depression Inventory (BDI), Immersive Tendencies Questionnaire (ITQ), Presence Questionnaire, EuroQoL-5D (EQ-5D). Inclusion criteria: Patients over 18 years of age with a primary or secondary diagnosis of Obsessive Compulsive Disorder with one of the following specifiers: with good or acceptable introspection (1) or with little introspection (2); persons with current activity at the Mental Health Center. Exclusion criteria: patients with a diagnosis of intellectual disability, autistic spectrum disorder, active substance-related disorders, neuro-cognitive disorder and/or severe personality disorder; acute psychopathological decompensation; insufficient command of Catalan and/or Spanish; advanced disease and/or disease that significantly hinders the follow-up of the intervention.

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
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Adults (≥18 years of age)
  • Outpatient
  • Current diagnostic of obsessive compulsive disorder with good or fair insight (1) or with poor insight (2)
  • Follow-up by mental health network in Vic Hospital Consortium of Catalonia
  • Signed informed consent

排除标准

  • Intellectual disabilities
  • Autism spectrum disorder
  • Active substance-related disorders
  • Neurocognitive disorders
  • Several personality disorders
  • Clinical acute psychotic relapse

结局指标

主要结局

Obsessive Compulsive Disorder symptomatology.

时间窗: 1, 3 & 6 months.

Changes in score of Yale-Brown Obsessive Compulsive Scale (Y-BOCS). Total score 0-40. Subclinical level (0-7); mild (8-15); moderate (16-23); severe (24-31) and very severe (32-40). Changes in minor categories and reduction in scores indicate improvement.

次要结局

  • Anxiety symptoms.(1, 3 & 6 months.)
  • Depressive mood symptoms.(1, 3 & 6 months.)
  • Perceived quality of life.(1, 3 & 6 months.)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Dr. Pere Roura-Poch

Head of Epidemiology

Consorci Hospitalari de Vic

研究点 (2)

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