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临床试验/NCT03101332
NCT03101332已完成不适用

Virtual Reality for Panic Disorder With Agoraphobia: a Clinical Trial

Karolinska Institutet2 个研究点 分布在 1 个国家目标入组 12 人开始时间: 2017年5月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
12
试验地点
2
主要终点
Mobility Inventory

研究概览

简要总结

Panic disorder with agoraphobia (PDA) is associated with considerable personal distress, functional disability and societal costs. A large number of studies have shown that Cognitive Behavior Therapy (CBT) is a highly effective treatment for PDA. However, the CBT-protocols proven to be most effective involves repeated exposure to the particular environments the agoraphobic patient fears such as trains, tunnels, lifts and shops. This cause great practical problems for health care services as such therapeutic efforts involves spending considerable time outside the clinic. For primary care services this is particularly challenging due to the large number of patients expected to be seen. Normally clinicians meet up to 7 patients daily which makes it almost practically impossible to offer 2-hour sessions, which is necessary to carry out the relevant exposure tasks. Hence, the treatment proven to be most effective, which primary care services are commissioned to deliver, is too comprehensive and time consuming to be applied in real practice.

The investigators believe that a possible solution to the above problem is to provide evidence-based CBT but with the exposure components carried out through Virtual Reality (VR) rather than in vivo. Some research has already been done with virtual reality and exposure therapy for anxiety disorders with promising results. The aim of this pilot study is to treat patients with agoraphobia with or with a history of panic disorder with a standardized exposure-based CBT-protocol through VR. The virtual environments that are used for the study are live sequences filmed in 360°. The investigators hypothesize that CBT with VR will be effective and lead to improvements on measures of panic disorder and agoraphobia.

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 —(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •A primary diagnosis of Agoraphobia with or with a history of panic disorder according to the Diagnostic and Statistical Manual of Mental Disorders 5 (DSM-5).
  • •Minimum 18 years of age.
  • •Able to read and write in Swedish

排除标准

  • •Other primary axis-I disorder
  • •Ongoing substance abuse or addiction
  • •Current or previous episode of psychosis or bipolar disorder
  • •Severe major depressive disorder:
  • •Moderate to severe suicidal risk
  • •Non-stable antidepressant medication (changed during the last month) or not agreeing to keep dosage constant throughout the study
  • •Ongoing concurrent psychological treatment
  • •Having received previous high quality Cognitive Therapy or Cognitive Behavior Therapy for agoraphobia during the recent year

研究组 & 干预措施

VR-CBT

Experimental

Virtual Reality cognitive behavior therapy. 10-12 sessions of individual Cognitive Behavior Therapy with exposure tasks carried out through Virtual Reality.

干预措施: Virtual Reality cognitive behavior therapy (Behavioral)

结局指标

主要结局

Mobility Inventory

时间窗: Baseline, post-treatment (10 weeks), 6-month follow-up, 12-month follow-up

Change at post-treatment (10 weeks), 6-month follow-up, and 12 month follow-up compared to baseline

次要结局

  • Patient Health Questionnaire(Baseline, post-treatment (10 weeks), 6-month follow-up, 12-month follow-up)
  • The World Health Organisation Quality of Life(Baseline, post-treatment (10 weeks), 6-month follow-up, 12-month follow-up)
  • Panic disorder severity scale(Baseline, post-treatment (10 weeks), 6-month follow-up, 12-month follow-up)
  • World Health Organisation Disability Assessment Schedule(Baseline, post-treatment (10 weeks), 6-month follow-up, 12-month follow-up)

研究者

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

Erik Hedman

Principal investigator, PhD

Karolinska Institutet

研究点 (2)

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