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临床试验/NCT04975854
NCT04975854已完成不适用

Virtual Reality Exposure Therapy Versus No Treatment for Acrophobia: A Randomized Controlled Trial

National Institute of Mental Health, Czech Republic1 个研究点 分布在 1 个国家目标入组 43 人开始时间: 2021年7月13日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
43
试验地点
1
主要终点
The IAPT phobia scale-avoidance

研究概览

简要总结

The aim of this study is to examine the efficacy of virtual reality exposure therapy (VRET) as a treatment for specific phobia (acrophobia). The study will randomly assign 42 participants with acrophobia to one of two conditions: a) the experimental condition (consisting of 3 sessions of virtual reality exposure) or b) a control condition. Both groups will receive short information session about general principles of exposure therapy before the start of the study. After the end of the study, the waitlist group will be invited to attend the short version (one or two-sessions) of the VRET. Both groups will receive a final follow-up questionnaires 2 months after the last session.

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
Single (Outcomes Assessor)

入排标准

年龄范围
18 Years 至 64 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • individual meeting ICD-10 criteria for diagnosis of specific phobia
  • fluent in Czech

排除标准

  • currently receiving psychological treatment for acrophobia
  • psychotropic medication (unless on stable dosage for the previous 1 month and stabilized for the duration of the study)
  • another severe mental disorder, such as bipolar disorder or psychotic disorder
  • contradictions to using a virtual reality (e.g., epilepsy, balance problems)

结局指标

主要结局

The IAPT phobia scale-avoidance

时间窗: 2-months Post-Treatment (Controlling for Immediate Post-Treatment Score)

The IAPT phobia scale-avoidance is a single item from the outcome measures administered by the UK National Health Service's IAPT programme (Improving Access to Psychological Therapies). The patient is asked to rate his/her avoidance of heights in daily situations on a scale from 0 (would not avoid it) to 8 (always avoid it).

Visual Height Intolerance Severity Scale (vHISS)

时间窗: 2-months Post-Treatment (Controlling for Immediate Post-Treatment Score)

The vHISS is a 8-item scale assessing the severity of visual height intolerance with additional questions for acrophobia.Raw score range from 0 to 13, where 0 = least severely affected and 13 = most severely affected.

Severity Measure for Specific Phobia-Adult (SMSP-A)

时间窗: 2-months Post-Treatment (Controlling for Immediate Post-Treatment Score)

SMSP-A is a 10-item scale that assesses the severity of specific phobias in individuals aged 18 and older over the past 7 days. Items are scored on a 5-point Likert scale with item scores of 1-4 respectively indicating mild, moderate, severe and extreme severity of specific phobia related distress.

次要结局

  • Six-item State-Trait Anxiety Inventory (STAI-6)(Immediately Post-Sessions)
  • Subjective Units of Distress Scale (SUDS)(Through study completion, an average of 1 months. During In-Sessions: week 1-3 (reported repeatedly during each session in response to presented exposure situations).)
  • Anxiety Hierarchy(Immediately Post-Treatment (Controlling for Baseline Score))

研究者

发起方
National Institute of Mental Health, Czech Republic
申办方类型
Other
责任方
Principal Investigator
主要研究者

Iveta Fajnerová

senior researcher

National Institute of Mental Health, Czech Republic

研究点 (1)

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