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临床试验/NCT05824884
NCT05824884已完成不适用

Self-efficacy Enhancement in a Virtual Reality Training for Fear of Heights: Promoting Mastery Experiences

Ruhr University of Bochum1 个研究点 分布在 1 个国家目标入组 83 人开始时间: 2023年6月22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
发起方
入组人数
83
试验地点
1
主要终点
Change in the Behavioural Approach Test (BAT)

研究概览

简要总结

Self-efficacy (SE) enhancement after virtual reality exposure (VRET) for heights can promote treatment-induced effects (Raeder et al. 2019). Raeder et al (2019) employed an intervention to enhance SE by introducing specific questions about autobiographical events of success and mastery experiences in the course of VRET. Building on these previous findings, the present study aims to examine whether SE-enhancement DURING and/or AFTER a brief VR-based exposure for fear of heights (in the following referred to as VR-height-exposure) is suitable to promote exposure-induced reductions in height-related fear and avoidance. To this end, repeated visual feedback DURING a brief VR-height-exposure will be used to selectively promote SE and mastery experiences. In a similar vein, SE-enhancement AFTER VR-height-exposure will be administered. The effects of these interventions will be assessed on different treatment outcome levels. It will be further examined whether the combined SE enhancement (DURING and AFTER exposure) is more effective that 1.) SE enhancement performed DURING VR-height-exposure only or 2.) SE enhancement performed AFTER VR-height-exposure only.

The investigators hypothesize that SE enhancement (either administered DURING or AFTER VR-height-exposure) will be more effective (as indicated by more pronounced reductions in height-related fear and avoidance) than VR-height-exposure alone. It is further expected that the combined SE enhancement DURING and AFTER VR-height-exposure will be more effective compared to SE enhancement DURING VR-height-exposure alone and/or SE enhancement DURING VR-height-exposure alone.

详细描述

The aim of this study is to evaluate whether visual feedback DURING VR-height-exposure and SE-enhancement strategies that are designed to promote mastery experience AFTER exposure are suitable to benefit exposure-induced reductions in height-related fear and avoidance.

Participants will be randomly assigned to one of the following conditions: a) visual feedback DURING VR-height-exposure and SE-enhancement targeting mastery experience AFTER VR-height-exposure b) no visual feedback DURING VR-height-exposure but SE-enhancement targeting mastery experience AFTER VR-height-exposure, c) visual feedback DURING VR-height-exposure but a control intervention AFTER VR-height-exposure d) no visual feedback and control intervention after VR-height- exposure. The SE-enhancement as well as the control intervention involve memory reactivation either with or without emphasis on a mastery experience attained during the VR-height-exposure. The visual feedback is presented in form of a progress-update combined with positive affirmation.

The VR-height-exposure concludes different exercises in a virtual environment that simulate situations, that can be challenging to height-fearful individuals in real life, such as glass-elevators, a glass-bridge, a tall ladder and lattice stairs. During VR-height-exposure, self-reported fear is measured in Subjective Units of Distress (SUDS). The VR-environment is presented via head-mounted displays and the participants can use touch-controllers to navigate through the exercises guided by the experimenter.

As outcome measures, subjective fear and height-related avoidance will be assessed at three time points: pre-exposure, post-exposure and at 3 months-follow-up.

Subjective fear is measured using the Acrophobia Questionnaire (AQ; Cohen, 1977). To measure height-related avoidance behavior, a Behavioural Approach Test (BAT) will be performed in a nearby church tower, that includes 13 steps of varying difficulty and requires active behavioral approach towards height-situations.

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 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • age 18 to 65 years
  • fear of heights
  • normal or corrected vision

排除标准

  • acute psychotherapy or psychotherapy in the past 2 years
  • acute psychiatric drug intake
  • acute schizophrenic or psychotic symptoms
  • acute major depressive episode with severe symptoms
  • acute substance use disorder
  • neurological disorder or mental disability
  • cardiac arrhythmias or pacemaker

研究组 & 干预措施

Active Comparator 1

Active Comparator

positive visual feedback during VR-height-exposure, and a placebo intervention after exposure.

干预措施: Visual Feedback (Behavioral)

Active Comparator 1

Active Comparator

positive visual feedback during VR-height-exposure, and a placebo intervention after exposure.

干预措施: placebo intervention (Behavioral)

Experimental 1

Experimental

positive visual feedback during VR-height-exposure combined with SE-enhancement after exposure.

干预措施: Visual Feedback (Behavioral)

Experimental 1

Experimental

positive visual feedback during VR-height-exposure combined with SE-enhancement after exposure.

干预措施: Self-efficacy enhancement: (Behavioral)

Active Comparator 2

Active Comparator

no visual feedback during exposure but SE-enhancement after exposure.

干预措施: Self-efficacy enhancement: (Behavioral)

Active Comparator 2

Active Comparator

no visual feedback during exposure but SE-enhancement after exposure.

干预措施: No visual feedback (Behavioral)

Placebo Comparator

Placebo Comparator

no visual feedback during exposure and placebo intervention after exposure.

干预措施: placebo intervention (Behavioral)

Placebo Comparator

Placebo Comparator

no visual feedback during exposure and placebo intervention after exposure.

干预措施: No visual feedback (Behavioral)

结局指标

主要结局

Change in the Behavioural Approach Test (BAT)

时间窗: from baseline to 24 hours after exposure and 3-months-follow-up

Change in subjective fear during the BAT

时间窗: from baseline to 24 hours after exposure and 3-months-follow-up

Subjective fear during the BATs will be measured using the Subjective Units of Distress Scale (SUDS)

Change in Acrophobia Questionnaire (AQ)

时间窗: from baseline to 24 hours after exposure and 3-months-follow-up

Changes in Heart Rate Variability (HRV) during the BAT

时间窗: at baseline, 24 hours after exposure and at 3-months-follow-up

次要结局

  • Change in Danger Expectancy Scale (DES)(from baseline to 24 hours after exposure and 3-months-follow-up)
  • Differences in GSE between the respective groups(at pre-exposure, immediately after exposure and 3-months-follow-up)
  • Differences in AQ between the respective groups(at baseline, 24 hours after exposure and 3-months-follow-up)
  • Change in Anxiety Expectancy Scale (AES)(from baseline to 24 hours after exposure and 3-months-follow-up)

研究者

发起方
Ruhr University of Bochum
申办方类型
Other
责任方
Principal Investigator
主要研究者

Armin Zlomuzica

Principal Investigator

Ruhr University of Bochum

研究点 (1)

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