Viewing Study NCT05824884



Ignite Creation Date: 2024-05-06 @ 6:54 PM
Last Modification Date: 2024-10-26 @ 2:56 PM
Study NCT ID: NCT05824884
Status: ENROLLING_BY_INVITATION
Last Update Posted: 2023-06-23
First Post: 2023-04-08

Brief Title: Self-efficacy Enhancement in a Virtual Reality Training for Fear of Heights
Sponsor: Ruhr University of Bochum
Organization: Ruhr University of Bochum

Study Overview

Official Title: Self-efficacy Enhancement in a Virtual Reality Training for Fear of Heights Promoting Mastery Experiences
Status: ENROLLING_BY_INVITATION
Status Verified Date: 2024-08
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
Brief Summary: 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 andor 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 andor SE enhancement DURING VR-height-exposure alone
Detailed Description: 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

Furthermore danger expectancies and fear expectancies DES AES will be measured at pre- and post-exposure as well as at 3-months-follow-up During all BATs and the VR-height-exposure heart-rate variability HRV will be assessed as a psychophysiological indicator for fear response

Moreover participants are asked to rate their general self-efficacy via Questionnaire GSE and their perceived self-efficacy via Visual Analogue Scales VAS at pre- and post-exposure as well as 3-months follow-up Furthermore the VAS measures mood excitement and distraction

Additionally several control variables are assessed pre-exposure including Becks Depression Inventory II BDI-II The State-and-Trait-Anxiety Inventory STAI-T STAI-S the Self-Efficacy Scale SES and the CSSES

Implicit Approach-Avoidance biases towards height-related stimuli will also be assessed pre- and post VR-height-training utilizing the Approach-Avoidance-Task AAT The participants are instructed to push away simulating avoidance vs pull towards simulating approach neutral vs height-related pictures according to the way they are tilted tilted-right vs tilted left using the computer mouse Reaction time delays in the pull towards height-related pictures condition can be an indicator for implicit avoidance tendencies

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: False
Is a FDA Regulated Device?: False
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None