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Self-efficacy Enhancement in a Virtual Reality Training for Fear of Heights

Primary Purpose

Fear of Heights, Specific Phobia, Situational

Status
Enrolling by invitation
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Visual Feedback
Self-efficacy enhancement:
placebo intervention
No visual feedback
Sponsored by
Ruhr University of Bochum
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Fear of Heights focused on measuring Specific phobia, fear of heights, Self-efficacy, virtual reality, exposure

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: age 18 to 65 years fear of heights normal or corrected vision Exclusion Criteria: 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

Sites / Locations

  • Mental Health Research and Treatment Center

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Active Comparator

Active Comparator

Placebo Comparator

Arm Label

Experimental 1

Active Comparator 1

Active Comparator 2

Placebo Comparator

Arm Description

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

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

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

no visual feedback during exposure and placebo intervention after exposure.

Outcomes

Primary Outcome Measures

Change in the Behavioural Approach Test (BAT)
Change in Acrophobia Questionnaire (AQ)
Change in subjective fear during the BAT
Subjective fear during the BATs will be measured using the Subjective Units of Distress Scale (SUDS)
Changes in Heart Rate Variability (HRV) during the BAT

Secondary Outcome Measures

Change in Danger Expectancy Scale (DES)
Change in Anxiety Expectancy Scale (AES)
Differences in GSE between the respective groups
ANOVA with mean GSE-scores
Differences in AQ between the respective groups
ANOVA with mean AQ-scores

Full Information

First Posted
April 8, 2023
Last Updated
June 22, 2023
Sponsor
Ruhr University of Bochum
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1. Study Identification

Unique Protocol Identification Number
NCT05824884
Brief Title
Self-efficacy Enhancement in a Virtual Reality Training for Fear of Heights
Official Title
Self-efficacy Enhancement in a Virtual Reality Training for Fear of Heights: Promoting Mastery Experiences
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Enrolling by invitation
Study Start Date
June 22, 2023 (Actual)
Primary Completion Date
May 31, 2024 (Anticipated)
Study Completion Date
May 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ruhr University of Bochum

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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 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.
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 Beck's 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fear of Heights, Specific Phobia, Situational
Keywords
Specific phobia, fear of heights, Self-efficacy, virtual reality, exposure

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Experimental 1
Arm Type
Experimental
Arm Description
positive visual feedback during VR-height-exposure combined with SE-enhancement after exposure.
Arm Title
Active Comparator 1
Arm Type
Active Comparator
Arm Description
positive visual feedback during VR-height-exposure, and a placebo intervention after exposure.
Arm Title
Active Comparator 2
Arm Type
Active Comparator
Arm Description
no visual feedback during exposure but SE-enhancement after exposure.
Arm Title
Placebo Comparator
Arm Type
Placebo Comparator
Arm Description
no visual feedback during exposure and placebo intervention after exposure.
Intervention Type
Behavioral
Intervention Name(s)
Visual Feedback
Intervention Description
Visual progress feedback and words of positive affirmation will be presented triggered by checkpoints set in the VR-height-exposure.
Intervention Type
Behavioral
Intervention Name(s)
Self-efficacy enhancement:
Intervention Description
specific instructions regarding the retrieval of mastery experiences during exposure will be given (modified version of the procedure used in Raeder et al. 2019).
Intervention Type
Behavioral
Intervention Name(s)
placebo intervention
Intervention Description
specific instructions regarding the retrieval of the exposure session will be given without an emphasis on personal mastery experience (modified version of the procedure used in Raeder et al. 2019).
Intervention Type
Behavioral
Intervention Name(s)
No visual feedback
Intervention Description
Participants can not trigger any checkpoints during VR and therefore not receive any progress feedback or positive affirmation.
Primary Outcome Measure Information:
Title
Change in the Behavioural Approach Test (BAT)
Time Frame
from baseline to 24 hours after exposure and 3-months-follow-up
Title
Change in Acrophobia Questionnaire (AQ)
Time Frame
from baseline to 24 hours after exposure and 3-months-follow-up
Title
Change in subjective fear during the BAT
Description
Subjective fear during the BATs will be measured using the Subjective Units of Distress Scale (SUDS)
Time Frame
from baseline to 24 hours after exposure and 3-months-follow-up
Title
Changes in Heart Rate Variability (HRV) during the BAT
Time Frame
at baseline, 24 hours after exposure and at 3-months-follow-up
Secondary Outcome Measure Information:
Title
Change in Danger Expectancy Scale (DES)
Time Frame
from baseline to 24 hours after exposure and 3-months-follow-up
Title
Change in Anxiety Expectancy Scale (AES)
Time Frame
from baseline to 24 hours after exposure and 3-months-follow-up
Title
Differences in GSE between the respective groups
Description
ANOVA with mean GSE-scores
Time Frame
at pre-exposure, immediately after exposure and 3-months-follow-up
Title
Differences in AQ between the respective groups
Description
ANOVA with mean AQ-scores
Time Frame
at baseline, 24 hours after exposure and 3-months-follow-up
Other Pre-specified Outcome Measures:
Title
Change in perceived SE from pre to post VR-height-exposure
Description
Changes in perceived SE will be measures with visual analogue scales (VAS)
Time Frame
from baseline to 24 hours after exposure and 3-months-follow-up
Title
Becks Depression Inventory II (BDI)
Time Frame
assessed at baseline
Title
State-Trait Anxiety Inventory (STAI-T/STAI-S)
Time Frame
assessed at baseline
Title
Self-Efficacy Scale (SES)
Time Frame
assessed at baseline
Title
Chronic Stress Self-Efficacy Scale (CSSES)
Time Frame
assessed at baseline
Title
Avoidance Bias in height-fearful individuals
Description
An Avoidance Bias will be assessed utilizing the AAT
Time Frame
assessed at baseline
Title
Changes in Avoidance Bias
Time Frame
from baseline to 24 hours after exposure

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: age 18 to 65 years fear of heights normal or corrected vision Exclusion Criteria: 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
Facility Information:
Facility Name
Mental Health Research and Treatment Center
City
Bochum
ZIP/Postal Code
44787
Country
Germany

12. IPD Sharing Statement

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Self-efficacy Enhancement in a Virtual Reality Training for Fear of Heights

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