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

Fear of Heights Clinical Trial

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT05824884
• Other study ID #: AZ 794
• Status: Enrolling by invitation
• Phase: N/A
• Start date: June 22, 2023
• Est. completion date: May 31, 2024

Study information

• Verified date: June 2023
• Source: Ruhr University of Bochum
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 60
• Est. completion date: May 31, 2024
• Est. primary completion date: May 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Fear of Heights
• Phobic Disorders
• Specific Phobia, Situational

Intervention

Behavioral:
• Visual Feedback
Visual progress feedback and words of positive affirmation will be presented triggered by checkpoints set in the VR-height-exposure.
• Self-efficacy enhancement:
specific instructions regarding the retrieval of mastery experiences during exposure will be given (modified version of the procedure used in Raeder et al. 2019).
• placebo intervention
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).
• No visual feedback
Participants can not trigger any checkpoints during VR and therefore not receive any progress feedback or positive affirmation.

Locations

Country	Name	City	State
Germany	Mental Health Research and Treatment Center	Bochum

Sponsors (1)

Lead Sponsor	Collaborator
Ruhr University of Bochum

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Change in perceived SE from pre to post VR-height-exposure	Changes in perceived SE will be measures with visual analogue scales (VAS)	from baseline to 24 hours after exposure and 3-months-follow-up
Other	Becks Depression Inventory II (BDI)		assessed at baseline
Other	State-Trait Anxiety Inventory (STAI-T/STAI-S)		assessed at baseline
Other	Self-Efficacy Scale (SES)		assessed at baseline
Other	Chronic Stress Self-Efficacy Scale (CSSES)		assessed at baseline
Other	Avoidance Bias in height-fearful individuals	An Avoidance Bias will be assessed utilizing the AAT	assessed at baseline
Other	Changes in Avoidance Bias		from baseline to 24 hours after exposure
Primary	Change in the Behavioural Approach Test (BAT)		from baseline to 24 hours after exposure and 3-months-follow-up
Primary	Change in Acrophobia Questionnaire (AQ)		from baseline to 24 hours after exposure and 3-months-follow-up
Primary	Change in subjective fear during the BAT	Subjective fear during the BATs will be measured using the Subjective Units of Distress Scale (SUDS)	from baseline to 24 hours after exposure and 3-months-follow-up
Primary	Changes in Heart Rate Variability (HRV) during the BAT		at baseline, 24 hours after exposure and at 3-months-follow-up
Secondary	Change in Danger Expectancy Scale (DES)		from baseline to 24 hours after exposure and 3-months-follow-up
Secondary	Change in Anxiety Expectancy Scale (AES)		from baseline to 24 hours after exposure and 3-months-follow-up
Secondary	Differences in GSE between the respective groups	ANOVA with mean GSE-scores	at pre-exposure, immediately after exposure and 3-months-follow-up
Secondary	Differences in AQ between the respective groups	ANOVA with mean AQ-scores	at baseline, 24 hours after exposure and 3-months-follow-up