Virtual Reality Exposure Therapy for Acrophobia

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

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.

Study Overview

• Status: Recruiting
• Conditions: Anxiety Disorders; Specific Phobia; Fear of Heights; Acrophobia
• Intervention / Treatment: Behavioral: Exposure Therapy (Virtual Reality); Other: Information Session

• Study Type: Interventional
• Enrollment (Anticipated): 50
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Iveta Fajnerova; Phone Number: 00420608501034; Email: iveta.fajnerova@nudz.cz
• Study Contact Backup: Name: Anna Francova; Email: anna.francova@nudz.cz

Study Locations

• Czechia
  • Klecany, Czechia
    • Recruiting
    • National Institute of Mental Health
    • Contact: Iveta Fajnerova

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 64 years (ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

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

Exclusion Criteria:

• 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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Virtual Reality Exposure; Participants complete three 30-40-minute sessions of exposure administered via a virtual reality headset. The exposure involve exposure to various heights and height cues in the virtual city environment. Experimental group also attends 20-minute online information session (prerecorded video).	Behavioral: Exposure Therapy (Virtual Reality); Virtual reality scenarios consists of increasingly intense exposures to phobic stimuli (e.g., looking over railings from various floor levels) with the support of the therapist. The goal of VRET is sufficient reduction in anxiety to allow the patients to expose themselves to heights in everyday situations.; Other: Information Session; This includes 20-minute information session about general principles of exposure therapy before the start of the study.
OTHER: Control; Control group attends a single 20-minute information session (prerecorded video) about general principles of exposure therapy and anxiety before the start of the study, but receives no exposure-based intervention.	Other: Information Session; This includes 20-minute information session about general principles of exposure therapy before the start of the study.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Visual Height Intolerance Severity Scale (vHISS)	The vHISS is a 8-item scale assessing the severity of visual height intolerance with additional questions for diagnosing acrophobia. Raw score range from 0 to 13, where 0 = least severely affected and 13 = most severely affected.	Immediately Post-Treatment (Controlling for Baseline Score)
Visual Height Intolerance Severity Scale (vHISS)	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.	2-months Post-Treatment (Controlling for Immediate Post-Treatment Score)
Severity Measure for Specific Phobia-Adult (SMSP-A)	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.	Immediately Post-Treatment (Controlling for Baseline Score)
Severity Measure for Specific Phobia-Adult (SMSP-A)	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.	2-months Post-Treatment (Controlling for Immediate Post-Treatment Score)
The IAPT phobia scale-avoidance	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).	2-Weeks In-Treatment (Controlling for Baseline Score)
The IAPT phobia scale-avoidance	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).	Immediately Post-Treatment (Controlling for Baseline Score)
The IAPT phobia scale-avoidance	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).	2-months Post-Treatment (Controlling for Immediate Post-Treatment Score)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Six-item State-Trait Anxiety Inventory (STAI-6)	The 6-item short form of the Spielberger State-Trait Anxiety Inventory (STAI) is used to measure self-reported symptoms of state anxiety with higher score indicating higher anxiety levels (prorated score range 20-80).	Immediately Post-Sessions
Subjective Units of Distress Scale (SUDS)	The SUDS is a visual analog scale in which the participant rates his/her anxiety/discomfort based on a range between 0 (no anxiety/discomfort) and 10 (very severe anxiety/discomfort). A SUDS rating will be collected at the end of each segment, reflecting maximum distress experienced during the interaction.	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	The patient is asked to develope a hierarchy of feared situations ranging from most-feared at the top to least-feared at the bottom. Then, he/she rates anticipated fear, anxiety or distress for each item (score 0-100 %, with higher score indicating higher anxiety) - according to how distressing they feel it would be to encounter that situation. The hierarchy is used to guide a process of VRET sessions.	Immediately Post-Treatment (Controlling for Baseline Score)

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
The Igroup Presence Questionnaire (IPQ)	The scale includes 3 subscales SP (spatial presence), INV (involvement) and REAL (experienced realism) with score range 0-7. Higher scores indication higher sense of presence. This measure might be positivelly associated with positive outcome.	Immediately Post-First Session
Simulator Sickness Questionnaire (SSQ)	The scale evaluates cybersickness symptoms in three subscales: nausea (N), oculomotor disturbance (O), disorientation (D). Total simulator sickness raw score 0-48 (adjusted total score 0-180). Higher scores on each scale indicatestronger perceptions of the underlying sickness symptoms and aretherefore undesired. This measure might be negatively associated with positive outcome and sense of presence.	Immediately Post-First Session

Collaborators and Investigators

• Sponsor: National Institute of Mental Health, Czech Republic

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): July 13, 2021
• Primary Completion (ANTICIPATED): June 1, 2022
• Study Completion (ANTICIPATED): June 1, 2022

Study Registration Dates

• First Submitted: July 12, 2021
• First Submitted That Met QC Criteria: July 22, 2021
• First Posted (ACTUAL): July 26, 2021

Study Record Updates

• Last Update Posted (ACTUAL): July 26, 2021
• Last Update Submitted That Met QC Criteria: July 22, 2021
• Last Verified: July 1, 2021

More Information

Terms related to this study

• Keywords: specific phobia; virtual reality exposure therapy; acrophobia
• Additional Relevant MeSH Terms: Mental Disorders; Anxiety Disorders
• Other Study ID Numbers: TL03000223-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: IPD (primary outcome measures) that underlie results in a publication.
• IPD Sharing Time Frame: IPD will be shared starting 6 month after the publication.
• IPD Sharing Access Criteria: Data access requests will be reviewed using an online form. Requestors will be required to sign a data access agreement.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No