NCT04975854

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
43

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jul 2021

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 12, 2021

Completed
1 day until next milestone

Study Start

First participant enrolled

July 13, 2021

Completed
13 days until next milestone

First Posted

Study publicly available on registry

July 26, 2021

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 17, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 17, 2022

Completed
Last Updated

May 16, 2024

Status Verified

May 1, 2024

Enrollment Period

11 months

First QC Date

July 12, 2021

Last Update Submit

May 15, 2024

Conditions

Keywords

virtual reality exposure therapyspecific phobiaacrophobia

Outcome Measures

Primary Outcomes (7)

  • 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 Outcomes (3)

  • Six-item State-Trait Anxiety Inventory (STAI-6)

    Immediately Post-Sessions

  • Subjective Units of Distress Scale (SUDS)

    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

    Immediately Post-Treatment (Controlling for Baseline Score)

Other Outcomes (2)

  • The Igroup Presence Questionnaire (IPQ)

    Immediately Post-First Session

  • Simulator Sickness Questionnaire (SSQ)

    Immediately Post-First Session

Study Arms (2)

Virtual Reality Exposure

EXPERIMENTAL

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)Other: Information Session

Control

OTHER

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

Interventions

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.

Virtual Reality Exposure

This includes 20-minute information session about general principles of exposure therapy before the start of the study.

ControlVirtual Reality Exposure

Eligibility Criteria

Age18 Years - 64 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Institute of Mental Health

Klecany, Czechia

Location

Related Publications (1)

  • Francova A, Jablonska MK, Lhotska L, Husak J, Fajnerova I. Efficacy of exposure scenario in virtual reality for the treatment of acrophobia: A randomized controlled trial. J Behav Ther Exp Psychiatry. 2025 Sep;88:102035. doi: 10.1016/j.jbtep.2025.102035. Epub 2025 Mar 30.

MeSH Terms

Conditions

Phobia, SpecificAcrophobiaAnxiety Disorders

Interventions

Virtual Reality Exposure Therapy

Condition Hierarchy (Ancestors)

Mental Disorders

Intervention Hierarchy (Ancestors)

Desensitization, PsychologicBehavior TherapyPsychotherapyBehavioral Disciplines and Activities

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
senior researcher

Study Record Dates

First Submitted

July 12, 2021

First Posted

July 26, 2021

Study Start

July 13, 2021

Primary Completion

June 17, 2022

Study Completion

June 17, 2022

Last Updated

May 16, 2024

Record last verified: 2024-05

Data Sharing

IPD Sharing
Will share

IPD (primary outcome measures) that underlie results in a publication.

Shared Documents
STUDY PROTOCOL
Time Frame
IPD will be shared starting 6 month after the publication.
Access Criteria
Data access requests will be reviewed using an online form. Requestors will be required to sign a data access agreement.

Locations