Specific PhobiaNCT04975854

Virtual Reality Exposure Therapy for Acrophobia

A study testing Exposure Therapy (Virtual Reality) and Information Session in people with Specific Phobia and Acrophobia, run by National Institute of Mental Health, Czech Republic at 1 site in Czechia.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 to 64 years
Conditions the study is for: Specific Phobia, Acrophobia, Fear of Heights
What is being tested?: Exposure Therapy (Virtual Reality) and Information Session
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 43 participants
Where: 1 siteCzechia
Study dates: 13 Jul 2021to 17 Jun 2022
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 64 years
All sexes
No healthy volunteers
Adult

Who may be able to join

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

Who cannot join

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)

Trial locations and contacts

1 site in 1 country.

Czechia1 site

National Institute of Mental Health
Klecany

Other trials in Czechia

About this study

Official title: 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.

Conditions: Specific Phobia, Acrophobia, Fear of Heights, Anxiety Disorders
Being tested: Exposure Therapy (Virtual Reality), Information Session
Keywords: virtual reality exposure therapy, specific phobia, acrophobia
Medical subject headings: Phobia, Specific, Acrophobia, Anxiety Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Exposure Therapy (Virtual Reality)Behavioural
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.
Information SessionOther
This includes 20-minute information session about general principles of exposure therapy before the start of the study.

Study groups in NCT04975854
Study group	Role	What they receive
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). Receives: 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. Receives: Other: Information Session

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 2-months Post-Treatment (Controlling for Immediate Post-Treatment Score)

Secondary outcomes (3)

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).
Measured: 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.
Measured: 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.
Measured: Immediately Post-Treatment (Controlling for Baseline Score)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

13 Jul 202117 Jun 2022

First posted26 Jul 2021
Study start13 Jul 2021
Primary completion17 Jun 2022
Study completion17 Jun 2022

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Specific PhobiaStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind
Who is masked: Outcomes assessor
Enrolment: 43 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04975854
Sponsor's protocol ID: TL03000223-01
Status last verified: May 2024
First submitted: 12 Jul 2021
Last updated: 16 May 2024
Results posted: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Yes: IPD (primary outcome measures) that underlie results in a publication.

Publications

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.
PubMed 40186999

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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All Specific Phobia trials

Study at a glance

From the registry record, last updated by the sponsor on 16 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Virtual Reality Exposure Therapy Versus No Treatment for Acrophobia: A Randomized Controlled Trial
ClinicalTrials.gov ID: NCT04975854
Acronym / sponsor ID: TL03000223-01
Conditions: Specific Phobia, Acrophobia, Fear of Heights, Anxiety Disorders
Keywords: virtual reality exposure therapy, specific phobia, acrophobia
Study type: Interventional
Recruitment status: Completed
Enrolment: 43 participants (actual)
Lead sponsor: National Institute of Mental Health, Czech RepublicUniversity, hospital or other
Study start: 13 Jul 2021 (actual)
Primary completion: 17 Jun 2022 (actual)
Study completion: 17 Jun 2022 (actual)
First posted: 26 Jul 2021 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Virtual Reality Exposure	Experimental	Behavioral: Exposure Therapy (Virtual Reality), Other: Information SessionParticipants 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).
Control	Other	Other: Information SessionControl 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.

Who may qualify

Ages: 18 to 64 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult

Key inclusion criteria (2 listed)

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

Key exclusion criteria (4 listed)

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)

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
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.	Behavioural	Virtual Reality Exposure
Information SessionThis includes 20-minute information session about general principles of exposure therapy before the start of the study.	Other	Control, Virtual Reality Exposure

Primary outcome

Visual Height Intolerance Severity Scale (vHISS)
Time frame: Immediately Post-Treatment (Controlling for Baseline Score)
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.
Visual Height Intolerance Severity Scale (vHISS)
Time frame: 2-months Post-Treatment (Controlling for Immediate Post-Treatment Score)
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.
Severity Measure for Specific Phobia-Adult (SMSP-A)
Time frame: Immediately Post-Treatment (Controlling for Baseline Score)
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.
Severity Measure for Specific Phobia-Adult (SMSP-A)
Time frame: 2-months Post-Treatment (Controlling for Immediate Post-Treatment Score)
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.
The IAPT phobia scale-avoidance
Time frame: 2-Weeks In-Treatment (Controlling for Baseline Score)
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).
The IAPT phobia scale-avoidance
Time frame: Immediately Post-Treatment (Controlling for Baseline Score)
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).
The IAPT phobia scale-avoidance
Time frame: 2-months Post-Treatment (Controlling for Immediate Post-Treatment Score)
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).

3 secondary outcomes

Six-item State-Trait Anxiety Inventory (STAI-6)
Time frame: Immediately Post-Sessions
Subjective Units of Distress Scale (SUDS)
Time frame: 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
Time frame: Immediately Post-Treatment (Controlling for Baseline Score)

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 16 May 2024.
Derived from this study: PubMed 40186999Francova 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.
Individual participant dataSharing planned: Yes. IPD (primary outcome measures) that underlie results in a publication.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 16 May 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Czechia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Visual Height Intolerance Severity Scale (vHISS) (time frame: Immediately Post-Treatment (Controlling for Baseline Score)). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04975854, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 May 2024.