Fear of HeightsVRAP-BaselNCT04003753
Efficacy of a VR Paradigm to Reduce Fear of Heights in a Clinical and Subclinical Population With Fear of Heights
A study testing VR App in people with Fear of Heights, run by Prof. Dominique de Quervain, MD at 1 site in Switzerland.
Trial summary
Investigation of the effectiveness and acceptability and usability of a VR height exposure App in individuals with fear of heights. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Fear of Heights
- What is being tested?
- VR App
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteSwitzerland
- Study dates
- 16 Oct 2018to 24 May 2019
- 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 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Clinical fear of heights (DSM-V) or subclinical fear of heights (fulfilment of DSM-C criteria A-E and G, but not F: distress/impairment)
- Physically healthy
- Aged between 18-60
- Fluent in German
Who cannot join
- Depression (BDI-II > 8)
- Suicidal ideation (BDI-II item 9 > 0)
- Concurrent psychotherapy or pharmacotherapy
- Previous therapy for height phobia
- Parallel participation in another study
- Pregnancy (will be excluded with a pregnancy test during screening)
Show all 11Show fewer
- Chronic medication intake (except oral contraceptives)
- Alcohol and medication intake before visit (less than 12 h)
- Cannabis or other psychoactive substances (including benzodiazepines) intake before visit (less than 5 days)
- Sleep-inducing drugs (incl. antihistamines) intake before visit (less than five days)
- Restricted 3D sight
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
University of Basel, Division of Cognitive Neuroscience
Basel, Canton of Basel-City, 4055
About this study
Official title: Randomized Controlled Trial on the Efficacy of a Virtual Reality Paradigm to Reduce Fear of Heights in a Clinical and Subclinical Population With Fear of Heights
Investigation of the effectiveness and acceptability and usability of a VR height exposure App in individuals with fear of heights.
Read the detailed description
The study will be conducted as a randomized controlled between subject trial. The study consists of two study phases. In study phase 1 the experimental group takes part in three VR exposure sessions (duration 20min each), whereas the control group takes part in three virtual tours (duration 20min each). All VR sessions and assessments of outcomes will be conducted on one study day for each participant.
In study phase 2 the experimental group will participate in a home training, spanning over two weeks (6x30-minutes sessions), whereas the control group will not receive any treatment (untreated comparison group). Assessment of outcomes will be conducted 3-5 weeks after completion of home trainings.
Group 1 (experimental group) consists of individuals with clinical and subclinical fear of heights, that will receive a three-session VR exposure (study phase 1) and take part in a 2-week treatment period with the same VR scenarios (study phase 2). Group 2 (control group) consists of individuals with clinical and subclinical fear of heights that will not receive any active treatment, but will participate in fear-unrelated tasks in study phase 1 or receive no treatment at all (study phase 2).
This design allows a direct comparison and therefore an estimation of the effectiveness of the VR exposure therapy. Before and after the virtual exposure/tours participants will undergo an in vivo BAT to assess the effects of the VR exposure therapy.
80 participants between 18 and 60 years with clinical or subclinical fear of heights will take part in the study. Two to three months after having finished study phase 1 the participants will be contacted again and asked to take part in study phase 2. All participants undergo a third in vivo BAT during study phase 2. The BAT will take place 3-5 weeks after completion of the home training.
- Conditions
- Fear of Heights
- Being tested
- VR App
- Medical subject headings
- Acrophobia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VR AppOther
Participants will be exposed in three different virtual height scenarios (rural mountain, urban town, cloudy weather). At the beginning of each exposure session participants will be standing on a virtual platform at ground level (level 0). From level 0 they will proceed to further levels according to a predefined exposure scheme based on SUDS ratings (scale 0=no fear to 10=extreme fear). Participants will have to stay at each level until their SUDS are 3 or below for two times consecutively (assessment via gaze selection). In each scenario there will be 15 different height levels available (corresponding to a range of heights between 1-75m). Each exposure session will be terminated by a time limit of 20 minutes (study phase 1) or 30 minutes (study phase 2) irrespective of achieved level.
| Study group | Role | What they receive |
|---|---|---|
| Exposure | Experimental | Study phase 1: The experimental intervention in the experimental group consists of three 20-minutes VR exposures (total duration in VR: 60 minutes).
Study phase 2: The experimental intervention in the experimental group consists of six 30-minutes VR exposures as home training (total duration in VR: 3 hours) within two weeks. Receives: Other: VR App |
| Control | No intervention | Study phase 1: The control group will not receive any active treatment. Instead they will use an App to make virtual tours (three times 20 minutes, total duration in VR: 60 minutes). Study phase 2: The control group will not receive any active treatment (untreated comparison group). |
What is being measured
The primary outcome is the main question the study is designed to answer.
Performance Behavioural Avoidance Test (BAT) in vivo
Change in BAT performance after VR exposure from baseline (before VR exposure). During the BAT participants will be requested to climb up to the Uetliberg Tower while continuously looking to the ground level. Participants will be asked to only proceed as far as their anxiety allows them. On each of the 14 platforms participants will be asked to lean on a predefined area of the railing (and touch it with their upper body) and to look down to the ground for 10 seconds, if their fear allows them to do so. The BAT will be terminated as soon as the participant indicates feeling uncomfortable to proceed (adapted from Emmelkamp, 2002 and Coelho, 2006) or the 10 minutes period, given to them to perform the complete task, runs out.
Measured: study phase 1: on study day within 1h after VR exposure, study phase 2: 3-5 weeks after completion of home training
Secondary outcomes (4)
Acrophobia Questionnaire (AQ)
Change in AQ after VR exposure from baseline (before VR exposure).This questionnaire describes twenty situations that can cause fear of heights (e.g., driving over a bridge, walking over a sidewalk grating, or sitting on an airplane) and asks for anxiety ratings on a 7-point Likert-type scale (0 = not at all afraid to 6 = very afraid, range 0-120, α = 0.80) (Cohen, 1977).
Measured: study phase 1: on study day within 1h after VR exposure, study phase 2: 3-5 weeks after completion of home training
Attitudes Towards Heights Questionnaire (ATHQ)
Change in ATHQ after VR exposure from baseline (before VR exposure).The ATHQ consists of six questions assessing participants' attitudes towards heights situations (e.g., "I think heights are … good - bad, secure - insecure"). Patients evaluate their attitudes towards heights by twelve adjectives on an 11-point scale ranging from a positive (0) to a negative (10) adjective (range 0-60; α = 0.81).
Measured: study phase 1: on study day within 1h after VR exposure, study phase 2: 3-5 weeks after completion of home training
Anxiety Expectancy Scale (AES)
Change in AES after VR exposure from baseline (before VR exposure). The AES assesses anxiety symptoms in a height situation. The AES consists of ten items describing anxiety symptoms (e.g., "you could feel dizzy"). Participants rate the likelihood of experiencing these symptoms while being in a height situation on a five-point scale (range 10-50) (Gursky \& Reiss, 1987).
Measured: study phase 1: on study day within 1h after VR exposure, study phase 2: 3-5 weeks after completion of home training
Danger Expectancy Scale (DES)
The DES assesses dysfunctional cognitions. The DES consists of five items. Participants rate the likelihood that each of the listed harmful events (e.g., "you might slip and fall over the guard rail on the observation deck") will pass through their minds while being in a height situation on a five-point scale (not likely at all (1), probably not (2) maybe (3), quite likely (4), or definitely (5), range 5-25) (Gursky \& Reiss, 1987).
Measured: study phase 1: on study day within 1h after VR exposure, study phase 2: 3-5 weeks after completion of home training
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2019
- Study start16 Oct 2018
- Primary completion24 May 2019
- Study completion24 May 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fear of HeightsStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- randomized controlled single-blind study design
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Prof. Dominique de Quervain, MD
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Prof. Dominique de Quervain, MD, University of Basel
- Investigators
- Dominique de Quervain, Prof., Principal investigator, University of Basel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04003753
- Sponsor's protocol ID
- 2018-01504
- Other IDs
- 2018
- Acronym
- VRAP-Basel
- Status last verified
- Jun 2019
- First submitted
- 24 Jun 2019
- Last updated
- 1 Jul 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Controlled Trial on the Efficacy of a Virtual Reality Paradigm to Reduce Fear of Heights in a Clinical and Subclinical Population With Fear of Heights
- ClinicalTrials.gov ID
- NCT04003753
- Acronym / sponsor ID
- VRAP-Basel / 2018-01504
- Conditions
- Fear of Heights
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Prof. Dominique de Quervain, MDUniversity, hospital or other
- Study start
- 16 Oct 2018 (actual)
- Primary completion
- 24 May 2019 (actual)
- Study completion
- 24 May 2019 (actual)
- First posted
- 1 Jul 2019 (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.
Investigation of the effectiveness and acceptability and usability of a VR height exposure App in individuals with fear of heights.
Detailed description
The study will be conducted as a randomized controlled between subject trial. The study consists of two study phases. In study phase 1 the experimental group takes part in three VR exposure sessions (duration 20min each), whereas the control group takes part in three virtual tours (duration 20min each). All VR sessions and assessments of outcomes will be conducted on one study day for each participant.
In study phase 2 the experimental group will participate in a home training, spanning over two weeks (6x30-minutes sessions), whereas the control group will not receive any treatment (untreated comparison group). Assessment of outcomes will be conducted 3-5 weeks after completion of home trainings.
Group 1 (experimental group) consists of individuals with clinical and subclinical fear of heights, that will receive a three-session VR exposure (study phase 1) and take part in a 2-week treatment period with the same VR scenarios (study phase 2). Group 2 (control group) consists of individuals with clinical and subclinical fear of heights that will not receive any active treatment, but will participate in fear-unrelated tasks in study phase 1 or receive no treatment at all (study phase 2).
This design allows a direct comparison and therefore an estimation of the effectiveness of the VR exposure therapy. Before and after the virtual exposure/tours participants will undergo an in vivo BAT to assess the effects of the VR exposure therapy.
80 participants between 18 and 60 years with clinical or subclinical fear of heights will take part in the study. Two to three months after having finished study phase 1 the participants will be contacted again and asked to take part in study phase 2. All participants undergo a third in vivo BAT during study phase 2. The BAT will take place 3-5 weeks after completion of the home training.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- randomized controlled single-blind study design
| Arm | Type | Receives |
|---|---|---|
| Exposure | Experimental | Other: VR AppStudy phase 1: The experimental intervention in the experimental group consists of three 20-minutes VR exposures (total duration in VR: 60 minutes). Study phase 2: The experimental intervention in the experimental group consists of six 30-minutes VR exposures as home training (total duration in VR: 3 hours) within two weeks. |
| Control | No intervention | –Study phase 1: The control group will not receive any active treatment. Instead they will use an App to make virtual tours (three times 20 minutes, total duration in VR: 60 minutes). Study phase 2: The control group will not receive any active treatment (untreated comparison group). |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Clinical fear of heights (DSM-V) or subclinical fear of heights (fulfilment of DSM-C criteria A-E and G, but not F: distress/impairment)
- Physically healthy
- Aged between 18-60
- Fluent in German
Key exclusion criteria (11 listed)
- Depression (BDI-II > 8)
- Suicidal ideation (BDI-II item 9 > 0)
- Concurrent psychotherapy or pharmacotherapy
- Previous therapy for height phobia
- Parallel participation in another study
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 |
|---|---|---|
| VR AppParticipants will be exposed in three different virtual height scenarios (rural mountain, urban town, cloudy weather). At the beginning of each exposure session participants will be standing on a virtual platform at ground level (level 0). From level 0 they will proceed to further levels according to a predefined exposure scheme based on SUDS ratings (scale 0=no fear to 10=extreme fear). Participants will have to stay at each level until their SUDS are 3 or below for two times consecutively (assessment via gaze selection). In each scenario there will be 15 different height levels available (corresponding to a range of heights between 1-75m). Each exposure session will be terminated by a time limit of 20 minutes (study phase 1) or 30 minutes (study phase 2) irrespective of achieved level. | Other | Exposure |
Primary outcome
Performance Behavioural Avoidance Test (BAT) in vivo
Time frame: study phase 1: on study day within 1h after VR exposure, study phase 2: 3-5 weeks after completion of home training
Change in BAT performance after VR exposure from baseline (before VR exposure). During the BAT participants will be requested to climb up to the Uetliberg Tower while continuously looking to the ground level. Participants will be asked to only proceed as far as their anxiety allows them. On each of the 14 platforms participants will be asked to lean on a predefined area of the railing (and touch it with their upper body) and to look down to the ground for 10 seconds, if their fear allows them to do so. The BAT will be terminated as soon as the participant indicates feeling uncomfortable to proceed (adapted from Emmelkamp, 2002 and Coelho, 2006) or the 10 minutes period, given to them to perform the complete task, runs out.
4 secondary outcomes
Acrophobia Questionnaire (AQ)
Time frame: study phase 1: on study day within 1h after VR exposure, study phase 2: 3-5 weeks after completion of home training
Attitudes Towards Heights Questionnaire (ATHQ)
Time frame: study phase 1: on study day within 1h after VR exposure, study phase 2: 3-5 weeks after completion of home training
Anxiety Expectancy Scale (AES)
Time frame: study phase 1: on study day within 1h after VR exposure, study phase 2: 3-5 weeks after completion of home training
Danger Expectancy Scale (DES)
Time frame: study phase 1: on study day within 1h after VR exposure, study phase 2: 3-5 weeks after completion of home training
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 1 Jul 2019.
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.
Dominique de Quervain, Prof. principal investigator
University of Basel
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing VR App in people with Fear of Heights, run by Prof. Dominique de Quervain, MD at 1 site in Switzerland.
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 4 inclusion and 11 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 1 Jul 2019. 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 Switzerland. 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?
Performance Behavioural Avoidance Test (BAT) in vivo (time frame: study phase 1: on study day within 1h after VR exposure, study phase 2: 3-5 weeks after completion of home training). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 1 Jul 2019.