Fear of HeightsNCT04737915
Virtual Reality Exposure Versus In Vivo Exposure for Fear of Heights
A study testing Exposure Therapy (In Vivo) and Exposure Therapy (Virtual Reality) in people with Fear of Heights and Acrophobia, run by University of Notre Dame at 1 site in United States.
Trial summary
This study randomly assigned 114 participants with significant fear of heights to one of three conditions: a) a single session of virtual reality exposure; b) a single session of in vivo exposure; or c) a control condition. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Fear of Heights, Acrophobia, Specific Phobia
- What is being tested?
- Exposure Therapy (In Vivo) and Exposure Therapy (Virtual Reality)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 114 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Jun 2018to 6 Mar 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Score >= 45 on the Acrophobia Questionnaire (AQ)
Who cannot join
- Already receiving therapy specifically for fear of heights.
- Has any contraindications to using a virtual reality headset.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparing the Efficacy of a Single-Session Virtual Reality Treatment for Fear of Heights to In Vivo Exposure and No Treatment
This study randomly assigned 114 participants with significant fear of heights to one of three conditions: a) a single session of virtual reality exposure; b) a single session of in vivo exposure; or c) a control condition. The aim of this study was to compare the efficacy of virtual reality exposure to the efficacy of in vivo exposure or no exposure for participants with significant fear of heights.
- Conditions
- Fear of Heights, Acrophobia, Specific Phobia, Anxiety Disorder
- Being tested
- Exposure Therapy (In Vivo), Exposure Therapy (Virtual Reality)
- Medical subject headings
- Acrophobia, Phobia, Specific, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exposure Therapy (In Vivo)Behavioural
Participant completes a single session of exposure therapy for fear of heights by looking over railings into an atrium at various floor levels in a virtual environment.
Exposure Therapy (Virtual Reality)Behavioural
Participant completes a single session of exposure therapy for fear of heights by looking over railings into an atrium at various floor levels in a real environment.
| Study group | Role | What they receive |
|---|---|---|
| Virtual Reality Exposure | Experimental | Participants completed a single session of exposure administered via a virtual reality headset. The exposure exercise involved looking over virtual railings into an atrium at various floor levels (the virtual environment was designed to look like the atrium in the in vivo exposure condition). Exposure was conducted in six 6-minute trials for a total of 36 minutes of exposure. Receives: Behavioral: Exposure Therapy (Virtual Reality) |
| In Vivo Exposure | Experimental | Participants completed a single session of exposure administered in vivo. The exposure exercise involved looking over actual railings into an atrium at various floor levels. Exposure was conducted in six 6-minute trials for a total of 36 minutes of exposure. Receives: Behavioral: Exposure Therapy (In Vivo) |
| Waitlist Control | No intervention | Participants watched a neutral video during the time participants in other conditions were completing the exposure exercise. Participants received no exposure-based intervention. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Acrophobia Questionnaire (AQ)
Participants completed the anxiety subscale of the AQ, a 20-item questionnaire that assesses self-reported anxiety related to acrophobia. Scores for the subscale are summed, and totals range from 0 to 120, with higher scores indicating greater anxiety.
Measured: Immediately Post-Treatment (Controlling for Baseline Scores)
Behavioral Approach Task (BAT)
Participants walked up a staircase until they reach the highest level they can complete, while stopping to look over the ledge toward the floor at each landing. During each BAT, fear response was assessed behaviorally (highest step reached) and subjectively (self reported levels of fear).
Measured: Immediately Post-Treatment (Controlling for Baseline Scores)
Heights Interpretation Questionnaire (HIQ)
Participants completed the HIQ, a 16-item questionnaire that assesses self-reported interpretations of an imagined experience of heights. Items are summed scored, and totals ranged from 16 to 80, with higher scores indicating greater height fear-relevant interpretation bias.
Measured: Immediately Post-Treatment (Controlling for Baseline Scores)
Acrophobia Questionnaire (AQ)
Participants completed the anxiety subscale of the AQ, a 20-item questionnaire that assesses self-reported anxiety related to acrophobia. Scores for the subscale are summed, and totals range from 0 to 120, with higher scores indicating greater anxiety.
Measured: 1-Week Post-Treatment (Controlling for Immediate Post-Treatment Scores)
Behavioral Approach Task (BAT)
Participants walked up a staircase until they reach the highest level they can complete, while stopping to look over the ledge toward the floor at each landing. During each BAT, fear response was assessed behaviorally (highest step reached) and subjectively (self reported levels of fear).
Measured: 1-Week Post-Treatment (Controlling for Immediate Post-Treatment Scores)
Heights Interpretation Questionnaire (HIQ)
Participants completed the HIQ, a 16-item questionnaire that assesses self-reported interpretations of an imagined experience of heights. Items are summed scored, and totals ranged from 16 to 80, with higher scores indicating greater height fear-relevant interpretation bias.
Measured: 1-Week Post-Treatment (Controlling for Immediate Post-Treatment Scores)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Feb 2021
- Study start11 Jun 2018
- Primary completion6 Mar 2019
- Study completion6 Mar 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Eligible participants were randomly assigned to one of three conditions: a) single session virtual reality exposure; b) single session in vivo exposure; c) waitlist control
- Masking
- None (open label)
- Enrolment
- 114 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Notre Dame
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jennifer Hames, University of Notre Dame
- Investigators
- Jennifer L Hames, Ph.D., Principal investigator, University of Notre Dame
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04737915
- Sponsor's protocol ID
- Interventional
- Status last verified
- Feb 2021
- First submitted
- 28 Jan 2021
- Last updated
- 8 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Study protocols and de-identified data will be shared at the request of other researchers.
Study at a glance
From the registry record, last updated by the sponsor on 8 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparing the Efficacy of a Single-Session Virtual Reality Treatment for Fear of Heights to In Vivo Exposure and No Treatment
- ClinicalTrials.gov ID
- NCT04737915
- Acronym / sponsor ID
- Interventional
- Conditions
- Fear of Heights, Acrophobia, Specific Phobia, Anxiety Disorder
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 114 participants (actual)
- Lead sponsor
- University of Notre DameUniversity, hospital or other
- Study start
- 11 Jun 2018 (actual)
- Primary completion
- 6 Mar 2019 (actual)
- Study completion
- 6 Mar 2019 (actual)
- First posted
- 4 Feb 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.
This study randomly assigned 114 participants with significant fear of heights to one of three conditions: a) a single session of virtual reality exposure; b) a single session of in vivo exposure; or c) a control condition. The aim of this study was to compare the efficacy of virtual reality exposure to the efficacy of in vivo exposure or no exposure for participants with significant fear of heights.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Eligible participants were randomly assigned to one of three conditions: a) single session virtual reality exposure; b) single session in vivo exposure; c) waitlist control
| Arm | Type | Receives |
|---|---|---|
| Virtual Reality Exposure | Experimental | Behavioral: Exposure Therapy (Virtual Reality)Participants completed a single session of exposure administered via a virtual reality headset. The exposure exercise involved looking over virtual railings into an atrium at various floor levels (the virtual environment was designed to look like the atrium in the in vivo exposure condition). Exposure was conducted in six 6-minute trials for a total of 36 minutes of exposure. |
| In Vivo Exposure | Experimental | Behavioral: Exposure Therapy (In Vivo)Participants completed a single session of exposure administered in vivo. The exposure exercise involved looking over actual railings into an atrium at various floor levels. Exposure was conducted in six 6-minute trials for a total of 36 minutes of exposure. |
| Waitlist Control | No intervention | –Participants watched a neutral video during the time participants in other conditions were completing the exposure exercise. Participants received no exposure-based intervention. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Score >= 45 on the Acrophobia Questionnaire (AQ)
Key exclusion criteria (2 listed)
- Already receiving therapy specifically for fear of heights.
- Has any contraindications to using a virtual reality headset.
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 (In Vivo)Participant completes a single session of exposure therapy for fear of heights by looking over railings into an atrium at various floor levels in a virtual environment. | Behavioural | In Vivo Exposure |
| Exposure Therapy (Virtual Reality)Participant completes a single session of exposure therapy for fear of heights by looking over railings into an atrium at various floor levels in a real environment. | Behavioural | Virtual Reality Exposure |
Primary outcome
Acrophobia Questionnaire (AQ)
Time frame: Immediately Post-Treatment (Controlling for Baseline Scores)
Participants completed the anxiety subscale of the AQ, a 20-item questionnaire that assesses self-reported anxiety related to acrophobia. Scores for the subscale are summed, and totals range from 0 to 120, with higher scores indicating greater anxiety.
Behavioral Approach Task (BAT)
Time frame: Immediately Post-Treatment (Controlling for Baseline Scores)
Participants walked up a staircase until they reach the highest level they can complete, while stopping to look over the ledge toward the floor at each landing. During each BAT, fear response was assessed behaviorally (highest step reached) and subjectively (self reported levels of fear).
Heights Interpretation Questionnaire (HIQ)
Time frame: Immediately Post-Treatment (Controlling for Baseline Scores)
Participants completed the HIQ, a 16-item questionnaire that assesses self-reported interpretations of an imagined experience of heights. Items are summed scored, and totals ranged from 16 to 80, with higher scores indicating greater height fear-relevant interpretation bias.
Acrophobia Questionnaire (AQ)
Time frame: 1-Week Post-Treatment (Controlling for Immediate Post-Treatment Scores)
Participants completed the anxiety subscale of the AQ, a 20-item questionnaire that assesses self-reported anxiety related to acrophobia. Scores for the subscale are summed, and totals range from 0 to 120, with higher scores indicating greater anxiety.
Behavioral Approach Task (BAT)
Time frame: 1-Week Post-Treatment (Controlling for Immediate Post-Treatment Scores)
Participants walked up a staircase until they reach the highest level they can complete, while stopping to look over the ledge toward the floor at each landing. During each BAT, fear response was assessed behaviorally (highest step reached) and subjectively (self reported levels of fear).
Heights Interpretation Questionnaire (HIQ)
Time frame: 1-Week Post-Treatment (Controlling for Immediate Post-Treatment Scores)
Participants completed the HIQ, a 16-item questionnaire that assesses self-reported interpretations of an imagined experience of heights. Items are summed scored, and totals ranged from 16 to 80, with higher scores indicating greater height fear-relevant interpretation bias.
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 8 Feb 2021.
- Individual participant dataSharing planned: No. Study protocols and de-identified data will be shared at the request of other researchers.
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.
Jennifer L Hames, Ph.D. principal investigator
University of Notre Dame
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exposure Therapy (In Vivo) and Exposure Therapy (Virtual Reality) in people with Fear of Heights and Acrophobia, run by University of Notre Dame at 1 site in United States.
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 1 inclusion and 2 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 8 Feb 2021. 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 United States. 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?
Acrophobia Questionnaire (AQ) (time frame: Immediately Post-Treatment (Controlling for Baseline Scores)). The study lists 6 primary outcomes in all. 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 8 Feb 2021.