Specific PhobiaoVRcomeNCT04909177
oVRcome Self-guided Virtual Reality for Specific Phobias
A study testing Smartphone application (app) in combination with headset in people with Specific Phobia, run by University of Otago at 1 site in New Zealand.
Trial summary
Specific phobias: fear of flying, heights, spiders, dogs and needles are the extremely common and exposure therapy (ET) is the first line of treatment. Using Virtual Reality (VR), participants will have control in gradual exposure to their fears. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Specific Phobia
- What is being tested?
- Smartphone application (app) in combination with headset
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 126 participants
- Where
- 1 siteNew Zealand
- Study dates
- 2 Jun 2021to 7 Mar 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- In order to be eligible to participate in this study, a subject must meet all of the following criteria:
- are between 18-64 years old
- Have a fear of flying, heights, spiders, dogs, needles and score above 4 on the Brief Standard Self rating scale for phobic patients (Marks, I. Matthews ,A (1979) Behaviour Research and Therapy)
- have access to a smart phone and internet
- willing to participate in the research study and providing informed consent
Who cannot join
- A potential subject who meets any of the following criteria will be excluded from participation in this study:
- present with symptoms of severe depression or suicidality respectively as measured with the PHQ-9; total score > 19
- have insufficient knowledge of the English language
- are under current treatment for specific phobia or psychotropic medication (unless on stable dosage for the previous 3 months and no changes planned during the study period).
Trial locations and contacts
1 site in 1 country.
New Zealand1 site
University of Otago, Christchurch
Christchurch, Canterbury, 8011
About this study
Official title: oVRcome Self-guided Virtual Reality for Specific Phobias: A Randomized Controlled Trial
Specific phobias: fear of flying, heights, spiders, dogs and needles are the extremely common and exposure therapy (ET) is the first line of treatment. Using Virtual Reality (VR), participants will have control in gradual exposure to their fears. oVRcome (https://www.ovrcome.io/ Virtual reality app), is a self-help VRET for specific phobias, that is delivered through a smartphone application (app) in combination with a low cost headset that holds the smartphone and uses 360º video. The investigators hypothesize that oVRcome is effective in reducing specific phobia symptoms.
- Conditions
- Specific Phobia
- Being tested
- Smartphone application (app) in combination with headset
- Medical subject headings
- Phobia, Specific
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Smartphone application (app) in combination with headsetOther
The intervention oVRcome is self-help VRET for specific phobia, that is delivered through a smartphone application (app) in combination with headset that holds the smartphone and uses 360º video. oVRcome includes 6 modules of psychoeducation, relaxation, mindfulness, cognitive techniques, exposure through VR, and a relapse prevention module which are aimed to be completed weekly.
| Study group | Role | What they receive |
|---|---|---|
| Smartphone application (app) in combination with headset | Experimental | The intervention oVRcome is self-help VRET for specific phobia, that is delivered through a smartphone application (app) in combination with headset that holds the smartphone and uses 360º video. oVRcome includes 6 modules of psychoeducation, relaxation, mindfulness, cognitive techniques, exposure through VR, and a relapse prevention module which are aimed to be completed weekly. Receives: Other: Smartphone application (app) in combination with headset |
| Waitlist | No intervention | Participants in the waitlist condition will be offered the intervention directly after post-test. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Severity Measure for Specific Phobia-Adult American Psychological Association
The Severity Measure for Specific Phobia-Adult is a 10-item self-report measure that assesses the severity of specific phobia in individuals age 18 and older.
The total score can range from 0 to 40 with higher scores indicating greater severity of specific phobia.
Measured: Week 6
Secondary outcomes (8)
Brief Standard Self rating scale for phobic patients
The total score can range from 0 to 8 with higher scores indicating greater severity of specific phobia
Measured: 6 weeks, 12 weeks, 18 weeks
Clinical Global Impression of Change (CGI-C)
CGI-C scores range from 1 (very much improved) through to 7 (very much worse)
Measured: weekly (Weeks 1-6)
Patient Health Questionnaire - PHQ 9
PHQ-9 scores range from 1 through to 27, with higher scores indicating more severe depressive symptoms
Measured: 6 weeks, 12 weeks, 18 weeks
Subjective Units of Distress Scale
Scores range from 1 through to 100 with higher scores indicating higher levels of distress
Measured: Week 4, 5 and 6
Modified Gatineau Presence Questionnaire First item
Scores range from 1 (very realistic) through to 100 (not very realistic)
Measured: Week 4, 5 and 6
Fast Motion Sickness Scale (FMS)
Scores range from zero (no sickness at all) to 20 (frank sickness).
Measured: Week 4, 5 and 6
Brief Fear of Negative Evaluation Scale
Scores range from 1 through to 60 with higher scores indicating higher fear of negative evaluation
Measured: 6 weeks, 12 weeks, 18 weeks
Changes in behaviour that may have been previously avoided because of the phobia
Free text response
Measured: Weeks 6 and 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jun 2021
- Study start2 Jun 2021
- Primary completion7 Sep 2021
- Study completion7 Mar 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
- None (open label)
- Enrolment
- 126 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Otago
- Sponsor type
- University, hospital or other
- Collaborators
- oVRcome
- Responsible party
- Sponsor
- Investigators
- Cameron Lacey, PhD, Principal investigator, University of Otago
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04909177
- Sponsor's protocol ID
- oVRcome specific phobia
- Acronym
- oVRcome
- Status last verified
- Aug 2024
- First submitted
- 26 May 2021
- Last updated
- 22 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Lacey C, Frampton C, Beaglehole B. oVRcome - Self-guided virtual reality for specific phobias: A randomised controlled trial. Aust N Z J Psychiatry. 2023 May;57(5):736-744. doi: 10.1177/00048674221110779. Epub 2022 Jul 11.
PubMed 35818296
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- oVRcome Self-guided Virtual Reality for Specific Phobias: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04909177
- Acronym / sponsor ID
- oVRcome / oVRcome specific phobia
- Conditions
- Specific Phobia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 126 participants (actual)
- Lead sponsor
- University of OtagoUniversity, hospital or other
- Collaborators
- oVRcome
- Study start
- 2 Jun 2021 (actual)
- Primary completion
- 7 Sep 2021 (actual)
- Study completion
- 7 Mar 2022 (actual)
- First posted
- 1 Jun 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.
Specific phobias: fear of flying, heights, spiders, dogs and needles are the extremely common and exposure therapy (ET) is the first line of treatment. Using Virtual Reality (VR), participants will have control in gradual exposure to their fears. oVRcome (https://www.ovrcome.io/ Virtual reality app), is a self-help VRET for specific phobias, that is delivered through a smartphone application (app) in combination with a low cost headset that holds the smartphone and uses 360º video. The investigators hypothesize that oVRcome is effective in reducing specific phobia symptoms.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Smartphone application (app) in combination with headset | Experimental | Other: Smartphone application (app) in combination with headsetThe intervention oVRcome is self-help VRET for specific phobia, that is delivered through a smartphone application (app) in combination with headset that holds the smartphone and uses 360º video. oVRcome includes 6 modules of psychoeducation, relaxation, mindfulness, cognitive techniques, exposure through VR, and a relapse prevention module which are aimed to be completed weekly. |
| Waitlist | No intervention | –Participants in the waitlist condition will be offered the intervention directly after post-test. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- In order to be eligible to participate in this study, a subject must meet all of the following criteria:
- are between 18-64 years old
- Have a fear of flying, heights, spiders, dogs, needles and score above 4 on the Brief Standard Self rating scale for phobic patients (Marks, I. Matthews ,A (1979) Behaviour Research and Therapy)
- have access to a smart phone and internet
- willing to participate in the research study and providing informed consent
Key exclusion criteria (4 listed)
- A potential subject who meets any of the following criteria will be excluded from participation in this study:
- present with symptoms of severe depression or suicidality respectively as measured with the PHQ-9; total score > 19
- have insufficient knowledge of the English language
- are under current treatment for specific phobia or psychotropic medication (unless on stable dosage for the previous 3 months and no changes planned during the study period).
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 |
|---|---|---|
| Smartphone application (app) in combination with headsetThe intervention oVRcome is self-help VRET for specific phobia, that is delivered through a smartphone application (app) in combination with headset that holds the smartphone and uses 360º video. oVRcome includes 6 modules of psychoeducation, relaxation, mindfulness, cognitive techniques, exposure through VR, and a relapse prevention module which are aimed to be completed weekly. | Other | Smartphone application (app) in combination with headset |
Primary outcome
Severity Measure for Specific Phobia-Adult American Psychological Association
Time frame: Week 6
The Severity Measure for Specific Phobia-Adult is a 10-item self-report measure that assesses the severity of specific phobia in individuals age 18 and older. The total score can range from 0 to 40 with higher scores indicating greater severity of specific phobia.
8 secondary outcomes
Brief Standard Self rating scale for phobic patients
Time frame: 6 weeks, 12 weeks, 18 weeks
Clinical Global Impression of Change (CGI-C)
Time frame: weekly (Weeks 1-6)
Patient Health Questionnaire - PHQ 9
Time frame: 6 weeks, 12 weeks, 18 weeks
Subjective Units of Distress Scale
Time frame: Week 4, 5 and 6
Modified Gatineau Presence Questionnaire First item
Time frame: Week 4, 5 and 6
Fast Motion Sickness Scale (FMS)
Time frame: Week 4, 5 and 6
Brief Fear of Negative Evaluation Scale
Time frame: 6 weeks, 12 weeks, 18 weeks
Changes in behaviour that may have been previously avoided because of the phobia
Time frame: Weeks 6 and 12
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 22 Aug 2024.
- Derived from this study: PubMed 35818296Lacey C, Frampton C, Beaglehole B. oVRcome - Self-guided virtual reality for specific phobias: A randomised controlled trial. Aust N Z J Psychiatry. 2023 May;57(5):736-744. doi: 10.1177/00048674221110779. Epub 2022 Jul 11.
- Individual participant dataSharing planned: No
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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.
Cameron Lacey, PhD principal investigator
University of Otago
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Smartphone application (app) in combination with headset in people with Specific Phobia, run by University of Otago at 1 site in New Zealand.
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 5 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 22 Aug 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 New Zealand. 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?
Severity Measure for Specific Phobia-Adult American Psychological Association (time frame: Week 6). 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 NCT04909177, 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 22 Aug 2024.