Social AnxietyNCT05576259
oVRcome - Self Guided Virtual Reality for Social Anxiety Disorder
A study testing oVRcome phone app with headset in people with Social Anxiety, run by University of Otago at 1 site in New Zealand.
Trial summary
Social anxiety is characterised by excessive fear of being negatively judged, embarrassed or humiliated during social interactions and is common with a lifetime prevalence of 12.1%. Read more about this study
- Who is it for?
- Ages 18 to 64 years
- Conditions the study is for
- Social Anxiety
- What is being tested?
- oVRcome phone app with headset
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteNew Zealand
- Study dates
- 8 Oct 2022to 1 Nov 2023
- 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
- are between 18-64 years old
- have moderate (or higher) social anxiety disorder symptoms on Liebowitz social anxiety scale (>60)
- have access to a smart phone and internet
- willing to participate in the research study and providing informed consent
Who cannot join
- present with symptoms of severe depression or suicidality respectively as measured with the PHQ-9; total score > 19, =3 on suicidality item
- have insufficient knowledge of the English language
- are under current treatment for social 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.
About this study
Official title: oVRcome - Self Guided Virtual Reality for Social Anxiety Disorder. A Randomised Controlled Trial.
Social anxiety is characterised by excessive fear of being negatively judged, embarrassed or humiliated during social interactions and is common with a lifetime prevalence of 12.1%. Cognitive behavioural therapy is the first line of treatment, but people may not seek treatment due to a number of factors including the discomfort experienced in seeking help, inconvenience, and the experience of psychotherapy itself. With Virtual Reality (VR), users can have increased control in how gradually they expose themselves to social situations. In studies of VR in people with specific phobias, 76% of people prefer VR exposure to in vivo exposure. There is emerging evidence for the use of VR in social phobia.
oVRcome, is a self-help VRET for social anxiety symptoms and 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.
This study will evaluate the effectiveness of the oVRcome social anxiety program for social anxiety symptoms. We hypothesize that oVRcome will reduce social anxiety symptom severity over a 6-week treatment period compared to waiting-list control
- Conditions
- Social Anxiety
- Being tested
- oVRcome phone app with headset
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
oVRcome phone app with headsetOther
The intervention oVRcome is self-help VRET for social anxiety, 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 social anxiety, 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: oVRcome phone app 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.
Liebowitz social anxiety scale -self report (LSAS)
Assesses the way that social phobia plays a role in participants life across a variety of situations. Higher scores indicate more severe symptoms. Min 0 Max 144
Measured: Week 6
Secondary outcomes (6)
Brief Fear of Negative Evaluation Scale
Scores range from 1 through to 60 with higher scores indicating higher fear of negative evaluation
Measured: week 0,6,12,18
Patient's Global Impressions of Improvement (PGI-I) scale
Assesses patients' overall perception of their condition in a 1-item questionnaires that ask an individual patient to rate the perceived change in his/her condition in response to therapy at endpoint. Min 1 (very much improved) Max 7 (very much worse).
Measured: Week 1,2,3,4,5,6,7,8,9,10,11,12,18
Patient Health Questionnaire - PHQ 9
PHQ-9 scores range from 0 through to 27, with higher scores indicating more severe depressive symptoms
Measured: Week 0,6,12,18
Modified Gatineau Presence Questionnaire First item
Assess degree of realism using virtual reality. Scores range from 1 (very realistic) through to 100 (not very realistic)
Measured: Week 4,5,6
Fast Motion Sickness Scale (FMS)
Measures motion sickness with virtual reality. Scores range from zero (no sickness at all) to 20 (frank sickness).
Measured: Week 4,5,6
Changes in behaviour that may have been previously avoided because of the phobia
Free text response
Measured: Week 6,12,18
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Oct 2022
- Study start8 Oct 2022
- Primary completion1 Jul 2023
- Study completion1 Nov 2023
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 Social AnxietyStudies 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
- 100 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, Christchurch
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05576259
- Sponsor's protocol ID
- oVRcome social anxiety 1.2
- Status last verified
- Nov 2023
- First submitted
- 9 Oct 2022
- Last updated
- 9 Apr 2025
- 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. A self-guided virtual reality solution for social anxiety: Results from a randomized controlled study. J Psychiatr Res. 2024 Dec;180:333-339. doi: 10.1016/j.jpsychires.2024.10.032. Epub 2024 Nov 4.
PubMed 39515186
Study at a glance
From the registry record, last updated by the sponsor on 9 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- oVRcome - Self Guided Virtual Reality for Social Anxiety Disorder. A Randomised Controlled Trial.
- ClinicalTrials.gov ID
- NCT05576259
- Acronym / sponsor ID
- oVRcome social anxiety 1.2
- Conditions
- Social Anxiety
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- University of OtagoUniversity, hospital or other
- Collaborators
- oVRcome
- Study start
- 8 Oct 2022 (actual)
- Primary completion
- 1 Jul 2023 (actual)
- Study completion
- 1 Nov 2023 (actual)
- First posted
- 12 Oct 2022 (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.
Social anxiety is characterised by excessive fear of being negatively judged, embarrassed or humiliated during social interactions and is common with a lifetime prevalence of 12.1%. Cognitive behavioural therapy is the first line of treatment, but people may not seek treatment due to a number of factors including the discomfort experienced in seeking help, inconvenience, and the experience of psychotherapy itself. With Virtual Reality (VR), users can have increased control in how gradually they expose themselves to social situations. In studies of VR in people with specific phobias, 76% of people prefer VR exposure to in vivo exposure. There is emerging evidence for the use of VR in social phobia.
oVRcome, is a self-help VRET for social anxiety symptoms and 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.
This study will evaluate the effectiveness of the oVRcome social anxiety program for social anxiety symptoms. We hypothesize that oVRcome will reduce social anxiety symptom severity over a 6-week treatment period compared to waiting-list control
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: oVRcome phone app with headsetThe intervention oVRcome is self-help VRET for social anxiety, 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 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- are between 18-64 years old
- have moderate (or higher) social anxiety disorder symptoms on Liebowitz social anxiety scale (>60)
- have access to a smart phone and internet
- willing to participate in the research study and providing informed consent
Key exclusion criteria (3 listed)
- present with symptoms of severe depression or suicidality respectively as measured with the PHQ-9; total score > 19, =3 on suicidality item
- have insufficient knowledge of the English language
- are under current treatment for social 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 |
|---|---|---|
| oVRcome phone app with headsetThe intervention oVRcome is self-help VRET for social anxiety, 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
Liebowitz social anxiety scale -self report (LSAS)
Time frame: Week 6
Assesses the way that social phobia plays a role in participants life across a variety of situations. Higher scores indicate more severe symptoms. Min 0 Max 144
6 secondary outcomes
Brief Fear of Negative Evaluation Scale
Time frame: week 0,6,12,18
Patient's Global Impressions of Improvement (PGI-I) scale
Time frame: Week 1,2,3,4,5,6,7,8,9,10,11,12,18
Patient Health Questionnaire - PHQ 9
Time frame: Week 0,6,12,18
Modified Gatineau Presence Questionnaire First item
Time frame: Week 4,5,6
Fast Motion Sickness Scale (FMS)
Time frame: Week 4,5,6
Changes in behaviour that may have been previously avoided because of the phobia
Time frame: Week 6,12,18
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 9 Apr 2025.
- Derived from this study: PubMed 39515186Lacey C, Frampton C, Beaglehole B. A self-guided virtual reality solution for social anxiety: Results from a randomized controlled study. J Psychiatr Res. 2024 Dec;180:333-339. doi: 10.1016/j.jpsychires.2024.10.032. Epub 2024 Nov 4.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: No
Related trials for Social Anxiety
Not yet recruiting
Preventive and Personalized Digital Emotion Regulation Skills Intervention to Reduce Depression and Anxiety in Youths With Adverse Childhood Experiences
Adverse Childhood Experience, Depression / Major Depressive Disorder
Recruiting
Bonding Before Birth: A mHealth Intervention for First-time Expectant Couples
Anxiety, Pregnancy
Recruiting
Comprehensive Assessment of Rehabilitation Experience Using the SAFE Scale
Caregiver Anxiety, Acquired Brain Injury
Not yet recruiting
Online Study on the Impact of a Self-Help Tool for Social Anxiety
Social Anxiety
Active, not recruiting
Targeting Social Function in Anxiety and Eating Disorders
Eating Disorders, Anorexia Nervosa
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, Christchurch
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing oVRcome phone app with headset in people with Social Anxiety, 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 4 inclusion and 3 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 9 Apr 2025. 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?
Liebowitz social anxiety scale -self report (LSAS) (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 NCT05576259, 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 9 Apr 2025.