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oVRcome - Self Guided Virtual Reality for Social Anxiety Disorder

oVRcome - Self Guided Virtual Reality for Social Anxiety Disorder. A Randomised Controlled Trial.

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05576259
Enrollment
100
Registered
2022-10-12
Start date
2022-10-08
Completion date
2023-11-01
Last updated
2025-04-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Social Anxiety

Brief 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%. 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

Interventions

OTHERoVRcome phone app with headset

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.

Sponsors

oVRcome
CollaboratorUNKNOWN
University of Otago
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 64 Years
Healthy volunteers
No

Inclusion criteria

* 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

Exclusion criteria

* 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).

Design outcomes

Primary

MeasureTime frameDescription
Liebowitz social anxiety scale -self report (LSAS)Week 6Assesses 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

Secondary

MeasureTime frameDescription
Patient's Global Impressions of Improvement (PGI-I) scaleWeek 1,2,3,4,5,6,7,8,9,10,11,12,18Assesses 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).
Patient Health Questionnaire - PHQ 9Week 0,6,12,18PHQ-9 scores range from 0 through to 27, with higher scores indicating more severe depressive symptoms
Brief Fear of Negative Evaluation Scaleweek 0,6,12,18Scores range from 1 through to 60 with higher scores indicating higher fear of negative evaluation
Fast Motion Sickness Scale (FMS)Week 4,5,6Measures motion sickness with virtual reality. Scores range from zero (no sickness at all) to 20 (frank sickness).
Changes in behaviour that may have been previously avoided because of the phobiaWeek 6,12,18Free text response
Modified Gatineau Presence Questionnaire First itemWeek 4,5,6Assess degree of realism using virtual reality. Scores range from 1 (very realistic) through to 100 (not very realistic)

Countries

New Zealand

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 5, 2026