Clinical trial NCT05576259: oVRcome - Self Guided Virtual Reality for Social Anxiety Disorder
Official title: oVRcome - Self Guided Virtual Reality for Social Anxiety Disorder. A Randomised Controlled Trial.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Social Anxiety
Lead sponsor: University of Otago
Sponsor class: OTHER
Collaborators: name: oVRcome
First posted: 2022-10-12
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


Eligibility criteria: 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).

Primary outcomes:
measure: Liebowitz social anxiety scale -self report (LSAS)
timeFrame: Week 6
Secondary outcomes:
measure: Brief Fear of Negative Evaluation Scale
timeFrame: week 0,6,12,18
measure: Patient's Global Impressions of Improvement (PGI-I) scale
timeFrame: Week 1,2,3,4,5,6,7,8,9,10,11,12,18
measure: Patient Health Questionnaire - PHQ 9
timeFrame: Week 0,6,12,18
measure: Modified Gatineau Presence Questionnaire First item
timeFrame: Week 4,5,6
measure: Fast Motion Sickness Scale (FMS)
timeFrame: Week 4,5,6
measure: Changes in behaviour that may have been previously avoided because of the phobia
timeFrame: Week 6,12,18
Other outcomes:
Locations:
city: Christchurch
country: New Zealand
facility: University of Otago
Study officials:
affiliation: University of Otago, Christchurch
name: Cameron Lacey, PhD
role: PRINCIPAL_INVESTIGATOR
References: