oVRcome - Self Guided Virtual Reality for Social Anxiety Disorder

Social Anxiety Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05576259
• Other study ID #: oVRcome social anxiety 1.2
• Status: Completed
• Phase: N/A
• Start date: October 8, 2022
• Est. completion date: November 1, 2023

Study information

• Verified date: November 2023
• Source: University of Otago
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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%. 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: November 1, 2023
• Est. primary completion date: July 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 64 Years

Eligibility

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).

Related Conditions & MeSH terms

• Anxiety Disorders
• Phobia, Social
• Social Anxiety

Intervention

Other:
• oVRcome 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.

Locations

Country	Name	City	State
New Zealand	University of Otago	Christchurch

Sponsors (2)

Lead Sponsor	Collaborator
University of Otago	oVRcome

Country where clinical trial is conducted

New Zealand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Week 6
Secondary	Brief Fear of Negative Evaluation Scale	Scores range from 1 through to 60 with higher scores indicating higher fear of negative evaluation	week 0,6,12,18
Secondary	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).	Week 1,2,3,4,5,6,7,8,9,10,11,12,18
Secondary	Patient Health Questionnaire - PHQ 9	PHQ-9 scores range from 0 through to 27, with higher scores indicating more severe depressive symptoms	Week 0,6,12,18
Secondary	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)	Week 4,5,6
Secondary	Fast Motion Sickness Scale (FMS)	Measures motion sickness with virtual reality. Scores range from zero (no sickness at all) to 20 (frank sickness).	Week 4,5,6
Secondary	Changes in behaviour that may have been previously avoided because of the phobia	Free text response	Week 6,12,18

External Links

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