oVRcome - Self Guided Virtual Reality for Social Anxiety Disorder

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

Study Overview

• Status: Completed
• Conditions: Social Anxiety
• Intervention / Treatment: Other: oVRcome phone app with headset

• Study Type: Interventional
• Enrollment (Actual): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Cameron Lacey, PhD; Phone Number: +6433720400; Email: cameron.lacey@otago.ac.nz

Study Locations

• New Zealand
  • Christchurch, New Zealand, 8001
    • University of Otago

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 64 years (Adult)
• Accepts Healthy Volunteers: No

Description

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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Waitlist; Participants in the waitlist condition will be offered the intervention directly after post-test.
Experimental: Smartphone application (app) in combination 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.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
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
Changes in behaviour that may have been previously avoided because of the phobia	Free text response	Week 6,12,18

Collaborators and Investigators

• Sponsor: University of Otago
• Collaborators: oVRcome
• Investigators: Principal Investigator: Cameron Lacey, PhD, University of Otago, Christchurch

Publications and helpful links

Helpful Links

• Related Info

Study record dates

Study Major Dates

• Study Start (Actual): October 8, 2022
• Primary Completion (Actual): July 1, 2023
• Study Completion (Actual): November 1, 2023

Study Registration Dates

• First Submitted: October 9, 2022
• First Submitted That Met QC Criteria: October 9, 2022
• First Posted (Actual): October 12, 2022

Study Record Updates

• Last Update Posted (Actual): November 30, 2023
• Last Update Submitted That Met QC Criteria: November 28, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Phobic Disorders; Anxiety Disorders; Phobia, Social
• Other Study ID Numbers: oVRcome social anxiety 1.2

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No