oVRcome - Self Guided Virtual Reality for Social Anxiety Disorder

NCT05576259 | Completed

• 1 other identifier: oVRcome social anxiety 1.2
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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

Conditions

Social Anxiety

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Brief Fear of Negative Evaluation Scale

  week 0,6,12,18

• Patient's Global Impressions of Improvement (PGI-I) scale

  Week 1,2,3,4,5,6,7,8,9,10,11,12,18

• Patient Health Questionnaire - PHQ 9

  Week 0,6,12,18

• Modified Gatineau Presence Questionnaire First item

  Week 4,5,6

• Fast Motion Sickness Scale (FMS)

  Week 4,5,6

Study Arms (2)

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.

Other: oVRcome phone app with headset

Waitlist

NO INTERVENTION

Participants in the waitlist condition will be offered the intervention directly after post-test.

Interventions

oVRcome phone app with headset OTHER

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.

Smartphone application (app) in combination with headset

Eligibility Criteria

• Age: 18 Years - 64 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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).

Sponsors & Collaborators

• University of Otago: lead
• oVRcome: collaborator

Study Sites (1)

University of Otago

Christchurch, 8001, New Zealand

Location

Related Publications (1)

• 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.

  PMID: 39515186 DERIVED

Related Links

• Related Info

Study Officials

• Cameron Lacey, PhD

  University of Otago, Christchurch

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 9, 2022
• First Posted: October 12, 2022
• Study Start: October 8, 2022
• Primary Completion: July 1, 2023
• Study Completion: November 1, 2023
• Last Updated: April 9, 2025

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

NZ (1)