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oVRcome - Self Guided Virtual Reality for Social Anxiety Disorder

Primary Purpose

Social Anxiety

Status
Recruiting
Phase
Not Applicable
Locations
New Zealand
Study Type
Interventional
Intervention
oVRcome phone app with headset
Sponsored by
University of Otago
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Social Anxiety

Eligibility Criteria

18 Years - 64 Years (Adult)All SexesDoes not accept healthy volunteers

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).

Sites / Locations

  • University of OtagoRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Smartphone application (app) in combination with headset

Waitlist

Arm Description

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.

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Brief Fear of Negative Evaluation Scale
Scores range from 1 through to 60 with higher scores indicating higher fear of negative evaluation
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).
Patient Health Questionnaire - PHQ 9
PHQ-9 scores range from 0 through to 27, with higher scores indicating more severe depressive symptoms
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)
Fast Motion Sickness Scale (FMS)
Measures 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 phobia
Free text response

Full Information

First Posted
October 9, 2022
Last Updated
October 9, 2022
Sponsor
University of Otago
Collaborators
oVRcome
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1. Study Identification

Unique Protocol Identification Number
NCT05576259
Brief Title
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

2. Study Status

Record Verification Date
October 2022
Overall Recruitment Status
Recruiting
Study Start Date
October 8, 2022 (Actual)
Primary Completion Date
July 10, 2023 (Anticipated)
Study Completion Date
October 10, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Otago
Collaborators
oVRcome

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Social Anxiety

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Smartphone application (app) in combination with headset
Arm Type
Experimental
Arm Description
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.
Arm Title
Waitlist
Arm Type
No Intervention
Arm Description
Participants in the waitlist condition will be offered the intervention directly after post-test.
Intervention Type
Other
Intervention Name(s)
oVRcome phone app with headset
Intervention Description
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.
Primary Outcome Measure Information:
Title
Liebowitz social anxiety scale -self report (LSAS)
Description
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
Time Frame
Week 6
Secondary Outcome Measure Information:
Title
Brief Fear of Negative Evaluation Scale
Description
Scores range from 1 through to 60 with higher scores indicating higher fear of negative evaluation
Time Frame
week 0,6,12,18
Title
Patient's Global Impressions of Improvement (PGI-I) scale
Description
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).
Time Frame
Week 1,2,3,4,5,6,7,8,9,10,11,12,18
Title
Patient Health Questionnaire - PHQ 9
Description
PHQ-9 scores range from 0 through to 27, with higher scores indicating more severe depressive symptoms
Time Frame
Week 0,6,12,18
Title
Modified Gatineau Presence Questionnaire First item
Description
Assess degree of realism using virtual reality. Scores range from 1 (very realistic) through to 100 (not very realistic)
Time Frame
Week 4,5,6
Title
Fast Motion Sickness Scale (FMS)
Description
Measures motion sickness with virtual reality. Scores range from zero (no sickness at all) to 20 (frank sickness).
Time Frame
Week 4,5,6
Title
Changes in behaviour that may have been previously avoided because of the phobia
Description
Free text response
Time Frame
Week 6,12,18

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
64 Years
Accepts Healthy Volunteers
No
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).
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Cameron Lacey, PhD
Phone
+6433720400
Email
cameron.lacey@otago.ac.nz
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Cameron Lacey, PhD
Organizational Affiliation
University of Otago, Christchurch
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Otago
City
Christchurch
ZIP/Postal Code
8001
Country
New Zealand
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Cameron Lacey, PhD
Email
cameron.lacey@otago.ac.nz

12. IPD Sharing Statement

Plan to Share IPD
No
Links:
URL
http://ovrcome.io
Description
Related Info

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oVRcome - Self Guided Virtual Reality for Social Anxiety Disorder

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