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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT05576259
Registration number
NCT05576259
Ethics application status
Date submitted
9/10/2022
Date registered
12/10/2022
Date last updated
30/11/2023
Titles & IDs
Public title
oVRcome - Self Guided Virtual Reality for Social Anxiety Disorder
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Scientific title
oVRcome - Self Guided Virtual Reality for Social Anxiety Disorder. A Randomised Controlled Trial.
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Secondary ID [1]
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oVRcome social anxiety 1.2
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Social Anxiety
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Condition category
Condition code
Mental Health
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Anxiety
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Other interventions - oVRcome phone app with headset
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.
No Intervention: Waitlist - Participants in the waitlist condition will be offered the intervention directly after post-test.
Other interventions: 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.
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Intervention code [1]
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Other interventions
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Liebowitz social anxiety scale -self report (LSAS)
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Assessment method [1]
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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
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Timepoint [1]
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Week 6
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Secondary outcome [1]
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Brief Fear of Negative Evaluation Scale
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Assessment method [1]
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Scores range from 1 through to 60 with higher scores indicating higher fear of negative evaluation
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Timepoint [1]
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week 0,6,12,18
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Secondary outcome [2]
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Patient's Global Impressions of Improvement (PGI-I) scale
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Assessment method [2]
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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).
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Timepoint [2]
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Week 1,2,3,4,5,6,7,8,9,10,11,12,18
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Secondary outcome [3]
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Patient Health Questionnaire - PHQ 9
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Assessment method [3]
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PHQ-9 scores range from 0 through to 27, with higher scores indicating more severe depressive symptoms
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Timepoint [3]
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Week 0,6,12,18
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Secondary outcome [4]
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Modified Gatineau Presence Questionnaire First item
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Assessment method [4]
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Assess degree of realism using virtual reality. Scores range from 1 (very realistic) through to 100 (not very realistic)
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Timepoint [4]
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Week 4,5,6
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Secondary outcome [5]
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Fast Motion Sickness Scale (FMS)
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Assessment method [5]
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Measures motion sickness with virtual reality. Scores range from zero (no sickness at all) to 20 (frank sickness).
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Timepoint [5]
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Week 4,5,6
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Secondary outcome [6]
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Changes in behaviour that may have been previously avoided because of the phobia
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Assessment method [6]
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Free text response
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Timepoint [6]
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Week 6,12,18
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Eligibility
Key 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
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Minimum age
18
Years
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Maximum age
64
Years
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key 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).
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Parallel
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Other design features
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Phase
Not Applicable
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
8/10/2022
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
1/11/2023
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Sample size
Target
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Accrual to date
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Final
100
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Recruitment in Australia
Recruitment state(s)
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Recruitment outside Australia
Country [1]
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New Zealand
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State/province [1]
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Christchurch
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Funding & Sponsors
Primary sponsor type
Other
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Name
University of Otago
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Address
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Country
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Other collaborator category [1]
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Other
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Name [1]
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oVRcome
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Address [1]
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Country [1]
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Ethics approval
Ethics application status
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Summary
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
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Trial website
https://clinicaltrials.gov/ct2/show/NCT05576259
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Cameron Lacey, PhD
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Address
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University of Otago, Christchurch
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Address
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Country
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Phone
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Fax
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Email
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT05576259
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