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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/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
Scientific title
oVRcome - Self Guided Virtual Reality for Social Anxiety Disorder. A Randomised Controlled Trial.
Secondary ID [1] 0 0
oVRcome social anxiety 1.2
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Social Anxiety 0 0
Condition category
Condition code
Mental Health 0 0 0 0
Anxiety

Intervention/exposure
Study type
Interventional
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.
Intervention code [1] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Liebowitz social anxiety scale -self report (LSAS)
Timepoint [1] 0 0
Week 6
Secondary outcome [1] 0 0
Brief Fear of Negative Evaluation Scale
Timepoint [1] 0 0
week 0,6,12,18
Secondary outcome [2] 0 0
Patient's Global Impressions of Improvement (PGI-I) scale
Timepoint [2] 0 0
Week 1,2,3,4,5,6,7,8,9,10,11,12,18
Secondary outcome [3] 0 0
Patient Health Questionnaire - PHQ 9
Timepoint [3] 0 0
Week 0,6,12,18
Secondary outcome [4] 0 0
Modified Gatineau Presence Questionnaire First item
Timepoint [4] 0 0
Week 4,5,6
Secondary outcome [5] 0 0
Fast Motion Sickness Scale (FMS)
Timepoint [5] 0 0
Week 4,5,6
Secondary outcome [6] 0 0
Changes in behaviour that may have been previously avoided because of the phobia
Timepoint [6] 0 0
Week 6,12,18

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
Minimum age
18 Years
Maximum age
64 Years
Sex
Both males and females
Can healthy volunteers participate?
No
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).

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
8/10/2022
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/11/2023
Sample size
Target
Accrual to date
Final
100
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 0 0
New Zealand
State/province [1] 0 0
Christchurch

Funding & Sponsors
Primary sponsor type
Other
Name
University of Otago
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
oVRcome
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

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
Trial website
https://clinicaltrials.gov/study/NCT05576259
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Cameron Lacey, PhD
Address 0 0
University of Otago, Christchurch
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT05576259