Trial Review

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT04909177




Registration number
NCT04909177
Ethics application status
Date submitted
26/05/2021
Date registered
1/06/2021
Date last updated
24/02/2022

Titles & IDs
Public title
oVRcome Self-guided Virtual Reality for Specific Phobias
Scientific title
oVRcome Self-guided Virtual Reality for Specific Phobias: A Randomized Controlled Trial
Secondary ID [1] 0 0
oVRcome specific phobia
Universal Trial Number (UTN)
Trial acronym
oVRcome
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Specific Phobia 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 - Smartphone application (app) in combination with headset

Experimental: Smartphone application (app) in combination with headset - The intervention oVRcome is self-help VRET for specific phobia, 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: Smartphone application (app) in combination with headset
The intervention oVRcome is self-help VRET for specific phobia, 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
Severity Measure for Specific Phobia-Adult American Psychological Association
Timepoint [1] 0 0
Week 6
Secondary outcome [1] 0 0
Brief Standard Self rating scale for phobic patients
Timepoint [1] 0 0
6 weeks, 12 weeks, 18 weeks
Secondary outcome [2] 0 0
Clinical Global Impression of Change (CGI-C)
Timepoint [2] 0 0
weekly (Weeks 1-6)
Secondary outcome [3] 0 0
Patient Health Questionnaire - PHQ 9
Timepoint [3] 0 0
6 weeks, 12 weeks, 18 weeks
Secondary outcome [4] 0 0
Subjective Units of Distress Scale
Timepoint [4] 0 0
Week 4, 5 and 6
Secondary outcome [5] 0 0
Modified Gatineau Presence Questionnaire First item
Timepoint [5] 0 0
Week 4, 5 and 6
Secondary outcome [6] 0 0
Fast Motion Sickness Scale (FMS)
Timepoint [6] 0 0
Week 4, 5 and 6
Secondary outcome [7] 0 0
Brief Fear of Negative Evaluation Scale
Timepoint [7] 0 0
6 weeks, 12 weeks, 18 weeks
Secondary outcome [8] 0 0
Changes in behaviour that may have been previously avoided because of the phobia
Timepoint [8] 0 0
Weeks 6 and 12

Eligibility
Key inclusion criteria
In order to be eligible to participate in this study, a subject must meet all of the
following criteria:

- are between 18-64 years old

- Have a fear of flying, heights, spiders, dogs, needles and score above 4 on the Brief
Standard Self rating scale for phobic patients (Marks, I. Matthews ,A (1979) Behaviour
Research and Therapy)

- 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
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
A potential subject who meets any of the following criteria will be excluded from
participation in this study:

- present with symptoms of severe depression or suicidality respectively as measured
with the PHQ-9; total score > 19

- have insufficient knowledge of the English language

- are under current treatment for specific 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
Unknown status
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
2/06/2021
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
7/03/2022
Actual
Sample size
Target
Accrual to date
Final
126
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 0 0
New Zealand
State/province [1] 0 0
Canterbury

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
Specific phobias: fear of flying, heights, spiders, dogs and needles are the extremely common
and exposure therapy (ET) is the first line of treatment. Using Virtual Reality (VR),
participants will have control in gradual exposure to their fears. oVRcome
(https://www.ovrcome.io/ Virtual reality app), is a self-help VRET for 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. The investigators hypothesize that oVRcome is
effective in reducing specific phobia symptoms.
Trial website
https://clinicaltrials.gov/ct2/show/NCT04909177
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Cameron Lacey, PhD
Address 0 0
University of Otago
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/ct2/show/NCT04909177