Clinical trial NCT04909177: oVRcome Self-guided Virtual Reality for Specific Phobias
Official title: oVRcome Self-guided Virtual Reality for Specific Phobias: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Specific Phobia
Lead sponsor: University of Otago
Sponsor class: OTHER
Collaborators: name: oVRcome
First posted: 2021-06-01
Enrollment: 126
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

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).

Primary outcomes:
measure: Severity Measure for Specific Phobia-Adult American Psychological Association
timeFrame: Week 6
Secondary outcomes:
measure: Brief Standard Self rating scale for phobic patients
timeFrame: 6 weeks, 12 weeks, 18 weeks
measure: Clinical Global Impression of Change (CGI-C)
timeFrame: weekly (Weeks 1-6)
measure: Patient Health Questionnaire - PHQ 9
timeFrame: 6 weeks, 12 weeks, 18 weeks
measure: Subjective Units of Distress Scale
timeFrame: Week 4, 5 and 6
measure: Modified Gatineau Presence Questionnaire First item
timeFrame: Week 4, 5 and 6
measure: Fast Motion Sickness Scale (FMS)
timeFrame: Week 4, 5 and 6
measure: Brief Fear of Negative Evaluation Scale
timeFrame: 6 weeks, 12 weeks, 18 weeks
measure: Changes in behaviour that may have been previously avoided because of the phobia
timeFrame: Weeks 6 and 12
Other outcomes:
Locations:
city: Christchurch
country: New Zealand
facility: University of Otago, Christchurch
state: Canterbury
Study officials:
affiliation: University of Otago
name: Cameron Lacey, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Lacey C, Frampton C, Beaglehole B. oVRcome - Self-guided virtual reality for specific phobias: A randomised controlled trial. Aust N Z J Psychiatry. 2023 May;57(5):736-744. doi: 10.1177/00048674221110779. Epub 2022 Jul 11.