oVRcome Self-guided Virtual Reality for Specific Phobias (oVRcome)

oVRcome Self-guided Virtual Reality for Specific Phobias: A Randomized Controlled Trial

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Specific Phobia
• Intervention / Treatment: Other: Smartphone application (app) in combination with headset

• Study Type: Interventional
• Enrollment (Actual): 126
• Phase: Not Applicable

Contacts and Locations

Study Locations

• New Zealand
  • Canterbury
    • Christchurch, Canterbury, New Zealand, 8011
      • University of Otago, Christchurch

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.	Other: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Severity Measure for Specific Phobia-Adult American Psychological Association	The Severity Measure for Specific Phobia-Adult is a 10-item self-report measure that assesses the severity of specific phobia in individuals age 18 and older. The total score can range from 0 to 40 with higher scores indicating greater severity of specific phobia.	Week 6

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Brief Standard Self rating scale for phobic patients	The total score can range from 0 to 8 with higher scores indicating greater severity of specific phobia	6 weeks, 12 weeks, 18 weeks
Clinical Global Impression of Change (CGI-C)	CGI-C scores range from 1 (very much improved) through to 7 (very much worse)	weekly (Weeks 1-6)
Patient Health Questionnaire - PHQ 9	PHQ-9 scores range from 1 through to 27, with higher scores indicating more severe depressive symptoms	6 weeks, 12 weeks, 18 weeks
Subjective Units of Distress Scale	Scores range from 1 through to 100 with higher scores indicating higher levels of distress	Week 4, 5 and 6
Modified Gatineau Presence Questionnaire First item	Scores range from 1 (very realistic) through to 100 (not very realistic)	Week 4, 5 and 6
Fast Motion Sickness Scale (FMS)	Scores range from zero (no sickness at all) to 20 (frank sickness).	Week 4, 5 and 6
Brief Fear of Negative Evaluation Scale	Scores range from 1 through to 60 with higher scores indicating higher fear of negative evaluation	6 weeks, 12 weeks, 18 weeks
Changes in behaviour that may have been previously avoided because of the phobia	Free text response	Weeks 6 and 12

Collaborators and Investigators

• Sponsor: University of Otago
• Collaborators: oVRcome
• Investigators: Principal Investigator: Cameron Lacey, PhD, University of Otago

Publications and helpful links

General Publications

• Lacey C, Frampton C, Beaglehole B. oVRcome - Self-guided virtual reality for specific phobias: A randomised controlled trial. Aust N Z J Psychiatry. 2022 Jul 11:48674221110779. doi: 10.1177/00048674221110779. Online ahead of print.

Study record dates

Study Major Dates

• Study Start (Actual): June 2, 2021
• Primary Completion (Actual): September 7, 2021
• Study Completion (Anticipated): March 7, 2022

Study Registration Dates

• First Submitted: May 26, 2021
• First Submitted That Met QC Criteria: May 26, 2021
• First Posted (Actual): June 1, 2021

Study Record Updates

• Last Update Posted (Actual): February 24, 2022
• Last Update Submitted That Met QC Criteria: February 22, 2022
• Last Verified: February 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Anxiety Disorders; Phobic Disorders
• Other Study ID Numbers: oVRcome specific phobia

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No