oVRcome Self-guided Virtual Reality for Specific Phobias

Specific Phobia Clinical Trial

— oVRcome  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04909177
• Other study ID #: oVRcome specific phobia
• Status: Active, not recruiting
• Phase: N/A
• Start date: June 2, 2021
• Est. completion date: March 7, 2022

Study information

• Verified date: February 2022
• Source: University of Otago
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 126
• Est. completion date: March 7, 2022
• Est. primary completion date: September 7, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• Phobic Disorders
• Specific Phobia

Intervention

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.

Locations

Country	Name	City	State
New Zealand	University of Otago, Christchurch	Christchurch	Canterbury

Sponsors (2)

Lead Sponsor	Collaborator
University of Otago	oVRcome

Country where clinical trial is conducted

New Zealand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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)
Secondary	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
Secondary	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
Secondary	Modified Gatineau Presence Questionnaire First item	Scores range from 1 (very realistic) through to 100 (not very realistic)	Week 4, 5 and 6
Secondary	Fast Motion Sickness Scale (FMS)	Scores range from zero (no sickness at all) to 20 (frank sickness).	Week 4, 5 and 6
Secondary	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
Secondary	Changes in behaviour that may have been previously avoided because of the phobia	Free text response	Weeks 6 and 12