oVRcome Self-guided Virtual Reality for Specific Phobias

Not Applicable

Completed

• Conditions: Specific Phobia
• Interventions: Other: Smartphone application (app) in combination with headset

• Registration Number: NCT04909177
• Lead Sponsor: University of Otago

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-05-26
• Study First Submitted QC: 2021-05-26
• Study First Posted: 2021-06-01
• Study Start: 2021-06-02
• Primary Completion: 2021-09-07
• Study Completion: 2022-03-07
• Status Verified: 2024-08
• Last Update Submitted: 2024-08-20
• Last Update Posted: 2024-08-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 126

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Smartphone application (app) in combination with headset	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.

Primary Outcome Measures

Name	Time	Method
Severity Measure for Specific Phobia-Adult American Psychological Association	Week 6	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.

Secondary Outcome Measures

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

Trial Locations

Locations (1)

University of Otago, Christchurch; 🇳🇿 Christchurch, Canterbury, New Zealand