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

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 evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04909177
Recruitment Status : Active, not recruiting
First Posted : June 1, 2021
Last Update Posted : February 24, 2022
Sponsor:
Collaborator:
oVRcome
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Specific Phobia Other: Smartphone application (app) in combination with headset Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 126 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: oVRcome Self-guided Virtual Reality for Specific Phobias: A Randomized Controlled Trial
Actual Study Start Date : June 2, 2021
Actual Primary Completion Date : September 7, 2021
Estimated Study Completion Date : March 7, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Phobias

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.



Primary Outcome Measures :
  1. Severity Measure for Specific Phobia-Adult American Psychological Association [ Time Frame: 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 :
  1. Brief Standard Self rating scale for phobic patients [ Time Frame: 6 weeks, 12 weeks, 18 weeks ]
    The total score can range from 0 to 8 with higher scores indicating greater severity of specific phobia

  2. Clinical Global Impression of Change (CGI-C) [ Time Frame: weekly (Weeks 1-6) ]
    CGI-C scores range from 1 (very much improved) through to 7 (very much worse)

  3. Patient Health Questionnaire - PHQ 9 [ Time Frame: 6 weeks, 12 weeks, 18 weeks ]
    PHQ-9 scores range from 1 through to 27, with higher scores indicating more severe depressive symptoms

  4. Subjective Units of Distress Scale [ Time Frame: Week 4, 5 and 6 ]
    Scores range from 1 through to 100 with higher scores indicating higher levels of distress

  5. Modified Gatineau Presence Questionnaire First item [ Time Frame: Week 4, 5 and 6 ]
    Scores range from 1 (very realistic) through to 100 (not very realistic)

  6. Fast Motion Sickness Scale (FMS) [ Time Frame: Week 4, 5 and 6 ]
    Scores range from zero (no sickness at all) to 20 (frank sickness).

  7. Brief Fear of Negative Evaluation Scale [ Time Frame: 6 weeks, 12 weeks, 18 weeks ]
    Scores range from 1 through to 60 with higher scores indicating higher fear of negative evaluation

  8. Changes in behaviour that may have been previously avoided because of the phobia [ Time Frame: Weeks 6 and 12 ]
    Free text response



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04909177


Locations
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New Zealand
University of Otago, Christchurch
Christchurch, Canterbury, New Zealand, 8011
Sponsors and Collaborators
University of Otago
oVRcome
Investigators
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Principal Investigator: Cameron Lacey, PhD University of Otago
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Responsible Party: University of Otago
ClinicalTrials.gov Identifier: NCT04909177    
Other Study ID Numbers: oVRcome specific phobia
First Posted: June 1, 2021    Key Record Dates
Last Update Posted: February 24, 2022
Last Verified: February 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Phobic Disorders
Anxiety Disorders
Mental Disorders