oVRcome Self-guided Virtual Reality for Specific Phobias

Sponsor
University of Otago (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT04909177
Collaborator
oVRcome (Other)
126
1
2
9.1
13.8

Study Details

Study Description

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
  • Other: Smartphone application (app) in combination with headset
N/A

Study Design

Study Type:
Interventional
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 :
Jun 2, 2021
Actual Primary Completion Date :
Sep 7, 2021
Anticipated Study Completion Date :
Mar 7, 2022

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

  1. 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

  1. 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

  2. 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)

  3. 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

  4. 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

  5. Modified Gatineau Presence Questionnaire First item [Week 4, 5 and 6]

    Scores range from 1 (very realistic) through to 100 (not very realistic)

  6. Fast Motion Sickness Scale (FMS) [Week 4, 5 and 6]

    Scores range from zero (no sickness at all) to 20 (frank sickness).

  7. 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

  8. Changes in behaviour that may have been previously avoided because of the phobia [Weeks 6 and 12]

    Free text response

Eligibility Criteria

Criteria

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

Contacts and Locations

Locations

Site City State Country Postal Code
1 University of Otago, Christchurch Christchurch Canterbury New Zealand 8011

Sponsors and Collaborators

  • University of Otago
  • oVRcome

Investigators

  • Principal Investigator: Cameron Lacey, PhD, University of Otago

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
University of Otago
ClinicalTrials.gov Identifier:
NCT04909177
Other Study ID Numbers:
  • oVRcome specific phobia
First Posted:
Jun 1, 2021
Last Update Posted:
Feb 24, 2022
Last Verified:
Feb 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Feb 24, 2022