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

Primary Purpose

Specific Phobia

Status
Active
Phase
Not Applicable
Locations
New Zealand
Study Type
Interventional
Intervention
Smartphone application (app) in combination with headset
Sponsored by
University of Otago
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Specific Phobia

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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).

Sites / Locations

  • University of Otago, Christchurch

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Smartphone application (app) in combination with headset

Waitlist

Arm Description

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.

Participants in the waitlist condition will be offered the intervention directly after post-test.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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
Clinical Global Impression of Change (CGI-C)
CGI-C scores range from 1 (very much improved) through to 7 (very much worse)
Patient Health Questionnaire - PHQ 9
PHQ-9 scores range from 1 through to 27, with higher scores indicating more severe depressive symptoms
Subjective Units of Distress Scale
Scores range from 1 through to 100 with higher scores indicating higher levels of distress
Modified Gatineau Presence Questionnaire First item
Scores range from 1 (very realistic) through to 100 (not very realistic)
Fast Motion Sickness Scale (FMS)
Scores range from zero (no sickness at all) to 20 (frank sickness).
Brief Fear of Negative Evaluation Scale
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
Free text response

Full Information

First Posted
May 26, 2021
Last Updated
February 22, 2022
Sponsor
University of Otago
Collaborators
oVRcome
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1. Study Identification

Unique Protocol Identification Number
NCT04909177
Brief Title
oVRcome Self-guided Virtual Reality for Specific Phobias
Acronym
oVRcome
Official Title
oVRcome Self-guided Virtual Reality for Specific Phobias: A Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
February 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
June 2, 2021 (Actual)
Primary Completion Date
September 7, 2021 (Actual)
Study Completion Date
March 7, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Otago
Collaborators
oVRcome

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Specific Phobia

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
126 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Smartphone application (app) in combination with headset
Arm Type
Experimental
Arm Description
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.
Arm Title
Waitlist
Arm Type
No Intervention
Arm Description
Participants in the waitlist condition will be offered the intervention directly after post-test.
Intervention Type
Other
Intervention Name(s)
Smartphone application (app) in combination with headset
Intervention Description
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 Measure Information:
Title
Severity Measure for Specific Phobia-Adult American Psychological Association
Description
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.
Time Frame
Week 6
Secondary Outcome Measure Information:
Title
Brief Standard Self rating scale for phobic patients
Description
The total score can range from 0 to 8 with higher scores indicating greater severity of specific phobia
Time Frame
6 weeks, 12 weeks, 18 weeks
Title
Clinical Global Impression of Change (CGI-C)
Description
CGI-C scores range from 1 (very much improved) through to 7 (very much worse)
Time Frame
weekly (Weeks 1-6)
Title
Patient Health Questionnaire - PHQ 9
Description
PHQ-9 scores range from 1 through to 27, with higher scores indicating more severe depressive symptoms
Time Frame
6 weeks, 12 weeks, 18 weeks
Title
Subjective Units of Distress Scale
Description
Scores range from 1 through to 100 with higher scores indicating higher levels of distress
Time Frame
Week 4, 5 and 6
Title
Modified Gatineau Presence Questionnaire First item
Description
Scores range from 1 (very realistic) through to 100 (not very realistic)
Time Frame
Week 4, 5 and 6
Title
Fast Motion Sickness Scale (FMS)
Description
Scores range from zero (no sickness at all) to 20 (frank sickness).
Time Frame
Week 4, 5 and 6
Title
Brief Fear of Negative Evaluation Scale
Description
Scores range from 1 through to 60 with higher scores indicating higher fear of negative evaluation
Time Frame
6 weeks, 12 weeks, 18 weeks
Title
Changes in behaviour that may have been previously avoided because of the phobia
Description
Free text response
Time Frame
Weeks 6 and 12

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Cameron Lacey, PhD
Organizational Affiliation
University of Otago
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Otago, Christchurch
City
Christchurch
State/Province
Canterbury
ZIP/Postal Code
8011
Country
New Zealand

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
35818296
Citation
Lacey C, Frampton C, Beaglehole B. oVRcome - Self-guided virtual reality for specific phobias: A randomised controlled trial. Aust N Z J Psychiatry. 2023 May;57(5):736-744. doi: 10.1177/00048674221110779. Epub 2022 Jul 11.
Results Reference
derived

Learn more about this trial

oVRcome Self-guided Virtual Reality for Specific Phobias

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