NCT04909177

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
126

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jun 2021

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 26, 2021

Completed
6 days until next milestone

First Posted

Study publicly available on registry

June 1, 2021

Completed
1 day until next milestone

Study Start

First participant enrolled

June 2, 2021

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 7, 2021

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 7, 2022

Completed
Last Updated

August 22, 2024

Status Verified

August 1, 2024

Enrollment Period

3 months

First QC Date

May 26, 2021

Last Update Submit

August 20, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (8)

  • Brief Standard Self rating scale for phobic patients

    6 weeks, 12 weeks, 18 weeks

  • Clinical Global Impression of Change (CGI-C)

    weekly (Weeks 1-6)

  • Patient Health Questionnaire - PHQ 9

    6 weeks, 12 weeks, 18 weeks

  • Subjective Units of Distress Scale

    Week 4, 5 and 6

  • Modified Gatineau Presence Questionnaire First item

    Week 4, 5 and 6

  • +3 more secondary outcomes

Study Arms (2)

Smartphone application (app) in combination with headset

EXPERIMENTAL

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

Waitlist

NO INTERVENTION

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

Interventions

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.

Smartphone application (app) in combination with headset

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Otago, Christchurch

Christchurch, Canterbury, 8011, New Zealand

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Phobia, Specific

Interventions

Amyloid

Intervention Hierarchy (Ancestors)

Multiprotein ComplexesMacromolecular SubstancesProteinsAmino Acids, Peptides, and Proteins

Study Officials

  • Cameron Lacey, PhD

    University of Otago

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 26, 2021

First Posted

June 1, 2021

Study Start

June 2, 2021

Primary Completion

September 7, 2021

Study Completion

March 7, 2022

Last Updated

August 22, 2024

Record last verified: 2024-08

Data Sharing

IPD Sharing
Will not share

Locations