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Completed

NCT Number: NCT04909177

oVRcome Self-guided Virtual Reality for Specific Phobias

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.

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Key information

Conditions

Specific Phobia Phobia, Specific

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Otago, Christchurch

Christchurch, Canterbury, 8011, New Zealand

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Smartphone application (app) in combination with headset

Other

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 outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

University of Otago

Other

Collaborators

  • oVRcome

Registry information

Official study title

oVRcome Self-guided Virtual Reality for Specific Phobias: A Randomized Controlled Trial

Acronym: oVRcome

Important dates

Study start
2021
Primary completion
2021
Study completion
2022
First posted
Jun 1, 2021
Registry last updated
Aug 22, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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