Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
250 participants
INTERVENTIONAL
2024-08-09
2027-12-31
Brief Summary
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This is a randomized study. Participants will be randomized to either the intervention group or an active control.
Investigators hypothesize that participants in the intervention condition will show greater declines in self-reported dental fear and improved oral health-related quality of life during post-treatment and follow-up period.
Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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VRET Intervention
neVR Fear the Dentist
neVR Fear the DentistTM comprises two major evidence-based interventions. First is a self-administered eHealth app for CBT/ psychoeducation with exposure therapy - delivered via a mobile tablet - that can be completed anywhere. Second is a 1-hr virtual reality exposure treatment (VRET).
Active Control
No interventions assigned to this group
Interventions
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neVR Fear the Dentist
neVR Fear the DentistTM comprises two major evidence-based interventions. First is a self-administered eHealth app for CBT/ psychoeducation with exposure therapy - delivered via a mobile tablet - that can be completed anywhere. Second is a 1-hr virtual reality exposure treatment (VRET).
Eligibility Criteria
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Inclusion Criteria
2. Report dental fear of 4 or higher on a scale of 0-10 on the Gatchel dental fear item
3. Be able and willing to comply with study procedures
4. Provide a signed and dated informed consent form
5. Proficient in English because the intervention is in English
6. Have access to a smartphone or tablet
7. If self-referred, have a dental appointment already scheduled with their own dentist.
8. If self-referred, live in the NYC metro area or are willing to travel to the NYU College of Dentistry.
9. If self-referred, have access to an Oculus headset and live in the U.S.
Exclusion Criteria
2. Diagnosed with any of the following psychiatric conditions: Posttraumatic Stress Disorder (PTSD) due to dental trauma, Major Neurocognitive Disorder (Dementia), Schizophrenia, or Intellectual Disability
3. Current diagnosis of a balance disorder, such as vertigo
4. Lifetime history of cybersickness
5. Previous history of epileptic seizures
6. A history of cardiac problems
7. Are in pain, require urgent care, or whose necessary treatment will be delayed by participating in the study
13 Years
ALL
No
Sponsors
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Virtually Better, Inc.
INDUSTRY
New York University
OTHER
Responsible Party
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Principal Investigators
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Richard Heyman, PhD
Role: PRINCIPAL_INVESTIGATOR
New York University
Locations
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New York University
New York, New York, United States
Countries
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Central Contacts
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Facility Contacts
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Jennifer Piscitello, Ph.D
Role: primary
Other Identifiers
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s23-00772
Identifier Type: -
Identifier Source: org_study_id