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
1250 participants
INTERVENTIONAL
2023-09-11
2028-06-30
Brief Summary
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This is a randomized study. The time spent participating in the study will depend on which study condition(s) participants are randomly assigned to. Because this study compares the dental fear intervention to the standard approach, 25% of participants will not get the intervention during the study period. These participants (called controls) will be offered the opportunity to provide feedback about their experiences with dentists. Participants will be offered the intervention free of charge at the conclusion of the study.
For each step of the intervention (Dental FearLess app or one-on-one session) relative to treatment as usual, the investigators hypothesize that participants will show greater declines in self-reported dental fear and improved oral health-related quality of life at post-treatment and follow-up period. De-identified attendance records will be collected from dental practices.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
SEQUENTIAL
TREATMENT
SINGLE
Study Groups
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Dental FearLess App
Dental FearLess app is an e-health intervention that includes psychoeducation about anxiety; affective, cognitive, and behavioral strategies for coping at the dentist.
Dental FearLess
Dental FearLess is a self-administered CBT-based mobile app that takes approximately 1 hour to complete.
Treatment as Usual
No interventions assigned to this group
Interventions
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Dental FearLess
Dental FearLess is a self-administered CBT-based mobile app that takes approximately 1 hour to complete.
Eligibility Criteria
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Inclusion Criteria
* Willing to comply with all study procedures and be available for the duration of the study
* Be least 13 years old.
* Score 4 or above on the Gatchel single-item dental fear rating scale
* Willingness to allow access to dental attendance records
* Access to a smartphone or tablet
13 Years
99 Years
ALL
Yes
Sponsors
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University of Pennsylvania
OTHER
New York University
OTHER
Responsible Party
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Principal Investigators
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Richard Heyman, Ph.D
Role: PRINCIPAL_INVESTIGATOR
New York University
Mark Wolff, DDS
Role: PRINCIPAL_INVESTIGATOR
University of Pennsylvania
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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Other Identifiers
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23-042-E
Identifier Type: -
Identifier Source: org_study_id
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