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| Name | Class |
|---|---|
| University of Pennsylvania | OTHER |
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The purpose of this study is to compare an intervention for dental fear to the usual approach (i.e., whatever participants' dentist typically does to help participants manage their fear). The dental fear intervention has 2 separate steps. Step 1 (the less intensive or 'light touch' intervention step) involves using a mobile application (app). Step 2 consists of a one-hour telehealth session with a mental health provider tailored to individualized dental fear.
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dental FearLess Intervention | Experimental | Dental FearLess app is an e-health intervention that includes psychoeducation about anxiety; affective, cognitive, and behavioral strategies for coping at the dentist. |
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| Treatment as Usual | No Intervention |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| A stepped-care approach to the treatment of dental fear; Dental Fearless | Behavioral | Step 1. Dental FearLess is a self-administered CBT-based mobile app that takes approximately 1 hour to complete. Step 2. A one-hour, one-on-one telehealth session with a mental health provider tailored to the participant's individualized dental fear for those who still report moderate to severe dental fear following completion of the Dental Fearless app. |
| Measure | Description | Time Frame |
|---|---|---|
| Reduction in dental fear in intervention group | Assess the efficacy of a CBT-based stepped-care (i.e., progressive treatment dosing) approach in the reduction of moderate to severe dental fear (measured via subjective report on IDAF). | Up to 15-21-month period following enrollment and baseline measures. |
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Inclusion Criteria:
Exclusion Criteria:
Given the scope and nature of the study, there is no exclusion criteria.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Kelly Daly, PhD | Contact | 914-806-5093 | kd2691@nyu.edu |
| Name | Affiliation | Role |
|---|---|---|
| Richard Heyman, Ph.D | New York University | Principal Investigator |
| Mark Wolff, DDS | University of Pennsylvania | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| New York University | Recruiting | New York | New York | 10010 | United States |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| ICF | No | No | Yes | Informed Consent Form | Sep 30, 2025 | May 11, 2026 | ICF_000.pdf |
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