A Stepped Care Approach to Treating Dental Fear

Study Overview
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Brief Summary
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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.

Official Title
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A Stepped-Care Approach to Treating Dental Fear: A Sequential, Multiple Assignment, Randomized Trial for Cognitive-Behavioral Treatment Via Mobile App and Evidence-Based Collaborative Care

Conditions
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Dental Fear

Intervention / Treatment
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* Behavioral: Dental FearLess


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Provide signed and dated informed consent form Willing to comply with all study procedures and be available for the duration of the study Adult, at least 18 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 Exclusion Criteria: Given the scope and nature of the study, there is no exclusion criteria.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Dental FearLess App<br>Dental FearLess app is an e-health intervention that includes psychoeducation about anxiety; affective, cognitive, and behavioral strategies for coping at the dentist. | Behavioral: Dental FearLess<br>* Dental FearLess is a self-administered CBT-based mobile app that takes approximately 1 hour to complete.<br>|
| No Intervention: Treatment as Usual<br> | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reduction of moderate to severe dental fear. | 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). | baseline, upto 8 weeks, 5/6 month follow-up visit |