Actively Recruiting
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
Led by New York University · Updated on 2026-05-15
1000
Participants Needed
1
Research Sites
13 weeks
Total Duration
On this page
Sponsors
N
New York University
Lead Sponsor
U
University of Pennsylvania
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating a stepped-care approach to manage dental fear compared to the usual care provided by participants' dentists. The study aims to see if this intervention can reduce dental fear and improve oral health-related quality of life. The research involves a randomized design where some participants receive the intervention and others continue with their usual dental care. The study is sponsored by New York University and includes participants aged 13 to 99 years who have moderate to severe dental fear. The intervention has two steps. Step one is a self-administered cognitive-behavioral therapy (CBT) based mobile app called Dental FearLess, which takes about one hour to complete and offers education and coping strategies for dental anxiety. Step two is a one-hour telehealth session with a mental health provider tailored to individual dental fear for those who still report significant fear after the app. Participants may be randomly assigned to either this intervention or treatment as usual, with 25% receiving no intervention during the study period. Participants will be involved for up to 15 to 21 months following enrollment, during which self-reported dental fear and oral health-related quality of life will be assessed after treatment and at follow-up. Attendance records from dental practices will also be collected in a de-identified manner. Those assigned to the control group will provide feedback on their dental experiences and will have the option to receive the intervention free of charge after the study ends.
CONDITIONS
Brief Title
A Stepped Care Approach to Treating Dental Fear
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Provide signed and dated informed consent form
- Access to a smartphone or tablet
- Willing to comply with all study procedures and be available for the duration of the study
- 13 years or older, and if under 18 years, a parent or legal guardian can consent to their participation in the study
- Proficient in English
- Score 4 or above on the Gatchel single-item dental fear rating scale
- Willingness to allow access to dental attendance records
- Located in the USA
You will not qualify if you...
- No exclusion criteria
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person or remote)
Duration - Up to 21 months including sequential interventions
Participants complete a self-administered cognitive-behavioral therapy (CBT) mobile app designed to reduce dental fear. Those still experiencing moderate to severe dental fear after the app participate in a one-hour telehealth session with a mental health provider tailored to their needs.
1 initial app session and 1 telehealth session if needed
Trial Site Locations
Total: 1 location
1
New York University
New York, New York, United States, 10010
Actively Recruiting
Research Team
K
Kelly Daly, PhD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
2
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