MedTrace Logo

A Stepped Care Approach to Treating Dental Fear

NCT06024395 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 1000

Last updated 2026-05-15

No results posted yet for this study

Summary

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.

Conditions

  • Dental Fear

Interventions

BEHAVIORAL

A stepped-care approach to the treatment of dental fear; Dental Fearless

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.

Sponsors & Collaborators

Principal Investigators

  • Richard Heyman, Ph.D · New York University

  • Mark Wolff, DDS · University of Pennsylvania

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
SEQUENTIAL

Eligibility

Min Age
13 Years
Max Age
99 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-09-11
Primary Completion
2028-03-28
Completion
2028-06-30

Countries

  • United States

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06024395 on ClinicalTrials.gov