A Stepped Care Approach to Treating Dental Fear

July 31, 2026 updated by: New York University

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

1000

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Kelly Daly, PhD
  • Phone Number: 914-806-5093
  • Email: kd2691@nyu.edu

Study Locations

  • United States
    • New York
      • New York, New York, United States, 10010
        • Recruiting
        • New York University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

Given the scope and nature of the study, there is no exclusion criteria.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Sequential Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Treatment as Usual
Experimental: Dental FearLess Intervention
Dental FearLess app is an e-health intervention that includes psychoeducation about anxiety; affective, cognitive, and behavioral strategies for coping at the dentist.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in dental fear in intervention group
Time Frame: Up to 15-21-month period following enrollment and baseline measures.
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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

New York University

Collaborators

University of Pennsylvania

Investigators

  • Principal Investigator: Richard Heyman, Ph.D, New York University
  • Principal Investigator: Mark Wolff, DDS, University of Pennsylvania

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 11, 2023

Primary Completion (Estimated)

April 30, 2028

Study Completion (Estimated)

June 30, 2028

Study Registration Dates

First Submitted

August 21, 2023

First Submitted That Met QC Criteria

September 5, 2023

First Posted (Actual)

September 6, 2023

Study Record Updates

Last Update Posted (Actual)

August 3, 2026

Last Update Submitted That Met QC Criteria

July 31, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Other Study ID Numbers

  • 23-042-E

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Subscribe