A Stepped Care Approach to Treating Dental Fear

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: Dental Fear
• Intervention / Treatment: Behavioral: Dental FearLess

• Study Type: Interventional
• Enrollment (Estimated): 1250
• Phase: Not Applicable

Contacts and Locations

• 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

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Treatment as Usual
Experimental: Dental FearLess App; 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; Dental FearLess is a self-administered CBT-based mobile app that takes approximately 1 hour to complete.

What is the study measuring?

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

Collaborators and Investigators

• 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

Study Major Dates

• Study Start (Actual): August 21, 2023
• Primary Completion (Estimated): June 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): September 6, 2023
• Last Update Submitted That Met QC Criteria: September 5, 2023
• Last Verified: August 1, 2023

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