A Stepped Care Approach to Treating Dental Fear

NCT06024395 | Recruiting

• 1 other identifier: 23-042-E
• Study Type: interventional
• Target: 1,250
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Dental FearLess App

EXPERIMENTAL

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

Treatment as Usual

NO INTERVENTION

Interventions

Dental FearLess BEHAVIORAL

Dental FearLess is a self-administered CBT-based mobile app that takes approximately 1 hour to complete.

Dental FearLess App

Eligibility Criteria

• Age: 13 Years - 99 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Provide signed and dated informed consent/ assent form
• Willing to comply with all study procedures and be available for the duration of the study
• Be least 13 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

Sponsors & Collaborators

• New York University: lead
• University of Pennsylvania: collaborator

Study Sites (1)

New York University

New York, New York, 10010, United States

RECRUITING

Study Officials

• Richard Heyman, Ph.D

  New York University

  PRINCIPAL INVESTIGATOR

• Mark Wolff, DDS

  University of Pennsylvania

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Kelly Daly, PhD

CONTACT

914-806-5093; kd2691@nyu.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 21, 2023
• First Posted: September 6, 2023
• Study Start: September 11, 2023
• Primary Completion (Estimated): April 30, 2028
• Study Completion (Estimated): June 30, 2028
• Last Updated: June 13, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)