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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

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06024395
Enrollment
1000
Registered
2023-09-06
Start date
2023-09-11
Completion date
2028-06-30
Last updated
2026-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dental Fear

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.

Interventions

BEHAVIORALA 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

New York University
Lead SponsorOTHER
University of Pennsylvania
CollaboratorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
13 Years to 99 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Change in dental fear in intervention groupUp 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).

Countries

United States

Contacts

CONTACTKelly Daly, PhD
kd2691@nyu.edu914-806-5093
PRINCIPAL_INVESTIGATORRichard Heyman, Ph.D

New York University

PRINCIPAL_INVESTIGATORMark Wolff, DDS

University of Pennsylvania

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Aug 4, 2026