NCT06024395

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
• Phase: N/A
• Study type: Interventional
• Enrollment: 1,250 (estimated)
• Sponsor: New York University · Academic / Other
• Sex: All
• Age: 13 Years – 99 Years
• Healthy volunteers: Accepted

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

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

Timeline

• Start date: 2023-09-11
• Primary completion: 2028-04-30
• Completion: 2028-06-30
• First posted: 2023-09-06
• Last updated: 2025-06-13

Locations

1 site across 1 country: United States