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Recruiting NCT06024395

A Stepped Care Approach to Treating Dental Fear

Conditions: Dental Fear

Sex: All
Ages: 13 Years – 99 Years
Healthy volunteers: Yes
Phase: NA
Enrollment: 1000
Sponsor: New York University

Location: New York University New York New York

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.

Eligibility Criteria

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.

Interested in this study? View the official listing for contact and enrollment details.

View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT06024395). StuddyBuddy aggregates publicly available trial information.