A Stepped Care Approach to Treating Dental Fear

New York University (NYU)

Status: Enrolling

Conditions: Dental Fear

Treatments: Behavioral: Dental FearLess

Study type: Interventional

Funder types: Other

Identifiers

NCT06024395

23-042-E

Details and patient eligibility

About

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.

Enrollment: 1,250 estimated patients

Sex: All

Ages: 13 to 99 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• 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

Exclusion criteria

Given the scope and nature of the study, there is no exclusion criteria.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: Single Blind

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1,250 participants in 2 patient groups

Dental FearLess App

Experimental group

Description:

Dental FearLess app is an e-health intervention that includes psychoeducation about anxiety; affective, cognitive, and behavioral strategies for coping at the dentist.

Treatment:

Behavioral: Dental FearLess

Treatment as Usual

No Intervention group