A Stepped Care Approach to Treating Dental Fear

Not Applicable

Recruiting

• Conditions: Dental Fear
• Interventions: Behavioral: Dental FearLess

• Registration Number: NCT06024395
• Lead Sponsor: New York University

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2023-08
• Study Start: 2023-08-21
• Study First Submitted: 2023-08-21
• Study First Submitted QC: 2023-09-05
• Last Update Submitted: 2023-09-05
• Study First Posted: 2023-09-06
• Last Update Posted: 2023-09-06
• Primary Completion: 2028-06-30
• Study Completion: 2028-06-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 1250

Inclusion Criteria

• Provide signed and dated informed consent form
• Willing to comply with all study procedures and be available for the duration of the study
• Adult, at least 18 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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Reduction of moderate to severe dental fear.	baseline, upto 8 weeks, 5/6 month follow-up visit	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).

Trial Locations

Locations (1)

New York University; 🇺🇸 New York, New York, United States