A Stepped Care Approach to Treating Dental Fear

Dental Fear Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06024395
• Other study ID #: 23-042-E
• Status: Recruiting
• Phase: N/A
• Start date: August 21, 2023
• Est. completion date: June 30, 2028

Study information

• Verified date: August 2023
• Source: New York University
• Contact: Kelly Daly, PhD
• Phone: 914-806-5093
• Email: kd2691[@]nyu.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1250
• Est. completion date: June 30, 2028
• Est. primary completion date: June 30, 2028
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Dental Fear

Intervention

Behavioral:
• Dental FearLess
Dental FearLess is a self-administered CBT-based mobile app that takes approximately 1 hour to complete.

Locations

Country	Name	City	State
United States	New York University	New York	New York

Sponsors (2)

Lead Sponsor	Collaborator
New York University	University of Pennsylvania

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Reduction of moderate to severe dental fear.	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).	baseline, upto 8 weeks, 5/6 month follow-up visit