A Stepped Care Approach to Treating Dental Fear

Conditions

• Dental Fear

Eligibility Criteria

Sex

ALL

Age

13 Years - 99 Years

Healthy Volunteers

Accepted

Interventions

• A stepped-care approach to the treatment of dental fear; Dental Fearless — BEHAVIORAL
  Step 1. Dental FearLess is a self-administered CBT-based mobile app that takes approximately 1 hour to complete. Step 2. A one-hour, one-on-one telehealth session with a mental health provider tailored to the participant's individualized dental fear for those who still report moderate to severe dental fear following completion of the Dental Fearless app.

Study Details

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.

Key Dates

Start date

Sep 11, 2023

Status verified

May 2026

Primary completion

Mar 28, 2028

Completion

Jun 30, 2028

Study Design

Enrollment

1,000 participants (estimated)

Allocation

RANDOMIZED

Intervention model

SEQUENTIAL

Primary purpose

TREATMENT

Arms

• Experimental: Dental FearLess Intervention
  Dental FearLess app is an e-health intervention that includes psychoeducation about anxiety; affective, cognitive, and behavioral strategies for coping at the dentist.
• No Intervention: Treatment as Usual

Primary Outcome Measure

Reduction in dental fear in intervention group [ Time Frame: Up to 15-21-month period following enrollment and baseline measures. ]

Central Contacts

• Kelly Daly, PhD
  914-806-5093
  [email protected]

Locations (1)

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