A Stepped Care Approach to Treating Dental Fear

ConditionDental Fear
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age13-99
SponsorNew York University

About this trial

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

This trial accepts healthy volunteers

Qualifiers

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

Disqualifiers

None

Trial design

Design model

Sequential

Treatments tested in this trial

  • 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.

Treatment groups

1,000 Participants
are divided into 2 treatment groups
Group A: Dental FearLess InterventionExperimental treatment 1 intervention
Group B: Treatment as UsualNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

Change in dental fear in intervention group

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).

Time frame
Up to 15-21-month period following enrollment and baseline measures.

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

New York University

Lead sponsor

University of Pennsylvania

Collaborator