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NCT Number: NCT06024395

A Stepped Care Approach to Treating Dental Fear

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.

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Key information

Conditions

Age range

13 year–99 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

New York University

New York, 10010, United States

Location status: Recruiting

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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
  • Proficient in English
  • Score 4 or above on the Gatchel single-item dental fear rating scale
  • Willingness to allow access to dental attendance records
  • Located in the USA

Exclusion criteria

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

Treatment and study plan

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.

Primary outcomes

  1. Reduction in dental fear in intervention group

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

    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).

Study contacts

Contact information is provided by the study sponsor or research team.

Kelly Daly, PhD

CONTACT

[email protected]

914-806-5093

Sponsors and collaborators

Lead sponsor

New York University

Other

Collaborators

  • University of Pennsylvania

Registry information

Official study 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

Important dates

Study start
2023
Primary completion
2028
Study completion
2028
First posted
Sep 6, 2023
Registry last updated
May 15, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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