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Clinical Trial NCT06024395 for Dental Fear is recruiting. See the Trial Radar Card View and AI discovery tools for all the details. Or ask anything here.
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A Stepped Care Approach to Treating Dental Fear 1,250 Telehealth Randomized Mobile App

Recruiting
Clinical Trial NCT06024395 is an interventional study for Dental Fear that is recruiting. It started on September 11, 2023 with plans to enroll 1,250 participants. Led by New York University, it is expected to complete by June 30, 2028. The latest data from ClinicalTrials.gov was last updated on June 13, 2025.
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 provi...Show More
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

Conditions
Dental Fear
Other Study IDs
  • 23-042-E
NCT ID Number
NCT06024395
Start Date (Actual)
2023-09-11
Last Update Posted
2025-06-13
Completion Date (Estimated)
2028-06-30
Enrollment (Estimated)
1,250
Study Type
Interventional
PHASE
N/A
Status
Recruiting
Primary Purpose
Treatment
Design Allocation
Randomized
Interventional Model
Sequential
Masking
Single
Arms / Interventions
Participant Group/ArmIntervention/Treatment
ExperimentalDental FearLess App
Dental FearLess app is an e-health intervention that includes psychoeducation about anxiety; affective, cognitive, and behavioral strategies for coping at the dentist.
Dental FearLess
Dental FearLess is a self-administered CBT-based mobile app that takes approximately 1 hour to complete.
No InterventionTreatment as Usual
N/A
Primary Outcome Measures
Outcome MeasureMeasure DescriptionTime Frame
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
Participation Assistant
Eligibility Criteria

Eligible Ages
Child, Adult, Older Adult
Minimum Age
13 Years
Eligible Sexes
All
Accepts Healthy Volunteers
Yes
  • Provide signed and dated informed consent/ assent form
  • Willing to comply with all study procedures and be available for the duration of the study
  • Be least 13 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

Given the scope and nature of the study, there is no exclusion criteria.
New York University logoNew York University312 active studies to explore
University of Pennsylvania logoUniversity of Pennsylvania503 active studies to explore
Study Central Contact
Contact: Kelly Daly, PhD, 914-806-5093, [email protected]
1 Study Locations in 1 Countries

New York

New York University, New York, New York, 10010, United States
Recruiting