NCT06024395 A Stepped Care Approach to Treating Dental Fear
| NCT ID | NCT06024395 |
| Status | Recruiting |
| Phase | — |
| Sponsor | New York University |
| Condition | Dental Fear |
| Study Type | INTERVENTIONAL |
| Enrollment | 1,000 participants |
| Start Date | 2023-09-11 |
| Primary Completion | 2028-04-30 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 1,000 participants in total. It began in 2023-09-11 with a primary completion date of 2028-04-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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 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
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.
Contact & Investigator
Richard Heyman, Ph.D
PRINCIPAL INVESTIGATOR
New York University
Frequently Asked Questions
Who can join the NCT06024395 clinical trial?
This trial is open to participants of all sexes, aged 13 Years or older, up to 99 Years, studying Dental Fear. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06024395 currently recruiting?
Yes, NCT06024395 is actively recruiting participants. Contact the research team at kd2691@nyu.edu for enrollment information.
Where is the NCT06024395 trial being conducted?
This trial is being conducted at New York, United States.
Who is sponsoring the NCT06024395 clinical trial?
NCT06024395 is sponsored by New York University. The principal investigator is Richard Heyman, Ph.D at New York University. The trial plans to enroll 1,000 participants.