RECRUITING

A Stepped Care Approach to Treating Dental Fear

Conditions

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

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

Quick Facts

Study Start:2023-08-21
Study Completion:2028-06-30
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06024395

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Yes
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Provide signed and dated informed consent form
  2. * Willing to comply with all study procedures and be available for the duration of the study
  3. * Adult, at least 18 years old.
  4. * Score 4 or above on the Gatchel single-item dental fear rating scale
  5. * Willingness to allow access to dental attendance records
  6. * Access to a smartphone or tablet
  1. Pregnancy or breastfeeding
  2. Severe psychiatric disorders
  3. Active substance abuse
  4. Unstable medical conditions
  5. Inability to comply with study requirements

Contacts and Locations

Study Contact

Kelly Daly, PhD
CONTACT
914-806-5093
kd2691@nyu.edu

Principal Investigator

Richard Heyman, Ph.D
PRINCIPAL_INVESTIGATOR
New York University
Mark Wolff, DDS
PRINCIPAL_INVESTIGATOR
University of Pennsylvania

Study Locations (Sites)

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

Collaborators and Investigators

Sponsor: New York University

  • Richard Heyman, Ph.D, PRINCIPAL_INVESTIGATOR, New York University
  • Mark Wolff, DDS, PRINCIPAL_INVESTIGATOR, University of Pennsylvania

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-08-21
Study Completion Date2028-06-30

Study Record Updates

Study Start Date2023-08-21
Study Completion Date2028-06-30

Terms related to this study

Additional Relevant MeSH Terms

  • Dental Fear