A Stepped Care Approach to Treating Dental Fear

Sponsor
New York University (Other)
Overall Status
Recruiting
CT.gov ID
NCT06024395
Collaborator
University of Pennsylvania (Other)
1,250
1
2
58.3
21.4

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Dental FearLess
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
1250 participants
Allocation:
Randomized
Intervention Model:
Sequential Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
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
Actual Study Start Date :
Aug 21, 2023
Anticipated Primary Completion Date :
Jun 30, 2028
Anticipated Study Completion Date :
Jun 30, 2028

Arms and Interventions

Arm Intervention/Treatment
Experimental: Dental 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.

Behavioral: Dental FearLess
Dental FearLess is a self-administered CBT-based mobile app that takes approximately 1 hour to complete.

No Intervention: Treatment as Usual

Outcome Measures

Primary Outcome Measures

  1. Reduction of moderate to severe dental fear. [baseline, upto 8 weeks, 5/6 month follow-up visit]

    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).

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:
  • Provide signed and dated informed consent form

  • Willing to comply with all study procedures and be available for the duration of the study

  • Adult, at least 18 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

Exclusion Criteria:

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

Contacts and Locations

Locations

Site City State Country Postal Code
1 New York University New York New York United States 10010

Sponsors and Collaborators

  • New York University
  • University of Pennsylvania

Investigators

  • Principal Investigator: Richard Heyman, Ph.D, New York University
  • Principal Investigator: Mark Wolff, DDS, University of Pennsylvania

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
New York University
ClinicalTrials.gov Identifier:
NCT06024395
Other Study ID Numbers:
  • 23-042-E
First Posted:
Sep 6, 2023
Last Update Posted:
Sep 6, 2023
Last Verified:
Aug 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No

Study Results

No Results Posted as of Sep 6, 2023