Dissemination of a Brief Dental Fear Intervention

NCT05082298 | Completed

• 2 other identifiers: 1UG3DE029453-01-11UG3DE029453-01
• Study Type: interventional
• Target: 71
• Locations: 1 country
• Sites: 2

Brief Summary

Despite the fact that several efficacious interventions for dental fear exist, it continues to be among the most common, and least addressed phobias among individuals. This reality is largely due to dissemination, or lack thereof. Research is needed on how to disseminate and implement such treatment in a way that recognizes the barriers to accessing and entering treatment for dental fear. Using a collaborative care approach, the investigators will pilot test, for feasibility and acceptability, a brief 2-step dental fear intervention. The first step will be an app intervention for moderate-to-severe dental that can be accessed by participants on a mobile device. The second step will consist of a one-hour face-to-face CBT intervention for participants delivered by a mental health professional at their dentist's office.

Conditions

Dental Fear

Outcome Measures

Primary Outcomes (2)

• Usability of the Dental FearLess App

  A measure based on the System Usability Scale will assess participant feelings about the app. Each item is scored on a 1 to 5 Likert scale, with 7 of the 21 items reversed coded. Possible scores will range from 21 to 105 with higher scores indicating more favorable assessments regarding usability of the app

  Usability measures will be collected within 24 hours of app completion

• Usability of the In-Chair Intervention

  A measure based on the System Usability Scale will assess participants feelings about the in-chair intervention. Each item is scored on a 1 to 5 Likert scale, with 3 of the 16 items reversed coded. Possible scores range from 16 to 80, with higher scores indicating more favorable assessments regarding the usability of the intervention

  Usability measures will be collected within 24 hours of receipt of in-chair treatment

Secondary Outcomes (4)

• Dental Practice Retention

  Up to 6 months from enrollment

• Overall Effectiveness of 2-Step Model

  Up to 6 months from enrollment

• Global Dental Fear

  Assessed within the 24 hours before and within the 24 hours after app use.

• Appointment Post-Survey

  Assessed within 24 hours after using the app.

Study Arms (1)

Dental Fear Intervention

EXPERIMENTAL

All participants will receive a brief 2-step treatment for dental fear (Dental FearLess app, In-Chair Treatment)

Behavioral: Dental FearLess app; Behavioral: In-Chair Treatment Protocol

Interventions

Dental FearLess app BEHAVIORAL

Dental FearLess, is a self-administered psychoeducational intervention that will be accessed by participants via their personal smart device (In other words, this is an online application in which investigators present information about dental procedures. The user selects the procedure on which they would like information and then views a brief video on the selected procedure. It uses evidence-based tools to help participants manage their thoughts, feelings, and behavior related to dental fear to reduce fear during encounters with dental professionals.

Dental Fear Intervention

In-Chair Treatment Protocol BEHAVIORAL

This session is a 1-hour-in-person Cognitive Behavioral Therapy (CBT) dental fear session by study staff at the dental office. Participants will practice managing their thoughts, behaviors, and/or feelings when exposed to stimuli that they report still fearing. After each practice situation, the mental health provider and participant discuss the disconfirmatory evidence generated by the situation.

Dental Fear Intervention

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Moderate to severe dental fear
• years of age or older
• Fluent and literate in English
• Access to a device with which they will be piloting the intervention.

You may not qualify if:

• Does not have moderate to severe dental fear
• years of age or younger
• Does not speak English
• Does not have access to a device with which they would be piloting the intervention

Sponsors & Collaborators

• New York University: lead

Study Sites (2)

Noble Dental Care, PC

Brooklyn, New York, 11215, United States

Location

Allen & Schwarz Dental

New York, New York, 10019, United States

Location

Study Officials

• Richard E Heyman, PhD

  New York University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Piloting dissemination and feasibility of a two-step dental fear treatment at private practices in a large metropolitan city.

Study Record Dates

• First Submitted: September 17, 2021
• First Posted: October 18, 2021
• Study Start: August 31, 2021
• Primary Completion: November 30, 2022
• Study Completion: May 1, 2023
• Last Updated: November 13, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)