Dissemination of a Brief Dental Fear Intervention

Pilot Test of a Stepped-Care Approach for Dental Fear at Private Dental Clinics

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.

Study Overview

• Status: Completed
• Conditions: Dental Fear
• Intervention / Treatment: Behavioral: Dental FearLess app; Behavioral: In-Chair Treatment Protocol

Detailed Description

Dental fear is among the most common individual phobias, and has devastating effects on oral and physical health, as well as emotional well-being. The behavioral avoidance associated with dental fear leads to neglect of prophylactic care, more dental emergencies, increased pain and suffering for individuals, and greater financial burdens, both for patients and society at large. Treatment remains inaccessible to the vast majority of fearful patients. Extremely efficacious brief evidence-based interventions for dental fear have not been administered outside of the specialty clinics in which they were developed. This is despite the ubiquitous nature of dental fear and its well-document impact on public health. Further, none of these existing treatment models can be easily incorporating into dental practices (due to issues of logistics, credentialed providers, time, financial costs, and disruptions of workflow).

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. The investigators propose to pilot test, for feasibility and acceptability, Dental FearLess, a brief, free, self-directed, computerized intervention for moderate-to-severe dental fear that can be implemented in the waiting room of dental offices. Patients reporting moderate-to-severe dental fear after completing Dental FearLess will be offered a follow-up 1-hour session that covers the same content in person. Clearly, the challenge at present is not how to treat dental fear to reduce the financial and human suffering burden to public health, but how to disseminate and implement Evidence Based Interventions (EBIs) for dental fear in a way that recognizes the rewards and barriers in the U.S. healthcare system.

Stepped-care interventions have demonstrated efficacy for other behavioral and emotional problems. The investigators aim to test whether such interventions are feasible and acceptable, for both dentists and patients, for dental fear. If the pilot evaluation shows promise, it can be tested in larger studies and, if effective, be more widely implemented in the normal course of dental practice. This could improve uptake and, ultimately, patient outcomes compared with existing psychosocial interventions for dental fear.

• Study Type: Interventional
• Enrollment (Actual): 71
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New York
    • Brooklyn, New York, United States, 11215
      • Noble Dental Care, PC
    • New York, New York, United States, 10019
      • Allen & Schwarz Dental

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 100 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

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

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Dental Practice Retention	Behavioral data on dental appointment attendance, treatment adherence following intervention	Up to 6 months from enrollment
Overall Effectiveness of 2-Step Model	Change in dental fear assessed via several indicators (self reported absolute fear,experiences of anxiety disconfirmation, cognitions and affect experienced during next scheduled dental appointment)	Up to 6 months from enrollment
Global Dental Fear	Gatchel's dental fear item will be used during screening for its brevity. Participants rate their dental anxiety/fear on a 0 (none) to 10 (high) scale.	Assessed within the 24 hours before and within the 24 hours after app use.
Appointment Post-Survey	Dental visit experience and fear-belief confirmation or disconfirmation questions.	Assessed within 24 hours after using the app.

Collaborators and Investigators

• Sponsor: New York University
• Investigators: Principal Investigator: Richard E Heyman, PhD, New York University

Study record dates

Study Major Dates

• Study Start (Actual): August 31, 2021
• Primary Completion (Actual): November 30, 2022
• Study Completion (Actual): May 1, 2023

Study Registration Dates

• First Submitted: September 17, 2021
• First Submitted That Met QC Criteria: October 4, 2021
• First Posted (Actual): October 18, 2021

Study Record Updates

• Last Update Posted (Actual): November 13, 2023
• Last Update Submitted That Met QC Criteria: November 9, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: 1UG3DE029453-01-1; 1UG3DE029453-01 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No