Dissemination of a Brief Dental Fear Intervention

NCT ID: NCT05082298

Last Updated: 2023-11-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 71 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-08-31
• Study Completion Date: 2023-05-01

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.

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.

Conditions

Dental Fear

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Dental Fear Intervention

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

Group Type: EXPERIMENTAL

Dental FearLess app

Intervention Type: 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.

In-Chair Treatment Protocol

Intervention Type: 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.

Interventions

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.

Intervention Type: 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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 100 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

New York University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Richard E Heyman, PhD

Role: PRINCIPAL_INVESTIGATOR

New York University

Locations

Noble Dental Care, PC

Brooklyn, New York, United States

Allen & Schwarz Dental

New York, New York, United States

Countries

United States

Other Identifiers

1UG3DE029453-01

Identifier Type: NIH

Identifier Source: secondary_id

View Link

1UG3DE029453-01-1

Identifier Type: -

Identifier Source: org_study_id