Dissemination of a Brief Dental Fear Intervention

Dental Fear Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05082298
• Other study ID #: 1UG3DE029453-01-1
• Secondary ID: 1UG3DE029453-01
• Status: Completed
• Phase: N/A
• Start date: August 31, 2021
• Est. completion date: May 1, 2023

Study information

• Verified date: November 2023
• Source: New York University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 71
• Est. completion date: May 1, 2023
• Est. primary completion date: November 30, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

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

Related Conditions & MeSH terms

• Dental Fear

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	Noble Dental Care, PC	Brooklyn	New York
United States	Allen & Schwarz Dental	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
New York University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	Dental Practice Retention	Behavioral data on dental appointment attendance, treatment adherence following intervention	Up to 6 months from enrollment
Secondary	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
Secondary	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.
Secondary	Appointment Post-Survey	Dental visit experience and fear-belief confirmation or disconfirmation questions.	Assessed within 24 hours after using the app.