Clinical trial NCT05082298: Dissemination of a Brief Dental Fear Intervention
Official title: Pilot Test of a Stepped-Care Approach for Dental Fear at Private Dental Clinics
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dental Fear
Lead sponsor: New York University
Sponsor class: OTHER
First posted: 2021-10-18
Enrollment: 71
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Piloting dissemination and feasibility of a two-step dental fear treatment at private practices in a large metropolitan city.
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Usability of the Dental FearLess App
timeFrame: Usability measures will be collected within 24 hours of app completion
measure: Usability of the In-Chair Intervention
timeFrame: Usability measures will be collected within 24 hours of receipt of in-chair treatment
Secondary outcomes:
measure: Dental Practice Retention
timeFrame: Up to 6 months from enrollment
measure: Overall Effectiveness of 2-Step Model
timeFrame: Up to 6 months from enrollment
measure: Global Dental Fear
timeFrame: Assessed within the 24 hours before and within the 24 hours after app use.
measure: Appointment Post-Survey
timeFrame: Assessed within 24 hours after using the app.
Other outcomes:
Locations:
city: Brooklyn
country: United States
facility: Noble Dental Care, PC
state: New York
city: New York
country: United States
facility: Allen & Schwarz Dental
state: New York
Study officials:
affiliation: New York University
name: Richard E Heyman, PhD
role: PRINCIPAL_INVESTIGATOR
References: