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Completed

NCT Number: NCT05082298

Dissemination of a Brief Dental Fear Intervention

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.

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Key information

Conditions

Age range

18 year–100 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Noble Dental Care, PC, Brooklyn, New York, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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.

Primary outcomes

  1. Usability of the Dental FearLess App

    Time frame: Usability measures will be collected within 24 hours of app completion

    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

  2. Usability of the In-Chair Intervention

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

    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

Secondary outcomes

  1. Dental Practice Retention

    Time frame: Up to 6 months from enrollment

    Behavioral data on dental appointment attendance, treatment adherence following intervention

  2. Overall Effectiveness of 2-Step Model

    Time frame: Up to 6 months from enrollment

    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)

  3. Global Dental Fear

    Time frame: Assessed within the 24 hours before and within the 24 hours after app use.

    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.

  4. Appointment Post-Survey

    Time frame: Assessed within 24 hours after using the app.

    Dental visit experience and fear-belief confirmation or disconfirmation questions.

Sponsors and collaborators

Lead sponsor

New York University

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2022
Study completion
2023
First posted
Oct 18, 2021
Registry last updated
Nov 13, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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