Dental FearNCT05082298
Dissemination of a Brief Dental Fear Intervention
A study testing Dental FearLess app and In-Chair Treatment Protocol in people with Dental Fear, run by New York University at 2 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 100 yearsHealthy volunteers can take part
- Conditions the study is for
- Dental Fear
- What is being tested?
- Dental FearLess app and In-Chair Treatment Protocol
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 71 participants
- Where
- 2 sitesUnited States
- Study dates
- 31 Aug 2021to 1 May 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Noble Dental Care, PC
Brooklyn, New York, 11215
Allen & Schwarz Dental
New York, New York, 10019
About this study
Official title: 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.
Read the 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
- Being tested
- Dental FearLess app, In-Chair Treatment Protocol
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dental FearLess appBehavioural
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 ProtocolBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Dental Fear Intervention | Experimental | All participants will receive a brief 2-step treatment for dental fear (Dental FearLess app, In-Chair Treatment) Receives: Behavioral: Dental FearLess app; Behavioral: In-Chair Treatment Protocol |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: Usability measures will be collected within 24 hours of receipt of in-chair treatment
Secondary outcomes (4)
Dental Practice Retention
Behavioral data on dental appointment attendance, treatment adherence following intervention
Measured: 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)
Measured: 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.
Measured: 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.
Measured: Assessed within 24 hours after using the app.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Oct 2021
- Study start31 Aug 2021
- Primary completion30 Nov 2022
- Study completion1 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dental FearStudies of the same condition, open and under way.
- More trials run by New York UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Piloting dissemination and feasibility of a two-step dental fear treatment at private practices in a large metropolitan city.
- Masking
- None (open label)
- Enrolment
- 71 participants (actual)
Sponsor and investigators
- Lead sponsor
- New York University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Richard E Heyman, PhD, Principal investigator, New York University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05082298
- Sponsor's protocol ID
- 1UG3DE029453-01-1
- Other IDs
- 1UG3DE029453-01
- Status last verified
- Nov 2023
- First submitted
- 17 Sep 2021
- Last updated
- 13 Nov 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Test of a Stepped-Care Approach for Dental Fear at Private Dental Clinics
- ClinicalTrials.gov ID
- NCT05082298
- Acronym / sponsor ID
- 1UG3DE029453-01-1
- Conditions
- Dental Fear
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 71 participants (actual)
- Lead sponsor
- New York UniversityUniversity, hospital or other
- Study start
- 31 Aug 2021 (actual)
- Primary completion
- 30 Nov 2022 (actual)
- Study completion
- 1 May 2023 (actual)
- First posted
- 18 Oct 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Piloting dissemination and feasibility of a two-step dental fear treatment at private practices in a large metropolitan city.
| Arm | Type | Receives |
|---|---|---|
| Dental Fear Intervention | Experimental | Behavioral: Dental FearLess app, Behavioral: In-Chair Treatment ProtocolAll participants will receive a brief 2-step treatment for dental fear (Dental FearLess app, In-Chair Treatment) |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dental FearLess appDental 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. | Behavioural | Dental Fear Intervention |
| In-Chair Treatment ProtocolThis 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. | Behavioural | Dental Fear Intervention |
Primary outcome
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
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
4 secondary outcomes
Dental Practice Retention
Time frame: Up to 6 months from enrollment
Overall Effectiveness of 2-Step Model
Time frame: Up to 6 months from enrollment
Global Dental Fear
Time frame: Assessed within the 24 hours before and within the 24 hours after app use.
Appointment Post-Survey
Time frame: Assessed within 24 hours after using the app.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Nov 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Richard E Heyman, PhD principal investigator
New York University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dental FearLess app and In-Chair Treatment Protocol in people with Dental Fear, run by New York University at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Usability of the Dental FearLess App (time frame: Usability measures will be collected within 24 hours of app completion). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Nov 2023.