跳至主要内容
临床试验/NCT05082298
NCT05082298已完成不适用

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

New York University3 个研究点 分布在 1 个国家目标入组 71 人开始时间: 2021年8月31日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
71
试验地点
3
主要终点
Usability of the In-Chair Intervention

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 100 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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.

排除标准

  • 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

结局指标

主要结局

Usability of the In-Chair Intervention

时间窗: 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

Usability of the Dental FearLess App

时间窗: 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

次要结局

  • Appointment Post-Survey(Assessed within 24 hours after using the app.)
  • Dental Practice Retention(Up to 6 months from enrollment)
  • Overall Effectiveness of 2-Step Model(Up to 6 months from enrollment)
  • Global Dental Fear(Assessed within the 24 hours before and within the 24 hours after app use.)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (3)

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