跳至主要内容
临床试验/NCT06024395
NCT06024395招募中不适用

A Stepped-Care Approach to Treating Dental Fear: A Sequential, Multiple Assignment, Randomized Trial for Cognitive-Behavioral Treatment Via Mobile App and Evidence-Based Collaborative Care

New York University1 个研究点 分布在 1 个国家目标入组 1,000 人开始时间: 2023年9月11日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
1,000
试验地点
1
主要终点
Change in dental fear in intervention group

研究概览

简要总结

The purpose of this study is to compare an intervention for dental fear to the usual approach (i.e., whatever participants' dentist typically does to help participants manage their fear). The dental fear intervention has 2 separate steps. Step 1 (the less intensive or 'light touch' intervention step) involves using a mobile application (app). Step 2 consists of a one-hour telehealth session with a mental health provider tailored to individualized dental fear.

This is a randomized study. The time spent participating in the study will depend on which study condition(s) participants are randomly assigned to. Because this study compares the dental fear intervention to the standard approach, 25% of participants will not get the intervention during the study period. These participants (called controls) will be offered the opportunity to provide feedback about their experiences with dentists. Participants will be offered the intervention free of charge at the conclusion of the study.

For each step of the intervention (Dental FearLess app or one-on-one session) relative to treatment as usual, the investigators hypothesize that participants will show greater declines in self-reported dental fear and improved oral health-related quality of life at post-treatment and follow-up period. De-identified attendance records will be collected from dental practices.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Sequential
主要目的
Treatment
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
13 Years 至 99 Years(Child, Adult, Older Adult)
性别
All
接受健康志愿者
是

入选标准

  • •Provide signed and dated informed consent form
  • •Access to a smartphone or tablet
  • •Willing to comply with all study procedures and be available for the duration of the study
  • •13 years or older, and if under 18 years, a parent or legal guardian can consent to their participation in the study
  • •Proficient in English
  • •Score 4 or above on the Gatchel single-item dental fear rating scale
  • •Willingness to allow access to dental attendance records
  • •Located in the USA

排除标准

  • •Given the scope and nature of the study, there is no exclusion criteria.

研究组 & 干预措施

Dental FearLess Intervention

Experimental

Dental FearLess app is an e-health intervention that includes psychoeducation about anxiety; affective, cognitive, and behavioral strategies for coping at the dentist.

干预措施: A stepped-care approach to the treatment of dental fear; Dental Fearless (Behavioral)

Treatment as Usual

No Intervention

结局指标

主要结局

Change in dental fear in intervention group

时间窗: Up to 15-21-month period following enrollment and baseline measures.

Assess the efficacy of a CBT-based stepped-care (i.e., progressive treatment dosing) approach in the reduction of moderate to severe dental fear (measured via subjective report on IDAF).

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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