Efficacy of an Internet-based intervention for dental anxiety

基于互联网的牙科焦虑干预措施的有效性

• 批准号: 9979635
• 负责人: Eugene M Dunne
• 金额: $ 53.02万
• 依托单位: TEMPLE UNIV OF THE COMMONWEALTH
• 依托单位国家: 美国
• 财政年份: 2018
• 资助国家: 美国
• 起止时间: 2018-08-01 至 2023-07-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9979635
• 关键词: Adherence; Affect; Anxiety; Anxiety Disorders; Appointment; Appointments and Schedules; Behavioral; Blood; Caring; Characteristics; Client satisfaction; Clinic; Clinical; Clinical Psychology; Clinical Trials; Cognitive; Cognitive Therapy; Computers; Consumer Satisfaction; Dental; Dental Anxiety; Dental Care; Dental Clinics; Dental Offices; Dental Staff; Distress; Educational Curriculum; Emergency medical service; Enrollment; Evaluation Studies; Exhibits; Faculty; Failure; Feasibility Studies; Fright; Grant; Human Resources; Impairment; Injections; Injury; Internet; Intervention; Knowledge; Measures; Modernization; National Institute of Dental and Craniofacial Research; Notification; Oral health; Outcome Measure; Pain; Patients; Personnel Staffing; Phobias; Prevalence; Preventive dental care; Protocols documentation; Provider; Psychology; Public Health; Randomized; Randomized Controlled Trials; Research; Resources; Sampling; Schedule; School Dentistry; Specific Phobia; Specific qualifier value; Symptoms; Technology; Therapeutic; Time; Training; Treatment Efficacy; U-Series Cooperative Agreements; Universities; Waiting Lists; active control; anxiety reduction; anxiety treatment; arm; base; care providers; clinical biomarkers; design; distress tolerance; efficacy evaluation; efficacy testing; experience; pain sensitivity; post intervention; psychologic; research clinical testing; secondary outcome; treatment of anxiety disorders; two-arm study; validation studies; virtual; web platform

This is an application submitted under PAR-15-059 “NIDCR Clinical Trial or Biomarker Clinical Validation Study Cooperative Agreement (U01).” The clinical trial proposed herein will evaluate the efficacy of a brief Internet- based cognitive-behavioral intervention for the treatment of impairing dental anxiety among those seeking dental care at a university clinic. Preliminary experience with pilot subjects as well as the results of a randomized controlled trial with a computer-based version of this intervention, delivered in the 60 minutes before a scheduled dental appointment, have shown it to be acceptable to patients and provided initial evidence for its efficacy. However, the intervention has only been formally evaluated when administered with the assistance of clinical psychology personnel trained in the cognitive-behavioral treatment of anxiety disorders, which represents a potentially significant limitation to its implementation in dental settings where highly trained psychological personnel are a scarce resource. The planned U01 clinical trial will evaluate the efficacy of the Internet-based version of this intervention assisted by clinical psychology personnel and compare it to the efficacy of the intervention when assisted by dental staff. A finding that the intervention is efficacious, and equivalently so when assisted by dental personnel as when assisted by clinical psychology personnel, will make the dissemination and implementation of the intervention in a sustainable fashion much more feasible. This U01 application will build on a previous Clinical Trial or Biomarker Clinical Evaluation Study Planning Grant (R34), in which the feasibility and acceptability of the Internet-based version of the intervention were examined, materials for the training of dental staff were developed, a number of dental staff were trained to criterion, measures of intervention knowledge and fidelity of administration were developed and piloted, and dental staff (as well as psychology staff) administered the intervention to a small set of patients. Now we seek to fully evaluate whether the intervention administered by dental staff compares well to the intervention when administered by cognitive behaviorally trained clinical psychology personnel. In these two arms of the study, the treating dental provider will also be informed of the patient's score on a measure of dental anxiety, and a third arm of the study, in which informing the treating dental provider of the patient's score on a dental anxiety scale will be the sole intervention, will serve as a control condition. Primary (self-rated and assessor-rated dental anxiety/fear) and secondary outcome measures (e.g., pain sensitivity, distress tolerance, client satisfaction, blood-injury-injection phobia) will be administered at baseline and 1 and 3 months following the day of administration of the dental anxiety intervention. Attendance at scheduled dental appointments over the following 12-month period will also be examined to determine whether the intervention affects avoidance of dental procedures. Further analyses will examine whether baseline levels of distress tolerance and pain sensitivity moderate the efficacy of the Internet-based intervention in reducing dental anxiety across providers.

这是根据 PAR-15-059“NIDCR 临床试验或生物标志物临床验证研究”提交的申请 合作协议（U01）。”本文提出的临床试验将评估简短的互联网的有效性 基于认知行为干预治疗寻求牙科治疗的人的损害性牙科焦虑 大学诊所的牙科护理。试点主题的初步经验以及结果 随机对照试验，采用计算机版本的干预措施，在 60 分钟内完成 在预定的牙科预约之前，已证明患者可以接受并提供初步信息 其功效的证据。然而，干预措施仅在使用以下药物时才得到正式评估： 接受过焦虑认知行为治疗培训的临床心理学人员的协助 疾病，这代表了其在牙科环境中实施的潜在重大限制，其中 训练有素的心理人员是稀缺资源。计划中的 U01 临床试验将评估 在临床心理学人员的协助下，该干预措施的网络版本的功效以及 将其与牙科工作人员协助下的干预效果进行比较。研究发现，干预措施是 有效，并且在牙科人员的协助下与在临床心理学的协助下同等有效 人员，将以可持续的方式传播和实施干预措施 更可行。此 U01 申请将建立在之前的临床试验或生物标志物临床评估研究的基础上 规划补助金（R34），其中基于互联网版本的干预措施的可行性和可接受性 进行了审查，开发了牙科工作人员培训材料，培训了一些牙科工作人员 根据标准，制定并试行了干预知识和管理忠诚度的衡量标准，以及 牙科工作人员（以及心理工作人员）对一小部分患者进行了干预。现在我们寻求 充分评估牙科工作人员实施的干预措施是否与以下情况下的干预措施相比较： 由受过认知行为训练的临床心理学人员管理。在这两个研究领域中， 治疗牙科服务提供者还将获悉患者在牙科焦虑测量方面的得分，以及 该研究的第三部分，其中告知治疗牙科服务提供者患者的牙科焦虑评分 规模将是唯一的干预措施，将作为控制条件。小学（自我评分和评估者评分） 牙科焦虑/恐惧）和次要结果指标（例如疼痛敏感性、痛苦耐受性、客户 满意度、血伤注射恐惧症）将在基线以及治疗后 1 个月和 3 个月进行 进行牙科焦虑干预的当天。参加预定的牙科预约 还将检查接下来的 12 个月期间，以确定干预措施是否会影响避免 牙科手术。进一步的分析将检查痛苦耐受性和疼痛的基线水平是否 敏感性调节了基于互联网的干预措施在减少提供者之间牙科焦虑方面的效果。