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: 10228587
• 负责人: Eugene M Dunne
• 金额: $ 51.95万
• 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/10228587
• 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; Dissemination and Implementation; 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; acceptability and feasibility; active control; anxiety reduction; anxiety treatment; arm; base; care providers; clinical biomarkers; design; distress tolerance; efficacy evaluation; efficacy testing; experience; implementation intervention; pain sensitivity; post intervention; psychologic; research clinical testing; secondary outcome; treatment of anxiety disorders; two-arm study; validation studies; virtual; web platform; web-based intervention

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（U 01）”。本文提出的临床试验将评估一个简短的互联网- 基于认知行为干预的牙科焦虑症患者的治疗 大学诊所的牙科护理。试点项目的初步经验以及 一项随机对照试验，使用基于计算机的干预版本，在60分钟内完成 在预约牙医之前，已经证明患者可以接受，并提供了初步的 证明其功效。然而，干预措施只有在与 接受过焦虑认知行为治疗培训的临床心理学人员的协助 这代表了其在牙科环境中实施的潜在重大限制， 训练有素的心理学人员是一种稀缺资源。计划的U 01临床试验将评估 在临床心理学人员的协助下，这种干预的互联网版本的有效性， 将其与牙科工作人员协助时的干预效果进行比较。一个发现，干预是 有效，并且当由牙科人员协助时与由临床心理学协助时等效 人员，将使干预措施的传播和实施以可持续的方式， 更可行。本U 01申请将基于既往临床试验或生物标志物临床评价研究 规划补助金（R34），其中的可行性和可接受性的基于互联网的版本的干预措施 检查了牙科工作人员，编写了牙科工作人员培训材料， 制定并试行了干预知识和管理忠诚度的措施， 牙科工作人员（以及心理学工作人员）对一小部分患者进行干预。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干预措施相比， 由接受过认知行为学培训的临床心理学人员实施。在这两组研究中， 治疗牙科提供者还将被告知患者在牙科焦虑测量上的分数， 研究的第三部分，其中告知治疗牙科提供者患者的牙科焦虑评分 规模将是唯一的干预，将作为一个控制条件。小学（自评和评估员自评 牙科焦虑/恐惧）和次要结果测量（例如，疼痛敏感性，痛苦耐受性，来访者 满意度，血液损伤-注射恐惧症）将在基线和治疗后1个月和3个月进行。 牙科焦虑干预的给药日。年内定期牙科预约的出席率 还将审查12个月后的情况，以确定干预是否影响避免 牙科手术。进一步的分析将检查是否基线水平的痛苦容忍度和疼痛 敏感性缓和了基于互联网的干预在减少牙科焦虑症提供者之间的功效。