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提交的申请，“ NIDCR临床试验或生物标志物临床验证研究 合作协议（U01）。”本文提出的临床试验将评估简短互联网的效率 - 基于认知行为的干预措施，以治疗那些寻求的人的牙科动画 大学诊所的牙科护理。试点科目的初步经验以及 随机对照试验，具有基于计算机的此干预措施，在60分钟内交付 在预定的牙科预约之前，已经证明患者可以接受并提供初始 证据证明其效率。但是，只有在使用时才对干预进行正式评估 临床心理学人员的帮助，接受了动画认知行为治疗的培训 疾病，这代表了其在牙科环境中实施的潜在重大限制 训练有素的心理人员是一种稀缺的资源。计划的U01临床试验将评估 临床心理学人员和 将其与牙科人员协助时的干预效率进行比较。干预措施的发现 轻松，同样在牙科人员的协助下，就像在临床心理学的协助下一样 人员将以可持续的方式传播和实施干预措施 更可行。该U01应用将基于先前的临床试验或生物标志物临床评估研究 计划赠款（R34），其中基于Internet的干预版本的可行性和可接受性 检查了，开发了牙科人员培训的材料，对许多牙科人员进行了培训 为了标准，开发和试行了干预知识和行政管理的衡量标准，并且 牙科人员（以及心理学家）对一小组患者进行了干预。现在我们寻求 充分评估牙科人员进行的干预措施是否与干预措施相比 通过认知行为训练的临床心理学人员管理。在研究的这两个臂中， 治疗牙科提供者还将在牙科动画中获悉患者的分数，并 研究的第三臂，其中将患者的牙齿焦虑症分数告知治疗牙科提供者 比例尺将是唯一的干预，将作为控制条件。主要（自评和评估者评估 牙科动画/恐惧）和次要结局指标（例如，疼痛敏感性，痛苦宽容，客户 满意度，受伤恐惧症）将在基线时和3个月后进行1和3个月 牙科动画干预的管理日。预定的牙科约会 还将检查之后12个月的期间，以确定干预是否会影响避免 牙科程序。进一步的分析将检查遇险耐受性和疼痛的基线水平是否 敏感性适应基于Internet的干预措施在减少提供商牙科动画方面的效率。