Efficacy of an Internet-based Intervention for Dental Anxiety
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 503
- 试验地点
- 2
- 主要终点
- Change in Modified Dental Anxiety Scale (MDAS; Humphris et al., 1995).
研究概览
简要总结
The overall objective of the activities described in this protocol is to examine the efficacy of the Internet-based intervention in the reduction of dental anxiety in patients seeking dental treatment. This study has 2 primary objectives and 2 secondary objectives:
Primary Objective 1-Therapy Aides: To compare the efficacy of the intervention as administered by personnel with training and experience in cognitive behavioral therapy (CBT) to the efficacy of the intervention as administered by dental staff who have undergone a brief but specific training in the administration of the intervention.
Primary Objective 2-Intervention Efficacy: To compare the efficacy of the intervention, administered by either type of therapy aide (CBT personnel or dental staff), to an active control condition.
Secondary Objective 1-Tests of Moderators: To examine whether baseline levels of distress tolerance and pain sensitivity moderate the efficacy of the dental anxiety intervention, regardless of therapy aide, in comparison to an active control condition.
Secondary Objective 2-Other Intervention Effects: To explore effects of the intervention beyond primary efficacy, including attendance at recall visits in the 12 months after the intervention; pain intensity; avoidance due to fear of dental procedures; and client satisfaction.
详细描述
This clinical trial 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 the clinics of a university dental school. The primary objective of human subjects activities described in this protocol is to evaluate the efficacy of the Internet-based intervention for dental anxiety among patients presenting to the participating clinic(s). To achieve this overall objective, 2 primary objectives and 2 secondary objectives have been proposed:
Primary Objective 1-Therapy Aides: To compare the efficacy of the intervention as administered by personnel with training and experience in cognitive behavioral therapy (CBT) to the efficacy of the intervention as administered by dental staff who have undergone a brief but specific training in the administration of the intervention. Efficacy will be indexed by measures of dental anxiety and fear completed at 1-month and 3-month follow-up assessments.
Primary Objective 2-Intervention Efficacy: To compare the efficacy of the intervention, administered by either type of therapy aide (CBT personnel or dental staff), to an active control condition. Efficacy will be indexed by measures of dental anxiety and fear completed at 1-month and 3-month follow-up assessments.
Secondary Objective 1-Tests of Moderators: To examine whether baseline levels of distress tolerance and pain sensitivity moderate the efficacy of the dental anxiety intervention, regardless of therapy aide, in comparison to an active control condition.
Secondary Objective 2-Other Intervention Effects: To explore effects of the intervention beyond primary efficacy, including attendance at recall visits in the 12 months after the intervention; pain intensity; avoidance due to fear of dental procedures; and client satisfaction.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
盲法说明
Given the obvious differences between those who will receive the Internet-based dental anxiety and those who will not (i.e., those who are assigned to the control condition), we will not be able to blind patients to this aspect of randomization. Patients will not be informed about the professional affiliation of therapy aides, who will dress similarly (e.g., professional dress and a lab coat) and who will be instructed not to respond to questions related to this topic.
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patient endorses high dental anxiety (a score of 19 or a score of 4-5 on at least 2 of the 5 items) on the MDAS
- •endorses at least mild impairment as a result of that anxiety at the baseline interview as indexed by the appropriate rating in the specific phobia module of the ADIS-5
- •be between 18 and 75 years of age
- •be sufficiently fluent in written and spoken English in the judgment of project staff that the patient would be able to benefit from the intervention and validly complete the assessments.
排除标准
- •a self-reported current medical condition (e.g., cardiopulmonary disease, seizure disorder) that might make exposure to anxiety-evoking stimuli inadvisable
- •current suicidal/homicidal ideation/intent or other condition that would take priority over an intervention focused on dental anxiety
- •current psychosis, mental retardation, or other condition that would significantly diminish the patient's ability to adequately focus attention adaptively on the current protocol
- •inability to give informed consent.
结局指标
主要结局
Change in Modified Dental Anxiety Scale (MDAS; Humphris et al., 1995).
时间窗: The MDAS will be administered at the baseline assessment and at one- and three-month follow-ups.
The MDAS is a widely used 5-item measure assessing fear of dental procedures, including cleaning, drilling, and local anesthetic injections; for example, "If you were about to have your tooth drilled, how would you feel?" Items are rated on a 5-point Likert-type scale ranging from 1 (not anxious) to 5 (extremely anxious). The total score ranges from 5 to 25; a score of 19 or above indicates high anxiety based on receiver operating characteristic analyses from previous studies.
Change in Rating of Dental Fear From Anxiety and Related Disorders Interview Schedule for Diagnostic and Statistical Manual -5 (DSM-5) - Adult Version (ADIS-5- Brown & Barlow, 2014)
时间窗: The ADIS-5 will be administered at the baseline assessment and at one- and three-month follow-ups.
The ADIS-5 is a semi-structured interview designed to establish reliable diagnoses of the DSM-5 anxiety, mood, somatoform, and substance use disorders. To minimize participant burden, this study will utilize only the dental procedure-related section of the specific phobia module of the interview. This module includes ratings of fear and avoidance of dental procedures (0 = No fear/Never avoids to 8 = Very severe fear always avoids) as well as resultant interference (0 = None to 8 = Very severe; the latter being used to operationalize one of the inclusion criteria). For the dental phobia diagnosis, a dimensional clinical severity rating (CSR), ranging from 0 = none to 8 = very severely disturbing/disabling, will be assigned, with scores of 4 or above denoting clinical significance. All interviews will be audio-recorded. The 0-8 rating of dental fear will serve as the primary measure derived from the ADIS-5.
次要结局
- Change in Attendance at Dental Appointments(1 year post-dental anxiety intervention)
- Distress Tolerance Scale (DTS; Simons & Gaher, 2005).(The DTS will be administered at the baseline assessment and at one- and three-month follow-ups)
- Fear Questionnaire Blood-Injury-Injection Subscale (FQ-BII; Marks & Mathews, 1979).(It will be administered at the baseline assessment and at one- and three-month follow-ups.)
- Pain Intensity Numeric Rating Scale (PI-NRS).(These ratings will be administered as part of the post-appointment debriefing interview, as well as at the 1-month and 3-month follow-ups.)
- Distress Tolerance Scale (DTS; Simons & Gaher, 2005).(The DTS will be administered at the baseline assessment and at one- and three-month follow-ups)
- Change in Distress and Interference Rating From the ADIS-5(baseline assessment, and at one- and three-month follow-ups.)
- Change in Percentage of Dentally Phobic Patients From the ADIS-5(baseline assessment, and at one- and three-month follow-ups.)
- Change in Attendance at Dental Appointments(1 year post-dental anxiety intervention)
- Change in Avoidance Rating From the ADIS-5(baseline assessment, and at one- and three-month follow-ups.)
- Pain Sensitivity Index (PSI; Gross, 1992a).(It will be administered at baseline and the 1-month and 3-month follow-ups.)
- Fear Questionnaire Blood-Injury-Injection Subscale (FQ-BII; Marks & Mathews, 1979).(It will be administered at the baseline assessment and at one- and three-month follow-ups.)
- Client Satisfaction Questionnaire (CSQ-8; Larsen et al., 1979).(The CSQ-8 will be administered post-intervention (within 48 hours after the participant's dental appointment), as well as at the one- and three-month follow-ups.)