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临床试验/NCT03461016
NCT03461016已完成不适用

Randomized Clinical Trial of Smartphone-Based Exposure of Dental Anxiety

West Virginia University2 个研究点 分布在 1 个国家目标入组 37 人开始时间: 2016年4月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
37
试验地点
2
主要终点
Change in Dental Fear Survey (scale 20-item)

研究概览

简要总结

Exposure therapy, including its self-directed forms, is effective for treatment of specific phobias. Nevertheless, there are issues with patient adherence in the use of exposure therapy, including its self-directed formats. Technological advancements, as with smartphones, may improve adherence to self-directed exposure therapy, perhaps due to exposure stimuli being more readily accessible. Thus, there is a need to examine how presenting phobic material on a smartphone might promote increased adherence in conducting self-directed exposure. Additionally, exposure can incorporate phobic material from different perspectives (i.e., first-person or third-person), which is one factor that may impact treatment effectiveness. Participants will be randomly assigned to a treatment or control condition, and complete a pre-assessment and then a post-assessment two weeks later. The assessment consists of a multimodal approach (e.g., self-report, physiological response, and overt behavior). Participants in the treatment condition will be instructed to watch a standard exposure video of a dental examination and prophylaxis three times daily for two weeks. One week of videos was shown in a first-person perspective and the same video will be shown in a third-person perspective for one week. The study can demonstrate the potential utility of smartphone-based self-directed exposure therapy for specific phobia.

详细描述

  1. Recruitment efforts will be made in the community via advertisements and online advertisements (e.g., Craigslist, Facebook).

  2. Prospective participants will contact the investigators via email or by calling the study phone number listed on the advertisements.

  3. Once a participant indicates interest by contacting study personnel, a 5-minute screening interview will be conducted with the prospective participant using the screening questionnaire to ensure eligibility criteria are met. For those who do not qualify or agree to participate, the age and reason for non-qualification or declination to participate will be recorded; any other data will be destroyed by shredding or electronic shredding. For those who do qualify, name and contact information will be kept confidential and maintained in a locked room.

  4. After written agreement to enlist in the study, participants are randomly assigned to group (i.e., treatment or control) by previously prepared sealed opaque envelopes.

  5. Participants will complete the demographic questionnaire, the Dental Fear Survey, and the investigator will complete the specific phobia section of the ADIS-5 with the participant.

  6. Then a Behavioral Avoidance Task will be conducted with the participants

  7. One-minute baseline, in which the participant sat quietly.

  8. Then nine dental-related steps will be completed each lasted 30 seconds, and a SUDS rating was collected at each step.

  9. After completing the Behavioral Avoidance Task, the investigator provides a 15-minute demonstration to the participants.

  10. The control group watched a video on their smartphone about smartphone capabilities as an attention control.

  11. The treatment group was shown how to conduct self-directed exposure therapy and rate SUDS on their smartphone.

i. The video is a typical preventive visit to the dentist, including walking into the dental office, being called back for treatment by the dental assistant, sitting in the dental chair, and seeing the hygienist perform a teeth cleaning.

ii. The video is presented in a first and third person perspective, and the order is randomly assigned (e.g., view the first person perspective video during week 1 of treatment and then third person perspective during week 2 of treatment). 8. Researcher will model how to rate SUDS prior to watching the exposure video, how to access the exposure video, how to rate actual SUDS experienced during the video, and how to either continue to the next video or stop the exposure session.

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

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • fluency in the English language
  • being 18 years of age or older
  • own or have access to a smartphone
  • have an e-mail account

排除标准

  • Reporting a low level of discomfort with dental-related care (i.e., less than a rating of "somewhat" on a single-item dental fear question)

结局指标

主要结局

Change in Dental Fear Survey (scale 20-item)

时间窗: Change from Baseline to 14 days

Participant self-report of dental care-related fear and anxiety, range of 20-100

次要结局

  • Change in Subjective Units of Distress (scale 1-item)(Change from Baseline to 14 days)
  • Acceptability (scale 8-item)(14 days)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Daniel W. McNeil, PhD

Professor

West Virginia University

研究点 (2)

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