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临床试验/NCT03098134
NCT03098134Unknown2 期

The Efficacy of a VR Enhanced Video Exposure Therapy for Dental Phobia - a Randomized Controlled Trial

Ruhr University of Bochum0 个研究点目标入组 100 人开始时间: 2017年4月1日最近更新:
适应症
干预措施

试验速览

阶段
2 期
发起方
入组人数
100
主要终点
Change in Subjective Dental Anxiety

研究概览

简要总结

Evaluation of a one session VR - enhanced Video exposure therapy for dental phobia. Diagnosed dental phobics will be randomly assigned to one of two conditions: (1) Psychoeducation + VR exposure (2) Psychoeducation + Video Control treatment. Prior to getting the therapy, participants will be evaluated with a questionnaire battery, diagnosed with a structured clinical interview and will participate in a psychophysiological symptom assessment. Then, after a 2-week waiting period, participants again fill in questionnaires, and the Intervention will take place. Within 2-weeks after the second questionnaire assessment participants will be screened with the structured interview again and will fill in questionnaires.

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
否

入选标准

  • •diagnosed Specific Dental Phobia

排除标准

  • •Schizophrenia or other Psychotic Illnesses
  • •Bipolar Disorder
  • •Chronic Headache
  • •other neurological disorders such as epilepsy
  • •Hearing problems

研究组 & 干预措施

VR-Video-Exposure

Experimental

干预措施: Behavior Therapy (Behavioral)

Education-Video-

Active Comparator

干预措施: Health Education (Other)

结局指标

主要结局

Change in Subjective Dental Anxiety

时间窗: 4 month

Assessed at time 0 (at inclusion) 1 (pre therapy, two weeks after inclusion), 2(post therapy, 2 weeks after time 1) and at follow up (4 month after time 0) with Dental Anxiety Scale (DAS, 4-item scale, range 4-20)

Change in Dysfunctional Dental Cognitions

时间窗: 4 months

Assessed with Dental Cognition Questionnaire (DCQ, 38 dichotomous items, range 0-38) Assessed at time 0 (at inclusion), time 1 (pre therapy, two weeks after time 0), time 2 (post therapy, 2 weeks after time 1) and at follow up (4 month after time 0)

次要结局

  • Change in Psychophysiological defensive reactivity(4 weeks)

研究者

发起方
Ruhr University of Bochum
申办方类型
Other
责任方
Principal Investigator
主要研究者

Dirk Adolph

Head of Clinical Psychophysiology Lab

Ruhr University of Bochum

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