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临床试验/NCT03012035
NCT03012035已完成不适用

The Role of Treatment Expectation in Exposure Training With Spider Fearful Participants

University Hospital, Basel, Switzerland2 个研究点 分布在 1 个国家目标入组 70 人开始时间: 2017年5月18日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
70
试验地点
2
主要终点
Change in subjective anxiety assessed by questionnaire

研究概览

简要总结

This study evaluates the role of treatment success expectation in spider fearful individuals on the actual treatment success. Half of participants will have positive treatment success expectations, while the other half will have neutral treatment outcome expectations.

详细描述

The investigator plan to conduct a randomized, single blind study with two parallel groups. Both groups undergo the same standardized psychotherapeutic intervention, i.e. exposure training. All participants will receive the same exposure training in groups of maximum three participants of the same study group. The two study groups only differ regarding the induced treatment expectations towards the effects of the exposure training. While the experimental group will get an open administration of treatment and be informed in order to have a positive treatment expectation, the comparator group will receive a hidden administration of treatment and get neutral information, thus treatment expectations will be neutral. Study members conducting the exposure training with the participants will not be aware of the allocation of the study participants. Study participants will be informed about the aim of the allocated condition, but they will be blind to the aim of the study in order to induce the specific expectation. Differences in treatment outcomes are compared between both groups to investigate the association with treatment expectation.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Other
盲法
Single (Outcomes Assessor)

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

  • good knowledge of German language
  • fulfilling criteria A-E and G for specific phobia according to Diagnostic and Statistical Manual of Mental Disorders (DSM)-V (fulfilling criteria F is not an inclusion criteria)
  • marked fear or anxiety about spiders
  • spiders almost always provoke immediate fear or anxiety
  • spiders are actively avoided or endured with intense fear or anxiety
  • the fear or anxiety is out of proportion to the actual danger posed by spiders
  • the fear, anxiety, or avoidance is persistent, typically lasting for 6 months or more
  • the disturbance is not better explained by the symptoms of mental disorders as agoraphobia, obsessive-compulsive disorder, posttraumatic stress disorder, separation anxiety or social anxiety disorder

排除标准

  • acute or chronic psychiatric disorder
  • currently in psychological or psychiatric treatment
  • knowledge of exposure training

研究组 & 干预措施

experimental group

Experimental

Before participants undergo the exposure training their expectation of treatment efficacy is manipulated with different information regarding the following treatment. The experimental group will get positive treatment expectations induced with the accurate information, that exposure training refers to the gold standard in psychotherapy to reduce spider fear (= open administration of treatment).

干预措施: positive treatment expectations (Other)

comparator group

Other

The comparator group will get neutral expectations regarding treatment outcome. To induce neutral treatment expectations about the following exposure training, it is necessary to tell them they are in the comparator group and that they will receive a comparator condition exposure training for diagnostic purposes only (= hidden administration of treatment).

干预措施: neutral treatment expectations (Other)

结局指标

主要结局

Change in subjective anxiety assessed by questionnaire

时间窗: Baseline, Pre exposition, Post exposition, Recovery; time between baseline and recovery approximately lasts 21 days

assessment of change in subjective anxiety by questionnaire at selcted time points

次要结局

未报告次要终点

研究者

发起方
University Hospital, Basel, Switzerland
申办方类型
Other
责任方
Sponsor

研究点 (2)

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