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临床试验/NCT02905279
NCT02905279终止不适用

Enhancing Exposure Therapy for Spider Phobia With the Use of Threat-Relevant and Threat-Irrelevant Opposite Actions

University of Texas at Austin2 个研究点 分布在 1 个国家目标入组 44 人开始时间: 2016年6月1日最近更新:
适应症

试验速览

阶段
不适用
状态
终止
入组人数
44
试验地点
2
主要终点
Change in Performance on a Behavioral Approach Test in a Generalization Context (Pre-treatment to 2-week Follow-Up)

研究概览

简要总结

This study tests the effectiveness of exposure therapy for fear of spiders as enhanced by the use of antagonistic or opposite actions during treatment. The goal of the study is to compare the efficacy threat-relevant opposite actions and threat-irrelevant opposite actions in extinguishing fear.

详细描述

This study tests whether exposure therapy for fear of spiders can be enhanced with the use of opposite actions, which are actions opposite to fear-related action tendencies. The investigators will test two sub-types of opposite actions (a) threat-relevant opposite actions, which are actions antagonistic to specific threats associated with spider phobia, and (b) threat-irrelevant opposite actions, which are actions antagonistic to the fear response, but unrelated to specific threats associated with spider phobia. This exposure therapy enhanced with opposite actions will be compared with two control groups: standard exposure therapy and non-specific anxiety treatment (biofeedback relaxation training).

Individuals between the ages of 18-65 with elevated fear of spiders are randomly assigned to one of four treatment conditions (1) biofeedback relaxation training, (2) standard exposure therapy, (3) exposure therapy with threat-relevant opposite actions, and (4) exposure therapy with threat-irrelevant opposite actions. All participants undergo an online prescreen and a face-to-face screening assessment to determine eligibility and baseline (pre-treatment) symptom severity. Participants additionally complete assessments directly after treatment (post-treatment), and approximately two weeks after treatment (follow-up). The pre-treatment assessment occurs on the same day as treatment, the post-treatment assessment occurs during the treatment visit as soon as the treatment procedure is complete, and the follow-up assessment occurs within a window of 14-21 days after the completion of treatment. Participants complete two behavioral approach tests (in the treatment context and in the generalization context) at pre-treatment, post-treatment, and follow-up. Participants complete a battery of self-report questionnaires at pre-treatment and follow-up.

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 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • At Prescreen:
  • Total score of greater than or equal to 70 on the Fear of Spiders - Questionnaire (with higher scores indicating higher fear levels).
  • Indicates ongoing fear of spiders and inability to complete close approach towards spiders on brief questionnaire.
  • At Screening visit: inability to complete close approach toward spiders as determined by the treatment context and generalization context Behavioral Approach Tests

排除标准

  • Currently receiving psychotherapy for spider phobia

结局指标

主要结局

Change in Performance on a Behavioral Approach Test in a Generalization Context (Pre-treatment to 2-week Follow-Up)

时间窗: Change from pre-treatment (same day as treatment) to follow-up (window of 14-21 days after treatment)

Change in peak subjective fear (0 - 100 scale), behavioral approach (0 - 13 scale), and physiological reactivity (heart rate and skin conductance) to a live spider not used during treatment (generalization context) from pre-treatment to follow-up

次要结局

  • Change in Spider Belief Questionnaire from pre-treatment to follow-up (Pre-treatment to 2-Week Follow-Up)(Change from pre-treatment (same day as treatment) to follow-up (window of 14-21 days after treatment))
  • Change in Performance on a Behavioral Approach Test in a Generalization Context (Pre-treatment to Post-treatment)(Change from pre-treatment (same day as treatment) to post-treatment (within 30 minutes of completion of the treatment procedure))
  • Change in Performance on a Behavioral Approach Test in the Treatment Context (Pre-treatment to Post-treatment)(Change from pre-treatment (same day as treatment) to post-treatment (within 30 minutes of completion of the treatment procedure))
  • Change in Performance on a Behavioral Approach Test in the Treatment Context (Pre-treatment to 2-week Follow-Up)(Change from pre-treatment (same day as treatment) to follow-up (window of 14-21 days after treatment))
  • Change in Fear of Spiders Questionnaire (Pre-treatment to 2-week Follow-Up)(Change from pre-treatment (same day as treatment) to follow-up (window of 14-21 days after treatment))
  • Change in Armfield and Mattiske Disgust Questionnaire (Pre-treatment to 2-week Follow-Up)(Change from pre-treatment (same day as treatment) to follow-up (window of 14-21 days after treatment))

研究者

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

Michael J. Telch

Professor

University of Texas at Austin

研究点 (2)

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