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临床试验/NCT04470882
NCT04470882已完成不适用

Use of Safety Behaviors in Exposure Therapy for Arachnophobia

University of Nevada, Reno2 个研究点 分布在 1 个国家目标入组 59 人开始时间: 2019年2月28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
59
试验地点
2
主要终点
Behavioral approach test (generalization context) - subjective outcome

研究概览

简要总结

This study examines the impact of safety behaviors (i.e., unnecessary protective actions) on outcomes of exposure therapy for spider phobia. Researchers will compare exposure therapy with (a) no safety behaviors, (b) safety behaviors faded toward the end of treatment, and (c) unfaded safety behaviors.

详细描述

Some studies suggest that safety behaviors might undermine the efficacy of exposure therapy (Powers et al., 2010), whereas other studies suggest that there is no difference in exposure therapy outcomes whether or not safety behaviors are used (Deacon et al., 2010). Mixed findings could be explained by the parameters of safety behaviors use, such as whether they are used throughout the full course of therapy or faded toward the end of therapy. This will be the first study to directly compare the impact of faded and unfaded safety behaviors on exposure therapy outcomes. Specifically, researchers will randomize participants with a fear of spiders to receive exposure therapy (a) without safety behavior use, (b) with faded safety behavior use, and (c) with un-faded safety behavior use. Researchers will compare each condition's impact on fear reduction and on the tolerability/acceptability of treatment.

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

  • Fluent in English
  • Displays sufficiently high fear of spiders, as indicated by responses on (a) a self report questionnaire (the Fear of Spiders Questionnaire) at prescreening, and (b) Behavioral Avoidance Tests at baseline

排除标准

  • younger than 18 years old

结局指标

主要结局

Behavioral approach test (generalization context) - subjective outcome

时间窗: Change from baseline up to 4 weeks later (through follow up assessment)

Participants will approach a live, non-poisonous tarantula, placed in a clear tank on a table, at the opposite end of the room. The test is over when the participant has reached the hardest step that they can complete at that time. Steps include walking toward the spider and lowering one hand into the tank. During this BAT, investigators will assess fear response subjectively by having participants self report their peak fear level (on a 0 to 100 scale).

Behavioral approach test (generalization context) - physiological outcome

时间窗: Change from baseline up to 4 weeks later (through follow up assessment)

Participants will approach a live, non-poisonous tarantula, placed in a clear tank on a table, at the opposite end of the room. The test is over when the participant has reached the hardest step that they can complete at that time. Steps include walking toward the spider and lowering one hand into the tank. During this BAT, investigators will assess fear response physiologically by assessing heart rate variability.

Behavioral approach test (treatment context) - subjective outcome

时间窗: Change from baseline up to 4 weeks later (through follow up assessment)

Participants will approach a live, non-poisonous tarantula, placed on the floor, at the opposite end of the room. The participant will walk toward the spider during this test. The test is over when the participant has reached the hardest step that they can complete at that time. During this BAT, investigators will assess fear response subjectively by having participants self report their peak fear level (on a 0 to 100 scale).

Fear of Spiders Questionnaire (FSQ)

时间窗: Change from baseline up to 4 weeks later (through follow up assessment)

Self-report rating scale in which participants rate the extent that they agree with a number of statements that are representative of having a fear of spiders. Sum total scores will be calculated (range 0-108). Higher scores indicate more severe symptom levels.

Armfield and Mattiske Disgust Questionnaire (AMDQ)

时间窗: Change from baseline up to 4 weeks later (through follow up assessment)

Self-report questionnaire assessing feelings of disgust associated with spiders. Sum total scores will be calculated (range 0-48). Higher scores indicate more severe spider-related disgust.

Spider Phobia Beliefs Questionnaire (SBQ)

时间窗: Change from baseline up to 4 weeks later (through follow up assessment)

Self-report rating scale assessing the level to which the participant believes a number of cognitions/thoughts commonly associated with spider phobia. An overall average rating will be calculated (range 0-100). Higher average scores indicate greater belief in spider phobic cognitions.

Behavioral approach test (treatment context) - behavioral outcome

时间窗: Change from baseline up to 4 weeks later (through follow up assessment)

Participants will approach a live, non-poisonous tarantula, placed on the floor, at the opposite end of the room. The participant will walk toward the spider during this test. The test is over when the participant has reached the hardest step that they can complete at that time. During this BAT, investigators will assess fear response behaviorally by recording the most challenging step completed (range, steps 0 -12).

Behavioral approach test (treatment context) - physiological outcome

时间窗: Change from baseline up to 4 weeks later (through follow up assessment)

Participants will approach a live, non-poisonous tarantula, placed on the floor, at the opposite end of the room. The participant will walk toward the spider during this test. The test is over when the participant has reached the hardest step that they can complete at that time. During this BAT, investigators will assess fear response physiologically by assessing heart rate variability.

Behavioral approach test (generalization context) - behavioral outcome

时间窗: Change from baseline up to 4 weeks later (through follow up assessment)

Participants will approach a live, non-poisonous tarantula, placed in a clear tank on a table, at the opposite end of the room. The test is over when the participant has reached the hardest step that they can complete at that time. Steps include walking toward the spider and lowering one hand into the tank. During this BAT, investigators will assess fear response behaviorally by recording the most challenging step completed (range, steps 0-21).

Anxiety Disorders Interview Schedule for DSM-5 (ADIS-5)

时间窗: Change from baseline up to 4 weeks later (through follow up assessment)

Participants will be given a structured interview to identify whether they meet diagnostic criteria for specific phobia. Responses will be coded dichotomously (yes = has diagnosis; no = no diagnosis).

次要结局

  • Treatment Acceptability/Adherence Scale (Modified version)(Measured immediately after completing a one-session treatment)

研究者

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

Cynthia Lancaster

Assistant Professor, Clinical Psychology

University of Nevada, Reno

研究点 (2)

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