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临床试验/NCT02085343
NCT02085343Unknown不适用

Anti-phobic and Safety Behaviors in the Treatment of Acrophobia

University of Texas at Austin2 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2013年2月最近更新:
适应症
干预措施

试验速览

阶段
不适用
入组人数
100
试验地点
2
主要终点
Peak subjective fear (0 - 100) upon exposure to heights in the generalization context.

研究概览

简要总结

This study tests whether a single session of exposure therapy may be enhanced by the addition of anti-phobic actions beyond the mere fading of safety behaviors. A total of 100 acrophobic participants will be randomly assigned to receive standard exposure therapy (EXP), exposure therapy with safety behavior fading (EXP + SBF), exposure with safety behavior fading and anti-phobic actions (EXP + SBF + AA), or to a wait-list control group (WL).

详细描述

This study tests whether a single session of exposure therapy may be enhanced by the addition of one of two augmentation strategies, including engagement in anti-phobic actions and fading of safety behaviors. Because utilization of safety behaviors is functionally precluded by anti-phobic action, the present study design will both replicate and extend prior research by addressing whether anti-phobic actions enhance exposure therapy beyond the mere fading of safety behaviors. A total of 100 individuals between the ages of 18 and 65 meeting DSM-IV criteria for acrophobia (fear of heights) will be randomly assigned to one of four conditions including (1) standard exposure therapy, (2) exposure therapy with safety behavior fading, (3) exposure therapy with safety behavior fading and anti-phobic actions, and (4) a wait-list control condition. All participants will complete an online prescreen and face-to-face screening assessment to determine eligibility and pre-treatment symptom severity. Participants will also complete assessments at post-treatment and 1-month follow-up assessments. Subjective fear during two behavioral approach tests (in the treatment and generalization context, respectively) conducted at pre-treatment, post-treatment, and 1-month follow-up assessments will serve as the primary measure of treatment outcome. Additionally, a battery of self-report questionnaires will be completed at pre-treatment, during treatment, at post-treatment, and at a 1-month follow-up assessment.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Factorial
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

  • Fluent in English (written and spoken). This is required because assessment instruments are validated only in English.
  • Meet DSM-IV criteria for specific phobia, natural environment type, with acrophobic concerns, based on the Composite International Diagnostic Interview (CIDI-Auto; World Health Organization, 1997).
  • Report moderate fear or avoidance (i.e., a score of 30 or higher) on a modified version of the Acrophobia Questionnaire (AQ; Cohen, 1977).
  • Exhibit at least moderate fear (i.e., a fear score of 50 or higher, where 0 = no fear and 100 = extreme fear) during two behavioral approach tests (BATs) consisting of ascending two moderately challenging flights of stairs.

排除标准

  • Medical condition(s) which may prevent safely climbing or descending stairs or walking for more than 15 minutes at a time (It will be necessary to walk to different sites for the behavioral approach tests).

研究组 & 干预措施

EXP + SBF + AA

Experimental

Exposure therapy (EXP) with safety behavior fading (SBF) and anti-phobic action (AA)

干预措施: EXP (Behavioral)

EXP + SBF + AA

Experimental

Exposure therapy (EXP) with safety behavior fading (SBF) and anti-phobic action (AA)

干预措施: EXP + SBF (Behavioral)

EXP + SBF + AA

Experimental

Exposure therapy (EXP) with safety behavior fading (SBF) and anti-phobic action (AA)

干预措施: EXP + SBF + AA (Behavioral)

EXP + SBF

Active Comparator

Exposure therapy (EXP) with safety behavior fading (SBF)

干预措施: EXP (Behavioral)

EXP + SBF

Active Comparator

Exposure therapy (EXP) with safety behavior fading (SBF)

干预措施: EXP + SBF (Behavioral)

EXP

Active Comparator

Standard therapist-guided in vivo exposure therapy (EXP)

干预措施: EXP (Behavioral)

Wait-list control

No Intervention

Subjects assigned to this arm will undergo assessments at Weeks 0, Week 1, and Week 5, but will not receive any interventions.

结局指标

主要结局

Peak subjective fear (0 - 100) upon exposure to heights in the generalization context.

时间窗: Pre-treatment (1 week before treatment), treatment (1 week after pre-treatment), post-treatment (immediately following treatment), and follow-up (1 month after treatment).

Peak subjective fear ratings (0 - 100).

次要结局

  • Acrophobia Questionnaire - Modified (Cohen, 1977; Wolitzky & Telch, 2009)(Pre-treatment (1 week before treatment), treatment (1 week after pre-treatment), post-treatment (immediately following treatment), and follow-up (1 month after treatment).)
  • Height estimation task(Pre-treatment (1 week before treatment), treatment (1 week after pre-treatment), post-treatment (immediately following treatment), and follow-up (1 month after treatment).)
  • Heart rate(Pre-treatment (1 week before treatment), treatment (1 week after pre-treatment), post-treatment (immediately following treatment), and follow-up (1 month after treatment).)
  • Treatment Process Questionnaire(Treatment (1 week following pre-treatment assessment))

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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