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临床试验/NCT03925987
NCT03925987已完成不适用

Predicting Treatment Response to Exposure Therapy Using a CO2 Habituation Paradigm in Patients With High Levels of Anxiety Sensitivity

Laureate Institute for Brain Research, Inc.1 个研究点 分布在 1 个国家目标入组 70 人开始时间: 2018年6月7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
入组人数
70
试验地点
1
主要终点
Between-session habituation of self-reported anxiety

研究概览

简要总结

Anxiety disorders affect over a quarter of the population, yet very little is known about the variables that predict treatment outcome. The planned study explores whether a patient's response to a physiological test involving inhalation of carbon dioxide predicts their response to exposure therapy.

详细描述

Anxiety Sensitivity (AS) refers to an individual's fear of experiencing anxiety-related symptoms (e.g., dyspnea or heart palpitations) and is a core construct underlying the initiation and maintenance of pathological anxiety. Recent evidence suggests that reducing AS may be critical for the prevention and treatment of anxiety across diagnostic categories. Exposure therapy, an important component of cognitive behavioral therapy (CBT), is one of the most effective treatments for reducing AS, and has been shown to improve symptoms across a number of different anxiety disorders. Meta-analyses reveal an approximately 50% treatment response rate, with the remaining half of patients showing either no response or dropping out of treatment early. Unfortunately, there is a paucity of research exploring which variables predict treatment outcome and there are currently no tests for predicting which patients would benefit the most from exposure therapy. In this study, participants will complete two sessions of a carbon dioxide (CO2) habituation paradigm, a safe and noninvasive physiological test that entails repeated exposures to single vital capacity inhalations of 20% CO2. Both CO2 testing sessions will be completed within a 72-hour time period. Patients then complete a 10-week group-based exposure therapy to determine whether an individual's degree of habituation to CO2 predicts treatment outcome.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Basic Science
盲法
None

入排标准

年龄范围
18 Years 至 55 Years(Adult)
性别
All
接受健康志愿者
是

入选标准

  • •DSM-V diagnosis of an Anxiety disorder (Generalized Anxiety Disorder, Social Anxiety Disorder, Panic Disorder, Agoraphobia)
  • •Anxiety Sensitivity Index (ASI-3) total score > 29
  • •Overall Anxiety Severity and Impairment Scale (OASIS) score > 8
  • •Between 18-55 years of age
  • •Subject must be "treatment-seeking" and willing to enroll in the 10-week group-based Exposure Therapy

排除标准

  • •Comorbid Bipolar Disorder, Schizophrenia, Anorexia or Bulimia Nervosa, or Obsessive-Compulsive Disorder
  • •Current Substance Use Disorder > moderate (within the past 6 months)
  • •Currently taking a psychotropic medication
  • •Currently receiving psychotherapy/counseling for anxiety
  • •Currently being treated as an inpatient
  • •Active suicidal ideation with intent or plan
  • •History of neurological, cardiovascular or respiratory problems (e.g., asthma, severe brain injury)

研究组 & 干预措施

Exposure therapy

Experimental

Participants complete 10 weekly sessions of a group-based exposure therapy class for anxiety disorders.

干预措施: Exposure therapy (Behavioral)

结局指标

主要结局

Between-session habituation of self-reported anxiety

时间窗: Across two days of CO2 testing within a 72-hour window

Maximum anxiety rating on a 10-point rating dial (0=no anxiety to 10=most anxiety ever) during day 1 of CO2 testing minus the maximum anxiety rating during day 2 of CO2 testing

次要结局

  • Between-session habituation of self-reported dyspnea(Across two days of CO2 testing within a 72-hour window)
  • Between-session reduction in avoidance behavior(Across two days of CO2 testing within a 72-hour window)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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