Large-group One-session Exposure Therapy Protocol for Targeting Anxiety Sensitivity
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 399
- 试验地点
- 17
- 主要终点
- Anxiety Sensitivity
研究概览
简要总结
The current study seeks to test differences between a single-session large-group format of standard exposure, enhanced exposure, and a control condition in treating anxiety sensitivity. It is hypothesized that 1) participants assigned to either exposure condition will evidence greater reductions in anxiety sensitivity from pre-treatment to posttreatment relative to those in the control condition; 2) participants assigned to the enhanced exposure condition will evidence greater reductions in anxiety sensitivity from pre-treatment to posttreatment relative to those in the standard exposure condition. The investigators will test putative moderators and mechanisms of action. Prior to initiating the study for purposes of data analyses, the investigators will pilot study procedures during Spring 2020.
详细描述
Anxiety sensitivity (AS), or the fear of anxiety and related sensations, represents an individual difference variable implicated in the risk and maintenance of anxiety and related disorders. Best conceptualized as an amplification factor, AS, when elevated, interacts with changes in bodily sensations (e.g., racing heart, sweating, dizziness) to produce fear. Exposure therapy involves repeated confrontation to feared cues to help individuals reestablish a sense of safety around these cues. Exposure therapy is a transdiagnostic treatment strategy that has shown to be efficacious across anxiety and related disorders. Symptom induction exercises (e.g., spinning, voluntary hyperventilation, straw breathing, using a tongue depressor) are useful for providing exposure to benign bodily sensations (e.g., dizziness, racing heart, breathlessness, choking), allowing individuals with elevated AS to learn that, while perhaps uncomfortable, these sensations are not harmful, but safe.
In an effort to increase the access to exposure therapy, Margraf and colleagues developed a large-group one-session exposure therapy protocols involving brief psychoeducation followed by either observation or participation in exposure practice for fears of various cues, including spiders, dental procedures, and blood, injuries and injections. Initial testing indicates feasibility and shows that individuals participating in these protocols evidence significant improvement in anxiety symptoms.
The current study involves the development and testing of a large-group one-session exposure therapy protocol designed to target AS. The investigators will compare two variants of the protocol and include a general stress reduction protocol as a control condition (CONTROL). The first variant (STANDARD) is a standard protocol, modeled after those developed by Margraf and colleagues, that includes a combination of psychoeducation (about the nature and [exposure] therapy of anxiety sensitivity) and interoceptive exposure therapy modeling and practice. The second variant (ENHANCED) is identical to the first but also includes post-exposure practice processing aimed at facilitating threat reappraisal (i.e., safety learning). All interventions will be delivered in large-group format (N ≥ 25 participants) by a team of clinicians (N = 3) trained in the delivery of exposure therapy. In an effort to improve the quality of research on exposure therapy, another central aim of this study is to examine the feasibility of an exposure therapy consortium. The investigators have established a network of research sites (N=11) with expertise in exposure therapy. With UT as the coordinating site, the investigators propose to implement the study protocol at each of these sites, allowing us to obtain the data needed to examine replication and the identification of predictors, moderators and mediators of treatment effects.
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 70 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Ages 18-70
- •Students currently enrolled in enrolled in an introductory psychology course a psychology course
- •Elevated anxiety sensitivity (total ASI-3 score ≥ 23)
排除标准
- •History of respiratory or cardiovascular conditions (e.g., asthma, high blood pressure), neurological disorders (e.g., epilepsy), current pregnancy, or medical problems (e.g., inner ear problems, back or joint problems) that may interfere with an ability complete interoceptive exposure procedures
结局指标
主要结局
Anxiety Sensitivity
时间窗: 1 day
The primary outcome is Anxiety Sensitivity at the posttreatment endpoint. Anxiety Sensitivity will be measured with the Anxiety Sensitivity Index-3 scale (ASI-3; 0-72, lower scores mean better outcome).
次要结局
- Change in Anxiety Sensitivity(1 month)
- Depression(1 month)
- Anxiety(1 month)
研究者
Jasper A. Smits
Principal Investigator
University of Texas at Austin
