跳至主要内容
临床试验/NCT04259190
NCT04259190撤回不适用

Does a Values Rationale Increase Willingness to Tolerate Distress in Interoceptive Exposure: Examination of a One-Session Randomized Clinical Trial

Gina Boullion2 个研究点 分布在 1 个国家开始时间: 2022年6月1日最近更新:
适应症

试验速览

阶段
不适用
状态
撤回
发起方
试验地点
2
主要终点
Willingness to tolerate distress

研究概览

简要总结

The purpose of the current study is to examine the effect of emphasizing values in the treatment rationale on treatment response, willingness to tolerate distress, and acceptability of a one-session interoceptive exposure intervention for the reduction of anxiety sensitivity. A standard treatment rationale without values emphasis will serve as a control.

详细描述

Cognitive behavioral models of panic disorder maintain that recurrent, unexpected panic attacks result from anxiety sensitivity, or the fear of anxiety-related physiological sensations (e.g., fear of increased heart rate) and catastrophic misinterpretations regarding the danger of those sensations (e.g., misinterpreting increased heart rate as an oncoming heart attack). From these models and subsequent clinical research, interoceptive exposure has emerged as the most efficacious component of cognitive behavioral therapy for panic disorder treatment and, as expected, an efficacious intervention for decreasing anxiety sensitivity. Nevertheless, small-to-moderate effect sizes, wide variability in response rates and dropout rates indicated that panic disorder treatments may benefit from modifications to improve upon retention, response rates, and symptom reduction.

Patient motivation and lack of engagement have been identified as factors to intervene upon. Numerous therapeutic techniques have been used to facilitate patient motivation in treatment; however, one specific direction that has gained increasing empirical interest is the inclusion of values identification. Values have been incorporated as a motivational component in empirically supported behavioral techniques and treatments, including Motivational Interviewing, Behavioral Activation Treatment for Depression packages, and Acceptance and Commitment Therapy. Evidence from randomized controlled trials have generally supported the inclusion of packages containing values components in facilitating exposure therapy, and preliminary evidence has specifically favored the inclusion of packages containing values components in exposure therapy in cognitive behavioral therapy for panic disorder. However, there is no research known by the author that examines the influence of values on motivation in interoceptive exposure. Therefore, research examining the effect of a values component in isolation motivation in and acceptability of interoceptive exposure exercises has the potential to further improve treatment efficacy reducing costs associated with panic disorder and the many other conditions treated by interoceptive exposure. Therefore, the purpose of the current study is to examine the effect of emphasizing values in the treatment rationale on treatment response, willingness to tolerate distress, and acceptability of a one-session interoceptive exposure intervention among a clinical analogue sample with elevated anxiety sensitivity.

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

  • Score ≥ 23 on the Anxiety Sensitivity Index - 3 (ASI-3)

排除标准

  • Hypertension
  • Heart problems
  • Current pregnancy
  • Other health conditions exacerbated by intense exercise

结局指标

主要结局

Willingness to tolerate distress

时间窗: change from pre-intervention to immediately post-intervention

Willingness to tolerate distress will be assessed by identifying the activity item on the Albany Panic and Phobia Questionnaire (APPQ) - Agoraphobia subscale to which the participant responded with the highest score indicating most fear. The participant will then be asked, "How willing would you be to do \[most feared activity\] next week?" Responses will range from 0% to 100%.

次要结局

  • Straw breathing BAT peak fear ratings(pre-intervention)
  • Overbreathing BAT peak fear ratings(immediately post-intervention)
  • Anxiety Sensitivity Index - 3 (ASI-3)(change from pre-intervention to immediately post-intervention)
  • Albany Panic and Phobia Questionnaire (APPQ)(change from pre-intervention to immediately post-intervention)
  • Between trial tolerability ratings(change from pre-intervention to immediately post-intervention)
  • Between trial fear ratings(change from pre-intervention to immediately post-intervention)
  • Treatment Acceptability Questionnaire(immediately post-intervention)

研究者

发起方
Gina Boullion
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Gina Boullion

Doctoral Candidate

University of Mississippi, Oxford

研究点 (2)

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