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临床试验/NCT02826096
NCT02826096已完成不适用

A Brief Version of Biofeedback Therapy for Panic Disorder

National Taiwan University Hospital2 个研究点 分布在 1 个国家目标入组 34 人开始时间: 2015年12月21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
34
试验地点
2
主要终点
Changes from baseline Panic Disorder Severity Scale (PDSS)

研究概览

简要总结

The study is to examine the therapeutic effect of a brief version of biofeedback therapy (developed bu the research team) on panic disorder. It is a randomized controlled design. The severity of panic symptoms of two groups of panic patients (reveiving biofeedback therapy or not) were measured before and after the six week duration. Besides, the severity of anxiety, depressive, somatic symptoms, and physiological indexes were recorded.

详细描述

The purpose of this study is trying to find out whether our newly developed brief version of biofeedback is an effective treatment approach for panic disorder. At the same time, the investigators want to clarify the change of bio- and psycho- indices present through the process. Patient recently experienced panic attacks are recruited in this study. The diagnosis of "Panic Disorder" is made by psychiatrists according to The Diagnostic and Statistical Manual of Mental Disorders(DSM-5) criteria. Subjects are randomly assigned to medication group or biofeedback therapy. The biofeedback therapy is conducted by psychologists following the structure way. Every subject will be measured both the bio and psycho indices on week 0, 3, and 6 under 6-week observation. In the end of the study, the investigators hope to analyze and clarify the treatment effects of our design, and also to exam the meanings of these indices, in order to find out an effective treatment approach.

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
20 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

结局指标

主要结局

Changes from baseline Panic Disorder Severity Scale (PDSS)

时间窗: week 0, week 3, week 6

PDSS is a scale rating the severity of panic disorder. It is a 5-point Likert scale with 7 items. The scores range from 0 (lowest level of panic disorder) to 28 (highest level of panic disorder).

次要结局

  • Scores of Health Anxiety Questionnaire (HAQ)(week 0, week 3, week 6)
  • Penn State Worry Questionnaire (PSWQ)(week 0, week 3, week 6)
  • Scores of Beck Depression Inventory-II (BDI-II)(week 0, week 3, week 6)
  • Scores of Patient Health Questionnaire-15 (PHQ-15)(week 0, week 3, week 6)
  • Sheehan Function Inventory(week 0, week 3, week 6)
  • Scores of WHOQOL-BREF(week 0, week 3, week 6)
  • Scores of Beck Anxiety Inventory (BAI)(week 0, week 3, week 6)
  • Degree of Change in Physiological Parameters(week 0, week 6)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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