Investigation of the Canary Breathing System for Treating the Symptoms of Panic Disorder
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 69
- 试验地点
- 8
- 主要终点
- Percent of Subjects Achieving a 40% Decrease in Overall PDSS Score (Clinically Significant Response)
研究概览
简要总结
The purpose of this study is to test the effectiveness of the Canary Breathing System (CBS) in treating the symptoms of panic disorder.
详细描述
Panic disorder (PD) is associated with hyperventilation. The efficacy of a brief respiratory feedback program for PD has been previously established. The aim of the present study was to expand these results by testing a similar program with more clinically representative patients and settings. The intervention is delivered via home use following initial training by a clinician and provides remote monitoring of client adherence and progress by the clinician. Outcomes were assessed post-treatment and at 2- and 12-month follow-up.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Primary diagnosis of Panic Disorder
- •Subjects between 18 and 60 years of age (inclusive on day of enrollment)
- •Subjects with a Clinician's Global Impression of > or = to
- •If on psychotropic medication, on a stable dose for a minimum of 3 months prior to enrollment
- •If on psychotropic medication, an agreement to stay on their stable dose from study entry until the 2-month follow-up.
排除标准
- •Pregnancy
- •Current enrollment in another drug or device study
- •Current enrollment in another drug or device study that is not at least 30 days past the final follow-up
- •Currently undergoing cognitive behavioral therapy (or equivalent)
- •Refractory to either a breathing training program or cognitive behavioral therapy (or equivalent) in the 3 months prior to enrollment
- •Evidence of organic mental disorder
- •Severe suicidality
- •Presence of any psychotic disorder
- •Bipolar disorder that is present for < 5 years; a major depressive, manic or hypomanic episode in the last 12 months; failure to take and maintain a stable dose of medication in treatment of bipolar disorder in the last 12 months
- •Current alcohol or drug dependence
- •Cardiovascular or pulmonary disease
- •Epilepsy or seizures
- •Undergoing additional psychologic treatment at any point from study enrollment to 2-month follow-up to treat panic disorder
研究组 & 干预措施
Canary Breathing System
Treatment with Canary Breathing System
干预措施: Canary Breathing System (Device)
结局指标
主要结局
Percent of Subjects Achieving a 40% Decrease in Overall PDSS Score (Clinically Significant Response)
时间窗: Measured at 2 months post-treatment.
The Panic Disorder Severity Scale (PDSS) (Shear, 1997) is a widely used assessment tool measuring panic disorder symptom severity and impact. Seven questions are scored from 0 to 4 giving minimum and maximum scores of zero and 28 respectively. Higher scores represent more severe impact of symptoms. A 40% decrease has been reported to be clinically significant (Furukawa et al 2009) and is defined as "Response" in this study.
次要结局
- Percent of Subjects Achieving a 40% Decrease in Overall PDSS Score (Clinically Significant Response)(Measured at 12 months post-treatment.)
- Percent of Subjects Achieving Zero Panic Attacks Reported in Previous Week(Measured at 12 months post-treatment)