Using the Canary Breathing System for Panic Disorder Patients

Not Applicable

Completed

Brief Summary: The purpose of this study is to test the effectiveness of the Canary Breathing System (CBS) in treating the symptoms of panic disorder.

Detailed Description: 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.

Recruitment & Eligibility

Inclusion Criteria

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 4.
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.

Exclusion Criteria

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

Arm && Interventions

Group	Intervention	Description
Canary Breathing System	Canary Breathing System	Treatment with Canary Breathing System

Primary Outcome Measures

Name	Time	Method
Percent of Subjects Achieving a 40% Decrease in Overall PDSS Score (Clinically Significant Response)	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.

Secondary Outcome Measures

Name	Time	Method
Percent of Subjects Achieving a 40% Decrease in Overall PDSS Score (Clinically Significant Response)	Measured at 12 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.
Percent of Subjects Achieving Zero Panic Attacks Reported in Previous Week	Measured at 12 months post-treatment

Locations (4): Kansas City Center for Anxiety Treatment, P.A.
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Overland Park, Kansas, United States
San Francisco Bay Area Center for Cognitive Therapy
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Oakland, California, United States
Institute of Living
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Hartford, Connecticut, United States
Alexian Brothers Center for Anxiety and OCD
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Hoffman Estates, Illinois, United States