Panic Disorder
Conditions
Keywords
carbon dioxide monitoring, panic disorder, biofeedback, breathing training, Primary diagnosis, panic attacks
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.
Interventions
DEVICECanary Breathing System
The Canary Breathing System is a biofeedback device meant to assist patients in the re-training of abnormal breathing patterns.
Sponsors
Palo Alto Health Sciences, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| Percent of Subjects Achieving a 40% Decrease in Overall PDSS Score (Clinically Significant Response) | Measured post-treatment (week-5) | 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 post-treatment (week-5) | — |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Canary Breathing System Treatment with Canary Breathing System
Canary Breathing System: The Canary Breathing System is a biofeedback device meant to assist patients in the re-training of abnormal breathing patterns. | 69 |
| Total | 69 |
Baseline characteristics
| Characteristic | Canary Breathing System |
|---|---|
| Age, Continuous | 36.6 years STANDARD_DEVIATION 11 |
| Region of Enrollment United States | 69 participants |
| Sex: Female, Male Female | 41 Participants |
| Sex: Female, Male Male | 28 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 69 |
| other Total, other adverse events | 1 / 69 |
| serious Total, serious adverse events | 0 / 69 |
Outcome results
Primary
Percent of Subjects Achieving a 40% Decrease in Overall PDSS Score (Clinically Significant Response)
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.
Time frame: Measured at 2 months post-treatment.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Canary Breathing System | Percent of Subjects Achieving a 40% Decrease in Overall PDSS Score (Clinically Significant Response) | 33 Participants |
Secondary
Percent of Subjects Achieving a 40% Decrease in Overall PDSS Score (Clinically Significant Response)
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.
Time frame: Measured post-treatment (week-5)
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Canary Breathing System | Percent of Subjects Achieving a 40% Decrease in Overall PDSS Score (Clinically Significant Response) | 41 Participants |
Secondary
Percent of Subjects Achieving a 40% Decrease in Overall PDSS Score (Clinically Significant Response)
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.
Time frame: Measured at 12 months post-treatment.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Canary Breathing System | Percent of Subjects Achieving a 40% Decrease in Overall PDSS Score (Clinically Significant Response) | 27 Participants |
Secondary
Percent of Subjects Achieving Zero Panic Attacks Reported in Previous Week
Time frame: Measured post-treatment (week-5)
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Canary Breathing System | Percent of Subjects Achieving Zero Panic Attacks Reported in Previous Week | 34 Participants |
Secondary
Percent of Subjects Achieving Zero Panic Attacks Reported in Previous Week
Time frame: Measured at 2 months post-treatment
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Canary Breathing System | Percent of Subjects Achieving Zero Panic Attacks Reported in Previous Week | 33 Participants |
Secondary
Percent of Subjects Achieving Zero Panic Attacks Reported in Previous Week
Time frame: Measured at 12 months post-treatment
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Canary Breathing System | Percent of Subjects Achieving Zero Panic Attacks Reported in Previous Week | 26 Participants |