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This study will explore respiratory dysregulation in anxious outpatients and examine the effect of breathing training with biofeedback for those anxious patients.
In clinic testing and outside the clinic testing, we will assess the prevalence of respiratory dysregulation in a sample of 60 non-psychotic, not currently alcohol or drug abusing veteran outpatients from our MHC (Mental Hygiene Clinic) who experience episodic anxiety but who do not qualify and have never qualified for the diagnosis of PD (panic disorder). These patients will be compared to 30 patients who are not clinically anxious. Of these 60 anxious patients, 30 will be randomly assigned to a 4-week course of breathing training assisted by feedback of end-tidal pCO2 levels as an augmentation of their current treatment. They will be compared to 30 who simply will continue with their current treatment (TAU). The breathing training group will receive clinical and physiological assessments immediately before the treatment period, four weeks after the end of the treatment period, and at a 4-month follow-up. The TAU group will be assessed three times at equivalent intervals, and if they wish, may undergo breathing training after the third assessment. Treatment will take place mainly in the first two years, giving us adequate time for follow-up and data analysis. We expect that this therapy will be especially effective for treating anxiety in the patients with substantial respiratory dysregulation.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Raise CO2 | Experimental | Raise CO2 - biofeedback-assisted breathing training to raise baseline pCO2 |
|
| Lower CO2 | Active Comparator | Lower CO2 - biofeedback-assisted breathing training to lower baseline pCO2 |
|
| Waitlist | No Intervention | Waitlist - treatment as usual |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Breathing Training-Raise CO2 | Behavioral | while breathing 9 breaths per minute, patients are instructed to raise CO2 |
|
| Measure | Description | Time Frame |
|---|---|---|
| Episodic Anxiety Scale | Episodic Anxiety Scale (EAS) is a modification of the Panic Disorder Severity Scale (Shear et al., 1997) that includes 2 additional questions regarding acute anxiety episodes that may not meet full criteria for a panic attack. The EAS consists of 9 questions, each ranging from 0 (none) to 4 (worst possible). The EAS total score is the sum of all 9 items, such that the minimum total score = 0 (no anxiety symptoms) and maximum total score = 36 (worst possible anxiety symptoms). | 1 month |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Walton Roth, MD | VA Palo Alto Health Care System | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| VA Palo Alto Health Care System | Palo Alto | California | 94304-1290 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21373936 | Result | Wollburg E, Roth WT, Kim S. Effects of breathing training on voluntary hypo- and hyperventilation in patients with panic disorder and episodic anxiety. Appl Psychophysiol Biofeedback. 2011 Jun;36(2):81-91. doi: 10.1007/s10484-011-9150-5. | |
| 21320551 | Result | Doberenz S, Roth WT, Wollburg E, Maslowski NI, Kim S. Methodological considerations in ambulatory skin conductance monitoring. Int J Psychophysiol. 2011 May;80(2):87-95. doi: 10.1016/j.ijpsycho.2011.02.002. Epub 2011 Feb 21. |
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Participants were recruited from October 2005 to September 2008 from the local VA medical center and surrounding community. Participants were primarily recruited via posted flyers and other public advertisements (e.g., ads in local newspapers).
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| ID | Title | Description |
|---|---|---|
| FG000 | Raise CO2 | Raise CO2 Breathing Training-Raise CO2: while breathing 9 minutes per minute, patients are instructed to raise CO2 |
| FG001 | Lower CO2 | Lower CO2 Breathing Training- Lower CO2: while breathing 9 minutes per minute, patients are instructed to lower CO2 |
| FG002 | Waitlist | Waitlist Treatment as Usual |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Raise CO2 | Raise CO2 Breathing Training-Raise CO2: while breathing 9 minutes per minute, patients are instructed to raise CO2 |
| BG001 | Lower CO2 | Lower CO2 Breathing Training- Lower CO2: while breathing 9 minutes per minute, patients are instructed to lower CO2 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Episodic Anxiety Scale | Episodic Anxiety Scale (EAS) is a modification of the Panic Disorder Severity Scale (Shear et al., 1997) that includes 2 additional questions regarding acute anxiety episodes that may not meet full criteria for a panic attack. The EAS consists of 9 questions, each ranging from 0 (none) to 4 (worst possible). The EAS total score is the sum of all 9 items, such that the minimum total score = 0 (no anxiety symptoms) and maximum total score = 36 (worst possible anxiety symptoms). | Posted | Mean | Standard Deviation | units on a scale | 1 month |
|
3 years
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Raise CO2 | Breathing Training-Raise CO2: while breathing 9 minutes per minute, patients are instructed to raise CO2 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Walton T. Roth, M.D. | VA Palo Alto Health Care System / Stanford University School of Medicine | 650-493-5000 | 65243 | wtroth@stanford.edu |
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| ID | Term |
|---|---|
| D001008 | Anxiety Disorders |
| ID | Term |
|---|---|
| D001523 | Mental Disorders |
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| Breathing Training- Lower CO2 | Behavioral | while breathing 9 breaths per minute, patients are instructed to lower CO2 |
|
| BG002 | Waitlist | Waitlist Treatment as usual |
| BG003 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Number | participants |
|
| Episodic Anxiety Scale | Episodic Anxiety Scale (EAS) is a modification of the Panic Disorder Severity Scale (Shear et al., 1997) that includes 2 additional questions regarding acute anxiety episodes that may not meet full criteria for a panic attack. The EAS consists of 9 questions, each ranging from 0 (none) to 4 (worst possible). The EAS total score is the sum of all 9 items, such that the minimum total score = 0 (no anxiety symptoms) and maximum total score = 36 (worst possible anxiety symptoms). | Mean | Standard Deviation | units on a scale |
|
Lower CO2
Breathing Training- Lower CO2: while breathing 9 breaths per minute, patients are instructed to lower CO2
| OG002 | Waitlist | Waitlist Treatment as usual |
|
|
| 0 |
| 29 |
| 0 |
| 29 |
| EG001 | Lower CO2 | Breathing Training- Lower CO2: while breathing 9 minutes per minute, patients are instructed to lower CO2 | 0 | 28 | 0 | 28 |
| EG002 | Waitlist | Treatment as usual | 0 | 35 | 0 | 35 |
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