Anxiety
Conditions
Keywords
Anxiety, Breathing Training, Respiratory Dysregulation
Brief summary
This study will explore respiratory dysregulation in anxious outpatients and examine the effect of breathing training with biofeedback for those anxious patients.
Detailed description
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.
Interventions
BEHAVIORALBreathing Training-Raise CO2
while breathing 9 breaths per minute, patients are instructed to raise CO2
BEHAVIORALBreathing Training- Lower CO2
while breathing 9 breaths per minute, patients are instructed to lower CO2
Sponsors
US Department of Veterans Affairs
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Healthy volunteers
Yes
Inclusion criteria
* Patients must be rated 2 or more on both Q1 and Q3, but they must not meet the full criteria for PD as determined by the Anxiety Disorders Interview Schedule for DSM-IV-Lifetime Version (ADIS). * In addition, they must be clinically stable enough that changes in the patients' anxiety levels can be attributed to the breathing training rather than to other new treatment initiatives during the training and 1-month evaluation periods or to spontaneous fluctuations in anxiety levels. Thus, potential participants taking SSRIs or other antidepressants, or benzodiazepines have to have been on a stable dose of these medicines for at least the previous two months.
Exclusion criteria
* Potential participants taking short-acting benzodiazepines such as alprazolam in excess of 2.0 mg/day or the equivalent on any day in the past month are excluded, because improvement might show up only in terms of reduction of medication dosage and not on the evaluation measures planned.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Episodic Anxiety Scale | 1 month | 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). |
Countries
United States
Participant flow
Recruitment details
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).
Participants by arm
| Arm | Count |
|---|---|
| Raise CO2 Raise CO2
Breathing Training-Raise CO2: while breathing 9 minutes per minute, patients are instructed to raise CO2 | 29 |
| Lower CO2 Lower CO2
Breathing Training- Lower CO2: while breathing 9 minutes per minute, patients are instructed to lower CO2 | 28 |
| Waitlist Waitlist
Treatment as usual | 35 |
| Total | 92 |
Baseline characteristics
| Characteristic | Raise CO2 | Lower CO2 | Waitlist | Total |
|---|---|---|---|---|
| Age, Continuous | 47.3 years STANDARD_DEVIATION 13.2 | 40.6 years STANDARD_DEVIATION 12.2 | 49.9 years STANDARD_DEVIATION 10.9 | 45.9 years STANDARD_DEVIATION 12.1 |
| Episodic Anxiety Scale | 15.5 units on a scale STANDARD_DEVIATION 3.44 | 15.7 units on a scale STANDARD_DEVIATION 4.53 | 16.1 units on a scale STANDARD_DEVIATION 3.23 | 15.8 units on a scale STANDARD_DEVIATION 3.73 |
| Race/Ethnicity, Customized Other | 14 participants | 12 participants | 18 participants | 44 participants |
| Race/Ethnicity, Customized White | 15 participants | 16 participants | 17 participants | 48 participants |
| Sex: Female, Male Female | 16 Participants | 20 Participants | 25 Participants | 61 Participants |
| Sex: Female, Male Male | 13 Participants | 8 Participants | 10 Participants | 31 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 0 / 29 | 0 / 28 | 0 / 35 |
| serious Total, serious adverse events | 0 / 29 | 0 / 28 | 0 / 35 |
Outcome results
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).
Time frame: 1 month
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Raise CO2 | Episodic Anxiety Scale | 8.1 units on a scale | Standard Deviation 2.73 |
| Lower CO2 | Episodic Anxiety Scale | 9.0 units on a scale | Standard Deviation 3.89 |
| Waitlist | Episodic Anxiety Scale | 14.3 units on a scale | Standard Deviation 3.67 |