Respiratory Dysregulation and Breathing Training in Anxious Outpatients

• Sponsor: US Department of Veterans Affairs (U.S. Fed)
• Overall Status: Completed
• CT.gov ID: NCT00108277
• Collaborator: (none)
• Enrollment: 92
• Location: 1
• Arms: 3
• Duration (Months): 65
• Patients Per Site Per Month: 1.4

Study Details

Study Description

Brief Summary

This study will explore respiratory dysregulation in anxious outpatients and examine the effect of breathing training with biofeedback for those anxious patients.

Condition or Disease	Intervention/Treatment	Phase
Anxiety	Behavioral: Breathing Training-Raise CO2; Behavioral: Breathing Training- Lower CO2	N/A

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 92 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Respiratory Dysregulation and Breathing Training in Anxious Outpatients
• Study Start Date: Apr 1, 2005
• Actual Primary Completion Date: Dec 1, 2008
• Actual Study Completion Date: Sep 1, 2010

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Raise CO2 Raise CO2 - biofeedback-assisted breathing training to raise baseline pCO2	Behavioral: Breathing Training-Raise CO2; while breathing 9 breaths per minute, patients are instructed to raise CO2
Active Comparator: Lower CO2 Lower CO2 - biofeedback-assisted breathing training to lower baseline pCO2	Behavioral: Breathing Training- Lower CO2; while breathing 9 breaths per minute, patients are instructed to lower CO2
No Intervention: Waitlist Waitlist - treatment as usual

Outcome Measures

Primary Outcome Measures

1. 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).

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A and Older
• Sexes Eligible for Study: All
• Accepts 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	VA Palo Alto Health Care System	Palo Alto	California	United States	94304-1290

Sponsors and Collaborators

• US Department of Veterans Affairs

Investigators

• Principal Investigator: Walton Roth, MD, VA Palo Alto Health Care System

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: US Department of Veterans Affairs
• ClinicalTrials.gov Identifier: NCT00108277
• Other Study ID Numbers: MHBA-028-04S
• First Posted: Apr 15, 2005
• Last Update Posted: Jan 19, 2015
• Last Verified: Jan 1, 2015

• Keywords provided by US Department of Veterans Affairs: Anxiety; Breathing Training; Respiratory Dysregulation
• Additional relevant MeSH terms: Respiratory Aspiration

Study Results

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).

Arm/Group Title	Raise CO2	Lower CO2	Waitlist
Arm/Group Description	Raise CO2 Breathing Training-Raise CO2: while breathing 9 minutes per minute, patients are instructed to raise CO2	Lower CO2 Breathing Training- Lower CO2: while breathing 9 minutes per minute, patients are instructed to lower CO2	Waitlist Treatment as Usual
Period Title: Overall Study
STARTED	29	28	35
COMPLETED	19	16	19
NOT COMPLETED	10	12	16

Baseline Characteristics

Arm/Group Title	Raise CO2	Lower CO2	Waitlist	Total
Arm/Group Description	Raise CO2 Breathing Training-Raise CO2: while breathing 9 minutes per minute, patients are instructed to raise CO2	Lower CO2 Breathing Training- Lower CO2: while breathing 9 minutes per minute, patients are instructed to lower CO2	Waitlist Treatment as usual	Total of all reporting groups
Overall Participants	29	28	35	92
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	47.3 (13.2)	40.6 (12.2)	49.9 (10.9)	45.9 (12.1)
Sex: Female, Male (Count of Participants)
Female	16 55.2%	20 71.4%	25 71.4%	61 66.3%
Male	13 44.8%	8 28.6%	10 28.6%	31 33.7%
Race/Ethnicity, Customized (participants) [Number]
White	15 51.7%	16 57.1%	17 48.6%	48 52.2%
Other	14 48.3%	12 42.9%	18 51.4%	44 47.8%
Episodic Anxiety Scale (units on a scale) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [units on a scale]	15.5 (3.44)	15.7 (4.53)	16.1 (3.23)	15.8 (3.73)

Outcome Measures

1. Primary Outcome

Title	Episodic Anxiety Scale
Description	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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Raise CO2	Lower CO2	Waitlist
Arm/Group Description	Raise CO2 Breathing Training-Raise CO2: while breathing 9 breaths per minute, patients are instructed to raise CO2	Lower CO2 Breathing Training- Lower CO2: while breathing 9 breaths per minute, patients are instructed to lower CO2	Waitlist Treatment as usual
Measure Participants	19	16	19
Mean (Standard Deviation) [units on a scale]	8.1 (2.73)	9.0 (3.89)	14.3 (3.67)

Adverse Events

Time Frame	3 years
Arm/Group Title	Raise CO2		Lower CO2		Waitlist
Arm/Group Description	Breathing Training-Raise CO2: while breathing 9 minutes per minute, patients are instructed to raise CO2		Breathing Training- Lower CO2: while breathing 9 minutes per minute, patients are instructed to lower CO2		Treatment as usual
All Cause Mortality
	Raise CO2		Lower CO2		Waitlist
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)		/ (NaN)
Serious Adverse Events
	Raise CO2		Lower CO2		Waitlist
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/29 (0%)		0/28 (0%)		0/35 (0%)
Other (Not Including Serious) Adverse Events
	Raise CO2		Lower CO2		Waitlist
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/29 (0%)		0/28 (0%)		0/35 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.