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Respiratory Dysregulation and Breathing Training in Anxious Outpatients

Primary Purpose

Anxiety

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Breathing Training-Raise CO2
Breathing Training- Lower CO2
Sponsored by
US Department of Veterans Affairs
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Anxiety focused on measuring Anxiety, Breathing Training, Respiratory Dysregulation

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • VA Palo Alto Health Care System

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

No Intervention

Arm Label

Raise CO2

Lower CO2

Waitlist

Arm Description

Raise CO2 - biofeedback-assisted breathing training to raise baseline pCO2

Lower CO2 - biofeedback-assisted breathing training to lower baseline pCO2

Waitlist - treatment as usual

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

Full Information

First Posted
April 14, 2005
Last Updated
January 7, 2015
Sponsor
US Department of Veterans Affairs
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1. Study Identification

Unique Protocol Identification Number
NCT00108277
Brief Title
Respiratory Dysregulation and Breathing Training in Anxious Outpatients
Official Title
Respiratory Dysregulation and Breathing Training in Anxious Outpatients
Study Type
Interventional

2. Study Status

Record Verification Date
January 2015
Overall Recruitment Status
Completed
Study Start Date
April 2005 (undefined)
Primary Completion Date
December 2008 (Actual)
Study Completion Date
September 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
US Department of Veterans Affairs

4. Oversight

Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anxiety
Keywords
Anxiety, Breathing Training, Respiratory Dysregulation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
92 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Raise CO2
Arm Type
Experimental
Arm Description
Raise CO2 - biofeedback-assisted breathing training to raise baseline pCO2
Arm Title
Lower CO2
Arm Type
Active Comparator
Arm Description
Lower CO2 - biofeedback-assisted breathing training to lower baseline pCO2
Arm Title
Waitlist
Arm Type
No Intervention
Arm Description
Waitlist - treatment as usual
Intervention Type
Behavioral
Intervention Name(s)
Breathing Training-Raise CO2
Intervention Description
while breathing 9 breaths per minute, patients are instructed to raise CO2
Intervention Type
Behavioral
Intervention Name(s)
Breathing Training- Lower CO2
Intervention Description
while breathing 9 breaths per minute, patients are instructed to lower CO2
Primary Outcome Measure Information:
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

10. Eligibility

Sex
All
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Walton Roth, MD
Organizational Affiliation
VA Palo Alto Health Care System
Official's Role
Principal Investigator
Facility Information:
Facility Name
VA Palo Alto Health Care System
City
Palo Alto
State/Province
California
ZIP/Postal Code
94304-1290
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
21373936
Citation
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.
Results Reference
result
PubMed Identifier
21320551
Citation
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.
Results Reference
result

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Respiratory Dysregulation and Breathing Training in Anxious Outpatients

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