Respiratory Dysregulation and Breathing Training in Anxious Outpatients

This study has been completed.
Sponsor:
Information provided by:
Department of Veterans Affairs
ClinicalTrials.gov Identifier:
NCT00108277
First received: April 14, 2005
Last updated: February 12, 2010
Last verified: February 2010
  Purpose

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


Condition Intervention
Anxiety
Behavioral: Breathing Training-Raise CO2
Behavioral: Breathing Training- Lower CO2
Behavioral: Waitlist

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Respiratory Dysregulation and Breathing Training in Anxious Outpatients

Resource links provided by NLM:


Further study details as provided by Department of Veterans Affairs:

Primary Outcome Measures:
  • Episodic Anxiety Scale [ Time Frame: 1 month ] [ Designated as safety issue: No ]

Enrollment: 92
Study Start Date: April 2005
Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Raise CO2
Behavioral: Breathing Training-Raise CO2
while breathing 9 minutes per minute, patients are instructed to raise CO2
Active Comparator: 2
Lower CO2
Behavioral: Breathing Training- Lower CO2
while breathing 9 minutes per minute, patients are instructed to lower CO2
No Intervention: 3
Waitlist
Behavioral: Waitlist
Patients wait for breathing training.

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.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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.
  • 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.

Exclusion Criteria:

  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00108277

Locations
United States, California
VA Palo Alto Health Care System
Palo Alto, California, United States, 94304-1290
Sponsors and Collaborators
Investigators
Principal Investigator: Walton Roth, MD VA Palo Alto Health Care System
  More Information

No publications provided

Responsible Party: Roth, Walton - Principal Investigator, Department of Veterans Affairs
ClinicalTrials.gov Identifier: NCT00108277     History of Changes
Other Study ID Numbers: MHBA-028-04S
Study First Received: April 14, 2005
Last Updated: February 12, 2010
Health Authority: United States: Federal Government

Keywords provided by Department of Veterans Affairs:
Anxiety
Breathing Training
Respiratory Dysregulation

Additional relevant MeSH terms:
Anxiety Disorders
Respiratory Aspiration
Mental Disorders
Respiration Disorders
Respiratory Tract Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on September 15, 2014