Respiratory Dysregulation and Breathing Training in Anxious Outpatients

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

Study Overview

• Status: Completed
• Conditions: Anxiety
• Intervention / Treatment: Behavioral: Breathing Training-Raise CO2; Behavioral: Breathing Training- Lower CO2

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 Type: Interventional
• Enrollment (Actual): 92
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Palo Alto, California, United States, 94304-1290
      • VA Palo Alto Health Care System

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: US Department of Veterans Affairs

Publications and helpful links

General Publications

• 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.
• 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.

Study record dates

Study Major Dates

• Study Start: April 1, 2005
• Primary Completion (Actual): December 1, 2008
• Study Completion (Actual): September 1, 2010

Study Registration Dates

• First Submitted: April 14, 2005
• First Submitted That Met QC Criteria: April 14, 2005
• First Posted (Estimate): April 15, 2005

Study Record Updates

• Last Update Posted (Estimate): January 19, 2015
• Last Update Submitted That Met QC Criteria: January 7, 2015
• Last Verified: January 1, 2015

More Information

Terms related to this study

• Keywords: Anxiety; Breathing Training; Respiratory Dysregulation
• Additional Relevant MeSH Terms: Pathologic Processes; Respiratory Tract Diseases; Respiration Disorders; Respiratory Aspiration
• Other Study ID Numbers: MHBA-028-04S