Respiratory Dysregulation and Breathing Training in Anxious Outpatients

NCT ID: NCT00108277

Last Updated: 2015-01-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 92 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2005-04-30
• Study Completion Date: 2010-09-30

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.

Conditions

Anxiety

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Raise CO2

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

Group Type: EXPERIMENTAL

Breathing Training-Raise CO2

Intervention Type: BEHAVIORAL

while breathing 9 breaths per minute, patients are instructed to raise CO2

Lower CO2

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

Group Type: ACTIVE_COMPARATOR

Breathing Training- Lower CO2

Intervention Type: BEHAVIORAL

while breathing 9 breaths per minute, patients are instructed to lower CO2

Waitlist

Waitlist - treatment as usual

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Breathing Training-Raise CO2

while breathing 9 breaths per minute, patients are instructed to raise CO2

Intervention Type: BEHAVIORAL

Breathing Training- Lower CO2

while breathing 9 breaths per minute, patients are instructed to lower CO2

Intervention Type: BEHAVIORAL

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.

• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

US Department of Veterans Affairs

FED

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Walton Roth, MD

Role: PRINCIPAL_INVESTIGATOR

VA Palo Alto Health Care System

Locations

VA Palo Alto Health Care System

Palo Alto, California, United States

Countries

United States

References

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.

Reference Type: RESULT

PMID: 21373936 (View on PubMed)

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.

Reference Type: RESULT

PMID: 21320551 (View on PubMed)

Other Identifiers

MHBA-028-04S

Identifier Type: -

Identifier Source: org_study_id