Breathing Regulation Training for Individuals With Panic Disorder

Panic Disorder Clinical Trial

Official title:

Respiratory Therapeutic Procedures in Panic Disorder

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00183521
• Other study ID #: R01MH066953
• Secondary ID: R01MH066953DATR
• Status: Completed
• Phase: N/A
• First received: September 13, 2005
• Last updated: November 30, 2011
• Start date: March 2005
• Est. completion date: November 2008

Study information

• Verified date: November 2011
• Source: Stanford University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial Summary

This study will compare two different breathing regulation techniques to determine which is more effective in reducing the rate of panic attacks in people with panic disorder.

Description:

PD is a serious condition characterized by episodes of rapid heart rate, difficulty breathing, and other symptoms of fear. Explanations for panic attacks have been proposed in two theories: suffocation alarm theory and hyperventilation theory. The suffocation alarm theory claims that panic attacks are due to a "suffocation monitor" in the brain, erroneously signaling a lack of useful air. The hyperventilation theory suggests that stressful events cause people to slightly hyperventilate; some people have panic attacks as a result of their overreaction to the dizziness and lightheadedness they feel from hyperventilation. Both theories note the role of carbon dioxide (CO2) in panic attacks; they suggest that rising CO2 levels in arterial blood act as a panic stimulus. This study will compare two types of breathing regulation techniques based on the panic attack theories to determine which is more effective in reducing panic symptoms in people with PD.

This study will last 4 weeks and will include both people with PD and those without the condition. Participants will be randomly assigned to one of three groups: raise-CO2 breathing, lower-CO2 breathing, or a control group. Participants in both the raise-CO2 and lower-CO2 breathing groups will have five sessions of training in which they will learn specific breathing techniques. Participants in the raise-CO2 group will be taught techniques to recover from hyperventilation faster; participants in the lower-CO2 group will be taught techniques to reach hyperventilation levels, then switch to breathing techniques that reduce hyperventilation symptoms. Participants in the control group will not be taught any breathing techniques but will be included in all assessments.

Participants will be assessed at study entry, during each breathing training session, and at Months 1 and 6 after the study. During each assessment, questionnaires and self-report scales will be used to measure cognitive, psychological, and physiological changes related to participants' breathing.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 136
• Est. completion date: November 2008
• Est. primary completion date: November 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

Inclusion Criteria for Participants With PD:

• Diagnosis of PD

• History of panic attacks that are at least moderately severe in frequency and severity

• Able and willing to comply with all study requirements

Exclusion Criteria for All Participants:

• History of chest pain, heart attack, congestive heart failure, or clinically significant irregular heartbeat

• History of blood circulation problems or cerebrovascular accidents

• Diabetes mellitus

• Asthma or chronic obstructive pulmonary disease (COPD)

• History of schizophrenia, bipolar disorder, or dementia

• Drugs which would affect breathing

• Alcohol or other substance abuse within 1 year prior to study entry

• Current use of any recreational drugs or consumption of more than 15 alcoholic drinks per week

Exclusion Criteria for Participants Without PD:

• History of anxiety disorders

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Panic Disorder

Intervention

Behavioral:
• Raise-CO2 breathing regulation training
Reverse hyperventilation (defined by low arterial CO2) is often characteristic of individuals with panic disorder. Participants will be randomly assigned to one of three groups: raise-CO2 breathing, lower-CO2 breathing, or a control group. Participants in the raise-CO2 group will be taught techniques to recover from hyperventilation faster.
• Lower-CO2 breathing regulation training
According to the false suffocation alarm theory, anxiety is experienced when an overly sensitive hypothalamic mechanism is triggered by rising pCO2. Participants in the lower-CO2 group will be taught techniques to reach hyperventilation levels, then switch to breathing techniques that reduce hyperventilation symptoms.
• Control
Participants in the control group will not be taught any breathing techniques but will be included in all assessments.

Locations

Country	Name	City	State
United States	Stanford University & VA Health Care System	Palo Alto	California

Sponsors (2)

Lead Sponsor	Collaborator
Stanford University	National Institute of Mental Health (NIMH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Breathing regulation		Measured at Month 6 after completion of therapy	No