Breathing Regulation Training for Individuals With Panic Disorder

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Walton T Roth, Stanford University
ClinicalTrials.gov Identifier:
NCT00183521
First received: September 13, 2005
Last updated: November 30, 2011
Last verified: November 2011
  Purpose

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.


Condition Intervention
Panic Disorder
Behavioral: Raise-CO2 breathing regulation training
Behavioral: Lower-CO2 breathing regulation training
Behavioral: Control

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Respiratory Therapeutic Procedures in Panic Disorder

Resource links provided by NLM:


Further study details as provided by Stanford University:

Primary Outcome Measures:
  • Breathing regulation [ Time Frame: Measured at Month 6 after completion of therapy ] [ Designated as safety issue: No ]

Enrollment: 136
Study Start Date: March 2005
Study Completion Date: November 2008
Primary Completion Date: November 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Participants will receive raise-CO2 breathing regulation training
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.
Experimental: 2
Participants will receive lower-CO2 breathing regulation training
Behavioral: 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.
Active Comparator: 3
Participants will receive no breathing regulation training
Behavioral: Control
Participants in the control group will not be taught any breathing techniques but will be included in all assessments.

Detailed 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.

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00183521

Locations
United States, California
Stanford University & VA Health Care System
Palo Alto, California, United States, 94304
Sponsors and Collaborators
Stanford University
Investigators
Principal Investigator: Walton T. Roth, MD Stanford University and VA Health Care System
  More Information

No publications provided by Stanford University

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Walton T Roth, M.D., Stanford University
ClinicalTrials.gov Identifier: NCT00183521     History of Changes
Other Study ID Numbers: R01 MH066953, R01MH066953, DATR A2-AIR
Study First Received: September 13, 2005
Last Updated: November 30, 2011
Health Authority: United States: Federal Government

Keywords provided by Stanford University:
Hyperventilation
Breathing Exercises
Carbon Dioxide
Panic Attack

Additional relevant MeSH terms:
Panic Disorder
Anxiety Disorders
Mental Disorders

ClinicalTrials.gov processed this record on July 20, 2014