Breathing Regulation Training for Individuals With Panic Disorder - Full Text View

Sponsor:	Stanford University
Collaborator:	National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):	Walton T Roth, Stanford University
ClinicalTrials.gov Identifier:	NCT00183521

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:

MedlinePlus related topics: Anxiety Panic Disorder

Drug Information available for: Carbon dioxide

U.S. FDA Resources

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

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

National Institute of Mental Health (NIMH)

Investigators

Principal Investigator:

Walton T. Roth, MD

Stanford University and VA Health Care System

More Information

No publications provided

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 February 12, 2012