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Breathing Regulation Training for Individuals With Panic Disorder

Primary Purpose

Panic Disorder

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Raise-CO2 breathing regulation training
Lower-CO2 breathing regulation training
Control
Sponsored by
Stanford University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Panic Disorder focused on measuring Hyperventilation, Breathing Exercises, Carbon Dioxide, Panic Attack

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Stanford University & VA Health Care System

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Active Comparator

Arm Label

1

2

3

Arm Description

Participants will receive raise-CO2 breathing regulation training

Participants will receive lower-CO2 breathing regulation training

Participants will receive no breathing regulation training

Outcomes

Primary Outcome Measures

Breathing regulation

Secondary Outcome Measures

Full Information

First Posted
September 13, 2005
Last Updated
November 30, 2011
Sponsor
Stanford University
Collaborators
National Institute of Mental Health (NIMH)
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1. Study Identification

Unique Protocol Identification Number
NCT00183521
Brief Title
Breathing Regulation Training for Individuals With Panic Disorder
Official Title
Respiratory Therapeutic Procedures in Panic Disorder
Study Type
Interventional

2. Study Status

Record Verification Date
November 2011
Overall Recruitment Status
Completed
Study Start Date
March 2005 (undefined)
Primary Completion Date
November 2008 (Actual)
Study Completion Date
November 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Stanford University
Collaborators
National Institute of Mental Health (NIMH)

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Panic Disorder
Keywords
Hyperventilation, Breathing Exercises, Carbon Dioxide, Panic Attack

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
136 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
Participants will receive raise-CO2 breathing regulation training
Arm Title
2
Arm Type
Experimental
Arm Description
Participants will receive lower-CO2 breathing regulation training
Arm Title
3
Arm Type
Active Comparator
Arm Description
Participants will receive no breathing regulation training
Intervention Type
Behavioral
Intervention Name(s)
Raise-CO2 breathing regulation training
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Lower-CO2 breathing regulation training
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Control
Intervention Description
Participants in the control group will not be taught any breathing techniques but will be included in all assessments.
Primary Outcome Measure Information:
Title
Breathing regulation
Time Frame
Measured at Month 6 after completion of therapy

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Walton T. Roth, MD
Organizational Affiliation
Stanford University and VA Health Care System
Official's Role
Principal Investigator
Facility Information:
Facility Name
Stanford University & VA Health Care System
City
Palo Alto
State/Province
California
ZIP/Postal Code
94304
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
22901344
Citation
Kim S, Wollburg E, Roth WT. Opposing breathing therapies for panic disorder: a randomized controlled trial of lowering vs raising end-tidal P(CO(2)). J Clin Psychiatry. 2012 Jul;73(7):931-9. doi: 10.4088/JCP.11m07068.
Results Reference
derived

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Breathing Regulation Training for Individuals With Panic Disorder

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