Breathing Regulation Training for Individuals With Panic Disorder

NCT ID: NCT00183521

Last Updated: 2011-12-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

136 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-03-31

Study Completion Date

2008-11-30

Brief Summary

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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

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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.

Conditions

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Panic Disorder

Keywords

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Hyperventilation Breathing Exercises Carbon Dioxide Panic Attack

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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1

Participants will receive raise-CO2 breathing regulation training

Group Type EXPERIMENTAL

Raise-CO2 breathing regulation training

Intervention Type BEHAVIORAL

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.

2

Participants will receive lower-CO2 breathing regulation training

Group Type EXPERIMENTAL

Lower-CO2 breathing regulation training

Intervention Type BEHAVIORAL

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.

3

Participants will receive no breathing regulation training

Group Type ACTIVE_COMPARATOR

Control

Intervention Type BEHAVIORAL

Participants in the control group will not be taught any breathing techniques but will be included in all assessments.

Interventions

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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.

Intervention Type 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.

Intervention Type BEHAVIORAL

Control

Participants in the control group will not be taught any breathing techniques but will be included in all assessments.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* 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

* 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


* History of anxiety disorders
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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National Institute of Mental Health (NIMH)

NIH

Sponsor Role collaborator

Stanford University

OTHER

Sponsor Role lead

Responsible Party

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Walton T Roth

M.D.

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Walton T. Roth, MD

Role: PRINCIPAL_INVESTIGATOR

Stanford University and VA Health Care System

Locations

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Stanford University & VA Health Care System

Palo Alto, California, United States

Site Status

Countries

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United States

References

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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.

Reference Type DERIVED
PMID: 22901344 (View on PubMed)

Other Identifiers

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R01MH066953

Identifier Type: NIH

Identifier Source: secondary_id

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DATR A2-AIR

Identifier Type: -

Identifier Source: secondary_id

R01MH066953

Identifier Type: NIH

Identifier Source: org_study_id

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