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| Sponsored by: |
National Institute of Mental Health (NIMH) |
|---|---|
| Information provided by: | National Institute of Mental Health (NIMH) |
| 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: | Treatment, Randomized, Open Label, Parallel Assignment, Efficacy Study |
| Official Title: | Respiratory Therapeutic Procedures in Panic Disorder |
| Estimated Enrollment: | 100 |
| Study Start Date: | March 2005 |
| Estimated Study Completion Date: | June 2008 |
| Estimated Primary Completion Date: | June 2008 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
1: Experimental
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.
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2: Experimental
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.
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3: Active Comparator
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.
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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.
Eligibility| Ages Eligible for Study: | 18 Years to 60 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria for Participants With PD:
Exclusion Criteria for All Participants:
Exclusion Criteria for Participants Without PD:
Contacts and Locations| Contact: Walton T. Roth, MD | 650-493-5000 ext 65243 | wtroth@stanford.edu |
| United States, California | |
| Stanford University & VA Health Care System | Recruiting |
| Palo Alto, California, United States, 94304 | |
| Contact: Walton T. Roth, MD 650-493-5000 ext 65243 wtroth@stanford.edu | |
| Contact: Sunyoung Kim, PhD 650-493-5000 ext 66576 sykim47@stanford.edu | |
| Principal Investigator: Walton T. Roth, MD | |
| Sub-Investigator: Sunyoung Kim, PhD | |
| Principal Investigator: | Walton T. Roth, MD | Stanford University and VA Health Care System |
More Information
| Responsible Party: | Stanford University ( Dr. Walton T. Roth ) |
| Study ID Numbers: | R01 MH66953, DATR A2-AIR |
| Study First Received: | September 13, 2005 |
| Last Updated: | September 19, 2008 |
| ClinicalTrials.gov Identifier: | NCT00183521 |
| Health Authority: | United States: Federal Government |
|
Hyperventilation Breathing Exercises Carbon Dioxide Panic Attack |
|
Panic Disorder Anxiety Disorders Mental Disorders |
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Pathologic Processes Disease |
