|First Received Date †||September 13, 2005|
|Last Updated Date||March 25, 2009|
|Start Date †||March 2005|
|Current Primary Outcome Measures †
||Breathing regulation [ Time Frame: Measured at Month 6 after completion of therapy ] [ Designated as safety issue: No ]|
|Original Primary Outcome Measures †||Same as current|
|Change History||Complete list of historical versions of study NCT00183521 on ClinicalTrials.gov Archive Site|
|Current Secondary Outcome Measures †|
|Original Secondary Outcome Measures †|
|Brief Title †||Breathing Regulation Training for Individuals With Panic Disorder|
|Official Title †||Respiratory Therapeutic Procedures in Panic Disorder|
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.
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.
|Study Type †||Interventional|
|Study Design †||Treatment, Randomized, Open Label, Parallel Assignment, Efficacy Study|
|Condition †||Panic Disorder|
|Study Arms / Comparison Groups||
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
|Recruitment Status †||Completed|
|Estimated Enrollment †||100|
|Completion Date||November 2008|
|Primary Completion Date||November 2008 (final data collection date for primary outcome measure)|
|Eligibility Criteria †||
Inclusion Criteria for Participants With PD:
Exclusion Criteria for All Participants:
Exclusion Criteria for Participants Without PD:
|Ages||18 Years to 60 Years|
|Accepts Healthy Volunteers||Yes|
|Location Countries †||United States|
|Expanded Access Status|
|NCT ID †||NCT00183521|
|Responsible Party||Dr. Walton T. Roth, Stanford University|
|Secondary IDs ††||DATR A2-AIR|
|Study Sponsor †||National Institute of Mental Health (NIMH)|
|Information Provided By||National Institute of Mental Health (NIMH)|
|Verification Date||March 2009|
† Required WHO trial registration data element.
†† WHO trial registration data element that is required only if it exists.