Panic DisorderNCT00183521
Breathing Regulation Training for Individuals With Panic Disorder
A study testing Raise-CO2 breathing regulation training and Lower-CO2 breathing regulation training in people with Panic Disorder, run by Stanford University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Panic Disorder
- What is being tested?
- Raise-CO2 breathing regulation training and Lower-CO2 breathing regulation training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 136 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2005to Nov 2008
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 9Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Stanford University & VA Health Care System
Palo Alto, California, 94304
About this study
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.
Read the 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.
- Conditions
- Panic Disorder
- Being tested
- Raise-CO2 breathing regulation training, Lower-CO2 breathing regulation training, Control
- Keywords
- Hyperventilation, Breathing Exercises, Carbon Dioxide, Panic Attack
- Medical subject headings
- Panic Disorder, Hyperventilation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Raise-CO2 breathing regulation trainingBehavioural
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.
Lower-CO2 breathing regulation trainingBehavioural
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.
ControlBehavioural
Participants in the control group will not be taught any breathing techniques but will be included in all assessments.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Participants will receive raise-CO2 breathing regulation training Receives: Behavioral: Raise-CO2 breathing regulation training |
| 2 | Experimental | Participants will receive lower-CO2 breathing regulation training Receives: Behavioral: Lower-CO2 breathing regulation training |
| 3 | Active comparator | Participants will receive no breathing regulation training Receives: Behavioral: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Breathing regulation
Measured: Measured at Month 6 after completion of therapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2005 (estimated)
- Study startMar 2005
- Primary completionNov 2008
- Study completionNov 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Panic DisorderStudies of the same condition, open and under way.
- More trials run by Stanford UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 136 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Responsible party
- Principal investigator, Walton T Roth, Stanford University
- Investigators
- Walton T. Roth, MD, Principal investigator, Stanford University and VA Health Care System
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00183521
- Sponsor's protocol ID
- R01MH066953
- Other IDs
- R01MH066953, DATR A2-AIR
- Status last verified
- Nov 2011
- First submitted
- 13 Sep 2005
- Last updated
- 2 Dec 2011
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 22901344
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Respiratory Therapeutic Procedures in Panic Disorder
- ClinicalTrials.gov ID
- NCT00183521
- Acronym / sponsor ID
- R01MH066953
- Conditions
- Panic Disorder
- Keywords
- Hyperventilation, Breathing Exercises, Carbon Dioxide, Panic Attack
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 136 participants (actual)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- Mar 2005
- Primary completion
- Nov 2008 (actual)
- Study completion
- Nov 2008 (actual)
- First posted
- 16 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Behavioral: Raise-CO2 breathing regulation trainingParticipants will receive raise-CO2 breathing regulation training |
| 2 | Experimental | Behavioral: Lower-CO2 breathing regulation trainingParticipants will receive lower-CO2 breathing regulation training |
| 3 | Active comparator | Behavioral: ControlParticipants will receive no breathing regulation training |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Raise-CO2 breathing regulation trainingReverse 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. | Behavioural | 1 |
| Lower-CO2 breathing regulation trainingAccording 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. | Behavioural | 2 |
| ControlParticipants in the control group will not be taught any breathing techniques but will be included in all assessments. | Behavioural | 3 |
Primary outcome
Breathing regulation
Time frame: Measured at Month 6 after completion of therapy
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Dec 2011.
- Derived from this study: PubMed 22901344Kim 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Walton T. Roth, MD principal investigator
Stanford University and VA Health Care System
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Raise-CO2 breathing regulation training and Lower-CO2 breathing regulation training in people with Panic Disorder, run by Stanford University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Dec 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Breathing regulation (time frame: Measured at Month 6 after completion of therapy). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00183521, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Dec 2011; AzTrials last refreshed its copy on 4 Nov 2026.