AnxietyNCT00108277
Respiratory Dysregulation and Breathing Training in Anxious Outpatients
A study testing Breathing Training-Raise CO2 and Breathing Training- Lower CO2 in people with Anxiety, run by US Department of Veterans Affairs at 1 site in United States.
Trial summary
This study will explore respiratory dysregulation in anxious outpatients and examine the effect of breathing training with biofeedback for those anxious patients. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Anxiety
- What is being tested?
- Breathing Training-Raise CO2 and Breathing Training- Lower CO2
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 92 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2005to Sep 2010
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Patients must be rated 2 or more on both Q1 and Q3, but they must not meet the full criteria for PD as determined by the Anxiety Disorders Interview Schedule for DSM-IV-Lifetime Version (ADIS).
- In addition, they must be clinically stable enough that changes in the patients' anxiety levels can be attributed to the breathing training rather than to other new treatment initiatives during the training and 1-month evaluation periods or to spontaneous fluctuations in anxiety levels. Thus, potential participants taking SSRIs or other antidepressants, or benzodiazepines have to have been on a stable dose of these medicines for at least the previous two months.
Who cannot join
- Potential participants taking short-acting benzodiazepines such as alprazolam in excess of 2.0 mg/day or the equivalent on any day in the past month are excluded, because improvement might show up only in terms of reduction of medication dosage and not on the evaluation measures planned.
Trial locations and contacts
1 site in 1 country.
United States1 site
VA Palo Alto Health Care System
Palo Alto, California, 94304-1290
About this study
This study will explore respiratory dysregulation in anxious outpatients and examine the effect of breathing training with biofeedback for those anxious patients.
Read the detailed description
In clinic testing and outside the clinic testing, we will assess the prevalence of respiratory dysregulation in a sample of 60 non-psychotic, not currently alcohol or drug abusing veteran outpatients from our MHC (Mental Hygiene Clinic) who experience episodic anxiety but who do not qualify and have never qualified for the diagnosis of PD (panic disorder). These patients will be compared to 30 patients who are not clinically anxious. Of these 60 anxious patients, 30 will be randomly assigned to a 4-week course of breathing training assisted by feedback of end-tidal pCO2 levels as an augmentation of their current treatment. They will be compared to 30 who simply will continue with their current treatment (TAU). The breathing training group will receive clinical and physiological assessments immediately before the treatment period, four weeks after the end of the treatment period, and at a 4-month follow-up. The TAU group will be assessed three times at equivalent intervals, and if they wish, may undergo breathing training after the third assessment. Treatment will take place mainly in the first two years, giving us adequate time for follow-up and data analysis. We expect that this therapy will be especially effective for treating anxiety in the patients with substantial respiratory dysregulation.
- Conditions
- Anxiety
- Being tested
- Breathing Training-Raise CO2, Breathing Training- Lower CO2
- Keywords
- Anxiety, Breathing Training, Respiratory Dysregulation
- Medical subject headings
- Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Breathing Training-Raise CO2Behavioural
while breathing 9 breaths per minute, patients are instructed to raise CO2
Breathing Training- Lower CO2Behavioural
while breathing 9 breaths per minute, patients are instructed to lower CO2
| Study group | Role | What they receive |
|---|---|---|
| Raise CO2 | Experimental | Raise CO2 - biofeedback-assisted breathing training to raise baseline pCO2 Receives: Behavioral: Breathing Training-Raise CO2 |
| Lower CO2 | Active comparator | Lower CO2 - biofeedback-assisted breathing training to lower baseline pCO2 Receives: Behavioral: Breathing Training- Lower CO2 |
| Waitlist | No intervention | Waitlist - treatment as usual |
What is being measured
The primary outcome is the main question the study is designed to answer.
Episodic Anxiety Scale
Episodic Anxiety Scale (EAS) is a modification of the Panic Disorder Severity Scale (Shear et al., 1997) that includes 2 additional questions regarding acute anxiety episodes that may not meet full criteria for a panic attack. The EAS consists of 9 questions, each ranging from 0 (none) to 4 (worst possible). The EAS total score is the sum of all 9 items, such that the minimum total score = 0 (no anxiety symptoms) and maximum total score = 36 (worst possible anxiety symptoms).
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2005 (estimated)
- Study startApr 2005
- Primary completionDec 2008
- Study completionSep 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for AnxietyStudies of the same condition, open and under way.
- 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
- 92 participants (actual)
Sponsor and investigators
- Lead sponsor
- US Department of Veterans Affairs
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Walton Roth, MD, Principal investigator, VA Palo Alto Health Care System
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00108277
- Sponsor's protocol ID
- MHBA-028-04S
- Status last verified
- Jan 2015
- First submitted
- 14 Apr 2005
- Last updated
- 19 Jan 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Wollburg E, Roth WT, Kim S. Effects of breathing training on voluntary hypo- and hyperventilation in patients with panic disorder and episodic anxiety. Appl Psychophysiol Biofeedback. 2011 Jun;36(2):81-91. doi: 10.1007/s10484-011-9150-5.
PubMed 21373936Doberenz S, Roth WT, Wollburg E, Maslowski NI, Kim S. Methodological considerations in ambulatory skin conductance monitoring. Int J Psychophysiol. 2011 May;80(2):87-95. doi: 10.1016/j.ijpsycho.2011.02.002. Epub 2011 Feb 21.
PubMed 21320551
Study at a glance
From the registry record, last updated by the sponsor on 19 Jan 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Respiratory Dysregulation and Breathing Training in Anxious Outpatients
- ClinicalTrials.gov ID
- NCT00108277
- Acronym / sponsor ID
- MHBA-028-04S
- Conditions
- Anxiety
- Keywords
- Anxiety, Breathing Training, Respiratory Dysregulation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 92 participants (actual)
- Lead sponsor
- US Department of Veterans AffairsUS federal agency
- Study start
- Apr 2005
- Primary completion
- Dec 2008 (actual)
- Study completion
- Sep 2010 (actual)
- First posted
- 15 Apr 2005 (estimated)
- Results
- Posted 8 Jan 2015
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 explore respiratory dysregulation in anxious outpatients and examine the effect of breathing training with biofeedback for those anxious patients.
Detailed description
In clinic testing and outside the clinic testing, we will assess the prevalence of respiratory dysregulation in a sample of 60 non-psychotic, not currently alcohol or drug abusing veteran outpatients from our MHC (Mental Hygiene Clinic) who experience episodic anxiety but who do not qualify and have never qualified for the diagnosis of PD (panic disorder). These patients will be compared to 30 patients who are not clinically anxious. Of these 60 anxious patients, 30 will be randomly assigned to a 4-week course of breathing training assisted by feedback of end-tidal pCO2 levels as an augmentation of their current treatment. They will be compared to 30 who simply will continue with their current treatment (TAU). The breathing training group will receive clinical and physiological assessments immediately before the treatment period, four weeks after the end of the treatment period, and at a 4-month follow-up. The TAU group will be assessed three times at equivalent intervals, and if they wish, may undergo breathing training after the third assessment. Treatment will take place mainly in the first two years, giving us adequate time for follow-up and data analysis. We expect that this therapy will be especially effective for treating anxiety in the patients with substantial respiratory dysregulation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Raise CO2 | Experimental | Behavioral: Breathing Training-Raise CO2Raise CO2 - biofeedback-assisted breathing training to raise baseline pCO2 |
| Lower CO2 | Active comparator | Behavioral: Breathing Training- Lower CO2Lower CO2 - biofeedback-assisted breathing training to lower baseline pCO2 |
| Waitlist | No intervention | –Waitlist - treatment as usual |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Patients must be rated 2 or more on both Q1 and Q3, but they must not meet the full criteria for PD as determined by the Anxiety Disorders Interview Schedule for DSM-IV-Lifetime Version (ADIS).
- In addition, they must be clinically stable enough that changes in the patients' anxiety levels can be attributed to the breathing training rather than to other new treatment initiatives during the training and 1-month evaluation periods or to spontaneous fluctuations in anxiety levels. Thus, potential participants taking SSRIs or other antidepressants, or benzodiazepines have to have been on a stable dose of these medicines for at least the previous two months.
Key exclusion criteria (1 listed)
- Potential participants taking short-acting benzodiazepines such as alprazolam in excess of 2.0 mg/day or the equivalent on any day in the past month are excluded, because improvement might show up only in terms of reduction of medication dosage and not on the evaluation measures planned.
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 |
|---|---|---|
| Breathing Training-Raise CO2while breathing 9 breaths per minute, patients are instructed to raise CO2 | Behavioural | Raise CO2 |
| Breathing Training- Lower CO2while breathing 9 breaths per minute, patients are instructed to lower CO2 | Behavioural | Lower CO2 |
Primary outcome
Episodic Anxiety Scale
Time frame: 1 month
Episodic Anxiety Scale (EAS) is a modification of the Panic Disorder Severity Scale (Shear et al., 1997) that includes 2 additional questions regarding acute anxiety episodes that may not meet full criteria for a panic attack. The EAS consists of 9 questions, each ranging from 0 (none) to 4 (worst possible). The EAS total score is the sum of all 9 items, such that the minimum total score = 0 (no anxiety symptoms) and maximum total score = 36 (worst possible anxiety symptoms).
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jan 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 21373936Wollburg E, Roth WT, Kim S. Effects of breathing training on voluntary hypo- and hyperventilation in patients with panic disorder and episodic anxiety. Appl Psychophysiol Biofeedback. 2011 Jun;36(2):81-91. doi: 10.1007/s10484-011-9150-5.
- Results publication: PubMed 21320551Doberenz S, Roth WT, Wollburg E, Maslowski NI, Kim S. Methodological considerations in ambulatory skin conductance monitoring. Int J Psychophysiol. 2011 May;80(2):87-95. doi: 10.1016/j.ijpsycho.2011.02.002. Epub 2011 Feb 21.
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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 Roth, MD principal investigator
VA Palo Alto 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 Breathing Training-Raise CO2 and Breathing Training- Lower CO2 in people with Anxiety, run by US Department of Veterans Affairs 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 2 inclusion and 1 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 19 Jan 2015. 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?
Yes. Results are posted in the registry (first posted 8 Jan 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Episodic Anxiety Scale (time frame: 1 month). 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 NCT00108277, which also lists 2 linked publications.
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 19 Jan 2015.