Panic DisorderNCT01346241
Improving Access To Services to Community Based Outpatient Clinics (CBOC's)
A study of Panic Disorder, run by Michael E. DeBakey VA Medical Center at 1 site in United States.
Trial summary
The purpose of this study is to examine the feasibility of delivering IPCT in three rural VA community based outpatient clinics (CBOCs). Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Panic Disorder
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2011to Apr 2013
- 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- OEF/OIF/OND Veteran with current diagnosis of panic disorder with or without agoraphobia (presence of other anxiety disorders is acceptable)
Who cannot join
- Current substance dependence
- psychosis
- symptomatic bipolar disorder
- severe depression with suicidal intent or plan
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Michael E. DeBakey VA Medical Center and CBOC's (Lufkin, Texas City, and Conroe)
Houston, Texas, 77030
Ken Woods, 713-791-1414 ext. 2247, ken.woods@va.gov
About this study
Official title: Improving Access To Services With An Intensive Two-Day Treatment For Panic
The purpose of this study is to examine the feasibility of delivering IPCT in three rural VA community based outpatient clinics (CBOCs).
Read the detailed description
We will first need to develop a more thorough understanding of the potential barriers associated with implementing this novel form of treatment in these settings by conducting focus groups at each facility. This information will then be used to modify the treatment, which will then be piloted with Veterans enrolled in these clinics who have panic disorder.
- Conditions
- Panic Disorder
- Being tested
- Intensive Panic Control Treatment (IPCT)
- Keywords
- Panic, Anxiety
- Medical subject headings
- Panic Disorder, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intensive Panic Control Treatment (IPCT)Behavioural
Also called Panic Disorder
A manualized treatment that consists of psychoeducation about panic disorder
What is being measured
The primary outcome is the main question the study is designed to answer.
Intensive Panic Control Treatment (IPCT)
IPCT is a manualized treatment that consists of psychoeducation about panic disorder, behavioral exercises such as breathing retraining and interoceptive exposure to mimic symptoms during an actual panic attack, and cognitive restructuring (identifying thought distortions and replacing them with corrective thoughts based on realistic appraisals).
Measured: 3 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 May 2011 (estimated)
- Study startApr 2011
- Primary completionApr 2013 (estimated)
- Study completionApr 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Panic DisorderStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Michael E. DeBakey VA Medical Center
- Sponsor type
- US federal agency
- Investigators
- Ellen Teng, Ph.D, Principal investigator, Michael E. DeBakey VA Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01346241
- Sponsor's protocol ID
- H-28272
- Status last verified
- Apr 2011
- First submitted
- 29 Apr 2011
- Last updated
- 2 May 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 May 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Access To Services With An Intensive Two-Day Treatment For Panic
- ClinicalTrials.gov ID
- NCT01346241
- Acronym / sponsor ID
- H-28272
- Conditions
- Panic Disorder
- Keywords
- Panic, Anxiety
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Michael E. DeBakey VA Medical CenterUS federal agency
- Study start
- Apr 2011
- Primary completion
- Apr 2013 (estimated)
- Study completion
- Apr 2013 (estimated)
- First posted
- 2 May 2011 (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.
The purpose of this study is to examine the feasibility of delivering IPCT in three rural VA community based outpatient clinics (CBOCs).
Detailed description
We will first need to develop a more thorough understanding of the potential barriers associated with implementing this novel form of treatment in these settings by conducting focus groups at each facility. This information will then be used to modify the treatment, which will then be piloted with Veterans enrolled in these clinics who have panic disorder.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- OEF/OIF/OND Veteran with current diagnosis of panic disorder with or without agoraphobia (presence of other anxiety disorders is acceptable)
Key exclusion criteria (4 listed)
- Current substance dependence
- psychosis
- symptomatic bipolar disorder
- severe depression with suicidal intent or plan
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 |
|---|---|---|
| Intensive Panic Control Treatment (IPCT)Also: Panic DisorderA manualized treatment that consists of psychoeducation about panic disorder | Behavioural | – |
Primary outcome
Intensive Panic Control Treatment (IPCT)
Time frame: 3 Months
IPCT is a manualized treatment that consists of psychoeducation about panic disorder, behavioral exercises such as breathing retraining and interoceptive exposure to mimic symptoms during an actual panic attack, and cognitive restructuring (identifying thought distortions and replacing them with corrective thoughts based on realistic appraisals).
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 May 2011.
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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.
Ellen Teng, Ph.D principal investigator
Michael E. DeBakey VA Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study of Panic Disorder, run by Michael E. DeBakey VA Medical Center 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 1 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 2 May 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ken Woods (713-791-1414 ext. 2247, ken.woods@va.gov), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Intensive Panic Control Treatment (IPCT) (time frame: 3 Months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 May 2011.