Panic DisorderNCT00628979
Addressing Help-Seeking Barriers in Developing an Intensive Treatment for Veterans With Panic Disorder
A study testing CBT in people with Panic Disorder, run by US Department of Veterans Affairs at 1 site in United States.
Trial summary
The purpose of this study is to understand some of the reasons why recently deployed veterans decline psychosocial treatment options for panic disorder and to test a brief weekend treatment for panic attacks. Read more about this study
- Who is it for?
- Ages 18 to 74 years
- Conditions the study is for
- Panic Disorder
- What is being tested?
- CBT
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 23 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2008to Jul 2009
- 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 74 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Veterans;
- age 18-74;
- current diagnosis of panic disorder;
- PTSD symptoms that either meet full diagnostic criteria from the Diagnostic and Statistical Manual-Fourth Edition (DSM-IV) or are at a sub-clinical level. Sub-clinical PTSD is defined as patients who meet either PTSD criteria B and C or B and D, but fail to meet all three;
- panic disorder and PTSD present for at least 1 month;
- PART 1 only: patients who are clinically eligible to participate in the study and refuse standard psychosocial treatments (e.g., 12 weeks of cognitive behavioral therapy) for panic disorder.
Who cannot join
- Current substance dependence;
- diagnosed with bipolar disorder or psychosis;
- current suicidal/homicidal ideation and intent;
- severe depression (precluding participation in a research study);
- panic attacks related only to a diagnosis of a specific phobia;
- medical conditions mimicing anxiety (e.g., mitral valve prolapse);
- PART 1 only: patients who are clinically eligible for the study and are willing to engage in a minimum of 12 weeks of psychosocial treatment for panic disorder.
Trial locations and contacts
1 site in 1 country.
United States1 site
Michael E. DeBakey VA Medical Center (152)
Houston, Texas, 77030
About this study
The purpose of this study is to understand some of the reasons why recently deployed veterans decline psychosocial treatment options for panic disorder and to test a brief weekend treatment for panic attacks.
Read the detailed description
The population of interest for this program includes men and women returning from deployment in Iraq or Afghanistan who are seen in the TRP at the MEDVAMC. The study consists of two parts: PART 1 involves a qualitative investigation of treatment-seeking barriers specific to persons who refuse standard treatments and PART 2 is a pilot intervention to treat panic symptoms in service members who have co-existing PTSD symptoms. PART 1 will include approximately 15 individuals who will be interviewed by a member of the study staff. Patients will be interviewed individually following a semi-structured questionnaire designed to help identify treatment-seeking barriers. PART 2 will include 8 individuals who will be enrolled in an open-trial of a two-day intensive cognitive-behavioral treatment for panic disorder, which will occur over the weekend. No participants will be assigned to a control condition. All activities related to this project including the interviews and intervention will be delivered in either the TRP at the MEDVAMC or at the Houston Center for Quality of Care and Utilization Studies (HCQCUS), a nearby facility.
- Conditions
- Panic Disorder
- Being tested
- CBT
- Medical subject headings
- Panic Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CBTBehavioural
cognitive- behavioral treatment for panic disorder.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Other | CBT Receives: Behavioral: CBT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Qualitative data regarding treatment seeking barriers
Measured: 6 months
Secondary outcomes (1)
Panic attack frequency and severity; treatment acceptability
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2008 (estimated)
- Study startMar 2008
- Primary completionMar 2008
- Study completionJul 2009
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
- 23 participants (estimated)
Sponsor and investigators
- Lead sponsor
- US Department of Veterans Affairs
- Sponsor type
- US federal agency
- Investigators
- Ellen Teng, PhD, Principal investigator, Michael E. DeBakey VA Medical Center (152)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00628979
- Sponsor's protocol ID
- MIRECC004
- Status last verified
- Jul 2009
- First submitted
- 25 Feb 2008
- Last updated
- 3 Jul 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jul 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Addressing Help-Seeking Barriers in Developing an Intensive Treatment for Veterans With Panic Disorder
- ClinicalTrials.gov ID
- NCT00628979
- Acronym / sponsor ID
- MIRECC004
- Conditions
- Panic Disorder
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 23 participants (estimated)
- Lead sponsor
- US Department of Veterans AffairsUS federal agency
- Study start
- Mar 2008
- Primary completion
- Mar 2008 (actual)
- Study completion
- Jul 2009 (actual)
- First posted
- 5 Mar 2008 (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 understand some of the reasons why recently deployed veterans decline psychosocial treatment options for panic disorder and to test a brief weekend treatment for panic attacks.
Detailed description
The population of interest for this program includes men and women returning from deployment in Iraq or Afghanistan who are seen in the TRP at the MEDVAMC. The study consists of two parts: PART 1 involves a qualitative investigation of treatment-seeking barriers specific to persons who refuse standard treatments and PART 2 is a pilot intervention to treat panic symptoms in service members who have co-existing PTSD symptoms. PART 1 will include approximately 15 individuals who will be interviewed by a member of the study staff. Patients will be interviewed individually following a semi-structured questionnaire designed to help identify treatment-seeking barriers. PART 2 will include 8 individuals who will be enrolled in an open-trial of a two-day intensive cognitive-behavioral treatment for panic disorder, which will occur over the weekend. No participants will be assigned to a control condition. All activities related to this project including the interviews and intervention will be delivered in either the TRP at the MEDVAMC or at the Houston Center for Quality of Care and Utilization Studies (HCQCUS), a nearby facility.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Other | Behavioral: CBTCBT |
Who may qualify
- Ages
- 18 to 74 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Veterans;
- age 18-74;
- current diagnosis of panic disorder;
- PTSD symptoms that either meet full diagnostic criteria from the Diagnostic and Statistical Manual-Fourth Edition (DSM-IV) or are at a sub-clinical level. Sub-clinical PTSD is defined as patients who meet either PTSD criteria B and C or B and D, but fail to meet all three;
- panic disorder and PTSD present for at least 1 month;
Key exclusion criteria (7 listed)
- Current substance dependence;
- diagnosed with bipolar disorder or psychosis;
- current suicidal/homicidal ideation and intent;
- severe depression (precluding participation in a research study);
- panic attacks related only to a diagnosis of a specific phobia;
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 |
|---|---|---|
| CBTcognitive- behavioral treatment for panic disorder. | Behavioural | 1 |
Primary outcome
Qualitative data regarding treatment seeking barriers
Time frame: 6 months
1 secondary outcome
Panic attack frequency and severity; treatment acceptability
Time frame: 6 months
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 3 Jul 2009.
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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, PhD principal investigator
Michael E. DeBakey VA Medical Center (152)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CBT in people with Panic Disorder, 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 6 inclusion and 7 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 3 Jul 2009. 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?
Qualitative data regarding treatment seeking barriers (time frame: 6 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 3 Jul 2009.