Back to resultsAddressing Help-Seeking Barriers in Developing an Intensive Treatment for Veterans With Panic Disorder
Primary Purpose
Panic Disorder
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
CBT
Sponsored by
About this trial
This is an interventional treatment trial for Panic Disorder
Eligibility Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Sites / Locations
- Michael E. DeBakey VA Medical Center (152)
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
1
Arm Description
CBT
Outcomes
Primary Outcome Measures
Qualitative data regarding treatment seeking barriers
Secondary Outcome Measures
Panic attack frequency and severity; treatment acceptability
Full Information
NCT ID
NCT00628979
First Posted
February 25, 2008
Last Updated
July 1, 2009
Sponsor
US Department of Veterans Affairs
1. Study Identification
Unique Protocol Identification Number
NCT00628979
Brief Title
Addressing Help-Seeking Barriers in Developing an Intensive Treatment for Veterans With Panic Disorder
Official Title
Addressing Help-Seeking Barriers in Developing an Intensive Treatment for Veterans With Panic Disorder
Study Type
Interventional
2. Study Status
Record Verification Date
July 2009
Overall Recruitment Status
Completed
Study Start Date
March 2008 (undefined)
Primary Completion Date
March 2008 (Actual)
Study Completion Date
July 2009 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
US Department of Veterans Affairs
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Panic Disorder
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
23 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Other
Arm Description
CBT
Intervention Type
Behavioral
Intervention Name(s)
CBT
Intervention Description
cognitive- behavioral treatment for panic disorder.
Primary Outcome Measure Information:
Title
Qualitative data regarding treatment seeking barriers
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Panic attack frequency and severity; treatment acceptability
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
74 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ellen Teng, PhD
Organizational Affiliation
Michael E. DeBakey VA Medical Center (152)
Official's Role
Principal Investigator
Facility Information:
Facility Name
Michael E. DeBakey VA Medical Center (152)
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Addressing Help-Seeking Barriers in Developing an Intensive Treatment for Veterans With Panic Disorder
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