Clinical trial NCT00628979: 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
Overall status: COMPLETED
Phase: NA
Conditions: Panic Disorder
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
First posted: 2008-03-05
Enrollment: 23
Sex: ALL
Minimum age (years): 18
Maximum age (years): 74
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion Criteria:

1. Veterans;
2. age 18-74;
3. current diagnosis of panic disorder;
4. 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;
5. panic disorder and PTSD present for at least 1 month;
6. 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:

1. Current substance dependence;
2. diagnosed with bipolar disorder or psychosis;
3. current suicidal/homicidal ideation and intent;
4. severe depression (precluding participation in a research study);
5. panic attacks related only to a diagnosis of a specific phobia;
6. medical conditions mimicing anxiety (e.g., mitral valve prolapse);
7. 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.

Primary outcomes:
measure: Qualitative data regarding treatment seeking barriers
timeFrame: 6 months
Secondary outcomes:
measure: Panic attack frequency and severity; treatment acceptability
timeFrame: 6 months
Other outcomes:
Locations:
city: Houston
country: United States
facility: Michael E. DeBakey VA Medical Center (152)
state: Texas
Study officials:
affiliation: Michael E. DeBakey VA Medical Center (152)
name: Ellen Teng, PhD
role: PRINCIPAL_INVESTIGATOR
References: