Addressing Help-Seeking Barriers in Developing an Intensive Treatment for Veterans With Panic Disorder

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.

Study Overview

• Status: Completed
• Conditions: Panic Disorder
• Intervention / Treatment: Behavioral: CBT

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 Type: Interventional
• Enrollment (Anticipated): 23
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Texas
    • Houston, Texas, United States, 77030
      • Michael E. DeBakey VA Medical Center (152)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 74 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: 1; CBT	Behavioral: CBT; cognitive- behavioral treatment for panic disorder.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Qualitative data regarding treatment seeking barriers	6 months

Secondary Outcome Measures

Outcome Measure	Time Frame
Panic attack frequency and severity; treatment acceptability	6 months

Collaborators and Investigators

• Sponsor: US Department of Veterans Affairs
• Investigators: Principal Investigator: Ellen Teng, PhD, Michael E. DeBakey VA Medical Center (152)

Study record dates

Study Major Dates

• Study Start: March 1, 2008
• Primary Completion (Actual): March 1, 2008
• Study Completion (Actual): July 1, 2009

Study Registration Dates

• First Submitted: February 25, 2008
• First Submitted That Met QC Criteria: February 26, 2008
• First Posted (Estimate): March 5, 2008

Study Record Updates

• Last Update Posted (Estimate): July 3, 2009
• Last Update Submitted That Met QC Criteria: July 1, 2009
• Last Verified: July 1, 2009

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Anxiety Disorders; Panic Disorder
• Other Study ID Numbers: MIRECC004

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No