Clinical trial NCT01551199: Exposure Therapy for Veterans With PTSD and Panic Attacks (Phase 1)
Official title: Exposure Therapy for Veterans With PTSD and Panic Attacks (Phase 1)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: PTSD
Panic Attacks
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
First posted: 2012-03-12
Enrollment: 7
Sex: ALL
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: To evaluate the feasibility, acceptability and effectiveness of Multiple Channel Exposure Therapy-Veterans (MCET-V) as a treatment for returning service members with comorbid posttraumatic stress disorder (PTSD) and panic disorder (PD) in two phases. The first phase of the study will examine the feasibility and acceptability of MCET-V.

Detailed description: With the increasing number of Operations Iraqi Freedom and Enduring Freedom (OIF/OEF) veterans returning from war-zone areas, many will experience anxiety disorders such as PTSD and comorbid problems. Currently, about one in every six OIF/OEF veterans experiences PTSD and co-occurring PD. Although effective treatments exist for treating one or the other, we do not yet have treatments that can simultaneously target PTSD and PD. Thus, recent attention has focused on the development of multi-component treatments that simultaneously address PTSD and PD. This study is the first systematic investigation of a time-limited, multi-component cognitive-behavioral treatment for veterans with specific comorbid anxiety problems. The purpose of the first phase of the study is to evaluate the feasibility and acceptability of the multi-component cognitive-behavioral treatment in an open trial.

Eligibility criteria: Inclusion Criteria:

* being a veteran of any era;
* being enrolled in the Trauma Recovery Program (TRP) at the Michael E. DeBakey Veterans Affairs Medical Center (MEDVAMC), with a current diagnosis of PTSD and PD;
* being stable on psychotropic medication for 4 weeks before study participation; and
* being at least 18 years of age.

Exclusion Criteria:

* active substance dependence, or bipolar or psychotic disorders;
* severe depression and active suicidal ideation and intent (based on Structured Clinical Interview for DSM-IV disorders \[SCID-IV\] \& Beck Depression Inventory-2nd edition \[BDI-II\]);
* cognitive impairment as indicated by the St. Louis University Mental Status exam (SLUMS); and
* veterans currently receiving psychosocial treatment specifically targeting PTSD or panic symptoms.

Primary outcomes:
measure: Clinician Administered PTSD Scale (CAPS)
timeFrame: 1-week post-treatment (approximately week 14)
measure: Clinician Administered PTSD Scale (CAPS)
timeFrame: 3-month follow-up (approximately week 26)
Secondary outcomes:
measure: Anxiety Disorders Interview Schedule- DSM-IV (ADIS-IV)
timeFrame: 3 Months
Other outcomes:
Locations:
city: Houston
country: United States
facility: Michael E. DeBakey VA Medical Center, Houston, TX
state: Texas
Study officials:
affiliation: Michael E. DeBakey VA Medical Center, Houston, TX
name: Ellen Teng, PhD
role: PRINCIPAL_INVESTIGATOR
References: