Trauma Management Therapy for OEF and OIF Combat Veterans

Background: Troop deployment for OIF/OEF has been extensive for the past five years Among
returning veterans, up to 18.5% are diagnosed with posttraumatic stress disorder (PTSD). In
addition to its positive symptoms (intrusive thoughts, reexperiencing, hyperarousal, and
avoidance), PTSD is associated with social maladjustment, poor quality of life, medical
comorbidity, and general symptom severity. Social and emotional problems include social
avoidance, guilt, anger, and unemployment, impulsive or violent behavior, and family discord.
A majority (> 90%) of veterans seeking treatment for PTSD also seek disability compensation
for debilitating occupational impairment and there are virtually no administrative or
research data to indicate veterans are recovering from PTSD. Exposure therapy, which operates
on long-established and fundamental principles of behavior therapy, offers hope for acute
symptom alleviation, but may not address severe social impairment.

Objectives/Hypothesis: To test the hypothesis that Trauma Management Therapy (TMT), which
combines individual virtual reality (VR) assisted exposure therapy with group social and
emotional rehabilitation skills training (will be superior to a treatment consisting of the
same VR- exposure and group psychoeducational group therapy. Outcome will be assessed using
relevant clinical, process, and cost outcomes. Additionally, we will assess the potential of
olfactory stimulation as a trigger for PTSD symptoms of intrusive thoughts and
re-experiencing. Therefore, this proposal will integrate clinical and neurobiological
assessment studies designed to understand the role of these factors in the etiology,
maintenance, and treatment of PTSD.

Specific Aims: There are three specific aims: First, we will evaluate the efficacy of Trauma
Management Therapy (TMT) for the treatment of PTSD in OIF/OEF and determine if TMT (which
combines exposure and social/emotional rehabilitation) improves social/emotional functioning
compared to our comparison group (exposure plus psychoeducational group therapy). Second, we
will explore olfactory activation patterns that may aid understanding of brain mechanisms in
PTSD. Third, we will determine TMT's cost efficacy using treatment expenses and resource
utilization measures.

Study Design: In a prospective randomized clinical trial we will test the superiority of TMT
for OIF/OEF veterans with PTSD compared to exposure therapy plus psychoeducational group
therapy. TMT combines VR assisted exposure therapy (VR-EXP) with social and emotional
rehabilitation (SER). In addition to clinical, process, and cost outcomes relevant to PTSD
for this population, we will include fMRI assessment of the central olfactory system in order
to document its hypothesized role in fear acquisition and maintenance. Relevant outcome
domains will be reassessed at mid-treatment, post-treatment, and 3- and 6-month follow-up.

Inclusion criteria:

Veterans or active duty military personnel with combat-related PTSD as a result of
deployment to Iraq or Afghanistan.

Exclusion criteria:

1. Personnel with acute cardiac difficulties (angina, myocardial infarction, and severe
hypertension) will initially be excluded from the study due to concern that intensive
EXP, often accompanied by temporary increases in heart rate and blood pressure, may
pose risks of exacerbating cardiac status. They will be included once they are cleared
by the cardiologist.

2. Veterans with comorbid Axis I psychotic disorders or acute substance abuse disorders
initially will be excluded from the study but will be eligible once their substance
abuse is under control for at least two weeks. Additionally, an Axis II diagnosis of
antisocial personality disorder will be reason for exclusion.

3. Because PTSD typically is accompanied by high rates of comorbid psychiatric disorders
(Keane & Wolfe, 1990), patients with comorbid depressive disorders, anxiety disorders,
and personality disorders other than Antisocial Personality Disorder will be included.
Also, veterans who have a diagnosis of mild Traumatic Brain Injury will be included,
in order that our sample is as representative of OIF/OEF veterans as possible. We will
address the issue of comorbid mTBI in the data analysis. In all cases included, PTSD
must be considered the primary disorder.

4. Patients must have a symptom duration of at least 6 months.

5. Patients on benzodiazepines will be given an opportunity to discontinue and will be
off benzodiazepines for at least two weeks prior to beginning the study. This
exclusion is based on the empirical evidence to suggest that the efficacy of EXP for
other anxiety disorders may be attenuated by benzodiazepines (Gray, 1987; Wardle,
1990). Patients on SSRI antidepressant medication for PTSD (Ballenger et al., 2000;
Brady et al., 2000) will be included once their medication regimen has stabilized for
at least 2 weeks. SSRI medication dosage must remain stable throughout the course of
the study.