Trauma Management Therapy for OEF and OIF Combat Veterans
Condition: Post-Traumatic Stress Disorder; Combat Disorders
MeSH terms: Stress Disorders, Traumatic; Stress Disorders, Post-Traumatic; Combat Disorders
Study type: Interventional
Phase: Phase 2

Summary: 
      This trial will evaluate the efficacy and efficiency of Trauma Management Therapy (TMT;
      Frueh, Turner, Beidel, 1996; Beidel, Frueh, Uhde, under preparation), 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. TMT will be conducted in traditional
      17-week format, and a 3-week intensive treatment format. Outcome will be assessed using
      relevant clinical, process, and cost outcomes. Additionally, investigators 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.
    

Detailed description: 
      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.
    

Intervention name(s): 17 week Exposure Therapy Control Arm; Trauma Management Therapy; Intensive 3-Week Trauma Management Therapy
Intervention type(s): Behavioral; Behavioral; Behavioral
Intervention description(s): 15 individual VR-assisted exposure therapy sessions and 14 psychoeducational group sessions conducted over a period of 17 weeks. After the Education session, treatment occurs three times a week during the Virtual Reality (VR) assisted Exposure phase, and then once a week during the Psychoeducational phase.The psychoeducational group therapy, will include topics such as: DSM-IV criteria of PTSD, prevalence of PTSD, risk factors for PTSD, biological and conditioning models of PTSD, PTSD comorbidity, pharmacological treatment of PTSD, the impact of substance abuse, impairment in interpersonal functioning among veterans with PTSD, and issues related to anger control problems and suggested coping strategies; TMT consists of 29 treatment sessions administered over a period of 17 weeks. After the Education session, treatment occurs three times a week during the Virtual Reality (VR) assisted Exposure phase, and then once a week during Social and Emotional Regulation (SER). Education and exposure are implemented individually while SER is administered in small group sessions (3-5 people). All exposure treatment sessions will terminate after a decline of 50% in the highest rating recorded. SER sessions will be 90 minutes. The treatment program as a whole results in approximately 43.5 hours of therapist contact for each patient.; Intensive 3-Week Trauma Management Therapy consists of 29 treatment sessions administered over a period of 3 weeks. Individual VR-assisted exposure sessions and group sessions are conducted Monday-Friday with individual sessions conducted in the morning and Social and Emotional Regulation (SER) sessions conducted in the afternoon. Education and exposure are implemented individually while SER is administered in small group sessions (3-5 people). All exposure treatment sessions will terminate after a decline of 50% in the highest rating recorded. SER sessions will be 90 minutes. The treatment program as a whole results in approximately 43.5 hours of therapist contact for each patient.
Other intervention name(s): Exposure Therapy, Psychoeducation; TMT; Intensive TMT
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: efficiency; exposure therapy; PTSD; combat; veterans