Trauma Management Therapy for OEF and OIF Combat Veterans
- Conditions
- Combat DisordersPost-Traumatic Stress Disorder
- Registration Number
- NCT02809326
- Lead Sponsor
- University of Central Florida
- Brief 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 180
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Clinician-Administered PTSD Scale (CAPS; Blake et al., 1990; Weathers & Litz, 1994; Weathers et al., 1999) after 17 weeks for two study arms; after three weeks for the third study arm PTSD Symptom Severity
- Secondary Outcome Measures
Name Time Method Quality of Life Questionnaire (QLQ; Evans & Cope, 1989) after 17 weeks for two study arms; after three weeks for the third study arm Clinician-Administered PTSD Scale (Selected items) after 17 weeks for two study arms; after three weeks for the third study arm We will examine a subset of the CAPS separately, using frequency and intensity ratings on 4 items (interest in activities, social detachment, range of affect, anger control). These items were independently rated by 3 of the study investigators as being representative of social/emotional functioning
Objective Functional Indicators after 17 weeks for two study arms; after three weeks for the third study arm Data will be collected via a clinician-administered rating form regarding objective indicators of social functioning, such as changes in marital status, employment status, residential status, legal involvement, psychiatric hospitalization, and utilization of medical care.
Clinical Global Impressions Scale after 17 weeks for two study arms; after three weeks for the third study arm The Severity and Global Improvement Subscales are each 7-point scales which are part of the ECDEU Assessment Manual for Psychopharmacology. They will be used to assess overall severity and improvement. The CGI severity rating is a frequently used measure in pharmacological treatment studies and could be useful in making comparisons of rates of improvement from this study and those of drug studies.
Health-Related Functioning: Medical Outcome Study Short Form-36 Health Survey after 17 weeks for two study arms; after three weeks for the third study arm The SF-36 is a 36-item questionnaire that measures health status and functioning over the past four weeks
Patient Ratings after 17 weeks for two study arms; after three weeks for the third study arm For a one-week period at each assessment point, patients will keep a log of daily symptoms, such as nightmares, flashbacks, total hours of sleep, and exaggerated startle responses behavioral ratings to monitor the frequency and severity (on a 10-point scale) of PTSD
The PTSD Checklist (PCL-M; Weathers et al., 1993) after 17 weeks for two study arms; after three weeks for the third study arm PTSD Symptom Severity
Trial Locations
- Locations (1)
University of Central Florida
🇺🇸Orlando, Florida, United States
University of Central Florida🇺🇸Orlando, Florida, United States