Clinical Trial: Trauma Management Therapy for OEF and OIF Combat Veterans

Study Status: Active, not recruiting
Recruit Status: Active, not recruiting
Study Type: Interventional

Official Title: Trauma Management Therapy for OEF and OIF Combat Veterans

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 Summary:

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
Sponsor: University of Central Florida

Current Primary Outcome: Clinician-Administered PTSD Scale (CAPS; Blake et al., 1990; Weathers & Litz, 1994; Weathers et al., 1999) [ Time Frame: after 17 weeks for two study arms; after three weeks for the third study arm ]

PTSD Symptom Severity


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Quality of Life Questionnaire (QLQ; Evans & Cope, 1989) [ Time Frame: after 17 weeks for two study arms; after three weeks for the third study arm ]
  • Clinician-Administered PTSD Scale (Selected items) [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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) [ Time Frame: after 17 weeks for two study arms; after three weeks for the third study arm ]
    PTSD Symptom Severity


Original Secondary Outcome: Same as current

Information By: University of Central Florida

Dates:
Date Received: May 10, 2016
Date Started: November 2015
Date Completion: November 2017
Last Updated: October 30, 2016
Last Verified: October 2016