Clinical trial NCT02809326: Trauma Management Therapy for OEF and OIF Combat Veterans
Official title: Trauma Management Therapy for OEF and OIF Combat Veterans
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Post-Traumatic Stress Disorder
Combat Disorders
Keywords: efficiency
exposure therapy
PTSD
combat
veterans
Lead sponsor: University of Central Florida
Sponsor class: OTHER
First posted: 2016-06-22
Enrollment: 180
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Clinician-Administered PTSD Scale (CAPS; Blake et al., 1990; Weathers & Litz, 1994; Weathers et al., 1999)
timeFrame: after 17 weeks for two study arms; after three weeks for the third study arm
Secondary outcomes:
measure: Quality of Life Questionnaire (QLQ; Evans & Cope, 1989)
timeFrame: after 17 weeks for two study arms; after three weeks for the third study arm
measure: Clinician-Administered PTSD Scale (Selected items)
timeFrame: after 17 weeks for two study arms; after three weeks for the third study arm
measure: Objective Functional Indicators
timeFrame: after 17 weeks for two study arms; after three weeks for the third study arm
measure: Clinical Global Impressions Scale
timeFrame: after 17 weeks for two study arms; after three weeks for the third study arm
measure: Health-Related Functioning: Medical Outcome Study Short Form-36 Health Survey
timeFrame: after 17 weeks for two study arms; after three weeks for the third study arm
measure: Patient Ratings
timeFrame: after 17 weeks for two study arms; after three weeks for the third study arm
measure: The PTSD Checklist (PCL-M; Weathers et al., 1993)
timeFrame: after 17 weeks for two study arms; after three weeks for the third study arm
Other outcomes:
measure: Treatment Credibility
timeFrame: after week 3 for 17 week arms; after third day for 3 week arm
measure: Charleston Psychiatric Outpatient Satisfaction Scale (CPOSS-VA; Frueh et al., 2002):
timeFrame: after 17 weeks for two study arms; after three weeks for the third study arm
Locations:
city: Orlando
country: United States
facility: University of Central Florida
state: Florida
Study officials:
affiliation: University of Central Florida
name: Deborah C Beidel, Ph.D., ABPP
role: PRINCIPAL_INVESTIGATOR
References: