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Trauma Management Therapy for OEF and OIF Combat Veterans (TMT)

Primary Purpose

Post-Traumatic Stress Disorder, Combat Disorders

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
17 week Exposure Therapy Control Arm
Trauma Management Therapy
Intensive 3-Week Trauma Management Therapy
Sponsored by
University of Central Florida
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Post-Traumatic Stress Disorder focused on measuring efficiency, exposure therapy, PTSD, combat, veterans

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • University of Central Florida

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Active Comparator

Arm Label

17 week Trauma Management Therapy (TMT)

3 week Trauma Management Therapy (TMT)

17 week Exposure Therapy Control Arm

Arm Description

TMTconsists of 29 treatment sessions administered over a period of 3 weeks. Individual VR-assisted exposure sessions (14 sessions) are followed by Social and Emotional Regulation (SER) sessions conducted in small groups. Individual exposure therapy includes virtual reality to assist in augmenting exposure therapy. Group therapy includes anger management, social skills training, problem solving and behavioral activation for depression. 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.

The Control Arm of the study contains 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

Outcomes

Primary Outcome Measures

Clinician-Administered PTSD Scale (CAPS; Blake et al., 1990; Weathers & Litz, 1994; Weathers et al., 1999)
PTSD Symptom Severity

Secondary Outcome Measures

Quality of Life Questionnaire (QLQ; Evans & Cope, 1989)
Clinician-Administered PTSD Scale (Selected items)
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
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
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
The SF-36 is a 36-item questionnaire that measures health status and functioning over the past four weeks
Patient Ratings
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)
PTSD Symptom Severity

Full Information

First Posted
May 10, 2016
Last Updated
October 29, 2017
Sponsor
University of Central Florida
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1. Study Identification

Unique Protocol Identification Number
NCT02809326
Brief Title
Trauma Management Therapy for OEF and OIF Combat Veterans
Acronym
TMT
Official Title
Trauma Management Therapy for OEF and OIF Combat Veterans
Study Type
Interventional

2. Study Status

Record Verification Date
October 2017
Overall Recruitment Status
Completed
Study Start Date
November 2015 (undefined)
Primary Completion Date
June 2017 (Actual)
Study Completion Date
June 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Central Florida

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Post-Traumatic Stress Disorder, Combat Disorders
Keywords
efficiency, exposure therapy, PTSD, combat, veterans

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
180 (Actual)

8. Arms, Groups, and Interventions

Arm Title
17 week Trauma Management Therapy (TMT)
Arm Type
Experimental
Arm Description
TMTconsists of 29 treatment sessions administered over a period of 3 weeks. Individual VR-assisted exposure sessions (14 sessions) are followed by Social and Emotional Regulation (SER) sessions conducted in small groups. Individual exposure therapy includes virtual reality to assist in augmenting exposure therapy. Group therapy includes anger management, social skills training, problem solving and behavioral activation for depression. The treatment program as a whole results in approximately 43.5 hours of therapist contact for each patient.
Arm Title
3 week Trauma Management Therapy (TMT)
Arm Type
Experimental
Arm Description
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.
Arm Title
17 week Exposure Therapy Control Arm
Arm Type
Active Comparator
Arm Description
The Control Arm of the study contains 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
Intervention Type
Behavioral
Intervention Name(s)
17 week Exposure Therapy Control Arm
Other Intervention Name(s)
Exposure Therapy, Psychoeducation
Intervention Description
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
Intervention Type
Behavioral
Intervention Name(s)
Trauma Management Therapy
Other Intervention Name(s)
TMT
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Intensive 3-Week Trauma Management Therapy
Other Intervention Name(s)
Intensive TMT
Intervention Description
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.
Primary Outcome Measure Information:
Title
Clinician-Administered PTSD Scale (CAPS; Blake et al., 1990; Weathers & Litz, 1994; Weathers et al., 1999)
Description
PTSD Symptom Severity
Time Frame
after 17 weeks for two study arms; after three weeks for the third study arm
Secondary Outcome Measure Information:
Title
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
Title
Clinician-Administered PTSD Scale (Selected items)
Description
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
Time Frame
after 17 weeks for two study arms; after three weeks for the third study arm
Title
Objective Functional Indicators
Description
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.
Time Frame
after 17 weeks for two study arms; after three weeks for the third study arm
Title
Clinical Global Impressions Scale
Description
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.
Time Frame
after 17 weeks for two study arms; after three weeks for the third study arm
Title
Health-Related Functioning: Medical Outcome Study Short Form-36 Health Survey
Description
The SF-36 is a 36-item questionnaire that measures health status and functioning over the past four weeks
Time Frame
after 17 weeks for two study arms; after three weeks for the third study arm
Title
Patient Ratings
Description
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
Time Frame
after 17 weeks for two study arms; after three weeks for the third study arm
Title
The PTSD Checklist (PCL-M; Weathers et al., 1993)
Description
PTSD Symptom Severity
Time Frame
after 17 weeks for two study arms; after three weeks for the third study arm
Other Pre-specified Outcome Measures:
Title
Treatment Credibility
Description
To assess for differences in outcome expectancy, treatment credibility scales developed by Borkovec and Nau (1972) will be used. Four of the questions will be used for this study, with 10-point Likert scales. These include questions regarding how logical the treatment seems, how confident participants are about treatment, and their expectancy of success.
Time Frame
after week 3 for 17 week arms; after third day for 3 week arm
Title
Charleston Psychiatric Outpatient Satisfaction Scale (CPOSS-VA; Frueh et al., 2002):
Description
The CPOSS-VA is 16-item measure, with a Likert scale response format, based on a general measure of patient satisfaction (Pellegrin et al., 2001).
Time Frame
after 17 weeks for two study arms; after three weeks for the third study arm

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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: 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. 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. 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. Patients must have a symptom duration of at least 6 months. 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Deborah C Beidel, Ph.D., ABPP
Organizational Affiliation
University of Central Florida
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Central Florida
City
Orlando
State/Province
Florida
ZIP/Postal Code
32816
Country
United States

12. IPD Sharing Statement

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Trauma Management Therapy for OEF and OIF Combat Veterans

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