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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 17 week Trauma Management Therapy (TMT) | Experimental | 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. |
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| 3 week Trauma Management Therapy (TMT) | Experimental | 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. |
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| 17 week Exposure Therapy Control Arm | Active Comparator | 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 |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 17 week Exposure Therapy Control Arm | Behavioral | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Clinician-Administered PTSD Scale (CAPS; Blake et al., 1990; Weathers & Litz, 1994; Weathers et al., 1999) | PTSD Symptom Severity | after 17 weeks for two study arms; after three weeks for the third study arm |
| Measure | Description | Time Frame |
|---|---|---|
| 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) | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Treatment Credibility | 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. | after week 3 for 17 week arms; after third day for 3 week arm |
Inclusion criteria:
Veterans or active duty military personnel with combat-related PTSD as a result of deployment to Iraq or Afghanistan.
Exclusion criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Deborah C Beidel, Ph.D., ABPP | University of Central Florida | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Central Florida | Orlando | Florida | 32816 | United States |
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| ID | Term |
|---|---|
| D013313 | Stress Disorders, Post-Traumatic |
| D003130 | Combat Disorders |
| ID | Term |
|---|---|
| D040921 | Stress Disorders, Traumatic |
| D000068099 | Trauma and Stressor Related Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D007171 | Implosive Therapy |
| ID | Term |
|---|---|
| D003887 | Desensitization, Psychologic |
| D001521 | Behavior Therapy |
| D011613 | Psychotherapy |
| D004191 | Behavioral Disciplines and Activities |
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| Trauma Management Therapy | Behavioral | 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. |
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| Intensive 3-Week Trauma Management Therapy | Behavioral | 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. |
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| after 17 weeks for two study arms; after three weeks for the third study arm |
| 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. | after 17 weeks for two study arms; after three weeks for the third study arm |
| 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. | after 17 weeks for two study arms; after three weeks for the third study arm |
| 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 | after 17 weeks for two study arms; after three weeks for the third study arm |
| 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 | after 17 weeks for two study arms; after three weeks for the third study arm |
| The PTSD Checklist (PCL-M; Weathers et al., 1993) | PTSD Symptom Severity | after 17 weeks for two study arms; after three weeks for the third study arm |
| Charleston Psychiatric Outpatient Satisfaction Scale (CPOSS-VA; Frueh et al., 2002): | 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). | after 17 weeks for two study arms; after three weeks for the third study arm |