Effectiveness of Trauma Management Therapy and Prolonged Exposure Therapy

Study Overview
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Brief Summary
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The purpose of this requirement is to identify an effective exposure psychotherapy paradigm for the treatment of Post-Traumatic Stress Disorder (PTSD) in active duty service members and veterans by comparing different exposure psychotherapy modalities. The long-term goal of exposure psychotherapy is to improve the mental health of U.S. service members and veterans with military-related PTSD. Recovery from PTSD will reduce the economic burden not only for those persons experiencing PTSD, but also for the health care system and society as a whole (Galovski & Lyons, 2004).

Detailed Description
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This study will provide an evaluation of performance and suitability of the compressed versions of exposure psychotherapy to support the capability gap for the treatment of active duty service members and veterans with PTSD by comparing different exposure psychotherapy modalities. The overall objective of this study is to determine if compressed psychotherapy can be used as an effective alternative treatment for PTSD and to compare the impact of TMT and PE on social, familial, and occupational impairment. The primary objectives will be to compare 1) 3 week TMT with 12 week PE and 2) 3 week TMT with 2 week PE for the effectiveness of reducing PTSD symptoms in a gated approach or some other method to control for multiplicity. Outcomes will be determined based upon self-report, clinician ratings, as well as other aspects of psychopathology, and social/emotional functioning. The addition of the TMT group component will be assessed in particular to determine its impact on social, familial, and occupational impairment. Blood samples should be collected from participants at baseline and at the end of the treatment period in order to identify PTSD biomarkers, e.g. predictors of response, biological subtypes of PTSD, and therapeutic markers. Collection, storage, and transfer of the blood samples to DoD should be performed according to standardized protocols provided by the DoD. One or more site visits may occur in order to assess adherence to standardized protocols.

Official Title
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Effectiveness of Trauma Management Therapy and Prolonged Exposure Therapy for the Treatment of Post-Traumatic Stress Disorder in an Active Duty Sample: A Comparison Study

Conditions
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PTSD

Intervention / Treatment
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* Behavioral: Exposure Therapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Active duty military personnel with a diagnoses of PTSD Traumatic event must have occurred during military service Military sexual trauma limited to attempted or completed sexual assault. Exclusion Criteria: Acute cardiac difficulties Severe comorbid substance use disorders. Diagnosis of schizophrenia or other psychotic disorders Diagnosis of antisocial personality disorder Moderate or severe traumatic brain injury (TBI) Use of benzodiazepines

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 64 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Trauma Management Therapy<br>1. Trauma Management Therapy (TMT; Turner, Beidel, & Frueh, 2005): TMT is a multicomponent behavioral treatment program designed to target various aspects of chronic PTSD - reducing emotional and physiological reactivity to traumatic cues, reducing intrusive symptoms and avoidance behavior, improving interpersonal skills and emotion modulation (e.g., anger control), and increasing the range of enjoyable social activities. In this investigation and in line with our previous publications, TMT will include virtual-reality augmented exposure (i.e. olfactory stimulation, heart rate, and skin conductance); group therapy to address sleep, anger, depression, and social isolation; homework assignments; and programmed practice. In the 3-week treatment program, each participant receives virtual-reality assisted exposure in the morning followed by in vivo exposure and group therapy (SER) each afternoon for a total of 29 sessions. | Behavioral: Exposure Therapy<br>* Exposure Therapy is used to reduce the symptoms of PTSD<br>|
| Active Comparator: Prolonged Exposure<br>2. Standard Prolonged Exposure (PE; Foa, Hembree, & Rothbaum, 2007) consists of psychoeducation, imaginal exposure to trauma memories, in vivo exposure to situations that are avoided due to their association with the trauma, and emotional processing. The standard protocol consists of 12 imaginal exposure sessions, along with in vivo exposure/homework assignments and listening to a recording of the imaginal sessions at home during the evening. | Behavioral: Exposure Therapy<br>* Exposure Therapy is used to reduce the symptoms of PTSD<br>|
| Active Comparator: Compressed Prolonged Exposure<br>3. Compressed PE consists of 10 standard PE sessions delivered on consecutive work days. The imaginal exposure sessions take place in the morning, with in vivo exposures assigned (not therapist accompanied) for the afternoons. Patients are instructed to listen to the recordings of the imaginal exposure each night. Being most concerned with having enough time for in vivo practice, Session 1 does not start on a Monday, allowing for two full weekends in order to maximize in vivo exposures. Both versions of PE average 36 total treatment hours. | Behavioral: Exposure Therapy<br>* Exposure Therapy is used to reduce the symptoms of PTSD<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from Baseline on the Clinician-Administered PTSD Scale for DSM-5 | PTSD symptoms rating scale (severity and frequency) administered by blinded clinician | 1 week posttreatment | 
| Change from Baseline on the Clinician-Administered PTSD Scale for DSM-5 | PTSD symptoms rating scale (severity and frequency) administered by blinded clinician | 3 months posttreatment | 
| Change from Baseline on the Clinician-Administered PTSD Scale for DSM-5 | PTSD symptoms rating scale (severity and frequency) administered by blinded clinician | 6 months posttreatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from Baseline on the Posttraumatic Stress Disorder Checklist for DSM-5 (PCL-5) | Patient Self Report of PTSD symptoms | 1 week posttreatment | 
| Change from Baseline on the Posttraumatic Stress Disorder Checklist for DSM-5 (PCL-5) | Patient Self Report of PTSD symptoms | 3 months posttreatment | 
| Change from Baseline on the Posttraumatic Stress Disorder Checklist for DSM-5 (PCL-5) | Patient Self Report of PTSD symptoms | 6 months posttreatment | 
| Change from Baseline on the Traumatic Life Events Questionnaire (TLEQ) | self-report measure assessing lifetime history of 22 traumatic events | 1 week posttreatment | 
| Change from Baseline on the Traumatic Life Events Questionnaire (TLEQ) | self-report measure assessing lifetime history of 22 traumatic events | 3 months posttreatment | 
| Change from Baseline on the Traumatic Life Events Questionnaire (TLEQ) | self-report measure assessing lifetime history of 22 traumatic events | 6 months posttreatment | 
| Change from Baseline on the Trauma-Related Guilt Inventory (TRGI) | 32-item measure rating 3 domains of trauma-related guilt cognitions (Global Guilt, Distress, and Guilt Cognitions) | 1 week posttreatment | 
| Change from Baseline on the Trauma-Related Guilt Inventory (TRGI) | 32-item measure rating 3 domains of trauma-related guilt cognitions (Global Guilt, Distress, and Guilt Cognitions) | 3 months posttreatment | 
| Change from Baseline on the Trauma-Related Guilt Inventory (TRGI) | 32-item measure rating 3 domains of trauma-related guilt cognitions (Global Guilt, Distress, and Guilt Cognitions) | 6 months posttreatment | 
| Change from Baseline on the Posttraumatic Cognitions Inventory (PTCI) | 36-item measure assessing 3 domains of trauma-related cognitions (Negative Cognitions about Self, Negative Cognitions about the World, and Self-Blame) | 1 week posttreatment | 
| Change from Baseline on the Posttraumatic Cognitions Inventory (PTCI) | 36-item measure assessing 3 domains of trauma-related cognitions (Negative Cognitions about Self, Negative Cognitions about the World, and Self-Blame) | 3 months posttreatment | 
| Change from Baseline on the Posttraumatic Cognitions Inventory (PTCI) | 36-item measure assessing 3 domains of trauma-related cognitions (Negative Cognitions about Self, Negative Cognitions about the World, and Self-Blame) | 6 months posttreatment | 
| Change from Baseline on the Moral Injury Event Scale (MIES) | patient-report measure assessing psychological distress associated with violations of moral standards. | 1 week posttreatment | 
| Change from Baseline on the Moral Injury Event Scale (MIES) | patient-report measure assessing psychological distress associated with violations of moral standards. | 3 months posttreatment | 
| Change from Baseline on the Moral Injury Event Scale (MIES) | patient-report measure assessing psychological distress associated with violations of moral standards. | 6 months posttreatment | 
| Change from baseline on the World Health Organization Disability Assessment Schedule 2.0 (WHODAS 2.0) | patient report of impairment in six domains: cognition, mobility, self-care, getting along with people, life activities (at home and work), and participation in society | 1 week posttreatment | 
| Change from baseline on the World Health Organization Disability Assessment Schedule 2.0 (WHODAS 2.0) | patient report of impairment in six domains: cognition, mobility, self-care, getting along with people, life activities (at home and work), and participation in society | 3 months posttreatment | 
| Change from baseline on the World Health Organization Disability Assessment Schedule 2.0 (WHODAS 2.0) | patient report of impairment in six domains: cognition, mobility, self-care, getting along with people, life activities (at home and work), and participation in society | 6 months posttreatment | 
| Change from baseline on the Quality of Life Scale (QOLS) | Patient report of 6 domains of life: independence, recreation, personal development and fulfillment, material and physical well-being, relationships with others, and community and civic involvement | 1 week posttreatment | 
| Change from baseline on the Quality of Life Scale (QOLS) | Patient report of 6 domains of life: independence, recreation, personal development and fulfillment, material and physical well-being, relationships with others, and community and civic involvement | 3 months posttreatment | 
| Change from baseline on the Quality of Life Scale (QOLS) | Patient report of 6 domains of life: independence, recreation, personal development and fulfillment, material and physical well-being, relationships with others, and community and civic involvement | 6 months posttreatment | 
| Change from baseline on the Connor-Davidson Resilience Scale (CD-RISC) | Patient report of coping ability | 1 week posttreatment | 
| Change from baseline on the Connor-Davidson Resilience Scale (CD-RISC) | Patient report of coping ability | 3 months posttreatment | 
| Change from baseline on the Connor-Davidson Resilience Scale (CD-RISC) | Patient report of coping ability | 6 months posttreatment | 
| Change from baseline on the Patient Health Questionnaire-9 (PHQ-9) | Patient report measure of depression symptoms | 1 week posttreatment | 
| Change from baseline on the Patient Health Questionnaire-9 (PHQ-9) | Patient report measure of depression symptoms | 3 months posttreatment | 
| Change from baseline on the Patient Health Questionnaire-9 (PHQ-9) | Patient report measure of depression symptoms | 6 months posttreatment | 
| Change from baseline on the Generalized Anxiety Disorder-7 (GAD-7) | Patient report measure of general anxiety symptoms | 1 week posttreatment | 
| Change from baseline on the Generalized Anxiety Disorder-7 (GAD-7) | Patient report measure of general anxiety symptoms | 3 months posttreatment | 
| Change from baseline on the Generalized Anxiety Disorder-7 (GAD-7) | Patient report measure of general anxiety symptoms | 6 months posttreatment | 
| Change from baseline on the Dimensions of Anger Reactions-5 (DAR-5) | Patient report measure of anger | 1 week posttreatment | 
| Change from baseline on the Dimensions of Anger Reactions-5 (DAR-5) | Patient report measure of anger | 3 months posttreatment | 
| Change from baseline on the Dimensions of Anger Reactions-5 (DAR-5) | Patient report measure of anger | 6 months posttreatment | 
| Change from baseline on the Clinical Global Impressions Scales (CGI) | Clinician rated scales to evaluate the severity of pretreatment psychopathology and treatment change | 1 week posttreatment | 
| Change from baseline on the Clinical Global Impressions Scales (CGI) | Clinician rated scales to evaluate the severity of pretreatment psychopathology and treatment change | 3 months posttreatment | 
| Change from baseline on the Clinical Global Impressions Scales (CGI) | Clinician rated scales to evaluate the severity of pretreatment psychopathology and treatment change | 6 months posttreatment | 
| Sleep actigraphy - change from baseline in total sleep time | Objective assessment of sleep | 1 week posttreatment | 
| Sleep actigraphy - change from baseline in total sleep time | Objective assessment of sleep | 3 months posttreatment | 
| Sleep actigraphy - change from baseline in total sleep time | Objective assessment of sleep | 6 months posttreatment | 
| Sleep actigraphy - change from baseline in sleep onset latency | Objective assessment of sleep (# of minutes to sleep onset after getting into bed) | 1 week posttreatment | 
| Sleep actigraphy - change from baseline in sleep onset latency | Objective assessment of sleep (# of minutes to sleep onset after getting into bed) | 3 months posttreatment | 
| Sleep actigraphy - change from baseline in sleep onset latency | Objective assessment of sleep (# of minutes to sleep onset after getting into bed) | 6 months posttreatment | 
| Sleep actigraphy - change from baseline in sleep efficiency | Objective assessment of sleep (% of time in bed spent sleeping) | 1 week posttreatment | 
| Sleep actigraphy - change from baseline in sleep efficiency | Objective assessment of sleep (% of time in bed spent sleeping) | 3 months posttreatment | 
| Sleep actigraphy - change from baseline in sleep efficiency | Objective assessment of sleep (% of time in bed spent sleeping) | 6 months posttreatment | 
| Sleep actigraphy - change from baseline in wake minutes after sleep onset | Objective assessment of sleep (# of minutes awake after falling asleep) | 1 week posttreatment | 
| Sleep actigraphy - change from baseline in wake minutes after sleep onset | Objective assessment of sleep (# of minutes awake after falling asleep) | 3 months posttreatment | 
| Sleep actigraphy - change from baseline in wake minutes after sleep onset | Objective assessment of sleep (# of minutes awake after falling asleep) | 6 months posttreatment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Trauma Management Therapy, Exposure Therapy, Group Therapy, PTSD, Military