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).
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Exposure Therapy is used to reduce the symptoms of PTSD
UCF RESTORES, University of Central Florida
Orlando, Florida, United States
Change from Baseline on the Clinician-Administered PTSD Scale for DSM-5
PTSD symptoms rating scale (severity and frequency) administered by blinded clinician
Time frame: 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
Time frame: 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
Time frame: 6 months posttreatment
Change from Baseline on the Posttraumatic Stress Disorder Checklist for DSM-5 (PCL-5)
Patient Self Report of PTSD symptoms
Time frame: 1 week posttreatment
Change from Baseline on the Posttraumatic Stress Disorder Checklist for DSM-5 (PCL-5)
Patient Self Report of PTSD symptoms
Time frame: 3 months posttreatment
Change from Baseline on the Posttraumatic Stress Disorder Checklist for DSM-5 (PCL-5)
Patient Self Report of PTSD symptoms
Time frame: 6 months posttreatment
Change from Baseline on the Traumatic Life Events Questionnaire (TLEQ)
self-report measure assessing lifetime history of 22 traumatic events
Time frame: 1 week posttreatment
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Enrollment
134
Change from Baseline on the Traumatic Life Events Questionnaire (TLEQ)
self-report measure assessing lifetime history of 22 traumatic events
Time frame: 3 months posttreatment
Change from Baseline on the Traumatic Life Events Questionnaire (TLEQ)
self-report measure assessing lifetime history of 22 traumatic events
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 6 months posttreatment
Change from baseline on the Connor-Davidson Resilience Scale (CD-RISC)
Patient report of coping ability
Time frame: 1 week posttreatment
Change from baseline on the Connor-Davidson Resilience Scale (CD-RISC)
Patient report of coping ability
Time frame: 3 months posttreatment
Change from baseline on the Connor-Davidson Resilience Scale (CD-RISC)
Patient report of coping ability
Time frame: 6 months posttreatment
Change from baseline on the Patient Health Questionnaire-9 (PHQ-9)
Patient report measure of depression symptoms
Time frame: 1 week posttreatment
Change from baseline on the Patient Health Questionnaire-9 (PHQ-9)
Patient report measure of depression symptoms
Time frame: 3 months posttreatment
Change from baseline on the Patient Health Questionnaire-9 (PHQ-9)
Patient report measure of depression symptoms
Time frame: 6 months posttreatment
Change from baseline on the Generalized Anxiety Disorder-7 (GAD-7)
Patient report measure of general anxiety symptoms
Time frame: 1 week posttreatment
Change from baseline on the Generalized Anxiety Disorder-7 (GAD-7)
Patient report measure of general anxiety symptoms
Time frame: 3 months posttreatment
Change from baseline on the Generalized Anxiety Disorder-7 (GAD-7)
Patient report measure of general anxiety symptoms
Time frame: 6 months posttreatment
Change from baseline on the Dimensions of Anger Reactions-5 (DAR-5)
Patient report measure of anger
Time frame: 1 week posttreatment
Change from baseline on the Dimensions of Anger Reactions-5 (DAR-5)
Patient report measure of anger
Time frame: 3 months posttreatment
Change from baseline on the Dimensions of Anger Reactions-5 (DAR-5)
Patient report measure of anger
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 6 months posttreatment
Sleep actigraphy - change from baseline in total sleep time
Objective assessment of sleep
Time frame: 1 week posttreatment
Sleep actigraphy - change from baseline in total sleep time
Objective assessment of sleep
Time frame: 3 months posttreatment
Sleep actigraphy - change from baseline in total sleep time
Objective assessment of sleep
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 6 months posttreatment
Sleep actigraphy - change from baseline in sleep efficiency
Objective assessment of sleep (% of time in bed spent sleeping)
Time frame: 1 week posttreatment
Sleep actigraphy - change from baseline in sleep efficiency
Objective assessment of sleep (% of time in bed spent sleeping)
Time frame: 3 months posttreatment
Sleep actigraphy - change from baseline in sleep efficiency
Objective assessment of sleep (% of time in bed spent sleeping)
Time frame: 6 months posttreatment
Sleep actigraphy - change from baseline in wake minutes after sleep onset
Objective assessment of sleep (# of minutes awake after falling asleep)
Time frame: 1 week posttreatment
Sleep actigraphy - change from baseline in wake minutes after sleep onset
Objective assessment of sleep (# of minutes awake after falling asleep)
Time frame: 3 months posttreatment
Sleep actigraphy - change from baseline in wake minutes after sleep onset
Objective assessment of sleep (# of minutes awake after falling asleep)
Time frame: 6 months posttreatment