Clinical trial NCT03932773: Multi-site Confirmatory Efficacy Treatment Trial of Combat-related PTSD
Official title: Multi-site Confirmatory Efficacy Treatment Trial of Combat-related PTSD
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Post Traumatic Stress Disorder
Keywords: PTSD
post-traumatic stress disorder
military-related PTSD
CPT
cognitive processing therapy
rTMS
repetitive transcranial magnetic stimulation
combat
combat-related PTSD
Lead sponsor: The University of Texas at Dallas
Sponsor class: OTHER
Collaborators: name: University of Texas Southwestern Medical Center
name: Johns Hopkins University
name: Metrocare Services of Dallas
name: Florida State University
First posted: 2019-05-01
Enrollment: 330
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants will be randomly assigned to one of three treatment arms: (1) 1 Hz (hertz) repetitive transcranial magnetic stimulation (rTMS) to the right dorsolateral prefrontal cortex (rDLPFC) coupled with Cognitive Processing Therapy (CPT), (2) sham rTMS coupled with CPT, or (3) 1 Hz rTMS to the rDLPFC alone.
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to examine the benefits of combining repetitive Transcranial Magnetic Stimulation (rTMS) coupled with Cognitive Processing Therapy (CPT) in treating combat-related Posttraumatic Stress Disorder (PTSD) symptoms. The study will also examine change in depression, psychosocial functioning, and neurophysiological (i.e., electroencephalography and magnetic resonance images) measures.

Detailed description: Using three treatment arms, the study will examine Posttraumatic Stress Disorder (PTSD) symptom reduction when (1) 1 Hz (hertz) repetitive transcranial magnetic stimulation (rTMS) to the right dorsolateral prefrontal cortex (rDLPFC) is administered prior to each of 12 Cognitive Processing Therapy (CPT) sessions compared to when (2) sham rTMS is administered to the rDLPFC is administered prior to each of 12 CPT sessions and to when (3) 1 Hz rTMS is delivered to rDLPFC alone over 12 sessions.

Veterans with combat-related PTSD will be randomly assigned to one of the three treatment arms. Primary outcome PTSD symptom severity measures, secondary neuropsychological, electroencephalography (EEG), and magnetic resonance imaging (MRI) outcome measures, and prescreening assessments for study contraindicators will be collected prior to being assigned to a treatment arm (i.e., baseline).

Primary outcome PTSD symptom severity measures and secondary neuropsychological outcome measures will be collected twice within the span of the treatment sessions (i.e., sessions 5 and 9) and at three times following treatment competition (i.e., 1-month, 6-months, and 12-months). EEG also will be collected at the 1-month, 6-month, and 12-month assessments, and MRI will be collected at the 6-month and 12-month assessments.

Eligibility criteria: Inclusion Criteria:

* Veterans of Post-9/11 military conflicts
* with diagnosis of PTSD based on CAPS-5 related to Post-9/11 military combat

Exclusion Criteria:

* current enrollment in an acute experimental treatment for PTSD or trauma-focused psychotherapy treatment
* PTSD-inducing trauma exposure occurring within the last 3 months prior to pre-enrollment evaluation
* history of epilepsy or seizure disorder, a history of major head trauma,
* any neurologic condition likely to increase risk of seizures,
* brain tumors,
* moderate to severe substance use disorder in last 3 months or any substance use that puts the participant at increased risk or significant impairment
* stroke, and blood vessel abnormalities in the brain,
* dementia,
* Parkinson's disease, Huntington's chorea, or multiple sclerosis
* a high suicide risk
* a lifetime history of psychotic disorder or bipolar disorder
* inability to stop taking any medication that significantly lowers the seizure threshold
* pregnant or nursing
* metal fragments in the head, or any metal objects in or near the head that cannot be safely removed
* We will screen for a history of traumatic brain injury and exclude potential participants from the study if they have a history of severe TBI or are at high risk for seizures.
* history of seizures
* non-English speakers because not all of the screening forms, questionnaires, and tests are available in any language except for English
* cardiac pacemaker, implanted medication pumps of any sort that would increase the risk of rTMS
* any current medical condition that could preclude being able to safely participate in TMS treatment,
* use of prescription medication or illegal substances that lower the seizure threshold
* previous rTMS

Primary outcomes:
measure: Treatment group differences in change from baseline to 6-months post-treatment on the Clinician Administered Posttraumatic Stress Disorder Scale for Diagnostic and Statistical Manual of Mental Disorders (5th edition) (CAPS-5) Total Severity Score
timeFrame: Outcome measures will be measured twice over a period of 37 weeks: Baseline, 6-Month Post-Treatment
Secondary outcomes:
measure: Treatment group differences in change from baseline to 1 month post-treatment on the Clinician Administered Posttraumatic Stress Disorder Scale for Diagnostic and Statistical Manual of Mental Disorders (5th edition) (CAPS-5) Total Severity Score
timeFrame: Outcome measures will be measured twice over a period of 17 weeks: Baseline, 1-Month Post-Treatment
measure: Treatment group differences in change from baseline to 12 months post-treatment on the Clinician Administered Posttraumatic Stress Disorder Scale for Diagnostic and Statistical Manual of Mental Disorders (5th edition) (CAPS-5) Total Severity Score
timeFrame: Outcome measures will be measured twice over a period of 61 weeks: Baseline, 12-Month Post-Treatment
measure: Treatment group differences in change from baseline to 1 month post-treatment on the Posttraumatic Stress Disorder Checklist for for Diagnostic and Statistical Manual of Mental Disorders (5th edition) (PCL-5) Total Severity Score
timeFrame: Outcome measures will be measured twice over a period of 17 weeks: Baseline, 1-Month Post-Treatment
measure: Treatment group differences in change from baseline to 6 months post-treatment on the Posttraumatic Stress Disorder Checklist for for Diagnostic and Statistical Manual of Mental Disorders (5th edition) (PCL-5) Total Severity Score
timeFrame: Outcome measures will be measured twice over a period of 37 weeks: Baseline, 6-Month Post-Treatment
measure: Treatment group differences in change from baseline to 12 months post-treatment on the Posttraumatic Stress Disorder Checklist for for Diagnostic and Statistical Manual of Mental Disorders (5th edition) (PCL-5) Total Severity Score
timeFrame: Outcome measures will be measured twice over a period of 61 weeks: Baseline, 12-Month Post-Treatment
measure: Treatment group differences in change from baseline to 1 month post-treatment on the Clinician Administered Posttraumatic Stress Disorder Scale for Diagnostic and Statistical Manual of Mental Disorders (5th edition) (CAPS-5) Symptom Cluster Scores
timeFrame: Outcome measures will be measured twice over a period of 17 weeks: Baseline, 1-Month Post-Treatment
measure: Treatment group differences in change from baseline to 6 months post-treatment on the Clinician Administered Posttraumatic Stress Disorder Scale for Diagnostic and Statistical Manual of Mental Disorders (5th edition) (CAPS-5) Symptom Cluster Scores
timeFrame: Outcome measures will be measured twice over a period of 37 weeks: Baseline, 6-Month Post-Treatment
measure: Treatment group differences in change from baseline to 12 months post-treatment on the Clinician Administered Posttraumatic Stress Disorder Scale for Diagnostic and Statistical Manual of Mental Disorders (5th edition) (CAPS-5) Symptom Cluster Scores
timeFrame: Outcome measures will be measured twice over a period of 61 weeks: Baseline, 12-Month Post-Treatment
measure: Treatment group differences in change from baseline to 6 weeks (5th intervention session) on the Clinician Administered Posttraumatic Stress Disorder Scale for Diagnostic and Statistical Manual of Mental Disorders (5th edition) (CAPS-5) Total Score
timeFrame: Outcome measures will be measured twice over a period of 6 weeks: Baseline, 6 weeks
measure: Treatment group differences in change from baseline to 10 weeks (9th intervention session) on the Clinician Administered Posttraumatic Stress Disorder Scale for Diagnostic and Statistical Manual of Mental Disorders (5th edition) (CAPS-5) Total Score
timeFrame: Outcome measures will be measured twice over a period of 10 weeks: Baseline, 10 weeks
measure: Treatment group differences in change from baseline to 6 weeks (5th intervention session) on the Clinician Administered Posttraumatic Stress Disorder Scale for Diagnostic and Statistical Manual of Mental Disorders (5th edition) (CAPS-5) Symptom Cluster
timeFrame: Outcome measures will be measured twice over a period of 6 weeks: Baseline, 6 weeks
measure: Treatment group differences in change from baseline to 10 weeks (9th intervention session) on the Clinician Administered Posttraumatic Stress Disorder Scale for Diagnostic and Statistical Manual of Mental Disorders (5th edition) (CAPS-5) Symptom Clust
timeFrame: Outcome measures will be measured twice over a period of 10 weeks: Baseline, 10 weeks
measure: Treatment group differences in change from baseline to 1 month post-treatment on the Posttraumatic Stress Disorder Checklist for for Diagnostic and Statistical Manual of Mental Disorders (5th edition) (PCL-5) Symptom Cluster Scores
timeFrame: Outcome measures will be measured twice over a period of 17 weeks: Baseline, 1-Month Post-Treatment
measure: Treatment group differences in change from baseline to 6 months post-treatment on the Posttraumatic Stress Disorder Checklist for for Diagnostic and Statistical Manual of Mental Disorders (5th edition) (PCL-5) Symptom Cluster Scores
timeFrame: Outcome measures will be measured twice over a period of 37 weeks: Baseline, 6-Month Post-Treatment
measure: Treatment group differences in change from baseline to 12 months post-treatment on the Posttraumatic Stress Disorder Checklist for for Diagnostic and Statistical Manual of Mental Disorders (5th edition) (PCL-5) Symptom Cluster Scores
timeFrame: Outcome measures will be measured twice over a period of 61 weeks: Baseline, 12-Month Post-Treatment
measure: Treatment group differences in change from baseline to 6 weeks (5th intervention session) on the Posttraumatic Stress Disorder Checklist for for Diagnostic and Statistical Manual of Mental Disorders (5th edition) (PCL-5) Symptom Cluster Scores
timeFrame: Outcome measures will be measured twice over a period of 6 weeks: Baseline, 6 weeks
measure: Treatment group differences in change from baseline to 10 weeks (9th intervention session) on the Posttraumatic Stress Disorder Checklist for for Diagnostic and Statistical Manual of Mental Disorders (5th edition) (PCL-5) Symptom Cluster Scores
timeFrame: Outcome measures will be measured twice over a period of 10 weeks: Baseline, 10 weeks
measure: Treatment group differences in change from baseline to 1 month post-treatment on the Mississippi Scale for Combat Related Posttraumatic Stress Disorder
timeFrame: Outcome measures will be measured twice over a period of 17 weeks: Baseline, 1-Month Post-Treatment
measure: Treatment group differences in change from baseline to 6 months post-treatment on the Mississippi Scale for Combat Related Posttraumatic Stress Disorder
timeFrame: Outcome measures will be measured twice over a period of 37 weeks: Baseline, 6-Month Post-Treatment
measure: Treatment group differences in change from baseline to 12 months post-treatment on the Mississippi Scale for Combat Related Posttraumatic Stress Disorder
timeFrame: Outcome measures will be measured twice over a period of 61 weeks: Baseline, 12-Month Post-Treatment
measure: Treatment group differences in change from baseline to 1 month post-treatment on Montgomery Asberg Depression Rating Scale
timeFrame: Outcome measures will be measured twice over a period of 17 weeks: Baseline, 1-Month Post-Treatment
measure: Treatment group differences in change from baseline to 6 months post-treatment on Montgomery Asberg Depression Rating Scale
timeFrame: Outcome measures will be measured twice over a period of 37 weeks: Baseline, 6-Month Post-Treatment
measure: Treatment group differences in change from baseline to 12 months post-treatment on Montgomery Asberg Depression Rating Scale
timeFrame: Outcome measures will be measured twice over a period of 61 weeks: Baseline, 12-Month Post-Treatment
measure: Treatment group differences in change from baseline to 6 weeks (5th intervention session) on Montgomery Asberg Depression Rating Scale
timeFrame: Outcome measures will be measured twice over a period of 6 weeks: Baseline, 6 weeks
measure: Treatment group differences in change from baseline to 10 weeks (9th intervention session) on Montgomery Asberg Depression Rating Scale
timeFrame: Outcome measures will be measured twice over a period of 10 weeks: Baseline, 10 weeks
measure: Treatment group differences in change from baseline to 1 month post-treatment on the Quick Inventory of Depressive Symptomatology
timeFrame: Outcome measures will be measured twice over a period of 17 weeks: Baseline, 1-Month Post-Treatment
measure: Treatment group differences in change from baseline to 6 months post-treatment on the Quick Inventory of Depressive Symptomatology
timeFrame: Outcome measures will be measured twice over a period of 37 weeks: Baseline, 6-Month Post-Treatment
measure: Treatment group differences in change from baseline to 12 months post-treatment on the Quick Inventory of Depressive Symptomatology
timeFrame: Outcome measures will be measured twice over a period of 61 weeks: Baseline, 12-Month Post-Treatment
measure: Treatment group differences in change from baseline to 6 weeks (5th intervention session ) on the Quick Inventory of Depressive Symptomatology
timeFrame: Outcome measures will be measured twice over a period of 6 weeks: Baseline, 6 weeks
measure: Treatment group differences from baseline to 10 weeks (9th intervention session) on the Quick Inventory of Depressive Symptomatology
timeFrame: Outcome measures will be measured twice over a period of 10 weeks: Baseline, 10 weeks
measure: Treatment group differences in change from baseline to 1 month post-treatment on the Inventory of Psychosocial Functioning
timeFrame: Outcome measures will be measured twice over a period of 17 weeks: Baseline, 1-Month Post-Treatment
measure: Treatment group differences in change from baseline to 6 months post-treatment on the Inventory of Psychosocial Functioning
timeFrame: Outcome measures will be measured twice over a period of 37 weeks: Baseline, 6-Month Post-Treatment
measure: Treatment group differences in change from baseline to 12 months post-treatment on the Inventory of Psychosocial Functioning
timeFrame: Outcome measures will be measured twice over a period of 61 weeks: Baseline, 12-Month Post-Treatment
measure: Treatment group differences in change from baseline to 1 month post-treatment on the Short Impulsive Behavior Scale
timeFrame: Outcome measures will be measured twice over a period of 17 weeks: Baseline, 1-Month Post-Treatment
measure: Treatment group differences in change from baseline to 6 months post-treatment on the Short Impulsive Behavior Scale
timeFrame: Outcome measures will be measured twice over a period of 37 weeks: Baseline, 6-Month Post-Treatment
measure: Treatment group differences in change from baseline to 12 months post-treatment on the Short Impulsive Behavior Scale
timeFrame: Outcome measures will be measured twice over a period of 61 weeks: Baseline, 12-Month Post-Treatment
measure: Treatment group differences in change from baseline to 1 month post-treatment on the Short Impulsive Behavior Subscales
timeFrame: Outcome measures will be measured twice over a period of 17 weeks: Baseline, 1-Month Post-Treatment
measure: Treatment group differences in change from baseline to 6 months post-treatment on the Short Impulsive Behavior Subscales
timeFrame: Outcome measures will be measured twice over a period of 37 weeks: Baseline, 6-Month Post-Treatment
measure: Treatment group differences in change from baseline to 12 months post-treatment on the Short Impulsive Behavior Subscales
timeFrame: Outcome measures will be measured twice over a period of 61 weeks: Baseline, 12-Month Post-Treatment
measure: Treatment group differences in change in aggression from baseline to 1 month post-treatment on the Buss-Perry Aggression Questionnaire
timeFrame: Outcome measures will be measured twice over a period of 17 weeks: Baseline, 1-Month Post-Treatment
measure: Treatment group differences in change from baseline to 6 months post-treatment on the Buss-Perry Aggression Questionnaire
timeFrame: Outcome measures will be measured twice over a period of 37 weeks: Baseline, 6-Month Post-Treatment
measure: Treatment group differences in change from baseline to 12 months post-treatment on the Buss-Perry Aggression Questionnaire
timeFrame: Outcome measures will be measured twice over a period of 61 weeks: Baseline, 12-Month Post-Treatment
measure: Treatment group differences in change from baseline to 1 month post-treatment on the Buss-Perry Aggression Questionnaire Subscales
timeFrame: Outcome measures will be measured twice over a period of 17 weeks: Baseline, 1-Month Post-Treatment
measure: Treatment group differences in change from baseline to 6 months post-treatment on the Buss-Perry Aggression Questionnaire Subscales
timeFrame: Outcome measures will be measured twice over a period of 37 weeks: Baseline, 6-Month Post-Treatment
measure: Treatment group differences in change from baseline to 12 months post-treatment on the Buss-Perry Aggression Questionnaire Subscales
timeFrame: Outcome measures will be measured twice over a period of 61 weeks: Baseline, 12-Month Post-Treatment
measure: Treatment group differences in change from baseline to 1 month post-treatment in event-related potential in response to trauma-specific auditory stimuli
timeFrame: Outcome measures will be measured twice over a period of 17 weeks: Baseline, 1-Month Post-Treatment
measure: Treatment group differences in change from baseline to 6 months post-treatment in event-related potential in response to trauma-specific auditory stimuli
timeFrame: Outcome measures will be measured twice over a period of 37 weeks: Baseline, 6-Month Post-Treatment
measure: Treatment group differences in change from baseline to 12 months post-treatment in event-related potential in response to trauma-specific auditory stimuli
timeFrame: Outcome measures will be measured twice over a period of 61 weeks: Baseline, 12-Month Post-Treatment
measure: Treatment group differences in change from baseline to 1 month post-treatment in event-related potential in response to trauma-specific visual stimuli
timeFrame: Outcome measures will be measured twice over a period of 17 weeks: Baseline, 1-Month Post-Treatment
measure: Treatment group differences in change from baseline to 6 months post-treatment in event-related potential in response to trauma-specific visual stimuli
timeFrame: Outcome measures will be measured twice over a period of 37 weeks: Baseline, 6-Month Post-Treatment
measure: Treatment group differences in change from baseline to 12 months post-treatment in event-related potential in response to trauma-specific visual stimuli
timeFrame: Outcome measures will be measured twice over a period of 61 weeks: Baseline, 12-Month Post-Treatment
measure: Treatment group differences in change from baseline to 1 month post-treatment in electroencephalography power in response to trauma-specific auditory stimuli
timeFrame: Outcome measures will be measured twice over a period of 17 weeks: Baseline, 1-Month Post-Treatment
measure: Treatment group differences in change from baseline to 6 months post-treatment in electroencephalography power in response to trauma-specific auditory stimuli
timeFrame: Outcome measures will be measured twice over a period of 37 weeks: Baseline, 6-Month Post-Treatment
measure: Treatment group differences in change from baseline to 12 months post-treatment in electroencephalography power in response to trauma-specific auditory stimuli
timeFrame: Outcome measures will be measured twice over a period of 61 weeks: Baseline, 12-Month Post-Treatment
measure: Treatment group differences in change from baseline to 1 month post-treatment in electroencephalography power in response to trauma-specific visual stimuli
timeFrame: Outcome measures will be measured twice over a period of 17 weeks: Baseline, 1-Month Post-Treatment
measure: Treatment group differences in change from baseline to 6 months post-treatment in electroencephalography power in response to trauma-specific visual stimuli
timeFrame: Outcome measures will be measured twice over a period of 37 weeks: Baseline, 6-Month Post-Treatment
measure: Treatment group differences in change from baseline to 12 months post-treatment in electroencephalography power in response to trauma-specific visual stimuli
timeFrame: Outcome measures will be measured twice over a period of 61 weeks: Baseline, 12-Month Post-Treatment
measure: Treatment group differences in change from baseline to 1 month post-treatment in event-related potential responses in inhibitory control
timeFrame: Outcome measures will be measured twice over a period of 17 weeks: Baseline, 1-Month Post-Treatment
measure: Treatment group differences in change from baseline to 6 months post-treatment in event-related potential responses in inhibitory control
timeFrame: Outcome measures will be measured twice over a period of 37 weeks: Baseline, 6-Month Post-Treatment
measure: Treatment group differences in change from baseline to 12-month post-treatment in event-related potential responses in inhibitory control
timeFrame: Outcome measures will be measured twice over a period of 61 weeks: Baseline, 12-Month Post-Treatment
measure: Treatment group differences in change from baseline to 1-month post-treatment in resting-state electroencephalography power
timeFrame: Outcome measures will be measured twice over a period of 17 weeks: Baseline, 1-Month Post-Treatment
measure: Treatment group differences in change from baseline to 6-months post-treatment in resting-state electroencephalography power
timeFrame: Outcome measures will be measured twice over a period of 37 weeks: Baseline, 6-Month Post-Treatment
measure: Treatment group differences in change from baseline to 12-months post-treatment in resting-state electroencephalography power
timeFrame: Outcome measures will be measured twice over a period of 61 weeks: Baseline, 12-Month Post-Treatment
measure: Treatment group differences in change from baseline to 6-months post-treatment trauma-specific responses in blood oxygen level dependent functional magnetic resonance imaging
timeFrame: Outcome measures will be measured twice over a period of 37 weeks: Baseline, 6-Month Post-Treatment
measure: Treatment group differences in change from baseline to 12 months post-treatment trauma-specific responses in blood oxygen level dependent functional magnetic resonance imaging
timeFrame: Outcome measures will be measured twice over a period of 61 weeks: Baseline, 12-Month Post-Treatment
measure: Treatment group differences in change from baseline to 6 months post-treatment in resting-state functional connectivity
timeFrame: Outcome measures will be measured twice over a period of 37 weeks: Baseline, 6-Month Post-Treatment
measure: Treatment group differences in change from baseline to 12 months post-treatment in resting-state functional connectivity
timeFrame: Outcome measures will be measured twice over a period of 61 weeks: Baseline, 12-Month Post-Treatment
Other outcomes:
Locations:
city: Tallahassee
country: United States
facility: Florida State University College of Medicine
state: Florida
city: Addison
country: United States
facility: Metrocare Services of Dallas
state: Texas
city: Dallas
country: United States
facility: The University of Texas at Dallas
state: Texas
Study officials:
affiliation: The University of Texas at Dallas
name: John Hart, Jr., MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Florida State University, College of Medicine
name: F. Andrew Kozel, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Metrocare Services of Dallas
name: John Burruss, MD
role: PRINCIPAL_INVESTIGATOR
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citation: Maguire MJ, Brier MR, Moore PS, Ferree TC, Ray D, Mostofsky S, Hart J Jr, Kraut MA. The influence of perceptual and semantic categorization on inhibitory processing as measured by the N2-P3 response. Brain Cogn. 2009 Dec;71(3):196-203. doi: 10.1016/j.bandc.2009.08.018. Epub 2009 Sep 20.
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