Post Traumatic Stress DisorderNCT03932773
Multi-site Confirmatory Efficacy Treatment Trial of Combat-related PTSD
A study testing Active rTMS and Cognitive Processing Therapy in people with Post Traumatic Stress Disorder, run by The University of Texas at Dallas at 3 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Post Traumatic Stress Disorder
- What is being tested?
- Active rTMS and Cognitive Processing Therapy
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 330 participants
- Where
- 3 sitesUnited States
- Study dates
- 1 May 2019to 1 Jan 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Veterans of Post-9/11 military conflicts
- with diagnosis of PTSD based on CAPS-5 related to Post-9/11 military combat
Who cannot join
- 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
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- 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
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States3 sites, 3 recruiting
- Recruiting
Metrocare Services of Dallas
Addison, Texas, 75001
Steven A Cohen Military Family Clinic at Metrocare, 469-680-3500, MFC@MetrocareServices.org
- Recruiting
The University of Texas at Dallas
Dallas, Texas, 75235
Celia Higginbotham, 972-883-3171, neurolab@utdallas.edu
Crista Thyvelikakath, MA, 972-883-3171, neurolab@utdallas.edu
- Recruiting
Florida State University College of Medicine
Tallahassee, Florida, 32308
FSU Neuromodulation, 850-644-2824, FSUN@med.fsu.edu
About this study
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.
Read the 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.
- Conditions
- Post Traumatic Stress Disorder
- Being tested
- Active rTMS, Sham rTMS, Cognitive Processing Therapy
- Keywords
- PTSD, post-traumatic stress disorder, military-related PTSD, CPT, cognitive processing therapy, rTMS, repetitive transcranial magnetic stimulation, combat, combat-related PTSD
- Medical subject headings
- Stress Disorders, Post-Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Active rTMSDevice
Also called 1 Hz repetitive transcranial magnetic stimulation
A Magstim Rapid2 Stimulator repetitive transcranial magnetic stimulation (rTMS) device will be used to deliver 1 hertz (Hz) stimulation to right dorsolateral prefrontal cortex (rDLPFC) at 110% of a participant's rTMS motor threshold. The device passes electric current through a coil generating an alternating magnetic field. When positioned over the skull, the changing magnetic field causes electromagnetic inducted current flow in brain regions subjacent to the coil. Magnetic pulses (1.5-2.0 Tesla) lasting 100-300 microseconds at 1 Hz will be used.
Motor threshold will be defined by the TMS intensity to right motor region required to induce visually perceptible movement of the contralateral abductor pollicus brevis 50 percent of the time.
Sham rTMSDevice
Also called sham repetitive transcranial magnetic stimulation
A Magstim Rapid2 Stimulator repetitive transcranial magnetic stimulation (rTMS) device will be paired with sham coil. The sham coil will induce electrical current flow in the tissue above the skull but will not induce current flow in brain tissue. The sham coil will be placed over the right prefrontal scalp region to target current flow in rDLPFC. Magnetic pulses lasting for 100-300 microseconds at 1 Hz will be used.
For consistency across the rTMS conditions, motor threshold in the sham condition also will be determined by positioning the active rTMS coil over the right motor region and identifying the stimulation intensity required to induce visually perceptible movement of the contralateral abductor pollicus brevis 50 percent of the time.
Cognitive Processing TherapyBehavioural
Also called CPT
Cognitive Processing Therapy (CPT) is an evidenced based, trauma-focused treatment for Posttraumatic Stress Disorder (PTSD). CPT is a recommended form of treatment in the Veterans Administration - Department of Defense Clinical Practice Guideline for PTSD. The CPT manual delineates the agenda for each of 12 sessions (60 minutes per session): 1) Introduction to CPT and Patient Education regarding PTSD, 2) Meaning of the Trauma, 3) Identification of Thoughts and Feelings related to the Trauma, 4) Remembering the Trauma, 5) Identification of Stuck points, 6) Challenging Questions about the Trauma, 7) Dysfunctional/Maladaptive Thinking patterns related to the Trauma, 8) Safety Issues, 9) Trust Issues, 10) Power and Control Issues, 11) Self-Esteem Issues, and 12) Intimacy Issues.
| Study group | Role | What they receive |
|---|---|---|
| Sham rTMS + CPT | Sham comparator | 30 minutes of sham repetitive transcranial magnetic stimulation (rTMS) to the right dorsolateral prefrontal cortex (rDLPFC) prior to each Cognitive Processing Therapy (CPT) session Receives: Device: Active rTMS; Behavioral: Cognitive Processing Therapy |
| Active rTMS + CPT | Active comparator | 30 minutes of 1 Hz rTMS to rDLPFC prior to each CPT session Receives: Device: Sham rTMS; Behavioral: Cognitive Processing Therapy |
| Active rTMS Alone | Active comparator | 30 minutes of 1 Hz rTMS to rDLPFC at 1 session per week over 12 weeks Receives: Device: Active rTMS |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Evaluation of treatment group differences on the Clinician Administered Posttraumatic Stress Disorder Scale for Diagnostic and Statistical Manual of Mental Disorders (5th edition) (CAPS-5) Total Severity Score (20 item sum, range 0-80, higher score=greater severity) in change from baseline to 6 months after the 12-week interventions.
Weathers, FW, Blake, DD, Schnurr, PP, Kaloupek, DG, Marx, BP, \& Keane, TM. The Clinician-Administered PTSD Scale for DSM-5 (CAPS-5). www.ptsd.va.gov: National Center for PTSD, 2013.
Measured: Outcome measures will be measured twice over a period of 37 weeks: Baseline, 6-Month Post-Treatment
Secondary outcomes (67)
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
Evaluation of treatment group differences on the Clinician Administered Posttraumatic Stress Disorder Scale for Diagnostic and Statistical Manual of Mental Disorders (5th edition) (CAPS-5) Total Severity Score (20 item sum, range 0-80, higher score=greater severity) in change from baseline to 1 month after the 12-week interventions.
Weathers, FW, Blake, DD, Schnurr, PP, Kaloupek, DG, Marx, BP, \& Keane, TM. The Clinician-Administered PTSD Scale for DSM-5 (CAPS-5). www.ptsd.va.gov: National Center for PTSD, 2013.
Measured: Outcome measures will be measured twice over a period of 17 weeks: Baseline, 1-Month Post-Treatment
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
Evaluation of treatment group differences on the Clinician Administered Posttraumatic Stress Disorder Scale for Diagnostic and Statistical Manual of Mental Disorders (5th edition) (CAPS-5) Total Severity Score (20 item sum, range 0-80, higher score=greater severity) in change from baseline to 12 months after the 12-week interventions.
Weathers, FW, Blake, DD, Schnurr, PP, Kaloupek, DG, Marx, BP, \& Keane, TM. The Clinician-Administered PTSD Scale for DSM-5 (CAPS-5). www.ptsd.va.gov: National Center for PTSD, 2013.
Measured: Outcome measures will be measured twice over a period of 61 weeks: Baseline, 12-Month Post-Treatment
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
Evaluation of treatment group differences on the Posttraumatic Stress Disorder Checklist for for Diagnostic and Statistical Manual of Mental Disorders (5th edition) (PCL-5) Total Severity Score (20 item sum, range 0-80, higher score=greater severity) in change from baseline to 1 month after the 12-week interventions.
Weathers FW, Litz BT, Keane TM, Palmieri PA, Marx BP, Schnurr PP. The PTSD Checklist for DSM-5 (PCL-5). Scale available from the National Center for PTSD at www.ptsd.va.gov, 2013.
Measured: Outcome measures will be measured twice over a period of 17 weeks: Baseline, 1-Month Post-Treatment
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
Evaluation of treatment group differences on the Posttraumatic Stress Disorder Checklist for for Diagnostic and Statistical Manual of Mental Disorders (5th edition) (PCL-5) Total Severity Score (20 item sum, range 0-80, higher score=greater severity) in change from baseline to 6 months after the 12-week interventions.
Weathers FW, Litz BT, Keane TM, Palmieri PA, Marx BP, Schnurr PP. The PTSD Checklist for DSM-5 (PCL-5). Scale available from the National Center for PTSD at www.ptsd.va.gov, 2013.
Measured: Outcome measures will be measured twice over a period of 37 weeks: Baseline, 6-Month Post-Treatment
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
Evaluation of treatment group differences on the Posttraumatic Stress Disorder Checklist for for Diagnostic and Statistical Manual of Mental Disorders (5th edition) (PCL-5) Total Severity Score (20 item sum, range 0-80, higher score=greater severity) in change from baseline to 12 months after the 12-week interventions.
Weathers FW, Litz BT, Keane TM, Palmieri PA, Marx BP, Schnurr PP. The PTSD Checklist for DSM-5 (PCL-5). Scale available from the National Center for PTSD at www.ptsd.va.gov, 2013.
Measured: Outcome measures will be measured twice over a period of 61 weeks: Baseline, 12-Month Post-Treatment
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
Evaluation of treatment group differences on Clinician Administered Posttraumatic Stress Disorder Scale for Diagnostic and Statistical Manual of Mental Disorders (5th edition) (CAPS-5) Symptom Cluster Scores (cluster item sum, higher scores=greater severity) in change from baseline to 1 month after the 12-week interventions. Evaluations of 4-Symptom Cluster Model ([1] Intrusions, range 0-20, [2] Avoidance, range 0-8, [3] Negative Cognition/Mood, range 0-28, and [4] Arousal/Reactivity, range 0-24) and 7-Symptom Cluster Model ([1] Intrusions, range 0-20, [2] Avoidance, range 0-8, [3] Negative Affect, range 0-16), [4] Anhedonia, range 0-12, [5] Externalizing, range 0-8, [6] Anxious Arousal, range 0-8, and [7] Dysphoric Arousal, range 0-8).
Weathers FW, Bovin MJ, Lee DJ, Sloan DM, Schnurr PP, Kaloupek DG, Keane TM, Marx BP. The Clinician-Administered PTSD Scale for DSM-5 (CAPS-5): Development and initial psychometric evaluation in military veterans. Psychol Assess 30(3):383-395, 2018.
Measured: Outcome measures will be measured twice over a period of 17 weeks: Baseline, 1-Month Post-Treatment
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
Evaluation of treatment group differences on Clinician Administered Posttraumatic Stress Disorder Scale for Diagnostic and Statistical Manual of Mental Disorders (5th edition) (CAPS-5) Symptom Cluster Scores (cluster item sum, higher scores=greater severity) in change from baseline to 6 months after the 12-week interventions. Evaluations of 4-Symptom Cluster Model ([1] Intrusions, range 0-20, [2] Avoidance, range 0-8, [3] Negative Cognition/Mood, range 0-28, and [4] Arousal/Reactivity, range 0-24) and 7-Symptom Cluster Model ([1] Intrusions, range 0-20, [2] Avoidance, range 0-8, [3] Negative Affect, range 0-16), [4] Anhedonia, range 0-12, [5] Externalizing, range 0-8, [6] Anxious Arousal, range 0-8, and [7] Dysphoric Arousal, range 0-8).
Weathers FW, Bovin MJ, Lee DJ, Sloan DM, Schnurr PP, Kaloupek DG, Keane TM, Marx BP. The Clinician-Administered PTSD Scale for DSM-5 (CAPS-5): Development and initial psychometric evaluation in military veterans. Psychol Assess 30(3):383-395, 2018.
Measured: Outcome measures will be measured twice over a period of 37 weeks: Baseline, 6-Month Post-Treatment
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
Evaluation of treatment group differences on Clinician Administered Posttraumatic Stress Disorder Scale for Diagnostic and Statistical Manual of Mental Disorders (5th edition) (CAPS-5) Symptom Cluster Scores (cluster item sum, higher scores=greater severity) in change from baseline to 12 months after the 12-week intervention. Evaluations of 4-Symptom Cluster Model ([1] Intrusions, range 0-20, [2] Avoidance, range 0-8, [3] Negative Cognition/Mood, range 0-28, and [4] Arousal/Reactivity, range 0-24) and 7-Symptom Cluster Model ([1] Intrusions, range 0-20, [2] Avoidance, range 0-8, [3] Negative Affect, range 0-16), [4] Anhedonia, range 0-12, [5] Externalizing, range 0-8, [6] Anxious Arousal, range 0-8, and [7] Dysphoric Arousal, range 0-8).
Weathers FW, Bovin MJ, Lee DJ, Sloan DM, Schnurr PP, Kaloupek DG, Keane TM, Marx BP. The Clinician-Administered PTSD Scale for DSM-5 (CAPS-5): Development and initial psychometric evaluation in military veterans. Psychol Assess 30(3):383-395, 2018.
Measured: Outcome measures will be measured twice over a period of 61 weeks: Baseline, 12-Month Post-Treatment
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
Evaluation of treatment group differences on the Clinician Administered Posttraumatic Stress Disorder Scale for Diagnostic and Statistical Manual of Mental Disorders (5th edition) (CAPS-5) Total Severity Score (20 item sum, range 0-80, higher score=greater severity) in change from baseline to 6 weeks.
Weathers, F.W., Blake, D.D., Schnurr, P.P., Kaloupek, D.G., Marx, B.P., \& Keane, T.M. (2013). The Clinician-Administered PTSD Scale for DSM-5 (CAPS-5). Interview available from the National Center for PTSD at www.ptsd.va.gov.
Measured: Outcome measures will be measured twice over a period of 6 weeks: Baseline, 6 weeks
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
Evaluation of treatment group differences on the Clinician Administered Posttraumatic Stress Disorder Scale for Diagnostic and Statistical Manual of Mental Disorders (5th edition) (CAPS-5) Total Severity Score (20 item sum, range 0-80, higher score=greater severity) in change from baseline to 10 weeks.
Weathers, F.W., Blake, D.D., Schnurr, P.P., Kaloupek, D.G., Marx, B.P., \& Keane, T.M. (2013). The Clinician-Administered PTSD Scale for DSM-5 (CAPS-5). Interview available from the National Center for PTSD at www.ptsd.va.gov.
Measured: Outcome measures will be measured twice over a period of 10 weeks: Baseline, 10 weeks
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
Evaluation of treatment group differences on Clinician Administered Posttraumatic Stress Disorder Scale for Diagnostic and Statistical Manual of Mental Disorders (5th edition) (CAPS-5) Symptom Cluster Scores (cluster item sum, higher scores=greater severity) in change from baseline to 6 weeks. Evaluations of 4-Symptom Cluster Model ([1] Intrusions, range 0-20, [2] Avoidance, range 0-8, [3] Negative Cognition/Mood, range 0-28, and [4] Arousal/Reactivity, range 0-24) and 7-Symptom Cluster Model ([1] Intrusions, range 0-20, [2] Avoidance, range 0-8, [3] Negative Affect, range 0-16), [4] Anhedonia, range 0-12, [5] Externalizing, range 0-8, [6] Anxious Arousal, range 0-8, and [7] Dysphoric Arousal, range 0-8).
Weathers FW, Bovin MJ, Lee DJ, Sloan DM, Schnurr PP, Kaloupek DG, Keane TM, Marx BP. The Clinician-Administered PTSD Scale for DSM-5 (CAPS-5): Development and initial psychometric evaluation in military veterans. Psychol Assess 30(3):383-395, 2018.
Measured: Outcome measures will be measured twice over a period of 6 weeks: Baseline, 6 weeks
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
Evaluation of treatment group differences on Clinician Administered Posttraumatic Stress Disorder Scale for Diagnostic and Statistical Manual of Mental Disorders (5th edition) (CAPS-5) Symptom Cluster Scores (cluster item sum, higher scores=greater severity) in change from baseline to 10 weeks. Evaluations of 4-Symptom Cluster Model ([1] Intrusions, range 0-20, [2] Avoidance, range 0-8, [3] Negative Cognition/Mood, range 0-28, and [4] Arousal/Reactivity, range 0-24) and 7-Symptom Cluster Model ([1] Intrusions, range 0-20, [2] Avoidance, range 0-8, [3] Negative Affect, range 0-16), [4] Anhedonia, range 0-12, [5] Externalizing, range 0-8, [6] Anxious Arousal, range 0-8, and [7] Dysphoric Arousal, range 0-8).
Weathers FW, Bovin MJ, Lee DJ, Sloan DM, Schnurr PP, Kaloupek DG, Keane TM, Marx BP. The Clinician-Administered PTSD Scale for DSM-5 (CAPS-5): Development and initial psychometric evaluation in military veterans. Psychol Assess 30(3):383-395, 2018.
Measured: Outcome measures will be measured twice over a period of 10 weeks: Baseline, 10 weeks
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
Evaluation of treatment group differences on Posttraumatic Stress Disorder Checklist for Diagnostic and Statistical Manual of Mental Disorders (5th edition) (PCL-5) Symptom Cluster Scores (cluster item sum, higher scores=greater severity) in change from baseline to 1 month after 12-week interventions. Evaluations of 4-Symptom Cluster Model ([1] Intrusions, range 0-20, [2] Avoidance, range 0-8, [3] Negative Cognition/Mood, range 0-28, and [4] Arousal/Reactivity, range 0-24) and 7-Symptom Cluster Model ([1] Intrusions, range 0-20, [2] Avoidance, range 0-8, [3] Negative Affect, range 0-16), [4] Anhedonia, range 0-12, [5] Externalizing, range 0-8, [6] Anxious Arousal, range 0-8, and [7] Dysphoric Arousal, range 0-8).
Bovin, MJ, Marx, BP, Weathers, FW, Gallagher, MW, Rodriguez, P, Schnurr, PP, Keane, TM. Psychometric properties of the PTSD Checklist for Diagnostic and Statistical Manual of Mental Disorders-Fifth Edition (PCL-5) in Veterans. Psychol Assess 28(11):1379-1391, 2016.
Measured: Outcome measures will be measured twice over a period of 17 weeks: Baseline, 1-Month Post-Treatment
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
Evaluation of treatment group differences on Posttraumatic Stress Disorder Checklist for Diagnostic and Statistical Manual of Mental Disorders (5th edition) (PCL-5) Symptom Cluster Scores (cluster item sum, higher scores=greater severity) in change from baseline to 6 months after 12-week interventions. Evaluations of 4-Symptom Cluster Model ([1] Intrusions, range 0-20, [2] Avoidance, range 0-8, [3] Negative Cognition/Mood, range 0-28, and [4] Arousal/Reactivity, range 0-24) and 7-Symptom Cluster Model ([1] Intrusions, range 0-20, [2] Avoidance, range 0-8, [3] Negative Affect, range 0-16), [4] Anhedonia, range 0-12, [5] Externalizing, range 0-8, [6] Anxious Arousal, range 0-8, and [7] Dysphoric Arousal, range 0-8).
Bovin, MJ, Marx, BP, Weathers, FW, Gallagher, MW, Rodriguez, P, Schnurr, PP, Keane, TM. Psychometric properties of the PTSD Checklist for Diagnostic and Statistical Manual of Mental Disorders-Fifth Edition (PCL-5) in Veterans. Psychol Assess 28(11):1379-1391, 2016.
Measured: Outcome measures will be measured twice over a period of 37 weeks: Baseline, 6-Month Post-Treatment
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
Evaluation of treatment group differences on Posttraumatic Stress Disorder Checklist for Diagnostic and Statistical Manual of Mental Disorders (5th edition) (PCL-5) Symptom Cluster Scores (cluster item sum, higher scores=greater severity) in change from baseline to 12 months after 12-week interventions. Evaluations of 4-Symptom Cluster Model ([1] Intrusions, range 0-20, [2] Avoidance, range 0-8, [3] Negative Cognition/Mood, range 0-28, and [4] Arousal/Reactivity, range 0-24) and 7-Symptom Cluster Model ([1] Intrusions, range 0-20, [2] Avoidance, range 0-8, [3] Negative Affect, range 0-16), [4] Anhedonia, range 0-12, [5] Externalizing, range 0-8, [6] Anxious Arousal, range 0-8, and [7] Dysphoric Arousal, range 0-8).
Bovin, MJ, Marx, BP, Weathers, FW, Gallagher, MW, Rodriguez, P, Schnurr, PP, Keane, TM. Psychometric properties of the PTSD Checklist for Diagnostic and Statistical Manual of Mental Disorders-Fifth Edition (PCL-5) in Veterans. Psychol Assess 28(11):1379-1391, 2016.
Measured: Outcome measures will be measured twice over a period of 61 weeks: Baseline, 12-Month Post-Treatment
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
Evaluation of treatment group differences on Posttraumatic Stress Disorder Checklist for Diagnostic and Statistical Manual of Mental Disorders (5th edition) (PCL-5) Symptom Cluster Scores (cluster item sum, higher scores=greater severity) in change from baseline to 6 weeks. Evaluations of 4-Symptom Cluster Model ([1] Intrusions, range 0-20, [2] Avoidance, range 0-8, [3] Negative Cognition/Mood, range 0-28, and [4] Arousal/Reactivity, range 0-24) and 7-Symptom Cluster Model ([1] Intrusions, range 0-20, [2] Avoidance, range 0-8, [3] Negative Affect, range 0-16), [4] Anhedonia, range 0-12, [5] Externalizing, range 0-8, [6] Anxious Arousal, range 0-8, and [7] Dysphoric Arousal, range 0-8).
Bovin, MJ, Marx, BP, Weathers, FW, Gallagher, MW, Rodriguez, P, Schnurr, PP, Keane, TM. Psychometric properties of the PTSD Checklist for Diagnostic and Statistical Manual of Mental Disorders-Fifth Edition (PCL-5) in Veterans. Psychol Assess 28(11):1379-1391, 2016.
Measured: Outcome measures will be measured twice over a period of 6 weeks: Baseline, 6 weeks
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
Evaluation of treatment group differences on Posttraumatic Stress Disorder Checklist for Diagnostic and Statistical Manual of Mental Disorders (5th edition) (PCL-5) Symptom Cluster Scores (cluster item sum, higher scores=greater severity) in change from baseline to 10 weeks. Evaluations of 4-Symptom Cluster Model ([1] Intrusions, range 0-20, [2] Avoidance, range 0-8, [3] Negative Cognition/Mood, range 0-28, and [4] Arousal/Reactivity, range 0-24) and 7-Symptom Cluster Model ([1] Intrusions, range 0-20, [2] Avoidance, range 0-8, [3] Negative Affect, range 0-16), [4] Anhedonia, range 0-12, [5] Externalizing, range 0-8, [6] Anxious Arousal, range 0-8, and [7] Dysphoric Arousal, range 0-8).
Bovin, MJ, Marx, BP, Weathers, FW, Gallagher, MW, Rodriguez, P, Schnurr, PP, Keane, TM. Psychometric properties of the PTSD Checklist for Diagnostic and Statistical Manual of Mental Disorders-Fifth Edition (PCL-5) in Veterans. Psychol Assess 28(11):1379-1391, 2016.
Measured: Outcome measures will be measured twice over a period of 10 weeks: Baseline, 10 weeks
Treatment group differences in change from baseline to 1 month post-treatment on the Mississippi Scale for Combat Related Posttraumatic Stress Disorder
Evaluation of treatment group differences on the Mississippi Scale for Combat Related Posttraumatic Stress Disorder Total Score (35 item sum, range 35-175, higher score=greater severity) in change from baseline to 1-month after the 12-week interventions.
Keane TM, Caddell JM, Taylor KL. Mississippi Scale for Combat-Related Posttraumatic Stress Disorder: three studies in reliability and validity. J Consult Clin Psychol 56(1):85-90, 1988.
Measured: Outcome measures will be measured twice over a period of 17 weeks: Baseline, 1-Month Post-Treatment
Treatment group differences in change from baseline to 6 months post-treatment on the Mississippi Scale for Combat Related Posttraumatic Stress Disorder
Evaluation of treatment group differences on the Mississippi Scale for Combat Related Posttraumatic Stress Disorder Total Score (35 item sum, range 35-175, higher score=greater severity) in change from baseline to 6-months after the 12-week interventions.
Keane TM, Caddell JM, Taylor KL. Mississippi Scale for Combat-Related Posttraumatic Stress Disorder: three studies in reliability and validity. J Consult Clin Psychol 56(1):85-90, 1988.
Measured: Outcome measures will be measured twice over a period of 37 weeks: Baseline, 6-Month Post-Treatment
Treatment group differences in change from baseline to 12 months post-treatment on the Mississippi Scale for Combat Related Posttraumatic Stress Disorder
Evaluation of treatment group differences on the Mississippi Scale for Combat Related Posttraumatic Stress Disorder Total Score (35 item sum, range 35-175, higher score=greater severity) in change from baseline to 12-months after the 12-week interventions.
Keane TM, Caddell JM, Taylor KL. Mississippi Scale for Combat-Related Posttraumatic Stress Disorder: three studies in reliability and validity. J Consult Clin Psychol 56(1):85-90, 1988.
Measured: Outcome measures will be measured twice over a period of 61 weeks: Baseline, 12-Month Post-Treatment
Treatment group differences in change from baseline to 1 month post-treatment on Montgomery Asberg Depression Rating Scale
Evaluation of treatment group differences on the Montgomery Asberg Depression Rating Scale (10 item sum, range 0-60, higher score=greater severity) in change from baseline to 1-month after the 12-week interventions.
Montgomery SA, Asberg M. A new depression scale designed to be sensitive to change. Br J Psychiatry 134:382-389, 1979.
Measured: Outcome measures will be measured twice over a period of 17 weeks: Baseline, 1-Month Post-Treatment
Treatment group differences in change from baseline to 6 months post-treatment on Montgomery Asberg Depression Rating Scale
Evaluation of treatment group differences on the Montgomery Asberg Depression Rating Scale (10 item sum, range 0-60, higher score=greater severity) in change from baseline to 6-months after the 12-week interventions.
Montgomery SA, Asberg M. A new depression scale designed to be sensitive to change. Br J Psychiatry 134:382-389, 1979.
Measured: Outcome measures will be measured twice over a period of 37 weeks: Baseline, 6-Month Post-Treatment
Treatment group differences in change from baseline to 12 months post-treatment on Montgomery Asberg Depression Rating Scale
Evaluation of treatment group differences on the Montgomery Asberg Depression Rating Scale (10 item sum, range 0-60, higher score=greater severity) in change from baseline to 12-months after the 12-week interventions.
Montgomery SA, Asberg M. A new depression scale designed to be sensitive to change. Br J Psychiatry 134:382-389, 1979.
Measured: Outcome measures will be measured twice over a period of 61 weeks: Baseline, 12-Month Post-Treatment
Treatment group differences in change from baseline to 6 weeks (5th intervention session) on Montgomery Asberg Depression Rating Scale
Evaluation of treatment group differences on the Montgomery Asberg Depression Rating Scale (10 item sum, range 0-60, higher score=greater severity) in change from baseline to 6 weeks.
Montgomery SA, Asberg M. A new depression scale designed to be sensitive to change. Br J Psychiatry 134:382-389, 1979.
Measured: Outcome measures will be measured twice over a period of 6 weeks: Baseline, 6 weeks
Treatment group differences in change from baseline to 10 weeks (9th intervention session) on Montgomery Asberg Depression Rating Scale
Evaluation of treatment group differences on the Montgomery Asberg Depression Rating Scale (10 item sum, range 0-60, higher score=greater severity) in change from baseline to 10 weeks.
Montgomery SA, Asberg M. A new depression scale designed to be sensitive to change. Br J Psychiatry 134:382-389, 1979.
Measured: Outcome measures will be measured twice over a period of 10 weeks: Baseline, 10 weeks
Treatment group differences in change from baseline to 1 month post-treatment on the Quick Inventory of Depressive Symptomatology
Evaluation of treatment group differences on the Quick Inventory of Depressive Symptomatology (QIDS) (9 domain sum, range 0-27, higher score=greater severity) in change from baseline to 1-month after the 12-week interventions.
Rush, AJ, Trivedi, MH, et al. The 16-Item Quick Inventory of Depressive Symptomatology (QIDS), clinician rating (QIDS-C), and self-report (QIDS-SR): a psychometric evaluation in patients with chronic major depression. Biol Psychiatry 54(5):573-583, 2003.
Measured: Outcome measures will be measured twice over a period of 17 weeks: Baseline, 1-Month Post-Treatment
Treatment group differences in change from baseline to 6 months post-treatment on the Quick Inventory of Depressive Symptomatology
Evaluation of treatment group differences on the Quick Inventory of Depressive Symptomatology (QIDS) (9 domain sum, range 0-27, higher score=greater severity) in change from baseline to 6-months after the 12-week interventions.
Rush, AJ, Trivedi, MH, et al. The 16-Item Quick Inventory of Depressive Symptomatology (QIDS), clinician rating (QIDS-C), and self-report (QIDS-SR): a psychometric evaluation in patients with chronic major depression. Biol Psychiatry 54(5):573-583, 2003.
Measured: Outcome measures will be measured twice over a period of 37 weeks: Baseline, 6-Month Post-Treatment
Treatment group differences in change from baseline to 12 months post-treatment on the Quick Inventory of Depressive Symptomatology
Evaluation of treatment group differences on the Quick Inventory of Depressive Symptomatology (QIDS) (9 domain sum, range 0-27, higher score=greater severity) in change from baseline to 12-months after the 12-week interventions.
Rush, AJ, Trivedi, MH, et al. The 16-Item Quick Inventory of Depressive Symptomatology (QIDS), clinician rating (QIDS-C), and self-report (QIDS-SR): a psychometric evaluation in patients with chronic major depression. Biol Psychiatry 54(5):573-583, 2003.
Measured: Outcome measures will be measured twice over a period of 61 weeks: Baseline, 12-Month Post-Treatment
Treatment group differences in change from baseline to 6 weeks (5th intervention session ) on the Quick Inventory of Depressive Symptomatology
Evaluation of treatment group differences on the Quick Inventory of Depressive Symptomatology (QIDS) (9 domain sum, range 0-27, higher score=greater severity) in change from baseline to 6 weeks.
Rush, AJ, Trivedi, MH, et al. The 16-Item Quick Inventory of Depressive Symptomatology (QIDS), clinician rating (QIDS-C), and self-report (QIDS-SR): a psychometric evaluation in patients with chronic major depression. Biol Psychiatry 54(5):573-583, 2003.
Measured: Outcome measures will be measured twice over a period of 6 weeks: Baseline, 6 weeks
Treatment group differences from baseline to 10 weeks (9th intervention session) on the Quick Inventory of Depressive Symptomatology
Evaluation of treatment group differences on the Quick Inventory of Depressive Symptomatology (QIDS) (9 domain sum, range 0-27, higher score=greater severity) in change from baseline to 10 weeks.
Rush, AJ, Trivedi, MH, et al. The 16-Item Quick Inventory of Depressive Symptomatology (QIDS), clinician rating (QIDS-C), and self-report (QIDS-SR): a psychometric evaluation in patients with chronic major depression. Biol Psychiatry 54(5):573-583, 2003.
Measured: Outcome measures will be measured twice over a period of 10 weeks: Baseline, 10 weeks
Treatment group differences in change from baseline to 1 month post-treatment on the Inventory of Psychosocial Functioning
Evaluation of treatment group differences on the Inventory of Psychosocial Functioning (IPF) Overall Score (mean of completed domain scores, range 0-100, higher score=greater impairment) in change from baseline to 1 month following the 12-week interventions.
Bovin MJ, Black SK, Rodriguez P, Lunney CA, Kleiman SE, Weathers FW, Schnurr PP, Spira J, Keane TM, Marx BP. Development and validation of a measure of PTSD-related psychosocial functional impairment: The Inventory of Psychosocial Functioning. Psychol Serv 15(2):216-229, 2018.
Measured: Outcome measures will be measured twice over a period of 17 weeks: Baseline, 1-Month Post-Treatment
Treatment group differences in change from baseline to 6 months post-treatment on the Inventory of Psychosocial Functioning
Evaluation of treatment group differences on the Inventory of Psychosocial Functioning (IPF) Overall Score (mean of completed domain scores, range 0-100, higher score=greater impairment) in change from baseline to 6 months after the 12-week interventions.
Bovin MJ, Black SK, Rodriguez P, Lunney CA, Kleiman SE, Weathers FW, Schnurr PP, Spira J, Keane TM, Marx BP. Development and validation of a measure of PTSD-related psychosocial functional impairment: The Inventory of Psychosocial Functioning. Psychol Serv 15(2):216-229, 2018.
Measured: Outcome measures will be measured twice over a period of 37 weeks: Baseline, 6-Month Post-Treatment
Treatment group differences in change from baseline to 12 months post-treatment on the Inventory of Psychosocial Functioning
Evaluation of treatment group differences on the Inventory of Psychosocial Functioning (IPF) Overall Score (mean of completed domain scores, range 0-100, higher score=greater impairment) in change from baseline to 12 months after the 12-week interventions.
Bovin MJ, Black SK, Rodriguez P, Lunney CA, Kleiman SE, Weathers FW, Schnurr PP, Spira J, Keane TM, Marx BP. Development and validation of a measure of PTSD-related psychosocial functional impairment: The Inventory of Psychosocial Functioning. Psychol Serv 15(2):216-229, 2018.
Measured: Outcome measures will be measured twice over a period of 61 weeks: Baseline, 12-Month Post-Treatment
Treatment group differences in change from baseline to 1 month post-treatment on the Short Impulsive Behavior Scale
Evaluation of treatment group differences on the Short Impulsive Behavior Scale (UPPS-P) Total Score (mean item rating, range 1-4, higher score=greater impulsivity) in change from baseline to 1 month after the 12-week interventions.
Cyders MA, Littlefield AK, Coffey S, Karyadi KA. Examination of a short English version of the UPPS-P Impulsive Behavior Scale. Addict Behav 39(9):1372-1376, 2014.
Measured: Outcome measures will be measured twice over a period of 17 weeks: Baseline, 1-Month Post-Treatment
Treatment group differences in change from baseline to 6 months post-treatment on the Short Impulsive Behavior Scale
Evaluation of treatment group differences on the Short Impulsive Behavior Scale (UPPS-P) Total Score (mean item rating, range 1-4, higher score=greater impulsivity) in change from baseline to 6 months after the 12-week interventions.
Cyders MA, Littlefield AK, Coffey S, Karyadi KA. Examination of a short English version of the UPPS-P Impulsive Behavior Scale. Addict Behav 39(9):1372-1376, 2014.
Measured: Outcome measures will be measured twice over a period of 37 weeks: Baseline, 6-Month Post-Treatment
Treatment group differences in change from baseline to 12 months post-treatment on the Short Impulsive Behavior Scale
Evaluation of treatment group differences on the Short Impulsive Behavior Scale (UPPS-P) Total Score (mean item rating, range 1-4, higher score=greater impulsivity) in change from baseline to 12 months after the 12-week interventions.
Cyders MA, Littlefield AK, Coffey S, Karyadi KA. Examination of a short English version of the UPPS-P Impulsive Behavior Scale. Addict Behav 39(9):1372-1376, 2014.
Measured: Outcome measures will be measured twice over a period of 61 weeks: Baseline, 12-Month Post-Treatment
Treatment group differences in change from baseline to 1 month post-treatment on the Short Impulsive Behavior Subscales
Evaluation of treatment group differences on the Short Impulsive Behavior Scale (UPPS-P) Subscale Scores (mean item rating, range 1-4, higher score=greater impulsivity) in change from baseline to 1 month after the 12-week interventions. Evaluations on (1) Negative Urgency, (2) Perseverance, (3) Premeditation, (4) Sensation Seeking, and (5) Positive Urgency
Cyders MA, Littlefield AK, Coffey S, Karyadi KA. Examination of a short English version of the UPPS-P Impulsive Behavior Scale. Addict Behav 39(9):1372-1376, 2014.
Measured: Outcome measures will be measured twice over a period of 17 weeks: Baseline, 1-Month Post-Treatment
Treatment group differences in change from baseline to 6 months post-treatment on the Short Impulsive Behavior Subscales
Evaluation of treatment group differences on the Short Impulsive Behavior Scale (UPPS-P) Subscale Scores (mean item rating, range 1-4, higher score=greater impulsivity) in change from baseline to 6 months after the 12-week interventions. Evaluations on (1) Negative Urgency, (2) Perseverance, (3) Premeditation, (4) Sensation Seeking, and (5) Positive Urgency
Cyders MA, Littlefield AK, Coffey S, Karyadi KA. Examination of a short English version of the UPPS-P Impulsive Behavior Scale. Addict Behav 39(9):1372-1376, 2014.
Measured: Outcome measures will be measured twice over a period of 37 weeks: Baseline, 6-Month Post-Treatment
Treatment group differences in change from baseline to 12 months post-treatment on the Short Impulsive Behavior Subscales
Evaluation of treatment group differences on the Short Impulsive Behavior Scale (UPPS-P) Subscale Scores (mean item rating, range 1-4, higher score=greater impulsivity) in change from baseline to 12 months after the 12-week interventions. Evaluations on (1) Negative Urgency, (2) Perseverance, (3) Premeditation, (4) Sensation Seeking, and (5) Positive Urgency
Cyders MA, Littlefield AK, Coffey S, Karyadi KA. Examination of a short English version of the UPPS-P Impulsive Behavior Scale. Addict Behav 39(9):1372-1376, 2014.
Measured: Outcome measures will be measured twice over a period of 61 weeks: Baseline, 12-Month Post-Treatment
Treatment group differences in change in aggression from baseline to 1 month post-treatment on the Buss-Perry Aggression Questionnaire
Evaluation of treatment group differences on the Buss-Perry Aggression Questionnaire Total Score (29 item sum, range 29-145, higher score=greater aggression) in change from baseline to 1 month after the 12-week interventions.
Buss AH, Perry M. The Aggression Questionnaire. J Pers Soc Psychol 63(3):452-459, 1992.
Measured: Outcome measures will be measured twice over a period of 17 weeks: Baseline, 1-Month Post-Treatment
Treatment group differences in change from baseline to 6 months post-treatment on the Buss-Perry Aggression Questionnaire
Evaluation of treatment group differences on the Buss-Perry Aggression Questionnaire Total Score (29 item sum, range 29-145, higher score=greater aggression) in change from baseline to 6 months after the 12-week interventions.
Buss AH, Perry M. The Aggression Questionnaire. J Pers Soc Psychol 63(3):452-459, 1992.
Measured: Outcome measures will be measured twice over a period of 37 weeks: Baseline, 6-Month Post-Treatment
Treatment group differences in change from baseline to 12 months post-treatment on the Buss-Perry Aggression Questionnaire
Evaluation of treatment group differences on the Buss-Perry Aggression Questionnaire Total Score (29 item sum, range 29-145, higher score=greater aggression) in change from baseline to 12 months after the 12-week interventions.
Buss AH, Perry M. The Aggression Questionnaire. J Pers Soc Psychol 63(3):452-459, 1992.
Measured: Outcome measures will be measured twice over a period of 61 weeks: Baseline, 12-Month Post-Treatment
Treatment group differences in change from baseline to 1 month post-treatment on the Buss-Perry Aggression Questionnaire Subscales
Evaluation of treatment group differences on the Buss-Perry Aggression Questionnaire Subscale Scores (subscale item sum, higher score=greater aggression) in change from baseline to 1 month after the 12-week interventions. Evaluated on: Physical Aggression (9 items, range 9-45), Verbal Aggression (5 items, range 5-25), Anger (7 items, range 7-35), and Hostility (8 items, range 8-40).
Buss AH, Perry M. The Aggression Questionnaire. J Pers Soc Psychol 63(3):452-459, 1992.
Measured: Outcome measures will be measured twice over a period of 17 weeks: Baseline, 1-Month Post-Treatment
Treatment group differences in change from baseline to 6 months post-treatment on the Buss-Perry Aggression Questionnaire Subscales
Evaluation of treatment group differences on the Buss-Perry Aggression Questionnaire Subscale Scores (subscale item sum, higher score=greater aggression) in change from baseline to 6 months after the 12-week interventions. Evaluated on: Physical Aggression (9 items, range 9-45), Verbal Aggression (5 items, range 5-25), Anger (7 items, range 7-35), and Hostility (8 items, range 8-40).
Buss AH, Perry M. The Aggression Questionnaire. J Pers Soc Psychol 63(3):452-459, 1992.
Measured: Outcome measures will be measured twice over a period of 37 weeks: Baseline, 6-Month Post-Treatment
Treatment group differences in change from baseline to 12 months post-treatment on the Buss-Perry Aggression Questionnaire Subscales
Evaluation of treatment group differences on the Buss-Perry Aggression Questionnaire Subscale Scores (subscale item sum, higher score=greater aggression) in change from baseline to 12 months after the 12-week interventions. Evaluated on: Physical Aggression (9 items, range 9-45), Verbal Aggression (5 items, range 5-25), Anger (7 items, range 7-35), and Hostility (8 items, range 8-40).
Buss AH, Perry M. The Aggression Questionnaire. J Pers Soc Psychol 63(3):452-459, 1992.
Measured: Outcome measures will be measured twice over a period of 61 weeks: Baseline, 12-Month Post-Treatment
Treatment group differences in change from baseline to 1 month post-treatment in event-related potential in response to trauma-specific auditory stimuli
Evaluation of treatment group differences in change from baseline to 1 month following the 12-week interventions in event-related potential (ERP) on trauma-specific threatening auditory stimuli compared to non-specific threatening and non-threatening auditory stimuli. Measured as change in microvolts separately on the N2 and P3 ERP components.
Tillman GD et al. Repetitive transcranial magnetic stimulation and threat memory: selective reduction of combat threat memory p300 response after right frontal-lobe stimulation. J Neuropsychiatry Clin Neurosci 23(1):40-7, 2011.
Measured: Outcome measures will be measured twice over a period of 17 weeks: Baseline, 1-Month Post-Treatment
Treatment group differences in change from baseline to 6 months post-treatment in event-related potential in response to trauma-specific auditory stimuli
Evaluation of treatment group differences in change from baseline to 6 months following the 12-week interventions in event-related potential (ERP) on trauma-specific threatening auditory stimuli compared to non-specific threatening and non-threatening auditory stimuli. Measured as change in microvolts separately on the N2 and P3 ERP components.
Tillman GD et al. Repetitive transcranial magnetic stimulation and threat memory: selective reduction of combat threat memory p300 response after right frontal-lobe stimulation. J Neuropsychiatry Clin Neurosci 23(1):40-7, 2011.
Measured: Outcome measures will be measured twice over a period of 37 weeks: Baseline, 6-Month Post-Treatment
Treatment group differences in change from baseline to 12 months post-treatment in event-related potential in response to trauma-specific auditory stimuli
Evaluation of treatment group differences in change from baseline to 12 months following the 12-week interventions in event-related potential (ERP) on trauma-specific threatening auditory stimuli compared to non-specific threatening and non-threatening auditory stimuli. Measured as change in microvolts separately on the N2 and P3 ERP components.
Tillman GD et al. Repetitive transcranial magnetic stimulation and threat memory: selective reduction of combat threat memory p300 response after right frontal-lobe stimulation. J Neuropsychiatry Clin Neurosci 23(1):40-7, 2011.
Measured: Outcome measures will be measured twice over a period of 61 weeks: Baseline, 12-Month Post-Treatment
Treatment group differences in change from baseline to 1 month post-treatment in event-related potential in response to trauma-specific visual stimuli
Evaluation of treatment group differences in change from baseline to 1 month following the 12-week interventions in event-related potential (ERP) on trauma-specific visual stimuli compared to non-specific threatening and non-threatening visual stimuli. Measured as change in microvolts separately on the N2 and P3 ERP components.
DeLaRosa BL et al. Electrophysiological spatiotemporal dynamics during implicit visual threat processing. Brain Cogn 91:54-61, 2014.
Measured: Outcome measures will be measured twice over a period of 17 weeks: Baseline, 1-Month Post-Treatment
Treatment group differences in change from baseline to 6 months post-treatment in event-related potential in response to trauma-specific visual stimuli
Evaluation of treatment group differences in change from baseline to 6 months following the 12-week interventions in event-related potential (ERP) on trauma-specific visual stimuli compared to non-specific threatening and non-threatening visual stimuli. Measured as change in microvolts separately on the N2 and P3 ERP components.
DeLaRosa BL et al. Electrophysiological spatiotemporal dynamics during implicit visual threat processing. Brain Cogn 91:54-61, 2014.
Measured: Outcome measures will be measured twice over a period of 37 weeks: Baseline, 6-Month Post-Treatment
Treatment group differences in change from baseline to 12 months post-treatment in event-related potential in response to trauma-specific visual stimuli
Evaluation of treatment group differences in change from baseline to 12 months following the 12-week interventions in event-related potential (ERP) on trauma-specific visual stimuli compared to non-specific threatening and non-threatening visual stimuli. Measured as change in microvolts separately on the N2 and P3 ERP components.
DeLaRosa BL et al. Electrophysiological spatiotemporal dynamics during implicit visual threat processing. Brain Cogn 91:54-61, 2014.
Measured: Outcome measures will be measured twice over a period of 61 weeks: Baseline, 12-Month Post-Treatment
Treatment group differences in change from baseline to 1 month post-treatment in electroencephalography power in response to trauma-specific auditory stimuli
Evaluation of treatment group differences in change from baseline to 1 month following the 12-week interventions in change in electroencephalography (EEG) power within alpha- and theta-bands to trauma-specific threatening auditory stimuli compared to non-specific threatening and non-threatening auditory stimuli. For task conditions of interest, EEG power will be calculated separately at each electrode as log transformed, absolute power averages in the delta (1.5-3.5 Hz), theta (4-7.5 Hz), alpha (8-13 Hz), and beta (13.5-25 Hz) bands over time.
Tillman GD et al. Repetitive transcranial magnetic stimulation and threat memory: selective reduction of combat threat memory p300 response after right frontal-lobe stimulation. J Neuropsychiatry Clin Neurosci 23(1):40-7, 2011.
Measured: Outcome measures will be measured twice over a period of 17 weeks: Baseline, 1-Month Post-Treatment
Treatment group differences in change from baseline to 6 months post-treatment in electroencephalography power in response to trauma-specific auditory stimuli
Evaluation of treatment group differences in change from baseline to 6 months following the 12-week interventions in change in electroencephalography (EEG) power within alpha- and theta-bands to trauma-specific threatening auditory stimuli compared to non-specific threatening and non-threatening auditory stimuli. For task conditions of interest, EEG power will be calculated separately at each electrode as log transformed, absolute power averages in the delta (1.5-3.5 Hz), theta (4-7.5 Hz), alpha (8-13 Hz), and beta (13.5-25 Hz) bands over time.
Tillman GD et al. Repetitive transcranial magnetic stimulation and threat memory: selective reduction of combat threat memory p300 response after right frontal-lobe stimulation. J Neuropsychiatry Clin Neurosci 23(1):40-7, 2011.
Measured: Outcome measures will be measured twice over a period of 37 weeks: Baseline, 6-Month Post-Treatment
Treatment group differences in change from baseline to 12 months post-treatment in electroencephalography power in response to trauma-specific auditory stimuli
Evaluation of treatment group differences in change from baseline to 12 months following the 12-week interventions in change in electroencephalography (EEG) power within alpha- and theta-bands to trauma-specific threatening auditory stimuli compared to non-specific threatening and non-threatening auditory stimuli. For task conditions of interest, EEG power will be calculated separately at each electrode as log transformed, absolute power averages in the delta (1.5-3.5 Hz), theta (4-7.5 Hz), alpha (8-13 Hz), and beta (13.5-25 Hz) bands over time.
Tillman GD et al. Repetitive transcranial magnetic stimulation and threat memory: selective reduction of combat threat memory p300 response after right frontal-lobe stimulation. J Neuropsychiatry Clin Neurosci 23(1):40-7, 2011.
Measured: Outcome measures will be measured twice over a period of 61 weeks: Baseline, 12-Month Post-Treatment
Treatment group differences in change from baseline to 1 month post-treatment in electroencephalography power in response to trauma-specific visual stimuli
Evaluation of treatment group differences in change from baseline to 1 month following the 12-week interventions in change in electroencephalography (EEG) power within alpha- and theta-bands to trauma-specific visual stimuli compared to non-specific threatening and non-threatening visual stimuli. For task conditions of interest, EEG power will be calculated separately at each electrode as log transformed, absolute power averages in the delta (1.5-3.5 Hz), theta (4-7.5 Hz), alpha (8-13 Hz), and beta (13.5-25 Hz) bands over time.
DeLaRosa BL et al. Electrophysiological spatiotemporal dynamics during implicit visual threat processing. Brain Cogn 91:54-61, 2014.
Measured: Outcome measures will be measured twice over a period of 17 weeks: Baseline, 1-Month Post-Treatment
Treatment group differences in change from baseline to 6 months post-treatment in electroencephalography power in response to trauma-specific visual stimuli
Evaluation of treatment group differences in change from baseline to 6 months following the 12-week interventions in change in electroencephalography (EEG) power within alpha- and theta-bands to trauma-specific visual stimuli compared to non-specific threatening and non-threatening visual stimuli. For task conditions of interest, EEG power will be calculated separately at each electrode as log transformed, absolute power averages in the delta (1.5-3.5 Hz), theta (4-7.5 Hz), alpha (8-13 Hz), and beta (13.5-25 Hz) bands over time.
DeLaRosa BL et al. Electrophysiological spatiotemporal dynamics during implicit visual threat processing. Brain Cogn 91:54-61, 2014.
Measured: Outcome measures will be measured twice over a period of 37 weeks: Baseline, 6-Month Post-Treatment
Treatment group differences in change from baseline to 12 months post-treatment in electroencephalography power in response to trauma-specific visual stimuli
Evaluation of treatment group differences in change from baseline to 12 months following the 12-week interventions in change in electroencephalography (EEG) power within alpha- and theta-bands to trauma-specific visual stimuli compared to non-specific threatening and non-threatening visual stimuli. For task conditions of interest, EEG power will be calculated separately at each electrode as log transformed, absolute power averages in the delta (1.5-3.5 Hz), theta (4-7.5 Hz), alpha (8-13 Hz), and beta (13.5-25 Hz) bands over time.
DeLaRosa BL et al. Electrophysiological spatiotemporal dynamics during implicit visual threat processing. Brain Cogn 91:54-61, 2014.
Measured: Outcome measures will be measured twice over a period of 61 weeks: Baseline, 12-Month Post-Treatment
Treatment group differences in change from baseline to 1 month post-treatment in event-related potential responses in inhibitory control
Evaluation of treatment group differences in change from baseline to 1 month following the 12-week interventions in change in event-related potential (ERP) on inhibitory control trials (i.e., No-Go trials on the semantically cued inhibitory control task). Measured as change in microvolts separately on the N2 and P3 ERP components.
Maguire MJ et al. The influence of perceptual and semantic categorization on inhibitory processing as measured by the N2-P3 response. Brain Cog 71; 196-203, 2009.
Measured: Outcome measures will be measured twice over a period of 17 weeks: Baseline, 1-Month Post-Treatment
Treatment group differences in change from baseline to 6 months post-treatment in event-related potential responses in inhibitory control
Evaluation of treatment group differences in change from baseline to 6 months following the 12-week interventions in change in event-related potential (ERP) on inhibitory control trials (i.e., No-Go trials on the semantically cued inhibitory control task). Measured as change in microvolts separately on the N2 and P3 ERP components.
Maguire MJ et al. The influence of perceptual and semantic categorization on inhibitory processing as measured by the N2-P3 response. Brain Cog 71; 196-203, 2009.
Measured: Outcome measures will be measured twice over a period of 37 weeks: Baseline, 6-Month Post-Treatment
Treatment group differences in change from baseline to 12-month post-treatment in event-related potential responses in inhibitory control
Evaluation of treatment group differences in change from baseline to 12 months following the 12-week interventions in change in event-related potential (ERP) on inhibitory control trials (i.e., No-Go trials on the semantically cued inhibitory control task). Measured as change in microvolts separately on the N2 and P3 ERP components.
Maguire MJ et al. The influence of perceptual and semantic categorization on inhibitory processing as measured by the N2-P3 response. Brain Cog 71; 196-203, 2009.
Measured: Outcome measures will be measured twice over a period of 61 weeks: Baseline, 12-Month Post-Treatment
Treatment group differences in change from baseline to 1-month post-treatment in resting-state electroencephalography power
Evaluation of treatment group differences in change from baseline to 1 month following the 12-week interventions in change in resting-state electroencephalography (EEG) power. EEG power will be calculated separately at each electrode as the log transformed, absolute power in the delta (1.5-3.5 Hz), theta (4-7.5 Hz), alpha (8-13 Hz), and beta (13.5-25 Hz) bands for each eyes-open and eyes-closed epoch, and groups differences from baseline to 1-month in the average differences in the log transformed, absolute power between the eyes-open and eyes-closed conditions will be evaluated.
Measured: Outcome measures will be measured twice over a period of 17 weeks: Baseline, 1-Month Post-Treatment
Treatment group differences in change from baseline to 6-months post-treatment in resting-state electroencephalography power
Evaluation of treatment group differences in change from baseline to 6 months following the 12-week interventions in change in resting-state electroencephalography (EEG) power. EEG power will be calculated separately at each electrode as the log transformed, absolute power in the delta (1.5-3.5 Hz), theta (4-7.5 Hz), alpha (8-13 Hz), and beta (13.5-25 Hz) bands for each eyes-open and eyes-closed epoch, and groups differences from baseline to 1-month in the average differences in the log transformed, absolute power between the eyes-open and eyes-closed conditions will be evaluated.
Measured: Outcome measures will be measured twice over a period of 37 weeks: Baseline, 6-Month Post-Treatment
Treatment group differences in change from baseline to 12-months post-treatment in resting-state electroencephalography power
Evaluation of treatment group differences in change from baseline to 12 months following the 12-week interventions in change in resting-state electroencephalography (EEG) power. EEG power will be calculated separately at each electrode as the log transformed, absolute power in the delta (1.5-3.5 Hz), theta (4-7.5 Hz), alpha (8-13 Hz), and beta (13.5-25 Hz) bands for each eyes-open and eyes-closed epoch, and groups differences from baseline to 1-month in the average differences in the log transformed, absolute power between the eyes-open and eyes-closed conditions will be evaluated.
Measured: Outcome measures will be measured twice over a period of 61 weeks: Baseline, 12-Month Post-Treatment
Treatment group differences in change from baseline to 6-months post-treatment trauma-specific responses in blood oxygen level dependent functional magnetic resonance imaging
Evaluation of treatment group differences from baseline to 6 months following the 12-week interventions in functional magnetic resonance imaging (fMRI) blood oxygen level dependent (BOLD) signal change (mean percent signal-change from the task baseline) to trauma-specific visual stimuli compared to non-specific threatening and non-threatening visual stimuli.
Calley CS, et al. Threat as a feature in visual semantic object memory. Hum Brain Mapp. 34(8):1946-55, 2013.
Measured: Outcome measures will be measured twice over a period of 37 weeks: Baseline, 6-Month Post-Treatment
Treatment group differences in change from baseline to 12 months post-treatment trauma-specific responses in blood oxygen level dependent functional magnetic resonance imaging
Evaluation of treatment group differences from baseline to 12 months following the 12-week interventions in functional magnetic resonance imaging (fMRI) blood oxygen level dependent (BOLD) signal change (mean percent signal-change from the task baseline) to trauma-specific visual stimuli compared to non-specific threatening and non-threatening visual stimuli.
Calley CS, et al. Threat as a feature in visual semantic object memory. Hum Brain Mapp. 34(8):1946-55, 2013.
Measured: Outcome measures will be measured twice over a period of 61 weeks: Baseline, 12-Month Post-Treatment
Treatment group differences in change from baseline to 6 months post-treatment in resting-state functional connectivity
Evaluation of treatment group differences from baseline to 6 months following the 12-week interventions in functional magnetic resonance imaging (fMRI) blood oxygen level dependent (BOLD) resting-state connectivity. Group differences in seed-based connectivity indices (mean standardized coherence parameter estimates) with right dorsolateral prefrontal cortex, amygdalae, thalamus, and dorsal anterior cingulate as the primary therapeutic targets will be calculated.
Measured: Outcome measures will be measured twice over a period of 37 weeks: Baseline, 6-Month Post-Treatment
Treatment group differences in change from baseline to 12 months post-treatment in resting-state functional connectivity
Evaluation of treatment group differences from baseline to 12 months following the 12-week interventions in functional magnetic resonance imaging (fMRI) blood oxygen level dependent (BOLD) resting-state connectivity. Group differences in seed-based connectivity indices (mean standardized coherence parameter estimates) with right dorsolateral prefrontal cortex, amygdalae, thalamus, and dorsal anterior cingulate as the primary therapeutic targets will be calculated.
Measured: Outcome measures will be measured twice over a period of 61 weeks: Baseline, 12-Month Post-Treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2019
- Study start1 May 2019
- Primary completion1 Jan 2028 (estimated)
- Study completion1 Jan 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (14)Papers the sponsor has linked to this study.
- Other trials for Post Traumatic Stress DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 330 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The University of Texas at Dallas
- Sponsor type
- University, hospital or other
- Collaborators
- University of Texas Southwestern Medical Center, Johns Hopkins University, Metrocare Services of Dallas, Florida State University
- Responsible party
- Principal investigator, John Hart, Jr., The University of Texas at Dallas
- Investigators
- John Hart, Jr., MD, Principal investigator, The University of Texas at DallasF. Andrew Kozel, MD, Principal investigator, Florida State UniversityJohn Burruss, MD, Principal investigator, Metrocare Services of Dallas
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03932773
- Sponsor's protocol ID
- 18-123
- Other IDs
- CDMRP-BA160594
- Status last verified
- Aug 2026
- First submitted
- 4 Apr 2019
- Last updated
- 20 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Publications
Weathers, FW, Blake, DD, Schnurr, PP, Kaloupek, DG, Marx, BP, & Keane, TM. The Clinician-Administered PTSD Scale for DSM-5 (CAPS-5). www.ptsd.va.gov: National Center for PTSD, 2013.
Weathers FW, Litz BT, Keane TM, Palmieri PA, Marx BP, Schnurr PP. The PTSD Checklist for DSM-5 (PCL-5). Scale available from the National Center for PTSD at www.ptsd.va.gov, 2013.
Rush AJ, Trivedi MH, Ibrahim HM, Carmody TJ, Arnow B, Klein DN, Markowitz JC, Ninan PT, Kornstein S, Manber R, Thase ME, Kocsis JH, Keller MB. The 16-Item Quick Inventory of Depressive Symptomatology (QIDS), clinician rating (QIDS-C), and self-report (QIDS-SR): a psychometric evaluation in patients with chronic major depression. Biol Psychiatry. 2003 Sep 1;54(5):573-83. doi: 10.1016/s0006-3223(02)01866-8.
PubMed 12946886Montgomery SA, Asberg M. A new depression scale designed to be sensitive to change. Br J Psychiatry. 1979 Apr;134:382-9. doi: 10.1192/bjp.134.4.382.
PubMed 444788Keane TM, Caddell JM, Taylor KL. Mississippi Scale for Combat-Related Posttraumatic Stress Disorder: three studies in reliability and validity. J Consult Clin Psychol. 1988 Feb;56(1):85-90. doi: 10.1037//0022-006x.56.1.85. No abstract available.
PubMed 3346454Bovin MJ, Black SK, Rodriguez P, Lunney CA, Kleiman SE, Weathers FW, Schnurr PP, Spira J, Keane TM, Marx BP. Development and validation of a measure of PTSD-related psychosocial functional impairment: The Inventory of Psychosocial Functioning. Psychol Serv. 2018 May;15(2):216-229. doi: 10.1037/ser0000220.
PubMed 29723024Cyders MA, Littlefield AK, Coffey S, Karyadi KA. Examination of a short English version of the UPPS-P Impulsive Behavior Scale. Addict Behav. 2014 Sep;39(9):1372-6. doi: 10.1016/j.addbeh.2014.02.013. Epub 2014 Mar 3.
PubMed 24636739Buss AH, Perry M. The aggression questionnaire. J Pers Soc Psychol. 1992 Sep;63(3):452-9. doi: 10.1037//0022-3514.63.3.452.
PubMed 1403624Monson CM, Schnurr PP, Resick PA, Friedman MJ, Young-Xu Y, Stevens SP. Cognitive processing therapy for veterans with military-related posttraumatic stress disorder. J Consult Clin Psychol. 2006 Oct;74(5):898-907. doi: 10.1037/0022-006X.74.5.898.
PubMed 17032094Weathers FW, Bovin MJ, Lee DJ, Sloan DM, Schnurr PP, Kaloupek DG, Keane TM, Marx BP. The Clinician-Administered PTSD Scale for DSM-5 (CAPS-5): Development and initial psychometric evaluation in military veterans. Psychol Assess. 2018 Mar;30(3):383-395. doi: 10.1037/pas0000486. Epub 2017 May 11.
PubMed 28493729Tillman GD, Kimbrell TA, Calley CS, Kraut MA, Freeman TW, Hart J Jr. Repetitive transcranial magnetic stimulation and threat memory: selective reduction of combat threat memory p300 response after right frontal-lobe stimulation. J Neuropsychiatry Clin Neurosci. 2011 Winter;23(1):40-7. doi: 10.1176/jnp.23.1.jnp40.
PubMed 21304137DeLaRosa BL, Spence JS, Shakal SK, Motes MA, Calley CS, Calley VI, Hart J Jr, Kraut MA. Electrophysiological spatiotemporal dynamics during implicit visual threat processing. Brain Cogn. 2014 Nov;91:54-61. doi: 10.1016/j.bandc.2014.08.003. Epub 2014 Sep 15.
PubMed 25222294Maguire 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.
PubMed 19773108Calley CS, Motes MA, Chiang HS, Buhl V, Spence JS, Abdi H, Anand R, Maguire M, Estevez L, Briggs R, Freeman T, Kraut MA, Hart J Jr. Threat as a feature in visual semantic object memory. Hum Brain Mapp. 2013 Aug;34(8):1946-55. doi: 10.1002/hbm.22039. Epub 2012 Mar 25.
PubMed 22451240
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multi-site Confirmatory Efficacy Treatment Trial of Combat-related PTSD
- ClinicalTrials.gov ID
- NCT03932773
- Acronym / sponsor ID
- 18-123
- Conditions
- Post Traumatic Stress Disorder
- Keywords
- PTSD, post-traumatic stress disorder, military-related PTSD, CPT, cognitive processing therapy, rTMS, repetitive transcranial magnetic stimulation, combat
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 330 participants (estimated)
- Lead sponsor
- The University of Texas at DallasUniversity, hospital or other
- Collaborators
- University of Texas Southwestern Medical Center, Johns Hopkins University, Metrocare Services of Dallas, Florida State University
- Study start
- 1 May 2019 (actual)
- Primary completion
- 1 Jan 2028 (estimated)
- Study completion
- 1 Jan 2028 (estimated)
- First posted
- 1 May 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 3
- 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.
| Arm | Type | Receives |
|---|---|---|
| Sham rTMS + CPT | Sham comparator | Device: Active rTMS, Behavioral: Cognitive Processing Therapy30 minutes of sham repetitive transcranial magnetic stimulation (rTMS) to the right dorsolateral prefrontal cortex (rDLPFC) prior to each Cognitive Processing Therapy (CPT) session |
| Active rTMS + CPT | Active comparator | Device: Sham rTMS, Behavioral: Cognitive Processing Therapy30 minutes of 1 Hz rTMS to rDLPFC prior to each CPT session |
| Active rTMS Alone | Active comparator | Device: Active rTMS30 minutes of 1 Hz rTMS to rDLPFC at 1 session per week over 12 weeks |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Veterans of Post-9/11 military conflicts
- with diagnosis of PTSD based on CAPS-5 related to Post-9/11 military combat
Key exclusion criteria (21 listed)
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Active rTMSAlso: 1 Hz repetitive transcranial magnetic stimulationA Magstim Rapid2 Stimulator repetitive transcranial magnetic stimulation (rTMS) device will be used to deliver 1 hertz (Hz) stimulation to right dorsolateral prefrontal cortex (rDLPFC) at 110% of a participant's rTMS motor threshold. The device passes electric current through a coil generating an alternating magnetic field. When positioned over the skull, the changing magnetic field causes electromagnetic inducted current flow in brain regions subjacent to the coil. Magnetic pulses (1.5-2.0 Tesla) lasting 100-300 microseconds at 1 Hz will be used. Motor threshold will be defined by the TMS intensity to right motor region required to induce visually perceptible movement of the contralateral abductor pollicus brevis 50 percent of the time. | Device | Active rTMS Alone, Sham rTMS + CPT |
| Sham rTMSAlso: sham repetitive transcranial magnetic stimulationA Magstim Rapid2 Stimulator repetitive transcranial magnetic stimulation (rTMS) device will be paired with sham coil. The sham coil will induce electrical current flow in the tissue above the skull but will not induce current flow in brain tissue. The sham coil will be placed over the right prefrontal scalp region to target current flow in rDLPFC. Magnetic pulses lasting for 100-300 microseconds at 1 Hz will be used. For consistency across the rTMS conditions, motor threshold in the sham condition also will be determined by positioning the active rTMS coil over the right motor region and identifying the stimulation intensity required to induce visually perceptible movement of the contralateral abductor pollicus brevis 50 percent of the time. | Device | Active rTMS + CPT |
| Cognitive Processing TherapyAlso: CPTCognitive Processing Therapy (CPT) is an evidenced based, trauma-focused treatment for Posttraumatic Stress Disorder (PTSD). CPT is a recommended form of treatment in the Veterans Administration - Department of Defense Clinical Practice Guideline for PTSD. The CPT manual delineates the agenda for each of 12 sessions (60 minutes per session): 1) Introduction to CPT and Patient Education regarding PTSD, 2) Meaning of the Trauma, 3) Identification of Thoughts and Feelings related to the Trauma, 4) Remembering the Trauma, 5) Identification of Stuck points, 6) Challenging Questions about the Trauma, 7) Dysfunctional/Maladaptive Thinking patterns related to the Trauma, 8) Safety Issues, 9) Trust Issues, 10) Power and Control Issues, 11) Self-Esteem Issues, and 12) Intimacy Issues. | Behavioural | Active rTMS + CPT, Sham rTMS + CPT |
Primary outcome
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
Time frame: Outcome measures will be measured twice over a period of 37 weeks: Baseline, 6-Month Post-Treatment
Evaluation of treatment group differences on the Clinician Administered Posttraumatic Stress Disorder Scale for Diagnostic and Statistical Manual of Mental Disorders (5th edition) (CAPS-5) Total Severity Score (20 item sum, range 0-80, higher score=greater severity) in change from baseline to 6 months after the 12-week interventions. Weathers, FW, Blake, DD, Schnurr, PP, Kaloupek, DG, Marx, BP, \& Keane, TM. The Clinician-Administered PTSD Scale for DSM-5 (CAPS-5). www.ptsd.va.gov: National Center for PTSD, 2013.
67 secondary outcomes
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
Time frame: Outcome measures will be measured twice over a period of 17 weeks: Baseline, 1-Month Post-Treatment
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
Time frame: Outcome measures will be measured twice over a period of 61 weeks: Baseline, 12-Month Post-Treatment
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
Time frame: Outcome measures will be measured twice over a period of 17 weeks: Baseline, 1-Month Post-Treatment
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
Time frame: Outcome measures will be measured twice over a period of 37 weeks: Baseline, 6-Month Post-Treatment
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
Time frame: Outcome measures will be measured twice over a period of 61 weeks: Baseline, 12-Month Post-Treatment
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
Time frame: Outcome measures will be measured twice over a period of 17 weeks: Baseline, 1-Month Post-Treatment
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
Time frame: Outcome measures will be measured twice over a period of 37 weeks: Baseline, 6-Month Post-Treatment
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
Time frame: Outcome measures will be measured twice over a period of 61 weeks: Baseline, 12-Month Post-Treatment
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
Time frame: Outcome measures will be measured twice over a period of 6 weeks: Baseline, 6 weeks
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
Time frame: Outcome measures will be measured twice over a period of 10 weeks: Baseline, 10 weeks
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
Time frame: Outcome measures will be measured twice over a period of 6 weeks: Baseline, 6 weeks
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
Time frame: Outcome measures will be measured twice over a period of 10 weeks: Baseline, 10 weeks
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
Time frame: Outcome measures will be measured twice over a period of 17 weeks: Baseline, 1-Month Post-Treatment
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
Time frame: Outcome measures will be measured twice over a period of 37 weeks: Baseline, 6-Month Post-Treatment
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
Time frame: Outcome measures will be measured twice over a period of 61 weeks: Baseline, 12-Month Post-Treatment
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
Time frame: Outcome measures will be measured twice over a period of 6 weeks: Baseline, 6 weeks
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
Time frame: Outcome measures will be measured twice over a period of 10 weeks: Baseline, 10 weeks
Treatment group differences in change from baseline to 1 month post-treatment on the Mississippi Scale for Combat Related Posttraumatic Stress Disorder
Time frame: Outcome measures will be measured twice over a period of 17 weeks: Baseline, 1-Month Post-Treatment
Treatment group differences in change from baseline to 6 months post-treatment on the Mississippi Scale for Combat Related Posttraumatic Stress Disorder
Time frame: Outcome measures will be measured twice over a period of 37 weeks: Baseline, 6-Month Post-Treatment
Treatment group differences in change from baseline to 12 months post-treatment on the Mississippi Scale for Combat Related Posttraumatic Stress Disorder
Time frame: Outcome measures will be measured twice over a period of 61 weeks: Baseline, 12-Month Post-Treatment
Treatment group differences in change from baseline to 1 month post-treatment on Montgomery Asberg Depression Rating Scale
Time frame: Outcome measures will be measured twice over a period of 17 weeks: Baseline, 1-Month Post-Treatment
Treatment group differences in change from baseline to 6 months post-treatment on Montgomery Asberg Depression Rating Scale
Time frame: Outcome measures will be measured twice over a period of 37 weeks: Baseline, 6-Month Post-Treatment
Treatment group differences in change from baseline to 12 months post-treatment on Montgomery Asberg Depression Rating Scale
Time frame: Outcome measures will be measured twice over a period of 61 weeks: Baseline, 12-Month Post-Treatment
Treatment group differences in change from baseline to 6 weeks (5th intervention session) on Montgomery Asberg Depression Rating Scale
Time frame: Outcome measures will be measured twice over a period of 6 weeks: Baseline, 6 weeks
Treatment group differences in change from baseline to 10 weeks (9th intervention session) on Montgomery Asberg Depression Rating Scale
Time frame: Outcome measures will be measured twice over a period of 10 weeks: Baseline, 10 weeks
Treatment group differences in change from baseline to 1 month post-treatment on the Quick Inventory of Depressive Symptomatology
Time frame: Outcome measures will be measured twice over a period of 17 weeks: Baseline, 1-Month Post-Treatment
Treatment group differences in change from baseline to 6 months post-treatment on the Quick Inventory of Depressive Symptomatology
Time frame: Outcome measures will be measured twice over a period of 37 weeks: Baseline, 6-Month Post-Treatment
Treatment group differences in change from baseline to 12 months post-treatment on the Quick Inventory of Depressive Symptomatology
Time frame: Outcome measures will be measured twice over a period of 61 weeks: Baseline, 12-Month Post-Treatment
Treatment group differences in change from baseline to 6 weeks (5th intervention session ) on the Quick Inventory of Depressive Symptomatology
Time frame: Outcome measures will be measured twice over a period of 6 weeks: Baseline, 6 weeks
Treatment group differences from baseline to 10 weeks (9th intervention session) on the Quick Inventory of Depressive Symptomatology
Time frame: Outcome measures will be measured twice over a period of 10 weeks: Baseline, 10 weeks
Treatment group differences in change from baseline to 1 month post-treatment on the Inventory of Psychosocial Functioning
Time frame: Outcome measures will be measured twice over a period of 17 weeks: Baseline, 1-Month Post-Treatment
Treatment group differences in change from baseline to 6 months post-treatment on the Inventory of Psychosocial Functioning
Time frame: Outcome measures will be measured twice over a period of 37 weeks: Baseline, 6-Month Post-Treatment
Treatment group differences in change from baseline to 12 months post-treatment on the Inventory of Psychosocial Functioning
Time frame: Outcome measures will be measured twice over a period of 61 weeks: Baseline, 12-Month Post-Treatment
Treatment group differences in change from baseline to 1 month post-treatment on the Short Impulsive Behavior Scale
Time frame: Outcome measures will be measured twice over a period of 17 weeks: Baseline, 1-Month Post-Treatment
Treatment group differences in change from baseline to 6 months post-treatment on the Short Impulsive Behavior Scale
Time frame: Outcome measures will be measured twice over a period of 37 weeks: Baseline, 6-Month Post-Treatment
Treatment group differences in change from baseline to 12 months post-treatment on the Short Impulsive Behavior Scale
Time frame: Outcome measures will be measured twice over a period of 61 weeks: Baseline, 12-Month Post-Treatment
Treatment group differences in change from baseline to 1 month post-treatment on the Short Impulsive Behavior Subscales
Time frame: Outcome measures will be measured twice over a period of 17 weeks: Baseline, 1-Month Post-Treatment
Treatment group differences in change from baseline to 6 months post-treatment on the Short Impulsive Behavior Subscales
Time frame: Outcome measures will be measured twice over a period of 37 weeks: Baseline, 6-Month Post-Treatment
Treatment group differences in change from baseline to 12 months post-treatment on the Short Impulsive Behavior Subscales
Time frame: Outcome measures will be measured twice over a period of 61 weeks: Baseline, 12-Month Post-Treatment
Treatment group differences in change in aggression from baseline to 1 month post-treatment on the Buss-Perry Aggression Questionnaire
Time frame: Outcome measures will be measured twice over a period of 17 weeks: Baseline, 1-Month Post-Treatment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Aug 2026.
- BackgroundWeathers, FW, Blake, DD, Schnurr, PP, Kaloupek, DG, Marx, BP, & Keane, TM. The Clinician-Administered PTSD Scale for DSM-5 (CAPS-5). www.ptsd.va.gov: National Center for PTSD, 2013.
- BackgroundWeathers FW, Litz BT, Keane TM, Palmieri PA, Marx BP, Schnurr PP. The PTSD Checklist for DSM-5 (PCL-5). Scale available from the National Center for PTSD at www.ptsd.va.gov, 2013.
- Background: PubMed 12946886Rush AJ, Trivedi MH, Ibrahim HM, Carmody TJ, Arnow B, Klein DN, Markowitz JC, Ninan PT, Kornstein S, Manber R, Thase ME, Kocsis JH, Keller MB. The 16-Item Quick Inventory of Depressive Symptomatology (QIDS), clinician rating (QIDS-C), and self-report (QIDS-SR): a psychometric evaluation in patients with chronic major depression. Biol Psychiatry. 2003 Sep 1;54(5):573-83. doi: 10.1016/s0006-3223(02)01866-8.
- Background: PubMed 444788Montgomery SA, Asberg M. A new depression scale designed to be sensitive to change. Br J Psychiatry. 1979 Apr;134:382-9. doi: 10.1192/bjp.134.4.382.
- Background: PubMed 3346454Keane TM, Caddell JM, Taylor KL. Mississippi Scale for Combat-Related Posttraumatic Stress Disorder: three studies in reliability and validity. J Consult Clin Psychol. 1988 Feb;56(1):85-90. doi: 10.1037//0022-006x.56.1.85. No abstract available.
- Background: PubMed 29723024Bovin MJ, Black SK, Rodriguez P, Lunney CA, Kleiman SE, Weathers FW, Schnurr PP, Spira J, Keane TM, Marx BP. Development and validation of a measure of PTSD-related psychosocial functional impairment: The Inventory of Psychosocial Functioning. Psychol Serv. 2018 May;15(2):216-229. doi: 10.1037/ser0000220.
- Background: PubMed 24636739Cyders MA, Littlefield AK, Coffey S, Karyadi KA. Examination of a short English version of the UPPS-P Impulsive Behavior Scale. Addict Behav. 2014 Sep;39(9):1372-6. doi: 10.1016/j.addbeh.2014.02.013. Epub 2014 Mar 3.
- Background: PubMed 1403624Buss AH, Perry M. The aggression questionnaire. J Pers Soc Psychol. 1992 Sep;63(3):452-9. doi: 10.1037//0022-3514.63.3.452.
- Background: PubMed 17032094Monson CM, Schnurr PP, Resick PA, Friedman MJ, Young-Xu Y, Stevens SP. Cognitive processing therapy for veterans with military-related posttraumatic stress disorder. J Consult Clin Psychol. 2006 Oct;74(5):898-907. doi: 10.1037/0022-006X.74.5.898.
- Background: PubMed 28493729Weathers FW, Bovin MJ, Lee DJ, Sloan DM, Schnurr PP, Kaloupek DG, Keane TM, Marx BP. The Clinician-Administered PTSD Scale for DSM-5 (CAPS-5): Development and initial psychometric evaluation in military veterans. Psychol Assess. 2018 Mar;30(3):383-395. doi: 10.1037/pas0000486. Epub 2017 May 11.
- Background: PubMed 21304137Tillman GD, Kimbrell TA, Calley CS, Kraut MA, Freeman TW, Hart J Jr. Repetitive transcranial magnetic stimulation and threat memory: selective reduction of combat threat memory p300 response after right frontal-lobe stimulation. J Neuropsychiatry Clin Neurosci. 2011 Winter;23(1):40-7. doi: 10.1176/jnp.23.1.jnp40.
- Background: PubMed 25222294DeLaRosa BL, Spence JS, Shakal SK, Motes MA, Calley CS, Calley VI, Hart J Jr, Kraut MA. Electrophysiological spatiotemporal dynamics during implicit visual threat processing. Brain Cogn. 2014 Nov;91:54-61. doi: 10.1016/j.bandc.2014.08.003. Epub 2014 Sep 15.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
John Hart, Jr., MD principal investigator
The University of Texas at Dallas
F. Andrew Kozel, MD principal investigator
Florida State University
John Burruss, MD principal investigator
Metrocare Services of Dallas
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Active rTMS and Cognitive Processing Therapy in people with Post Traumatic Stress Disorder, run by The University of Texas at Dallas at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 20 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Elizabeth "Ellen" Morris, PhD (214-883-3171, neurolab@utdallas.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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 (time frame: Outcome measures will be measured twice over a period of 37 weeks: Baseline, 6-Month Post-Treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03932773, which also lists 14 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Aug 2026.