Multi-site Confirmatory Efficacy Treatment Trial of Combat-related PTSD
- Conditions
- Post Traumatic Stress Disorder
- Interventions
- Device: Active rTMSDevice: Sham rTMSBehavioral: Cognitive Processing Therapy
- Registration Number
- NCT03932773
- Lead Sponsor
- The University of Texas at Dallas
- Brief Summary
The purpose of this study is to examine the benefits of combining repetitive Transcranial Magnetic Stimulation (rTMS) coupled with Cognitive Processing Therapy (CPT) in treating combat-related Posttraumatic Stress Disorder (PTSD) symptoms. The study will also examine change in depression, psychosocial functioning, and neurophysiological (i.e., electroencephalography and magnetic resonance images) measures.
- Detailed Description
Using three treatment arms, the study will examine Posttraumatic Stress Disorder (PTSD) symptom reduction when (1) 1 Hz (hertz) repetitive transcranial magnetic stimulation (rTMS) to the right dorsolateral prefrontal cortex (rDLPFC) is administered prior to each of 12 Cognitive Processing Therapy (CPT) sessions compared to when (2) sham rTMS is administered to the rDLPFC is administered prior to each of 12 CPT sessions and to when (3) 1 Hz rTMS is delivered to rDLPFC alone over 12 sessions.
Veterans with combat-related PTSD will be randomly assigned to one of the three treatment arms. Primary outcome PTSD symptom severity measures, secondary neuropsychological, electroencephalography (EEG), and magnetic resonance imaging (MRI) outcome measures, and prescreening assessments for study contraindicators will be collected prior to being assigned to a treatment arm (i.e., baseline).
Primary outcome PTSD symptom severity measures and secondary neuropsychological outcome measures will be collected twice within the span of the treatment sessions (i.e., sessions 5 and 9) and at three times following treatment competition (i.e., 1-month, 6-months, and 12-months). EEG also will be collected at the 1-month, 6-month, and 12-month assessments, and MRI will be collected at the 6-month and 12-month assessments.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 330
- Veterans of Post-9/11 military conflicts
- with diagnosis of PTSD based on CAPS-5 related to Post-9/11 military combat
- current enrollment in an acute experimental treatment for PTSD or trauma-focused psychotherapy treatment
- PTSD-inducing trauma exposure occurring within the last 3 months prior to pre-enrollment evaluation
- history of epilepsy or seizure disorder, a history of major head trauma,
- any neurologic condition likely to increase risk of seizures,
- brain tumors,
- moderate to severe substance use disorder in last 3 months or any substance use that puts the participant at increased risk or significant impairment
- stroke, and blood vessel abnormalities in the brain,
- dementia,
- Parkinson's disease, Huntington's chorea, or multiple sclerosis
- a high suicide risk
- a lifetime history of psychotic disorder or bipolar disorder
- inability to stop taking any medication that significantly lowers the seizure threshold
- pregnant or nursing
- metal fragments in the head, or any metal objects in or near the head that cannot be safely removed
- We will screen for a history of traumatic brain injury and exclude potential participants from the study if they have a history of severe TBI or are at high risk for seizures.
- history of seizures
- non-English speakers because not all of the screening forms, questionnaires, and tests are available in any language except for English
- cardiac pacemaker, implanted medication pumps of any sort that would increase the risk of rTMS
- any current medical condition that could preclude being able to safely participate in TMS treatment,
- use of prescription medication or illegal substances that lower the seizure threshold
- previous rTMS
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Active rTMS Alone Active rTMS 30 minutes of 1 Hz rTMS to rDLPFC at 1 session per week over 12 weeks Sham rTMS + CPT Active rTMS 30 minutes of sham repetitive transcranial magnetic stimulation (rTMS) to the right dorsolateral prefrontal cortex (rDLPFC) prior to each Cognitive Processing Therapy (CPT) session Sham rTMS + CPT Cognitive Processing Therapy 30 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 Sham rTMS 30 minutes of 1 Hz rTMS to rDLPFC prior to each CPT session Active rTMS + CPT Cognitive Processing Therapy 30 minutes of 1 Hz rTMS to rDLPFC prior to each CPT session
- Primary Outcome Measures
Name Time Method 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 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.
- Secondary Outcome Measures
Name Time Method Treatment group differences in change from baseline to 6 weeks (5th intervention session ) on the Quick Inventory of Depressive Symptomatology Outcome measures will be measured twice over a period of 6 weeks: Baseline, 6 weeks 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.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 Outcome measures will be measured twice over a period of 61 weeks: Baseline, 12-Month Post-Treatment 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.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 Outcome measures will be measured twice over a period of 6 weeks: Baseline, 6 weeks 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.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 Outcome measures will be measured twice over a period of 17 weeks: Baseline, 1-Month Post-Treatment 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.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 Outcome measures will be measured twice over a period of 17 weeks: Baseline, 1-Month Post-Treatment 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.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 Outcome measures will be measured twice over a period of 10 weeks: Baseline, 10 weeks 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.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 Outcome measures will be measured twice over a period of 37 weeks: Baseline, 6-Month Post-Treatment 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.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 Outcome measures will be measured twice over a period of 17 weeks: Baseline, 1-Month Post-Treatment 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.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 Outcome measures will be measured twice over a period of 61 weeks: Baseline, 12-Month Post-Treatment 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.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 Outcome measures will be measured twice over a period of 10 weeks: Baseline, 10 weeks 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.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 Outcome measures will be measured twice over a period of 17 weeks: Baseline, 1-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 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.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 Outcome measures will be measured twice over a period of 61 weeks: Baseline, 12-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 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.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 Outcome measures will be measured twice over a period of 6 weeks: Baseline, 6 weeks 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.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 Outcome measures will be measured twice over a period of 10 weeks: Baseline, 10 weeks 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.Treatment group differences in change from baseline to 12 months post-treatment on Montgomery Asberg Depression Rating Scale Outcome measures will be measured twice over a period of 61 weeks: Baseline, 12-Month Post-Treatment 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.Treatment group differences in change from baseline to 6 months post-treatment on the Quick Inventory of Depressive Symptomatology Outcome measures will be measured twice over a period of 37 weeks: Baseline, 6-Month Post-Treatment 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.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 Outcome measures will be measured twice over a period of 37 weeks: Baseline, 6-Month Post-Treatment 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.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 Outcome measures will be measured twice over a period of 37 weeks: Baseline, 6-Month Post-Treatment 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.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 Outcome measures will be measured twice over a period of 6 weeks: Baseline, 6 weeks 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.Treatment group differences in change from baseline to 6 months post-treatment on Montgomery Asberg Depression Rating Scale Outcome measures will be measured twice over a period of 37 weeks: Baseline, 6-Month Post-Treatment 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.Treatment group differences in change from baseline to 10 weeks (9th intervention session) on Montgomery Asberg Depression Rating Scale Outcome measures will be measured twice over a period of 10 weeks: Baseline, 10 weeks 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.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 Outcome measures will be measured twice over a period of 61 weeks: Baseline, 12-Month Post-Treatment 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.Treatment group differences in change from baseline to 1 month post-treatment on the Mississippi Scale for Combat Related Posttraumatic Stress Disorder Outcome measures will be measured twice over a period of 17 weeks: Baseline, 1-Month Post-Treatment 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.Treatment group differences in change from baseline to 12 months post-treatment on the Mississippi Scale for Combat Related Posttraumatic Stress Disorder Outcome measures will be measured twice over a period of 61 weeks: Baseline, 12-Month Post-Treatment 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.Treatment group differences in change from baseline to 6 weeks (5th intervention session) on Montgomery Asberg Depression Rating Scale Outcome measures will be measured twice over a period of 6 weeks: Baseline, 6 weeks 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.Treatment group differences in change from baseline to 12 months post-treatment on the Quick Inventory of Depressive Symptomatology Outcome measures will be measured twice over a period of 61 weeks: Baseline, 12-Month Post-Treatment 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.Treatment group differences in change from baseline to 6 months post-treatment on the Inventory of Psychosocial Functioning Outcome measures will be measured twice over a period of 37 weeks: Baseline, 6-Month Post-Treatment 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.Treatment group differences in change from baseline to 6 months post-treatment on the Short Impulsive Behavior Scale Outcome measures will be measured twice over a period of 37 weeks: Baseline, 6-Month Post-Treatment 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.Treatment group differences in change from baseline to 1 month post-treatment on Montgomery Asberg Depression Rating Scale Outcome measures will be measured twice over a period of 17 weeks: Baseline, 1-Month Post-Treatment 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.Treatment group differences in change from baseline to 1 month post-treatment on the Quick Inventory of Depressive Symptomatology Outcome measures will be measured twice over a period of 17 weeks: Baseline, 1-Month Post-Treatment 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.Treatment group differences from baseline to 10 weeks (9th intervention session) on the Quick Inventory of Depressive Symptomatology Outcome measures will be measured twice over a period of 10 weeks: Baseline, 10 weeks 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.Treatment group differences in change from baseline to 1 month post-treatment on the Buss-Perry Aggression Questionnaire Subscales Outcome measures will be measured twice over a period of 17 weeks: Baseline, 1-Month Post-Treatment 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.Treatment group differences in change from baseline to 6 months post-treatment on the Mississippi Scale for Combat Related Posttraumatic Stress Disorder Outcome measures will be measured twice over a period of 37 weeks: Baseline, 6-Month Post-Treatment 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.Treatment group differences in change from baseline to 1 month post-treatment on the Inventory of Psychosocial Functioning Outcome measures will be measured twice over a period of 17 weeks: Baseline, 1-Month Post-Treatment 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.Treatment group differences in change from baseline to 1 month post-treatment on the Short Impulsive Behavior Scale Outcome measures will be measured twice over a period of 17 weeks: Baseline, 1-Month Post-Treatment 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.Treatment group differences in change from baseline to 1 month post-treatment on the Short Impulsive Behavior Subscales Outcome measures will be measured twice over a period of 17 weeks: Baseline, 1-Month Post-Treatment 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.Treatment group differences in change from baseline to 6 months post-treatment on the Short Impulsive Behavior Subscales Outcome measures will be measured twice over a period of 37 weeks: Baseline, 6-Month Post-Treatment 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.Treatment group differences in change from baseline to 12 months post-treatment on the Buss-Perry Aggression Questionnaire Subscales Outcome measures will be measured twice over a period of 61 weeks: Baseline, 12-Month Post-Treatment 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.Treatment group differences in change from baseline to 6 months post-treatment in event-related potential in response to trauma-specific visual stimuli Outcome measures will be measured twice over a period of 37 weeks: Baseline, 6-Month Post-Treatment 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.Treatment group differences in change from baseline to 12 months post-treatment on the Inventory of Psychosocial Functioning Outcome measures will be measured twice over a period of 61 weeks: Baseline, 12-Month Post-Treatment 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.Treatment group differences in change from baseline to 12 months post-treatment in event-related potential in response to trauma-specific auditory stimuli Outcome measures will be measured twice over a period of 61 weeks: Baseline, 12-Month Post-Treatment 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.Treatment group differences in change from baseline to 12 months post-treatment in event-related potential in response to trauma-specific visual stimuli Outcome measures will be measured twice over a period of 61 weeks: Baseline, 12-Month Post-Treatment 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.Treatment group differences in change from baseline to 12 months post-treatment in electroencephalography power in response to trauma-specific auditory stimuli Outcome measures will be measured twice over a period of 61 weeks: Baseline, 12-Month Post-Treatment 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.Treatment group differences in change from baseline to 12 months post-treatment in electroencephalography power in response to trauma-specific visual stimuli Outcome measures will be measured twice over a period of 61 weeks: Baseline, 12-Month Post-Treatment 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.Treatment group differences in change from baseline to 12 months post-treatment on the Short Impulsive Behavior Scale Outcome measures will be measured twice over a period of 61 weeks: Baseline, 12-Month Post-Treatment 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.Treatment group differences in change in aggression from baseline to 1 month post-treatment on the Buss-Perry Aggression Questionnaire Outcome measures will be measured twice over a period of 17 weeks: Baseline, 1-Month Post-Treatment 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.Treatment group differences in change from baseline to 6 months post-treatment on the Buss-Perry Aggression Questionnaire Outcome measures will be measured twice over a period of 37 weeks: Baseline, 6-Month Post-Treatment 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.Treatment group differences in change from baseline to 6 months post-treatment on the Buss-Perry Aggression Questionnaire Subscales Outcome measures will be measured twice over a period of 37 weeks: Baseline, 6-Month Post-Treatment 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.Treatment group differences in change from baseline to 1 month post-treatment in event-related potential in response to trauma-specific visual stimuli Outcome measures will be measured twice over a period of 17 weeks: Baseline, 1-Month Post-Treatment 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.Treatment group differences in change from baseline to 1 month post-treatment in electroencephalography power in response to trauma-specific auditory stimuli Outcome measures will be measured twice over a period of 17 weeks: Baseline, 1-Month Post-Treatment 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.Treatment group differences in change from baseline to 1 month post-treatment in electroencephalography power in response to trauma-specific visual stimuli Outcome measures will be measured twice over a period of 17 weeks: Baseline, 1-Month Post-Treatment 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.Treatment group differences in change from baseline to 12 months post-treatment on the Short Impulsive Behavior Subscales Outcome measures will be measured twice over a period of 61 weeks: Baseline, 12-Month Post-Treatment 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.Treatment group differences in change from baseline to 12 months post-treatment on the Buss-Perry Aggression Questionnaire Outcome measures will be measured twice over a period of 61 weeks: Baseline, 12-Month Post-Treatment 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.Treatment group differences in change from baseline to 6 months post-treatment in event-related potential in response to trauma-specific auditory stimuli Outcome measures will be measured twice over a period of 37 weeks: Baseline, 6-Month Post-Treatment 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.Treatment group differences in change from baseline to 1 month post-treatment in event-related potential in response to trauma-specific auditory stimuli Outcome measures will be measured twice over a period of 17 weeks: Baseline, 1-Month Post-Treatment 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.Treatment group differences in change from baseline to 6 months post-treatment in electroencephalography power in response to trauma-specific auditory stimuli Outcome measures will be measured twice over a period of 37 weeks: Baseline, 6-Month Post-Treatment 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.Treatment group differences in change from baseline to 1 month post-treatment in event-related potential responses in inhibitory control Outcome measures will be measured twice over a period of 17 weeks: Baseline, 1-Month Post-Treatment 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.Treatment group differences in change from baseline to 6 months post-treatment in electroencephalography power in response to trauma-specific visual stimuli Outcome measures will be measured twice over a period of 37 weeks: Baseline, 6-Month Post-Treatment 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.Treatment group differences in change from baseline to 12-month post-treatment in event-related potential responses in inhibitory control Outcome measures will be measured twice over a period of 61 weeks: Baseline, 12-Month Post-Treatment 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.Treatment group differences in change from baseline to 6-months post-treatment trauma-specific responses in blood oxygen level dependent functional magnetic resonance imaging Outcome measures will be measured twice over a period of 37 weeks: Baseline, 6-Month Post-Treatment 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.Treatment group differences in change from baseline to 12 months post-treatment trauma-specific responses in blood oxygen level dependent functional magnetic resonance imaging Outcome measures will be measured twice over a period of 61 weeks: Baseline, 12-Month Post-Treatment 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.Treatment group differences in change from baseline to 12 months post-treatment in resting-state functional connectivity Outcome measures will be measured twice over a period of 61 weeks: Baseline, 12-Month Post-Treatment 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.
Treatment group differences in change from baseline to 6-months post-treatment in resting-state electroencephalography power Outcome measures will be measured twice over a period of 37 weeks: Baseline, 6-Month Post-Treatment 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.
Treatment group differences in change from baseline to 12-months post-treatment in resting-state electroencephalography power Outcome measures will be measured twice over a period of 61 weeks: Baseline, 12-Month Post-Treatment 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.
Treatment group differences in change from baseline to 6 months post-treatment in event-related potential responses in inhibitory control Outcome measures will be measured twice over a period of 37 weeks: Baseline, 6-Month Post-Treatment 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.Treatment group differences in change from baseline to 1-month post-treatment in resting-state electroencephalography power Outcome measures will be measured twice over a period of 17 weeks: Baseline, 1-Month Post-Treatment 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.
Treatment group differences in change from baseline to 6 months post-treatment in resting-state functional connectivity Outcome measures will be measured twice over a period of 37 weeks: Baseline, 6-Month Post-Treatment 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.
Trial Locations
- Locations (3)
Florida State University College of Medicine
🇺🇸Tallahassee, Florida, United States
The University of Texas at Dallas
🇺🇸Dallas, Texas, United States
Metrocare Services of Dallas
🇺🇸Addison, Texas, United States