Multi-site Confirmatory Efficacy Treatment Trial of Combat-related PTSD

The University of Texas at Dallas3 个研究点分布在 1 个国家目标入组 330 人2019年5月1日

适应症Post Traumatic Stress Disorder

概览

阶段: 不适用
干预措施: 未指定
疾病 / 适应症: Post Traumatic Stress Disorder
发起方: The University of Texas at Dallas
入组人数: 330
试验地点: 3
主要终点: 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
状态: 招募中
最后更新: 8个月前

概览研究者入排标准结局指标研究点相似试验

概览

简要总结

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.

详细描述

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.

注册库

clinicaltrials.gov

开始日期

2019年5月1日

结束日期

2026年7月31日

最后更新

8个月前

研究类型

Interventional

研究设计

Parallel

性别

All

研究者

发起方

The University of Texas at Dallas

责任方

Principal Investigator

主要研究者

John Hart, Jr.

Professor

The University of Texas at Dallas

入排标准

入选标准

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

排除标准

•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

结局指标

主要结局

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

时间窗: 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.

次要结局

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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)