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

Обзор

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.

Подробное описание

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.

Вмешательства

• Устройство Active rTMS
  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 Tesl
• Устройство Sham rTMS
  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 condit
• Поведенческое Cognitive Processing Therapy
  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)

Первичные конечные точки

• 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 [Срок оценки: Outcome measures will be measured twice over a period of 37 weeks: Baseline, 6-Month Post-Treatment]

Вторичные конечные точки (12)

• 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 [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: Outcome measures will be measured twice over a period of 10 weeks: Baseline, 10 weeks]

Критерии участия

Критерии включения

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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Тройное слепое

Основная цель

Лечение

Центры проведения

США · 3 центра

• Florida State University College of Medicine — Tallahassee
• Metrocare Services of Dallas — Addison
• The University of Texas at Dallas — Dallas

Публикации

• 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) PMID 12946886
• Montgomery 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. PMID 444788
• Keane 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. PMID 3346454
• 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. 2018 May;15(2):216-229. doi: 10.1037/ser0000220. PMID 29723024
• Cyders 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. PMID 24636739
• Buss AH, Perry M. The aggression questionnaire. J Pers Soc Psychol. 1992 Sep;63(3):452-9. doi: 10.1037//0022-3514.63.3.452. PMID 1403624

Идентификаторы

NCT: NCT03932773 · 18-123 · CDMRP-BA160594

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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