A Randomized Clinical Trial Using Noninvasive Brain Stimulation Combined With Written Exposure Therapy for PTSD in Military Personnel With TBI
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- Clinician Administered PTSD Scale (CAPS-5)
研究概览
简要总结
In this study, the investigators are evaluating whether transcranial direct current stimulation (tDCS), a brain stimulation technique, can be combined with Written Exposure Therapy (WET), a standard talk therapy for posttraumatic stress disorder (PTSD) to improve treatment response and improve symptom of traumatic brain injury (TBI).
After consenting to be in the study, participants will be asked to complete a baseline assessment of your psychological and physical health that will determine whether you are able to participate in the study. Following the baseline, you will be randomly assigned to receive tDCS or a sham/placebo. Everyone will also participate in 5 weekly WET psychotherapy sessions for 5 consecutive weeks. The first appointment will be 90 minutes and the subsequent appointments will be 60 minutes. tDCS or sham/placebo will occur during the writing portion of the session. All participants will also be asked to complete 1-, 3-, and 6-month posttreatment follow-up assessments.
详细描述
The primary objective of this study is to build upon a previously conducted pilot study and formally test the synergistic effects of tDCS with WET for PTSD in military service members and veterans with TBI. Secondary objectives are to evaluate improvements in persistent PCS of TBI, examine tDCS effects on physiological outcomes of extinction learning, and explore the dynamic timing of PTSD and PCS improvements to better understand how tDCS treatment influences these comorbid conditions.
Aim 1: To conduct a 2-arm, double-blind, sham-controlled randomized clinical trial of active tDCS with WET vs. sham tDCS with WET for PTSD in military service members and veterans with TBI (N = 150).
Aim 2: To evaluate physiological outcomes during the writing exposure portion of WET as potential mechanisms of change in the treatment of PTSD.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
tDCS dosing will be double-blind so that none of the participants, investigators, and study staff (including study coordinators, research assistants, assessors, clinicians, clinical supervisors) who interact with participants will know the randomized condition. Only team member(s) who manage randomization will know the randomized dose condition.
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •U.S military service member or veteran (18-70 years old)
- •PTSD diagnosis as assessed by Clinician-Administered Posttraumatic Stress Scale (CAPS-5-R)
- •History of mild to moderate Traumatic Brain Injury (TBI)
- •Able to speak, read, and write in English (due to assessment measures and writing intervention)
排除标准
- •TBI that occurred within the past three months prior to the baseline assessment
- •History of significant intracranial pathology (e.g., severe TBI)
- •History of major neurological disorder (e.g., epilepsy, dementia)
- •Metallic objects other than dental appliances/fillings above the shoulders.
- •Electronic implants that could be susceptible to electrical current (e.g., cardiac pacemaker)
- •History of skin condition at site of stimulation (e.g., psoriasis)
- •Current suicidal ideation severe enough to warrant immediate attention
- •Current manic episode or psychotic symptoms requiring immediate stabilization or hospitalization
- •Current substance use requiring stabilization or hospitalization
- •Change in anti-convulsive or benzodiazepine medication regimen in past month.
- •History of adverse effects to previous noninvasive brain stimulation.
- •Concurrent engagement in another noninvasive brain stimulation or trauma focused psychotherapy.
- •Currently pregnant or breastfeeding.
结局指标
主要结局
Clinician Administered PTSD Scale (CAPS-5)
时间窗: Baseline to 6 months
The CAPS-5 is structured interview that assesses the Diagnostic and Statistical Manual of Mental Disorders v5 (DSM-5) criteria for PTSD. Each item is rated on a severity scale ranging from 0 (Absent) to 4 (Extreme/incapacitating) and combines information about frequency and intensity for each of the 20 symptoms.Subscale scores are calculated by summing severity scores for items in the following PTSD symptom clusters: re-experiencing, avoidance, negative alterations in cognitions and mood, and hyperarousal. Scores ≥ 25 indicate a probable diagnosis of PTSD. Scores range from 0 to 80. Change in score will be reported.
Neurobehavioral Symptom Inventory (NSI)
时间窗: Baseline to 6 months
The NSI consists of 22 non-specific complaints commonly reported after concussion and is used by clinicians to quantify TBI symptom severity and select symptoms for treatment. The NSI asks the patient to rate each of the symptoms according to how much the symptom has disturbed him/her using a five-point scale. Scores range from 0-88 with a higher score indicating more neurobehavioral symptoms
次要结局
未报告次要终点
研究者
Casey Straud
Associate Professor
The University of Texas Health Science Center at San Antonio