Safety, Feasibility, and Benefits of Transcranial Direct Current Stimulation (tDCS) in Human Subjects With Posttraumatic Stress Disorder (PTSD) Receiving an Exposure-based, Behavioral Therapy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 25
- 试验地点
- 2
- 主要终点
- Posttraumatic Stress Disorder Checklist (PCL-5)
研究概览
简要总结
The primary objective of this study is to evaluate the safety, feasibility, and psychological and physiological treatment benefits of transcranial direct current stimulation (tDCS), a noninvasive brain stimulation technique, when delivered in combination with Written Exposure Therapy (WET), for posttraumatic stress disorder posttraumatic stress disorder (PTSD).
详细描述
While the potential for non-invasive brain stimulation is exciting, research is needed to determine the safety, feasibility, and benefits of non-invasive brain stimulation in human subjects with PTSD. Towards this end, the study team will conduct a single-blind randomized controlled pilot study of transcranial direct current stimulation (tDCS) vs. a sham condition in a sample of 40 adults with PTSD receiving 5 weekly sessions of Written Exposure Therapy (WET), an exposure-based, behavioral psychotherapy for 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
- Single (Participant)
盲法说明
Subjects will be blinded to whether they receive actual tDCS or sham treatment. All study team members will also be blinded to randomization, with the exception of the study team coordinator who will allocate device codes. This will allow for the blind to be broken in case of an emergency or serious adverse event.
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Individuals between the ages of 18 and 65 years old at time of screening.
- •PTSD diagnosis as assessed by the Clinician-Administered Posttraumatic Stress Scale (CAPS-5)
- •Able to write, read, and speak English
排除标准
- •History of epilepsy or seizures.
- •History of significant intracranial pathology (e.g., severe traumatic brain injury) or neurological disorder (e.g., Stroke, Multiple Sclerosis, Amyotrophic Lateral Sclerosis, Alzheimer's, Dementia, Parkinson's, and/or Huntington's).
- •History of skin condition (e.g., eczema, psoriasis) where electrodes will be applied.
- •Electronic implants in the body that could be susceptible to electrical current (e.g., cardiac pacemaker, cochlear implants, medical pump).
- •Metallic objects other than dental appliances/fillings near the site of stimulation
- •Current manic episode or psychotic symptoms requiring immediate stabilization or hospitalization (as determined by clinical judgement).
- •Current moderate or severe substance use disorder.
- •Suicidality and/or psychiatric risk requiring immediate intervention or a higher level of care than can be provided by the study treatment.
- •Change in anticonvulsive or benzodiazepine medication regimen in the past month.
- •History of adverse effects to previous tDCS or other brain stimulation technique.
- •Concurrent engagement in another brain simulation technique or trauma-related psychotherapy for PTSD.
- •Currently pregnant or breastfeeding.
结局指标
主要结局
Posttraumatic Stress Disorder Checklist (PCL-5)
时间窗: Baseline to 9 weeks (one month post study treatment)
The PCL-5 is a 20-item self-report measure update of the PCL designed to assess PTSD symptoms as defined by the DSM-5. The PCL-5 is currently available and has been shown to have good psychometric properties. The PCL-5 evaluates how much participants have been bothered by PTSD symptoms in the past week (for all assessments during treatment) or the past two weeks (all other assessment time points) as a result of a specific life event. Each item of the PCL-5 is scored on a five-point scale ranging from 0 "not at all") to 4 ("extremely). This measure will be administered at the baseline assessment, prior to each therapy session, and the one-month follow-up assessment. The potential scores range from 0-80, with a lower score indicating less symptoms of PTSD.
Number of Subjects That Completed All 5 WET Sessions
时间窗: 5 weeks
Tracking feasibility through number of subjects that complete all written exposure therapy
次要结局
- Generalize Anxiety Disorder-7 (GAD)(Baseline to 9 weeks (one month post study treatment))
- Patient Health Questionnaire-9 (PHQ)(Baseline to 9 weeks (one month post study treatment))
- Clinician Administer PTSD Scale-5 (CAPS-5)(Baseline to 9 weeks (one month post study treatment))
研究者
Casey Straud
Associate Professor
The University of Texas Health Science Center at San Antonio