Neuromodulation + Prolonged Exposure Therapy: Evaluation of a Technology-Enhanced, Entirely Remote 2-Week Integrated Treatment for Pain and PTSD
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 146
- 试验地点
- 1
- 主要终点
- Change in pain intensity as measured by the Defense and Veterans Pain Rating Scale (DVPRS)
研究概览
简要总结
The purpose of this study is to examine comparative effectiveness of two home-based telemedicine delivered interventions: transcranial Direct Current Stimulation (tDCS) combined with Massed Prolonged Exposure (Massed-PE) vs. Sham tDCS combined with Massed PE, focusing on pain and PTSD outcomes, to determine the comparative effectiveness of the two interventions on process outcomes of patient satisfaction, treatment attrition, and treatment compliance and to explore changes in blood biomarkers associated with stress and inflammatory processes related to pain and PTSD symptom improvements following treatment.
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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Presence of musculoskeletal, chronic, non-cancer pain with a rating of ≥ 3 out of 10 on a 0-10 on the Defense and Veterans Pain Rating Scale (DVPRS) and a pain intensity and interference score of 1 standard deviation above PROMIS normative data (see Measures section below). Symptoms will be required to be of at least six months duration and verified diagnosis in their medical chart authorized by informed consent
- •Diagnosis of PTSD assigned on the basis of the Clinician Administered PTSD Scale (CAPS-5) and PCL-5 ≥ 30
- •willing to participate in study randomization, treatment assignment, and assessments.
排除标准
- •Having a household member who is already enrolled in the study
- •Active psychosis or dementia at screening
- •Suicidal ideation with clear intent
- •Current substance dependence
- •current opioid medication for pain and/or current use of sodium channel blockers, calcium channel blockers, or N-Methyl-D-aspartate receptor antagonists, because these medications can block tDCS effects
- •pregnancy and/or lactation
- •concurrent enrollment in another pain clinical trial
- •tDCS or medical related contraindications such as open-injury TBI (penetrating injury), seizure disorder (independently of the type of TBI or condition causing the seizure disorder), pregnancy, implanted metal, claustrophobia
- •having pain that is not chronic, presence of severe and frequent migraines, fibromyalgia, or pain caused by a primary condition such as cancer.
研究组 & 干预措施
Sham Transcranial Direct Current Stimulation (tDCS) and Massed-Prolonged Exposure (PE)
干预措施: Sham Transcranial Direct Current Stimulation (tDCS) (Device)
Sham Transcranial Direct Current Stimulation (tDCS) and Massed-Prolonged Exposure (PE)
干预措施: Massed-Prolonged Exposure (PE) (Behavioral)
Transcranial Direct Current Stimulation (tDCS) and Massed-Prolonged Exposure (PE)
干预措施: Transcranial Direct Current Stimulation (tDCS) (Device)
Transcranial Direct Current Stimulation (tDCS) and Massed-Prolonged Exposure (PE)
干预措施: Massed-Prolonged Exposure (PE) (Behavioral)
结局指标
主要结局
Change in pain intensity as measured by the Defense and Veterans Pain Rating Scale (DVPRS)
时间窗: Baseline, midpoint(before session 6), post treatment (after session 10) 3 months, 6 months
The DVPRS is a validated 11-point numeric rating scale and is scored from 0(no pain at all) to 10(worst pain ever possible), higher scores indicate greater pain severity.
Change in PTSD symptoms as assessed by the Clinician-Administered PTSD Scale 5 (CAPS-5)
时间窗: Baseline, post treatment (after session 10) 3 months, 6 months
The CAPS-5 is a 30-item structured clinical interview used to assess the presence and severity of Posttraumatic Stress Disorder (PTSD) symptoms according to Diagnostic and Statistical Manual of Mental Disorders(DSM-5)diagnostic criteria. The scale includes 20 core PTSD symptom items rated on a 5-point scale (0-4) for both frequency and intensity. Each item receives a severity score ranging from 0 (absent) to 4 (extreme/incapacitating), for a total score range of 0 to 80. Higher scores indicate greater PTSD symptom severity.
次要结局
- Change in pain intensity as assessed by the Patient-Reported Outcomes Measurement Information System (PROMIS) Pain 3a Intensity Scale(Baseline, midpoint(before session 6), post treatment (after session 10) 3 months, 6 months)
- Change in pain interference as assessed by the PROMIS Pain 8a Interference Scale(Baseline, midpoint(before session 6), post treatment (after session 10) 3 months, 6 months)
- Change in symptoms of Post-Traumatic Stress Disorder (PTSD)as assessed by the PTSD Checklist-5 Civilian (PCL-5)(Baseline, midpoint(before session 6), post treatment (after session 10) 3 months, 6 months)
- Change in Quality of life as assessed by the World Health Organization Quality of Life - Short Form (WHOQOL-BREF)(Baseline, midpoint(before session 6), post treatment (after session 10) 3 months, 6 months)
- Change in anxiety as assessed by the Generalized Anxiety Disorder Scale 7 (GAD-7)(Baseline,post treatment (after session 10) 3 months, 6 months)
- Quality of sleep as assessed by the Pittsburgh Sleep Quality Index (PSQI)(Baseline, post treatment (after session 10) 3 months, 6 months)
- Change in depression as assessed by the The Patient Health Questionnaire (PHQ-9)(Baseline, post treatment (after session 10) 3 months, 6 months)
研究者
Melba Hernandez-Tejada, PhD, DHA
Associate Professor
The University of Texas Health Science Center, Houston