Management of Chronic Pain and PTSD in Gulf War Veterans With tDCS+Prolonged Exposure
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 21
- 试验地点
- 2
- 主要终点
- Feasibility of Recruitment as Assessed by Number of Participants Enrolled in the Study
研究概览
简要总结
Gulf War Veterans (a DoD/VA defined service era corresponding to the first Gulf War under operations Desert Storm and Desert Shield 1990-1991), especially those who present with Post-Traumatic Stress Disorder (PTSD), are particularly likely to experience chronic pain. Veterans with co-morbid chronic pain and PTSD utilize healthcare services at a higher rate than those with pain or PTSD alone. Unfortunately, there are no integrated treatments for Pain and PTSD. Moreover, non-pharmacological treatments for pain such as Cognitive Behavioral Therapy are useful in only about 50% of cases. Transcranial direct current stimulation (tDCS) may be an effective treatment for pain, and has been recently used to ameliorate PTSD symptoms. Prolonged Exposure Therapy (PE) is highly effective in treating PTSD symptoms. Therefore, we propose to (a) integrate & (b) gather feasibility data for home-based tDCS + PE for Pain and PTSD with 15 Gulf War Veterans.
The Overall Aim of the present proposal is to integrate, refine and investigate the feasibility (e.g., pilot testing, recruitment, attrition, assessment) of tDCS for treating chronic pain with a best practices evidence-based treatment for PTSD (i.e., Prolonged Exposure: PE) in 15 Gulf War veterans, a group for which both pain (fibromyalgia) and PTSD are particularly problematic.
详细描述
Chronic pain is one of the most prevalent health conditions among Americans, affecting about a third of the general population. In Gulf War (1990-1991) veterans, chronic pain is even more common, with a prevalence of about 50%. Indeed, the pain-related fibromyalgia diagnosis is part of Gulf War Syndrome and is highly comorbid with other common military service-related health problems such as Posttraumatic Stress Disorder (PTSD). Moreover, lack of effective, integrated, and available alternative treatments for chronic pain contributes to the opioid epidemic.
PTSD is also highly prevalent in Gulf War Veterans, at about 15-25% of Operation Desert Shield and Desert Storm Veterans. Moreover, several investigators note that PTSD treatment response is poorer for Veterans who experience chronic pain and for Veterans who served in the Gulf War.
The Overall Aim of the present proposal is to integrate, refine and investigate the feasibility (e.g., pilot testing, recruitment, attrition, assessment) of tDCS for treating chronic pain with a best practices evidence-based treatment for PTSD (i.e., Prolonged Exposure: PE) in 15 Gulf War veterans, a group for which both pain (fibromyalgia) and PTSD are particularly problematic.
SA1: Integrate the home-based tDCS+PE Treatment. The investigative team is comprised of Pain, PTSD, and salivary biomarker experts who will integrate tDCS into the 12 session PE treatment protocol.
H1: The 12 session PE protocol will yield itself well to tDCS component integration based on participant feedback.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Presence of chronic non-cancer pain and pain interference, defined as scoring 1 standard deviation above PROMIS normative data on both the 3-item PROMIS Pain Intensity 3a scal and the 8-item PROMIS Pain 8a Interference scale. Symptoms will be required to be of six-month duration or longer
- •Diagnosis of PTSD assigned on the basis of the Clinician Administered PTSD Scale.
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.
结局指标
主要结局
Feasibility of Recruitment as Assessed by Number of Participants Enrolled in the Study
时间窗: Week 0
Feasibility of Data Collection as Assessed by Percent of Missing Data
时间窗: Week 12
Feasibility as Indicated by Treatment Acceptability as Assessed by an Acceptability Scale
时间窗: Week 12
Treatment acceptability will be assessed by a scale, with a total score ranging from 0 to 10, with 0 being "not acceptable, this treatment should not be offered to veterans, those in pain, or those with PTSD" to 10 being "completely acceptable, this treatment is perfectly suited to veterans and others with pain and PTSD symptoms."
Feasibility of Biomarker Collection as Assessed by Number of Planned Saliva Samples Divided by Number of Planned Saliva Samples Collected
时间窗: Week 12
Feasibility of Biomarker Viability as Assessed by Percent of Viable Saliva Samples
时间窗: Week 12
Feasibility of Retention as Assessed by Number of Participants Who Complete at Least 8 Sessions
时间窗: Week 12
Feasibility as Indicated by Satisfaction as Assessed by the Charleston Psychiatric Outpatient Satisfaction Scale
时间窗: Week 12
The Charleston Psychiatric Outpatient Satisfaction Scale total score ranges from 13 to 65, with a higher score indicating higher satisfaction.
Feasibility as Indicated by Treatment Credibility as Assessed by a Credibility Scale
时间窗: Week 12
Treatment credibility will be assessed by a scale, with a total score ranging from 0 to 10, with 0 being "not credible, I did not think this treatment would help either my PTSD or Pain symptoms" to 10 being "completely credible, I was very sure this treatment would help both my PTSD and Pain symptoms."
Pain Interference as Assessed by the Patient-Reported Outcomes Measurement Information System (PROMIS) Pain 8a Interference Scale
时间窗: Week 12
PROMIS Pain interference 8a assesses self-reported consequences of pain on relevant aspects of one's life in the past 7 days. The measure includes 8-items rating pain from "Not at all" = 1 to "Very much" = 5, therefore the response range is 8-40 with higher scores indicating greater pain interference.
Pain Intensity as Assessed by the Patient-Reported Outcomes Measurement Information System (PROMIS) Pain 3a Intensity Scale
时间窗: Week 12
PROMIS Pain intensity 3a is a self-report measure that assesses how much a person hurts (intensity or severity) in the past 7 days. The measure includes three items rating pain from "Had no pain" = 1 to "Very severe" = 5, therefore the response range is 3-15 with higher scores indicating greater pain intensity. Raw scores are reported.
PTSD Intensity as Assessed by the Clinician-Administered PTSD Scale 5 (CAPS-5)
时间窗: Week 12
Total possible scores on the CAPS-5 scale range from 0 to 80, with a higher score indicating greater PTSD intensity.
次要结局
- Quality of Life as Assessed by the World Health Organization Quality of Life - Short Form (WHOQOL-BREF)(Week 12)
- PTSD as Assessed by the PTSD Checklist-5 (PCL-5)(Week 12)
- Pain as Assessed by the West Haven-Yale Multidimensional Pain Inventory (WHYMPI/MPI)(Week 12)
- Kinesiophobia as Assessed by the Tampa Scale of Kinesiophobia-Revised (TSK-R)(Week 12)
- Pain Catastrophizing as Assessed by the Pain Catastrophizing Scale (PCS)(Week 12)
- Depression as Assessed by the Patient Health Questionnaire-9 (PHQ-9)(Week 12)
- Salivary Biomarker Measurement(Week 12)
研究者
Melba Hernandez-Tejada, PhD, DHA
Associate Professor
The University of Texas Health Science Center, Houston