Resilience Skills Self-Management for Chronic Pain.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 300
- 试验地点
- 2
- 主要终点
- Fibromyalgia Impact Questionnaire-Revised (FIQ-R)
研究概览
简要总结
The investigators will conduct a randomized controlled trial of an 8-week resilience-enhanced CBT online self-management program for chronic pain plus usual care (PRISM), standard e-CBT self-management plus usual care (e-CBT), and usual care alone. Thus, 300 individuals with chronic pain will undergo a comprehensive pre-intervention assessment that includes a blood draw (T1). Participants will then be randomized 2:2:1 as follows: e-CBT (n=120), PRISM (n=120) and usual care (n = 60). Immediately post-intervention (T2) and at 6 months (T3) and 12 months (T4) after that, participants undergo the same in-person assessment including blood draw. Telomerase activity will be assessed at T1, T2 and T3; and telomere length at T1 and T4
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
- None
入排标准
- 年龄范围
- 35 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Primary back or spine pain diagnosis from the Back & Pain Center at University of Michigan.
- •High scores on the 2011 survey criteria for Fibromyalgia. The survey criteria for FM consist of an assessment of widespread pain and symptom severity.
排除标准
- •Co-morbid autoimmune disorders, including rheumatoid arthritis and systemic lupus erythematosus.
- •Medical conditions that can impair health status independent of spine pain and FM, including cardiopulmonary disorders (e.g. CHF, COPD), uncontrolled endocrine or allergic disorders (e.g., thyroid dysfunction, Type I diabetes), or malignancy within the preceding 2 years
- •Current psychotic disorder (schizophrenia, etc.), dissociative identity disorder, untreated bipolar disorder, active suicide risk, or current alcohol / drug dependence.
- •Planned major surgery in the next 12 months;
- •Pregnancy or taking steroid medications
- •Recent pain interventions ≤6 weeks prior to study (e.g., back surgery, epidural steroid injections) or planned interventions for the study period (e.g., surgery scheduled). Ongoing physical therapy will be allowed and new physical therapy or exercise regimen will be addressed during data analysis;
- •Cognitive impairment or dementia (inability to give consent or meaningfully participate);
- •Pending or recently received (within 1 years) pain-related disability or Workman's Compensation;
- •Unable to read or fluently converse in English;
- •Planning to move from the area in next 14 months;
- •In the judgment of the PIs the individual would not be able to meaningfully participant.
结局指标
主要结局
Fibromyalgia Impact Questionnaire-Revised (FIQ-R)
时间窗: At 8-week assessment point
The Fibromyalgia Impact Questionnaire-Revised (FIQR) assesses the total spectrum of problems and responses to therapy. The 2009 revised version contains 21 items assessing broad domains such as physical function, overall impact, and a wide range of symptoms. The measure is self-report with a recall period of the past week and requires only several minutes to complete.
次要结局
- Brief Pain Inventory (BPI)(At 8-week assessment point)
- Pain Catastrophizing Scale (PCS)(At 8-week assessment point)
- Patient Health Questionnaire 9-item (PHQ-9):(At 8-week assessment point)
- Generalized Anxiety Disorder 7-item (GAD-7)(At 8-week assessment point)
- Pittsburgh Sleep Quality Index (PSQI)(At 8-week assessment point)
- PROMIS Fatigue-Short Form(At 8-week assessment point)
- Multidimensional Inventory of Subjective Cognitive Impairment (MISCI)(At 8-week assessment point)
- Perceived Stress Scale (PSS)(At 8-week assessment point)
- Telomerase activity as measured by the Droplet Digital PCR (ddPCR) method(At 8-week assessment point)
- Telomere length(At 1 year assessment point)
- Subjective well-being(At 8-week assessment point)
- Six-Minute Walk Test (6MWT)(At 8-week assessment point)
- Sit-to-Stand Test(At 8-week assessment point)
研究者
Afton Hassett, Psy.D.
Associate Research Scientist
University of Michigan