Pain and Stress Management for Fibromyalgia
2016年3月15日 更新者：Mark A. Lumley、Wayne State University
Emotional Exposure and Cognitive Behavioral Therapies for Fibromyalgia
This interventional, randomized controlled study seeks to test the effects of an innovative emotional exposure and processing treatment that targets stress resolution, by comparing it with cognitive-behavioral therapy and a Fibromyalgia education comparison condition.
The investigators also will test proposed mediators of the intervention, including improved autonomic regulation, and explore which subgroups of patients benefit the most from each approach.
研究概览
研究类型
介入性
注册 (实际的)
230
阶段
- 阶段2
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
-
-
Michigan
-
Ann Arbor、Michigan、美国、48106
- University of Michigan Medical Center
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Detroit、Michigan、美国、48202
- Wayne State University
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Southfield、Michigan、美国、48075
- St. John Providence Hospital
-
-
参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
18年 至 75年 (成人、年长者)
接受健康志愿者
不
有资格学习的性别
全部
描述
Inclusion Criteria:
Meet Fibromyalgia (FM) criteria of the American College of Rheumatology (ACR)either:
- 1990 ACR criteria including tender points
- 2010 ACR modified clinical criteria that does not include tender points
Exclusion Criteria:
- Co-morbid autoimmune disorders, including rheumatoid arthritis and systemic lupus
- Other serious medical conditions that can impair health status independent of FM
- Current psychotic disorders (schizophrenia, bipolar disorder, etc.),dissociative identity (multiple personality) disorder, active suicide risk
- Alcohol/drug dependence in past 2 years
- Cognitive impairment or dementia
- Currently have pending (or recently received - within 2 years) FM pain related disability or workman's compensation
- Unable to fluently read or converse in English
- Planning to move from the area in the next 14 months
- Judgment of principle investigator as not appropriate for this trial or all intervention arms
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：单身的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的：Stress and Emotions
Seeks to reduce stress and physical symptoms by helping individual become aware of their emotions, express them, and resolve emotional difficulties.
It will use techniques such as writing about stress, role playing how to handle difficult relationships, recognizing and expressing anger and other feelings, and being more open with others.
|
Focus on emotions, writing about stress, assertiveness training, role playing new ways to handle relationships, and sharing feelings and experiences with others.
|
|
有源比较器：Thoughts and Behaviors
Seeks to help individuals function better and improve symptoms by teaching various cognitive and behavioral skills to manage symptoms of fibromyalgia.
It will use techniques such as relaxation training, engaging in pleasant activities, pacing yourself, and changing unhelpful ways of thinking.
|
Focus on cognitive and behavioral skills, such as relaxation, increasing pleasant activities, pacing, and changing ways of thinking.
|
|
有源比较器：Brain and Body
Seeks to help individuals improve health by educating about fibromyalgia so that one can better understand and more effectively communicate about their health.
It will explain the latest scientific information about fibromyalgia, including its causes, the role of the nervous system and body, various medical and alternative treatments, and how to understand research findings.
|
Focus on the empowering patients by providing the latest scientific information about fibromyalgia, including causes, the role of the nervous system, and various treatments.
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研究衡量的是什么？
主要结果指标
结果测量 |
大体时间 |
|---|---|
|
Brief Pain Inventory
大体时间：Baseline, post-treatment, 6 months post-treatment (primary endpoint), and 12 months post-treatment
|
Baseline, post-treatment, 6 months post-treatment (primary endpoint), and 12 months post-treatment
|
次要结果测量
结果测量 |
大体时间 |
|---|---|
|
SF-12
大体时间：Baseline, post-treatment, 6 months post-treatment (primary endpoint), and 12 months post-treatment
|
Baseline, post-treatment, 6 months post-treatment (primary endpoint), and 12 months post-treatment
|
|
PROMIS Fatigue short form
大体时间：Baseline, post-treatment, 6 months post-treatment (primary endpoint), and 12 months post-treatment
|
Baseline, post-treatment, 6 months post-treatment (primary endpoint), and 12 months post-treatment
|
|
Pittsburgh Sleep Quality Index
大体时间：Baseline, post-treatment, 6 months post-treatment (primary endpoint), and 12 months post-treatment
|
Baseline, post-treatment, 6 months post-treatment (primary endpoint), and 12 months post-treatment
|
|
Center for Epidemiological Studies - Depression Scale
大体时间：Baseline, post-treatment, 6 months post-treatment (primary endpoint), and 12 months post-treatment
|
Baseline, post-treatment, 6 months post-treatment (primary endpoint), and 12 months post-treatment
|
|
Generalized Anxiety Disorder - 7
大体时间：Baseline, post-treatment, 6 months post-treatment (primary endpoint), and 12 months post-treatment
|
Baseline, post-treatment, 6 months post-treatment (primary endpoint), and 12 months post-treatment
|
|
Positive and Negative Affect Schedule
大体时间：Baseline, post-treatment, 6 months post-treatment (primary endpoint), and 12 months post-treatment
|
Baseline, post-treatment, 6 months post-treatment (primary endpoint), and 12 months post-treatment
|
|
Satisfaction with Life Scale
大体时间：Baseline, post-treatment, 6 months post-treatment (primary endpoint), and 12 months post-treatment
|
Baseline, post-treatment, 6 months post-treatment (primary endpoint), and 12 months post-treatment
|
|
Multiple Ability Self-Report Questionnaire
大体时间：Baseline, post-treatment, 6 months post-treatment (primary endpoint), and 12 months post-treatment
|
Baseline, post-treatment, 6 months post-treatment (primary endpoint), and 12 months post-treatment
|
|
Patient Global Assessment of Change
大体时间：Baseline, post-treatment, 6 months post-treatment (primary endpoint), and 12 months post-treatment
|
Baseline, post-treatment, 6 months post-treatment (primary endpoint), and 12 months post-treatment
|
|
Health Care Utilization Scale
大体时间：Baseline, post-treatment, 6 months post-treatment (primary endpoint), and 12 months post-treatment
|
Baseline, post-treatment, 6 months post-treatment (primary endpoint), and 12 months post-treatment
|
|
Real-time Physical Activity (Actiwatch)
大体时间：Baseline, post-treatment, and 6 months post-treatment (primary endpoint)
|
Baseline, post-treatment, and 6 months post-treatment (primary endpoint)
|
|
Heart Rate Variability
大体时间：Baseline, post-treatment, and 6 months post-treatment (primary endpoint)
|
Baseline, post-treatment, and 6 months post-treatment (primary endpoint)
|
|
Levels of Emotional Awareness Scale
大体时间：Baseline, post-treatment, and 6 months post-treatment (primary endpoint)
|
Baseline, post-treatment, and 6 months post-treatment (primary endpoint)
|
|
Emotional Expressivity Scale
大体时间：Baseline, post-treatment, and 6 months post-treatment (primary endpoint)
|
Baseline, post-treatment, and 6 months post-treatment (primary endpoint)
|
|
Ambivalence over Emotional Expression
大体时间：Baseline, post-treatment, and 6 months post-treatment (primary endpoint)
|
Baseline, post-treatment, and 6 months post-treatment (primary endpoint)
|
|
Toronto Alexithymia Scale-20
大体时间：Baseline, post-treatment, and 6 months post-treatment (primary endpoint)
|
Baseline, post-treatment, and 6 months post-treatment (primary endpoint)
|
|
Impact of Events Scale - Revised
大体时间：Baseline, post-treatment, and 6 months post-treatment (primary endpoint)
|
Baseline, post-treatment, and 6 months post-treatment (primary endpoint)
|
|
BBCA - short form
大体时间：Baseline, post-treatment, and 6 months post-treatment (primary endpoint)
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Baseline, post-treatment, and 6 months post-treatment (primary endpoint)
|
|
Pain Catastrophizing
大体时间：Baseline, post-treatment, and 6 months post-treatment (primary endpoint)
|
Baseline, post-treatment, and 6 months post-treatment (primary endpoint)
|
|
Beliefs in Pain Control Questionnaire
大体时间：Baseline, post-treatment, and 6 months post-treatment (primary endpoint)
|
Baseline, post-treatment, and 6 months post-treatment (primary endpoint)
|
|
Communication Thoughts and Feelings Questionnaire
大体时间：Baseline, post-treatment, and 6 months post-treatment (primary endpoint)
|
Baseline, post-treatment, and 6 months post-treatment (primary endpoint)
|
|
Experimental (thumb nail pressure) threshold and tolerance ratings
大体时间：Baseline, post-treatment, and 6 months post-treatment (primary endpoint)
|
Baseline, post-treatment, and 6 months post-treatment (primary endpoint)
|
|
2010 ACR modified clinical criteria for FM, including widespread pain index
大体时间：Baseline, post-treatment, and 6 months post-treatment (primary endpoint)
|
Baseline, post-treatment, and 6 months post-treatment (primary endpoint)
|
合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 首席研究员：Mark A Lumley, Ph.D.、Wayne State University
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始
2011年5月1日
初级完成 (实际的)
2015年7月1日
研究完成 (实际的)
2015年7月1日
研究注册日期
首次提交
2010年11月2日
首先提交符合 QC 标准的
2011年1月28日
首次发布 (估计)
2011年2月1日
研究记录更新
最后更新发布 (估计)
2016年3月17日
上次提交的符合 QC 标准的更新
2016年3月15日
最后验证
2016年3月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.