Mindfulness Based Stress Reduction in Multiple Sclerosis (MS)
2014年11月19日 更新者：Lauren Krupp、Stony Brook University
Mindfulness Based Stress Reduction in MS
This study focuses on stress, cognition, mood and fatigue and its effect on medication compliance. Medication compliance is measured by the weight of discarded needles. The investigators will be administering neuropsychological testing at baseline and the final visit. The subjects will complete self-report assessments during their 8 weeks in the study.
Group A will have additional weekly phone support for meditation, while Group B will have meditation training only.
研究概览
研究类型
介入性
注册 (实际的)
31
阶段
- 不适用
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
-
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New York
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Stony Brook、New York、美国、11786-8121
- Stony Brook University
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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 70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:
- Patients with either definite MS according to the revised McDonald criteria (Polman 2005) or patients with CIS (defined as an initial MS relapse with objective documentation and 2 or more lesions within the CNS of which at least one must involve the brain)
- Patients on GA therapy for at least 6 months
- Age 18 - 70
Exclusion Criteria:
- Unwilling to comply with study procedures
- Use of other DMT in conjunction with GA
- Unable to provide informed consent.
- Current (past 30 days) substance abuse
- Newly initiated (past 30 days) psychiatry treatment
- Enrolled in another program of meditation in the past six months.
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：支持治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：单身的
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Electronic measure of needle disposals (MEMS TrackCaps)
大体时间：Medication adherence will be measured by total number of missed doses, calculated from total needle disposals. The total number of missed doses across the six weeks will be compared between the two treatment groups at study end.
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During the six-week MSBR program, medication adherence will be monitored with a widely used electronic measure of needle disposals (MEMS TrackCaps) This method has been demonstrated to be more accurate in MS than data obtained from either self-report or interview.
At one month intervals the patient will bring the needle container to the Study Coordinator.
All patients who attend at least introduction session and one telephone session will be included in the analysis.
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Medication adherence will be measured by total number of missed doses, calculated from total needle disposals. The total number of missed doses across the six weeks will be compared between the two treatment groups at study end.
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Perceived Stress Scale-10
大体时间：Baseline, 1 X between weeks 3-7, Week 8
|
A 10-item scale of global perceived stress, where each item is rated from 1 to 5 according to intensity of stressor.
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Baseline, 1 X between weeks 3-7, Week 8
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Holmes and Rahe Social Readjustment Rating Scale (SRRS
大体时间：Baseline, 1 X between weeks 3-7, Week 8
|
Stressful life events will be rated using the SRRS, which asks subjects to check if they have experienced any of a series of life events.
We will use a modification of the scale used in previous MS research that eliminates several items specifically associated with MS disease activity (e.g., "major illness or injury", "sexual difficulties", "pregnancy").
The SRRS differentiates three types of stress: positive ("outstanding personal achievement"), major negative stress (death of family member), conflict and disruption in routine (e.g., family or job conflict, life changes).
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Baseline, 1 X between weeks 3-7, Week 8
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Chicago Multiscale Depression Inventory (CMDI)
大体时间：Baseline, 1 X betweeen Weeks 3-7, Week 8
|
CMDI is a self-report questionnaire designed specifically for use in MS and other medical patient groups.
It has vegetative, mood, and evaluative scales consisting of 14 items each.
The use of the CMDI makes it possible to separate out neurovegetative symptoms of depression which are a potential confound in medical populations such as MS
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Baseline, 1 X betweeen Weeks 3-7, Week 8
|
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State Trait Anxiety Inventory (STAI)
大体时间：Baseline, 1 X betweeen Weeks 3-7, Week 8
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The STAI is a widely used measure of state and trait anxiety.
We will focus on the measurement of state related anxiety in this study.
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Baseline, 1 X betweeen Weeks 3-7, Week 8
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Positive and Negative Affect Scale (PANAS)
大体时间：Baseline, 1 X between Weeks 3 - 7, Week 8
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; Watson, Clark & Tellegen, 1989): State related positive and negative affect will be assessed by the well validated PANAS scales.
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Baseline, 1 X between Weeks 3 - 7, Week 8
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Fatigue Severity Scale (FSS)
大体时间：Baseline, 1 X between Weeks 3 - 7, Week 8
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The fatigue severity scale is a reliable and valid commonly used measure of the frequent symptom of fatigue in MS.
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Baseline, 1 X between Weeks 3 - 7, Week 8
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MACFIMS neuropsychological battery
大体时间：Baseline and Week 8
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At baseline and study end, an abbreviated version of the MACFIMS will be administered.
This is a standard neurocognitive battery used with studies of MS subjects and includes the SDMT, PASAT, SRT, BVMT, and 9-hole peg test.
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Baseline and Week 8
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Expanded Disability Status Scale (EDSS)
大体时间：Baseline and Week 8
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Expanded Disability Status Scale is the oldest and probably the most widely utilized assessment instruments in MS for determination of neurological impairment in MS.
It is the standard for characterization of MS patients and for outcomes of clinical trials.
It will be used to characterize patients' level of disability.
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Baseline and Week 8
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Physiologic Markers of Stress
大体时间：Baseline and Week 8
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DHEA, epinephrine, and norepinephrine.
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Baseline and Week 8
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Physiologic Maker of Stress
大体时间：Baseline, 1 X between Week 3 - 7, Weeek 8
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cortisol
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Baseline, 1 X between Week 3 - 7, Weeek 8
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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：Lauren B Krupp, M.D.、Stony Brook 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)
2013年4月1日
研究完成 (实际的)
2014年11月1日
研究注册日期
首次提交
2010年11月5日
首先提交符合 QC 标准的
2011年8月16日
首次发布 (估计)
2011年8月18日
研究记录更新
最后更新发布 (估计)
2014年11月20日
上次提交的符合 QC 标准的更新
2014年11月19日
最后验证
2014年11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.