Mindfulness-based Stress Reduction for Multiple Sclerosis
2018年4月6日 更新者:Angela Senders, ND, MCR、National University of Natural Medicine
The primary purpose of this study is to assess the feasibility of mindfulness-based stress reduction (MBSR) for adults with any type of multiple sclerosis.
The secondary objectives are to: 1) Explore the ability of MBSR to improve perceived stress and quality of life compared to an education control group; and 2) Explore the durability of the effects of MBSR over one year.
研究概览
研究类型
介入性
注册 (实际的)
67
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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Oregon
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Portland、Oregon、美国、97201
- National College of Natural Medicine
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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 及以上 (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:
- Men and women 18 years of age or older
- Definite relapsing remitting, secondary progressive, or primary progressive MS by revised McDonald criteria;
- Expanded Disability Severity Scale ≤ 8 at baseline;
- Stable on MS disease modifying, anxiolytic, or antidepressant medications for three months prior to baseline visit;
- Mild to moderate stress defined by a score of ≥ 10 on the Perceived Stress Scale at screening;
- Ability to read and write in English;
- Willingness to provide informed consent and comply with study activities, including weekly MBSR sessions and daily practice or weekly Education Control classes.
Exclusion Criteria:
- MBSR or cognitive behavioral therapy training within the last 5 years;
- Current regular meditation or yoga practice (weekly or more often);
- MS exacerbation within 30 days of Baseline Visit;
- Mini-Mental Status Examination (MMSE) score of ≤ 26 at Screening Visit;
- Active suicidal ideation (Beck Depression Inventory) at Screening Visit;
- Reported or medically recorded diagnoses of current serious psychological disorders other than depression and anxiety;
- Other current life-threatening or severely disabling physical disorders;
- Positive pregnancy urine test at Baseline and women planning pregnancy during the study period (contraception not required);
- Cancer, other than basal or squamous skin cancers; or
- Inability or unwillingness of individual or legal guardian/representative to give written informed consent.
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:双倍的
武器和干预
参与者组/臂 |
干预/治疗 |
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实验性的:Mindfulness-base Stress Reduction
Mindfulness-based stress reduction is a formalized, experiential, 8-week stress-management program.
Participants attend weekly two-hour classes and a half-day retreat during which they learn mindfulness meditation, breath work, yoga postures, self-reflection and awareness.
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其他名称:
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有源比较器:MS Education Control
The MS Education Control program is matched to MBSR for time and attention yet has no overlap with intervention content.
Each two-hour class uses a pamphlet published by the National MS Society to present information about a different MS topic such as Fatigue; Bowel and Bladder Problems; Diet; Spasticity; and Nutritional Supplementation: Vitamins, Minerals, and Herbs.
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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 |
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Recruitment: Number of participants enrolled over a ten-month period
大体时间:Recruitment will be tracked monthly with an expected recruitment period of 10 months..
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Feasible recruitment is defined as the ability to recruit and enroll 60 participants with multiple sclerosis (MS) over a ten-month time frame.
Recruitment rate will be calculated as the proportion of eligible patients who provided informed consent per month.
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Recruitment will be tracked monthly with an expected recruitment period of 10 months..
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Adherence to Mindfulness-based Stress Reduction (MBSR): Number of Participants who are present for at least 5 of the classes, including the final class, and complete at least 70% of homework.
大体时间:Baseline to 8 weeks
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Adherence will be tracked with a sign-in/sign out sheet at each class and with daily homework logs.
Attendance will be calculated by a sign in/sign out sheet, being present for at least 75% of a class will count as attended.
Homework will be tabulated as both a frequency count (number of days homework was completed) and amount (total number of minutes completed).
Participants who are present for at least 5 of the classes, including the final class, and complete at least 70% of homework will be recorded as 'adherent'.
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Baseline to 8 weeks
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Adoption: Qualitative assessment of facilitators of and barriers to participation in the MBSR program.
大体时间:Week 4 and week 8 of the 8 week intervention.
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Adoption is defined as the ability of participants to take part in activities such as yoga poses and meditative exercises.
Qualitative outcomes include a brief, semi-structured focus group conducted at the beginning of the MBSR classes during weeks five and eight.
Focus groups will address successes and any challenges participants may be experiencing.
Focus groups will be audio recorded and transcribed verbatim for qualitative analysis.
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Week 4 and week 8 of the 8 week intervention.
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Completion: Number of participants with complete follow-up at 12 months post-intervention.
大体时间:14 months
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A feasible completion rate is defined as complete follow-up in at least 70% of enrolled subjects at 12-months post-intervention.
Completion indicates acceptability of a long-term trial and will inform future study designs.
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14 months
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
---|---|---|
Change from baseline in Perceived Stress Scale at 8 weeks
大体时间:Baseline and 8 weeks
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Baseline and 8 weeks
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Change in Perceived Stress Scale from 8 weeks to 12 months
大体时间:8 weeks and 12 months
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8 weeks and 12 months
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Change from baseline in Short Form-36 Mental Health Subscale to 8 weeks
大体时间:Baseline and 8 weeks
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Mental health-related quality of life.
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Baseline and 8 weeks
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Change in Short Form-36 Mental Health Subscale from 8 weeks to 12 months
大体时间:8 weeks and 12 months
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Mental health-related quality of life.
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8 weeks and 12 months
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Change in baseline Patient Reported Outcomes Measurement Information System (PROMIS) Anxiety Score to 8 weeks
大体时间:Baseline and 8 weeks
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PROMIS Computerized Adaptive Test of Anxiety
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Baseline and 8 weeks
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Change in PROMIS Anxiety Score from 8 weeks to 12 months
大体时间:8 weeks and 12 months
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PROMIS Computerized Adaptive Test of Anxiety
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8 weeks and 12 months
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Change in baseline PROMIS Depression Score to 8 weeks
大体时间:Baseline and 8 weeks
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PROMIS Computerized Adaptive Test of Depression
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Baseline and 8 weeks
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Change in PROMIS Depression Score from 8 weeks to 12 months
大体时间:8 weeks and 12 months
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PROMIS Computerized Adaptive Test of Depression
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8 weeks and 12 months
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Change in baseline PROMIS Fatigue Score to 8 weeks
大体时间:Baseline and 8 weeks
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PROMIS Computerized Adaptive Test of Fatigue
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Baseline and 8 weeks
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Change in PROMIS Fatigue Score from 8 weeks to 12 months
大体时间:8 weeks and 12 months
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PROMIS Computerized Adaptive Test of Fatigue
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8 weeks and 12 months
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Change in baseline PROMIS Pain Score to 8 weeks
大体时间:Baseline and 8 weeks
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PROMIS Computerized Adaptive Test of Pain
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Baseline and 8 weeks
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Change in PROMIS Pain Score from 8 weeks to 12 months
大体时间:8 weeks and 12 months
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PROMIS Computerized Adaptive Test of Pain
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8 weeks and 12 months
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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。
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
一般刊物
- Senders A, Bourdette D, Hanes D, Yadav V, Shinto L. Perceived stress in multiple sclerosis: the potential role of mindfulness in health and well-being. J Evid Based Complementary Altern Med. 2014 Apr;19(2):104-11. doi: 10.1177/2156587214523291. Epub 2014 Feb 20.
- Senders A, Sando K, Wahbeh H, Peterson Hiller A, Shinto L. Managing psychological stress in the multiple sclerosis medical visit: Patient perspectives and unmet needs. J Health Psychol. 2016 Aug;21(8):1676-87. doi: 10.1177/1359105314562084. Epub 2014 Dec 19.
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
2015年5月1日
初级完成 (实际的)
2017年5月30日
研究完成 (实际的)
2017年5月30日
研究注册日期
首次提交
2015年1月11日
首先提交符合 QC 标准的
2015年1月13日
首次发布 (估计)
2015年1月19日
研究记录更新
最后更新发布 (实际的)
2018年4月9日
上次提交的符合 QC 标准的更新
2018年4月6日
最后验证
2018年4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.