Efficacy of 8 vs 4 Sessions Mindfulness-based Programs in a Non-clinical Population
2015年12月31日 更新者：Javier Garcia Campayo、Hospital Miguel Servet
Efficacy of 8 vs 4 Sessions Mindfulness-based Programs in a Non-clinical Population: a Controlled Study
The aim of this study was to assess and compare the efficacy of a standard 8-weeks protocol based on the Mindfulness Based Stress Reduction MBSR program versus a 4-week shortened version of the protocol in the improvement of wellbeing variables in a non-clinical population in Spain.
The investigators initial hypothesis was that both protocols are efficacious but the standard 8-week performs better that the short one.
研究概览
研究类型
介入性
注册 (实际的)
99
阶段
- 第一阶段早期
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:
- be adult (18-y or older);
- willingness to participate in the study and signing informed consent;
- ability to understand and write Spanish.
Exclusion Criteria:
- have an acute clinical or psychiatry condition;
- have no previous experience with mindfulness or other type of contemplative or mind-boy practices such as yoga, taichi or chikung.
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：预防
- 分配：随机化
- 介入模型：阶乘赋值
- 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：standard 8-weeks MBSR
8-week program
|
A 8 weekly sessions of 120 min based on the standard protocol of Kabat Zinn was performed.
The adapted program did not include a one-day retreat in silence, but one session in silence plus extra kindly awareness (compassion-based) and value-based exercises.
Home practice was not systematically assessed, but recommended to be of 45min per day, most of the days.
It was administered by a trained (3-y experience) and certified MBSR teacher (MMPD).
|
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实验性的：4-week shortened MBSR
Short 4 sessions intervention
|
This protocol was made up of 4 sessions of 120 mn administered by the same trained MBSR programme therapist to avoid variables associated to the therapist.
The rationale behind the shortened version of MBSR was to keep the core content and practices of the program, in fewer sessions: raisin exercise (experiential concept of mindfulness); and main anchors of attention (breathing, body sensations, body movements).
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无干预：Control Group
control group: No intervention
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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 |
|---|---|
|
医院焦虑抑郁量表 (HADS)
大体时间：基线
|
基线
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Hospital Anxiety and Depression Scale (HADS) change from baseline
大体时间：post-treatment 8 weeks from baseline in 8 weeks intervention group
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post-treatment 8 weeks from baseline in 8 weeks intervention group
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Hospital Anxiety and Depression Scale (HADS) change from baseline
大体时间：post-treatment 4 weeks from baseline in 4 weeks intervention group
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post-treatment 4 weeks from baseline in 4 weeks intervention group
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Hospital Anxiety and Depression Scale (HADS) change from baseline
大体时间：six-months follow-up
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six-months follow-up
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次要结果测量
结果测量 |
大体时间 |
|---|---|
|
Mindful Attention Awareness Scale (MAAS)
大体时间：baseline, post-treatment 8 weeks from baseline in 8 weeks intervention group, post-treatment 4 weeks from baseline in 4 weeks intervention group, and six-months follow-up
|
baseline, post-treatment 8 weeks from baseline in 8 weeks intervention group, post-treatment 4 weeks from baseline in 4 weeks intervention group, and six-months follow-up
|
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Five Facets Mindfulness Questionnaire (FFMQ)
大体时间：baseline, post-treatment 8 weeks from baseline in 8 weeks intervention group, post-treatment 4 weeks from baseline in 4 weeks intervention group, and six-months follow-up
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baseline, post-treatment 8 weeks from baseline in 8 weeks intervention group, post-treatment 4 weeks from baseline in 4 weeks intervention group, and six-months follow-up
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Self-Compassion Scale (SCS)
大体时间：baseline, post-treatment 8 weeks from baseline in 8 weeks intervention group, post-treatment 4 weeks from baseline in 4 weeks intervention group, and six-months follow-up
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baseline, post-treatment 8 weeks from baseline in 8 weeks intervention group, post-treatment 4 weeks from baseline in 4 weeks intervention group, and six-months follow-up
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The Positive and Negative Affect Scale (PANAS)
大体时间：baseline, post-treatment 8 weeks from baseline in 8 weeks intervention group, post-treatment 4 weeks from baseline in 4 weeks intervention group, and six-months follow-up
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baseline, post-treatment 8 weeks from baseline in 8 weeks intervention group, post-treatment 4 weeks from baseline in 4 weeks intervention group, and six-months follow-up
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Connor-Davidson Resilience Scale (10-item CD-RISC)
大体时间：baseline, post-treatment 8 weeks from baseline in 8 weeks intervention group, post-treatment 4 weeks from baseline in 4 weeks intervention group, and six-months follow-up
|
baseline, post-treatment 8 weeks from baseline in 8 weeks intervention group, post-treatment 4 weeks from baseline in 4 weeks intervention group, and six-months follow-up
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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。
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
2013年2月1日
初级完成 (实际的)
2013年4月1日
研究完成 (实际的)
2013年10月1日
研究注册日期
首次提交
2015年12月18日
首先提交符合 QC 标准的
2015年12月29日
首次发布 (估计)
2015年12月31日
研究记录更新
最后更新发布 (估计)
2016年1月1日
上次提交的符合 QC 标准的更新
2015年12月31日
最后验证
2015年12月1日
更多信息
与本研究相关的术语
其他研究编号
- PI12/00134
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)？
未定
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.