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The Mindfulness Intervention as Myocardial Infarction Rehabilitation Additive (MIMIRA) Study (MIMIRA)

2017年11月8日 更新者:Oskar Lundgren、Linkoeping University
The Mindfulness Intervention as Myocardial Infarction Rehabilitation Additive (MIMIRA) study aimed at studying the feasibility and acceptability of Mindfulness Based Stress Reduction - an 8 week course in meditation and yoga - in patients with a recent coronary artery event and elevated depressive symptoms. To address these questions patients with elevated scores on a depression scale were invited to participate in MBSR, and there evaluation of the course as well as a panel of psychological risk factors and resources was measured.

研究概览

详细说明

Depressive symptomatology in patients with coronary artery disease (CAD) has prognostic importance. Yet, psychological interventions in clinical practice are scarce. Here, we explored the feasibility and acceptability of mindfulness-based stress reduction (MBSR) in patients with depressive symptoms after a recent coronary event. A second aim was to investigate psychological risk factors and resources among participants.

To address the research questions, depressive symptoms were first measured in a reference population, at 1 and 12 months after a coronary event (myocardial infarction or unstable angina pectoris), and a cut-off for elevated depressive symptoms were obtained from the median in this group. Thereafter, similar CAD patients with elevated depressive symptoms (above median in the reference group), from the same outpatient clinic, were consecutively invited to an 8-week MBSR program. Serious physical or psychiatric illness that would be an obstacle to participation were exclusion criteria.

Patients who completed the MBSR-course were asked to evaluate its various facets, and completion rate and attendance were feasibility outcomes. Psychological variables were measured before, after the course as well as 12 months later.

研究类型

介入性

注册 (实际的)

24

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

      • Linköping、瑞典、581 83
        • Linköping University

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

有资格学习的性别

全部

描述

Inclusion Criteria:

  1. Recent (within 12 month) first time coronary artery event; defined as a diagnosis of myocardial infarction or unstable angina pectoris addressed with either percutaneous coronary intervention (PCI) or coronary artery by-pass graft surgery (CABG).
  2. Depressive symptoms above a score of 8 on the questionnaire centre for epidemiological studies depression scale (CES-D).
  3. Interest for participation in MBSR.

Exclusion Criteria:

  1. Major depression or other serious psychiatric illness (such as psychosis or ongoing life crisis).
  2. Severe comorbidities, such as cancer, severe cognitive impairment and alcohol or drug abuse.
  3. Practical hindrances for participation in MBSR.

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:不适用
  • 介入模型:单组作业
  • 屏蔽:无(打开标签)

武器和干预

参与者组/臂
干预/治疗
实验性的:MBSR participation
Participation in the 8 week Mindfulness Based Stress Reduction (MBSR) course.
An 8-week course in mindfulness meditation, yoga training and weekly group support in the form of weekly 2,5 hour meetings at the hospital.

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
Feasibility
大体时间:Immediately after the 8-week intervention.
Patient evaluation questionnaire
Immediately after the 8-week intervention.

次要结果测量

结果测量
措施说明
大体时间
Depressive Symptoms
大体时间:Before, immediately after and 12 months post intervention.
Centre for Epidemiological Studies Scale Depression (CES-D) questionnaire (Radloff)
Before, immediately after and 12 months post intervention.
Anxiety
大体时间:Before, immediately after and 12 months post intervention.
Generalized Anxiety Disorder Scale - 7 (GAD-7) questionnaire (Spitzer)
Before, immediately after and 12 months post intervention.
Mindfulness
大体时间:Before, immediately after and 12 months post intervention.
Five Facets of Mindfulness Questionnaire (FFMQ) (Baer)
Before, immediately after and 12 months post intervention.
Acceptance
大体时间:Before, immediately after and 12 months post intervention.
Acceptance and Action Questionnaire II (AAQII) (Block)
Before, immediately after and 12 months post intervention.
Mastery
大体时间:Before, immediately after and 12 months post intervention.
Mastery questionnaire (Pearlin & Shooler)
Before, immediately after and 12 months post intervention.
Self-esteem
大体时间:Before, immediately after and 12 months post intervention.
Self-esteem questionnaire (Rosenberg)
Before, immediately after and 12 months post intervention.
Patients experiences of mindfulness training
大体时间:Continuously during the 8 week course.
Written journal entries (linguistic content)
Continuously during the 8 week course.

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:Lena LJ Jonasson, M.D. Ph.D.、Division of Cardiovascular Medicine, Department of Medical and Health Sciences, Linköping University

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 (实际的)

2012年1月31日

初级完成 (实际的)

2014年11月18日

研究完成 (实际的)

2014年11月30日

研究注册日期

首次提交

2017年11月6日

首先提交符合 QC 标准的

2017年11月8日

首次发布 (实际的)

2017年11月14日

研究记录更新

最后更新发布 (实际的)

2017年11月14日

上次提交的符合 QC 标准的更新

2017年11月8日

最后验证

2017年11月1日

更多信息

与本研究相关的术语

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)?

未定

IPD 计划说明

Individual participant data will be available on reasonable request.

药物和器械信息、研究文件

研究美国 FDA 监管的药品

研究美国 FDA 监管的设备产品

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