The Mindfulness Intervention as Myocardial Infarction Rehabilitation Additive (MIMIRA) Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 24
- 试验地点
- 2
- 主要终点
- Feasibility
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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).
- •Depressive symptoms above a score of 8 on the questionnaire centre for epidemiological studies depression scale (CES-D).
- •Interest for participation in MBSR.
排除标准
- •Major depression or other serious psychiatric illness (such as psychosis or ongoing life crisis).
- •Severe comorbidities, such as cancer, severe cognitive impairment and alcohol or drug abuse.
- •Practical hindrances for participation in MBSR.
研究组 & 干预措施
MBSR participation
Participation in the 8 week Mindfulness Based Stress Reduction (MBSR) course.
干预措施: Mindfulness Based Stress Reduction (MBSR) (Behavioral)
结局指标
主要结局
Feasibility
时间窗: Immediately after the 8-week intervention.
Patient evaluation questionnaire
次要结局
- Acceptance(Before, immediately after and 12 months post intervention.)
- Patients experiences of mindfulness training(Continuously during the 8 week course.)
- Depressive Symptoms(Before, immediately after and 12 months post intervention.)
- Anxiety(Before, immediately after and 12 months post intervention.)
- Mindfulness(Before, immediately after and 12 months post intervention.)
- Mastery(Before, immediately after and 12 months post intervention.)
- Self-esteem(Before, immediately after and 12 months post intervention.)
研究者
Oskar Lundgren
PhD Candidate
Linkoeping University