Effects of a Mindfulness-Based Intervention on Symptoms and Signs, Well-Being and Health in Patients With Chronic Heart Failure
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 50
- 主要终点
- Self-reported impact of fatigue
研究概览
简要总结
Patients with Chronic Heart Failure diagnosed and conventional treated, but still symptomatic (i.e. breathlessness, fatigue) is invited.
Eligible patients are randomised to (1) care as usual (i.e. optimized medical treatment) or (2) care as usual (i.e. optimized medical treatment) in combination with an 8-week mindfulness-based educational and training program.
Specific research questions:
- How are self-reported symptoms of breathlessness, fatigue, difficult sleeping, anxiety and depression affected by a mindfulness-based educational and training program (MBI)?
- Does the implementation of an 8-week Mindfulness-based program have any impact on personal experiences of well-being and health?
- What effects does an 8-week MBI have on objective signs of importance for the progression of heart failure?
详细描述
Effects of a Mindfulness-Based Intervention on Symptoms and Signs, Well-Being and Health in Patients with Chronic Heart Failure
Rationale: Despite progress in medical treatment, many patients with heart failure, still suffers from limiting symptoms with negative impact on their prognosis, wellbeing and health. Psychological distress, including anxiety and depression, is prevalent and difficult to treat in heart failure. Mindfulness-based interventions (MBIs), have shown beneficial effects on psychological and physiological symptoms, health and quality of life in other chronic conditions. The aims of the project were therefore to explore the feasibility and effects of MBI on symptoms and signs, well-being and health in patients diagnosed with chronic heart failure.
Hypothesis: was that outpatients with chronic heart failure would benefit from participating in an 8-week Mindfulness-based educational and training program (MBI) in addition to usual care (comprising standard health care and optimized medical treatment). With respect to (1) alleviate impact of symptoms (fatigue, breathlessness, impaired sleep, anxiety and depression), and (2) improve perceived wellbeing and health, and the sense of coherence (patient-reported outcomes), and (3) objective signs of importance for heart failure progression (heart rate, breathing rate, functional classification and capacity).
Study design: A prospective study, with a two-armed randomized and controlled designed, including two visits, was planned and initiated, integrated within the framework of a part-financed dissertation project. Complemented with qualitative research on participants' experiences of health, symptoms and the MBI.
Intervention: The intervention group received an 8-week MBI program in addition to treatment and care as usual (UC+MBI), while the control group received only treatment and care as usual (UC).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosed chronic heart (CHF) failure by echocardiography
- •Functional class II-IV according to the New York Heart Association (NYHA)
- •Symptoms of breathlessness and/or tiredness rated 2-5 by patients using five-point scales, ranging from asymptomatic (1) to symptoms at rest (5)
- •Stable condition, that is no deterioration of heart failure symptoms or new CHF drug or hospitalizations because of decompensated heart failure within the last four weeks
排除标准
- •Severe psychiatric diagnosis (requiring treatment)
- •Severe substance abuse (documented in journal)
- •Severe somatic disease with short expected survival (i.e., malignancy)
- •Communication difficulties (i.e., impaired vision or hearing, need of an interpreter to understand Swedish)
- •Cognitive or adherence difficulties (documented in journal)
- •Unstable angina pectoris
- •Post-partum cardiomyopathy
- •Ongoing participation in any other interventional study
- •Unwillingness to participate
研究组 & 干预措施
Control Group
Care as usual: (i.e. best medical treatment)
Mindfulness-Based Intervention
Care as usual (i.e. best medical treatment) in combination with an eight-week mindfulness-based educational and training program.
干预措施: Mindfulness-based intervention (Behavioral)
结局指标
主要结局
Self-reported impact of fatigue
时间窗: 10 weeks
Change from baseline to follow-up at week 10, will be measured at the Fatigue Severity Scale (FSS), a self-administered questionnaire including nine items investigating the impact of disabling fatigue on daily functioning during the past week. Grading of each item ranges from 1 to 7, with the total possible fatigue sum score ranging from 9 to 63, and higher scores indicating higher levels of indexed impact of fatigue. The FSS had not previously been tested in a heart failure population, and no cut-off score was found. The FSS was provided at visits and answered at home, and sent in to University address.
次要结局
- Anxiety(10 weeks)
- Depression(10 weeks)
- Psychological and General Well-Being(10 weeks)
- Sense of coherence(10 weeks)
- Health(10 weeks)
- Self-reported symptoms of impaired sleep(10 weeks)