Mindfulness-Based Stress Reduction Program as an Intervention in Patients With Fibromyalgia: A Three-Armed Randomized Clinical Study
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 180
- 试验地点
- 2
- 主要终点
- Fibromyalgia Impact Questionnaire (FIQ)
研究概览
简要总结
Fibromyalgia is a clinical syndrome with chronic pain, fatigue, and sleep disorders being the main symptoms. There is no commonly accepted efficacious treatment modality. Training in mindfulness-based stress reduction (MBSR) is a structured, 8-week, cognitively and affectively oriented intervention program, and has been shown to produce health benefits in a number of studies.
We plan to conduct a randomized, controlled, clinical study with the aim of testing the efficacy of MBSR for fibromyalgia. Because fibromyalgia is almost exclusively a female disorder, we will limit this investigation to women. 180 female, fibromyalgia patients will be randomized into three groups:
- Mindfulness training
- Active control
- Wait-list control.
The main outcome criteria are self-reported and fibromyalgia-specific Quality of Life (QOL), and a Biobehavioral Fibromyalgia Index composed of a variety of psychophysiological and behavioral variables. This index will be generated from data gathered via an ambulatory psychophysiological monitoring system, which comprises parameters of mobility, sleep quality, and cardiovascular well-being. These and other relevant variables (depression score, general QOL, pain quality, anxiety, mindfulness, compliance, other therapeutic measures) will be assessed at the beginning and end of the training, as well as at 4- and 12-months post-treatment. A primary focus will be assessing whether it is possible to promote psychological well-being through the learning of attentive presence and any resultant affective affirmation.
详细描述
Background:
Fibromyalgia is a clinical syndrome with chronic pain, fatigue, and sleep disorders being the main symptoms. There is no commonly accepted efficacious treatment modality. Training in mindfulness meditation or mindfulness-based stress reduction(MBSR) is based on procedures derived from Buddhist insight meditation and developed into an eight-week structured program by Kabat-Zinn (e.g. 1982, Gen Hosp Psychiat 4:33-47). However, although mindfulness meditation derives from Buddhist practices, the procedures are completely nonesoteric and nonsectarian. In essence, it may be largely characterized in terms of a cognitively and affectively oriented intervention program, and has been shown to produce health benefits in a number of pilot studies, uncontrolled observational studies, and randomized investigations. Promising pilot data are also available for fibromyalgia patients. In a meta-analysis conducted by the PI (principal investigator), clinically important and statistically significant health benefits were found across individuals with a wide range of conditions.
Hypotheses:
- A mindfulness-based stress reduction program (MBSR) is effective in improving the quality of life, psychological well-being and diminishing fibromyalgia-related symptoms in chronically ill patients;
- the mindfulness component of the MBSR, a spiritual-based method, allows the patient to receive the energy of love which is then transformative; 3) the effects of the mindfulness training will be visible in physiologic measurements including autonomic nervous system activity.
Method and Results:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Ability to understand the German language
- •Basic motivation to undergo a MBSR or similar training
- •Motivation to participate in a clinical trial, especially to answer thoroughly the questionnaires
- •Verified diagnosis of fibromyalgia according to the criteria of the American College of Rheumatology (ACR)
排除标准
- •Life threatening disease
- •Suppressed immune system
- •Participation in other clinical trials
- •Psychological or psychiatric disorders which constrain a normal interaction (assessed in an interview)
结局指标
主要结局
Fibromyalgia Impact Questionnaire (FIQ)
Biobehavioral Fibromyalgia Index
次要结局
- Quality of Life (PLC)
- Pain sensation (SES)
- Anxiety (STAI-G)
- Mindfulness (FIM)
- Quality of sleep (SF-B)
- Depression (ADS)
- Autonomic regulation
- Sleep related measures
- Concomitant therapies
- Compliance
- Physical activity measures