Cost-utility and Biological Underpinnings of Mindfulness-Based Stress Reduction (MBSR) in Fibromyalgia Syndrome: A Three-arm Randomized, Controlled Trial (EUDAIMON Project)
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 225
- 试验地点
- 1
- 主要终点
- Inflammatory markers: pro- and anti-inflammatory cytokines & hs-CRP
研究概览
简要总结
Purpose:
Fibromyalgia syndrome (FMS) is a disabling condition mainly characterized by chronic widespread pain, disturbed sleep, fatigue, and distress. The estimated overall prevalence of FMS in Europe is 2.9% and it incurs in high personal, social and healthcare costs. Available treatments in FMS are not curative and there is some evidence of positive effects of mindfulness-based stress reduction (MBSR) in patients with chronic pain and FMS. Nevertheless, although promising, the positive findings obtained in previous studies implementing mindfulness-based interventions in patients with FMS have to be interpreted with caution due to important methodological limitations (e.g. absence of randomization, high attrition rates, or small sample sizes). Therefore, further research in larger studies using more adequate methodologies is warranted. Furthermore, little is known about putative neurobiological processes underpinning the effects of mindfulness training in patients with chronic pain.
Aims: The aim of this randomized, controlled trial (RCT) is two-fold: firstly, to assess the effectiveness and cost-utility of MBSR added to treatment as usual (TAU); and secondly, to evaluate the effects of the compared interventions on neurobiological parameters. Specifically, MBSR will be compared to an active control which was previously reported as a cost-effective intervention (TAU + FibroQol psycho-educational program; Luciano et al., 2013) and also vs. TAU alone (in a 12-month follow-up RCT). Brain structure and function of pain-relevant areas and levels of inflammation markers (cytokines) will be assessed pre-post interventions in half of the study participants.
Methods:
Design: RCT with three arms:
- TAU + MBSR,
- TAU + FibroQoL and
- TAU.
Sample: 180 adults with FMS according to the ACR 1990 criteria (N=60 for each study arm) will be recruited from from the Parc Sanitari Sant Joan de Déu Rheumatology Service, Sant Boi de Llobregat, Spain. Half of the participants will be randomly selected to participate in the neurobiological pre-post evaluation (N= 30 each group). All patients will be assessed at baseline, post-intervention and 12-month follow-up for clinical variables, prep-post intervention for biomarkers study, and baseline and 12-month follow-up for cost-related variables.
详细描述
Detailed description of the study protocol has been published elsewhere (in an open-access journal):
http://bmccomplementalternmed.biomedcentral.com/articles/10.1186/s12906-016-1068-2
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
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients of both genders between 18-65 years old.
- •Verified diagnosis of FMS according to the American College of Rheumatology criteria (ACR 1990).
- •Ability to understand Spanish language.
- •Written informed consent.
排除标准
- •Participation in other clinical trials
- •Cognitive impairment according to MINI (total score ≤ 24)
- •Receiving psychological treatment during the last or the current year
- •Previous experience with meditation or mind-body therapies.
- •Physical/psychiatric comorbidity that interferes with treatment (any severe medical illness, psychotic symptoms, substance abuse).
- •Not being able to attend to group sessions.
- •Being involved in ongoing litigation relating to the FMS.
- •Additional Inclusion Criteria for the biomarkers sub-study (90 participants in total):
- •Female gender
- •Right-handed
- •Additional Exclusion Criteria for the biomarkers sub-study:
- •Neoplastic illnesses (diagnosed from the medical history), infection, cardiopulmonary, vascular or other internal medical conditions
- •Use of oral or local corticosteroids or anti-cytokine therapy
- •Needle-phobia
- •Impossibility of being scanned in MRI (due to agoraphobia, metal implants, pace-marker...)
- •BMI> 36kg/m2 or >110Kg
- •Consuming > 8 caffeine units per day
- •Smoking > 5 cigarettes per day
- •Acute pain not related to the FMS at the day of biomarkers evaluation
- •Being pregnant or breastfeeding.
研究组 & 干预措施
Mindfulness-Based Stress Reduction
Mindfulness-Based Stress Reduction (MBSR) The MBSR consists in eight 2-h group sessions and an all-day mindfulness retreat, and offers intensive and structured training in mindfulness meditation to help patients to relate to their physical and psychological conditions in more accepting and nonjudgmental ways. Participants will be encouraged to engage in home mindfulness practices. Sessions will be lead by 4 MBSR accredited instructors.
干预措施: MBSR (Behavioral)
Psycho-educational Program
Psycho-educational Program (FibroQol) It consists of eight 2-h group sessions including information about FMS (4 sessions) based on a consensus document of the Health Department of Catalonia + autogenic relaxation (4 sessions).
干预措施: FibroQol (Behavioral)
Psycho-educational Program
Psycho-educational Program (FibroQol) It consists of eight 2-h group sessions including information about FMS (4 sessions) based on a consensus document of the Health Department of Catalonia + autogenic relaxation (4 sessions).
干预措施: TAU (Drug)
Treatment As Usual
Treatment As Usual.
干预措施: TAU (Drug)
Mindfulness-Based Stress Reduction
Mindfulness-Based Stress Reduction (MBSR) The MBSR consists in eight 2-h group sessions and an all-day mindfulness retreat, and offers intensive and structured training in mindfulness meditation to help patients to relate to their physical and psychological conditions in more accepting and nonjudgmental ways. Participants will be encouraged to engage in home mindfulness practices. Sessions will be lead by 4 MBSR accredited instructors.
干预措施: TAU (Drug)
结局指标
主要结局
Inflammatory markers: pro- and anti-inflammatory cytokines & hs-CRP
时间窗: Change from baseline values at 2 months
Functional neuroimaging: pulsed continuous arterial spin labeling (pCASL)
时间窗: Change from baseline regional cerebral blood flow at 2 months
Analysis of changes in regional cerebral blood flow representing response to treatment throughout the brain and in a priori-specified network of brain regions postulated to underpin the sensory-discriminative, cognitive-evaluative and affective-motivational aspects of the pain experience.
Structural neuroimaging: Voxel-Based Morphometry (VBM)
时间窗: Change from baseline brain gray matter concentration at 2 months
Analysis of morphometric changes associated with participation in the three study arms voxel-by-voxel across the brain and in functionally-defined brain regions of interest relating to meta-awareness, body awareness, memory consolidation-reconsolidation, and emotion regulation.
EuroQoL questionnaire (EQ-5D-5L)
时间窗: Change from baseline scores at 12 months
Effectiveness Evaluation: Revised Fibromyalgia Impact Questionnaire (FIQR)
时间窗: Change from baseline scores at 12 months
Cost-utility: Client Service Receipt Inventory (CSRI)
时间窗: Change from baseline scores at 12 months
次要结局
- Fibromyalgia Survey Diagnostic Criteria (FSDC)(Baseline, 2-month & 12-month follow-up)
- Perceived Stress Scale (PSS-10)(Baseline, 2-month & 12-month follow-up)
- Multidimensional Inventory of Subjective Cognitive Impairment (MISCI)(Baseline, 2-month & 12-month follow-up)
- Hamilton Anxiety and Depression Scale (HADS)(Baseline, 2-month & 12-month follow-up)
- Pain Catastrophising Scale (PCS)(Baseline, 2-month & 12-month follow-up)
研究者
Juan Vicente Luciano
PhD
Fundació Sant Joan de Déu