Efficacy of Amygdala Retraining With Mindfulness (ART+MF) vs Compassion Therapy (CT) for the Treatment of Patients With Fibromyalgia: A Three-arm Randomized, Controlled Trial.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 主要终点
- Fibromyalgia Impact Questionnaire (FIQ)
研究概览
简要总结
Amygdala Retraining Treatment (ART) is a new and promising therapy for patients with Chronic Fatigue Syndrome (CFS) and Fibromyalgia (FM), however, randomized controlled trials (RCT) are scarce. The investigators have added mindfulness to this therapy, based on preliminary reports of its efficacy on patients, obtaining Amygdala Retraining Treatment with Mindfulness (ART+MF).
Other therapy that has been assessed in many psychiatric and medical disorders during the last years has been Compassion Therapy (CT). There are no studies on its efficacy in FM.
Aims: The aim of this trial is to assess the efficacy of both ART+MF and CT on the general function of the patients with FM. A secondary objective is to assess the effect of these therapies on psychological (pain, depression, anxiety, etc.) and biological variables (some biomarkers related with inflammation).
Methods:
- Design: Randomized, controlled trial with three arms: a) ART+MF, b) CT and c) Relaxation as control intervention.
- Sample: A sample (N=60 patients, about N=20 for each arm) will be recruited from primary care settings at the city of Zaragoza, Spain.
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
- 是
入选标准
- •Male or female aged between 18-65 years.
- •The patient needs to have the ability to read and understand Spanish
- •All the patients included in the study have been diagnosed with FM by a rheumatologist working for the Spanish National Health Service.
- •It is required that the patient does not modify during the trial the pharmacological treatment prescribed.
- •Signed informed consent.
排除标准
- •The patient should not meet any of the following criteria during the study:
- •Age <18 years or> 65 years.
- •The patients considered for exclusion are individuals with severe axis I psychiatric disorders (dementia, schizophrenia, paranoid disorder, alcohol and/or drug use disorders) and with severe somatic disorders that, from the clinician's point of view, prevented patients from carrying out a psychological assessment or participating in other clinical trials
- •It is not considered an exclusion criterion antidepressant use, as long as the treatment is not modified during the study period (treatment can be decreased, never increased).
研究组 & 干预措施
Amygdala Retraining Technique (ART) with Mindfulness
Consists of 10 weekly sessions, followed by 3 monthly sessions
干预措施: ART with Mindfulness (Behavioral)
Mindfulness Compassion
Includes the attentional training aspect of mindfulness and meditation practices, proved to bring benefits in relation to fibromyalgia and CFS symptoms, as fatigue and pain. Compassion training focuses on the ability to be kind to participants and their own experience, specifically to their experience of suffering. The protocol consists of 10 weekly sessions, followed by 3 following monthly sessions
干预措施: Mindfulness Compassion (Behavioral)
Relaxation
Consists of 10 weekly sessions, followed by 3 monthly sessions
干预措施: Relaxation (Behavioral)
结局指标
主要结局
Fibromyalgia Impact Questionnaire (FIQ)
时间窗: baseline
Change follow-up (6 months) Fibromyalgia Impact Questionnaire (FIQ)
时间窗: follow-up (6 months)
Change post-intervention (3 months) Fibromyalgia Impact Questionnaire (FIQ)
时间窗: post-intervention (3 months)
次要结局
- Change post-intervention (3 months) Five Facets Mindfulness Questionaire FFMQ(post-intervention (3 months))
- Self-compassion Scale(baseline)
- Change follow-up (6 months) Self-compassion Scale(follow-up (6 months))
- Serum levels of Tumor Necrosis Factor TNF alpha(baseline)
- Hospital Anxiety and Depression Scale (HADS)(baseline)
- Change post-intervention (3 months) Hospital Anxiety and Depression Scale (HADS)(post-intervention (3 months))
- Change post-intervention (3 months) Pain Catastrophizing Scale(post-intervention (3 months))
- Five Facets Mindfulness Questionaire FFMQ(baseline)
- Change follow-up (6 months) Hospital Anxiety and Depression Scale (HADS)(follow-up (6 months))
- Change follow-up (6 months) Fibrofatigue Scale (FFS)(follow-up (6 months))
- Pain Catastrophizing Scale(baseline)
- Acceptance Questionaire AAQ-II(baseline)
- Change post-intervention (3 months) Acceptance Questionaire AAQ-II(post-intervention (3 months))
- Change follow-up (6 months) Acceptance Questionaire AAQ-II(follow-up (6 months))
- Sociodemographic Data(baseline)
- Fibrofatigue Scale (FFS)(baseline)
- Change post-intervention (3 months) Fibrofatigue Scale (FFS)(post-intervention (3 months))
- Euroqol Quality of Life Questionnaire(baseline)
- Change follow-up (6 months) Pain Catastrophizing Scale(follow-up (6 months))
- Change post-intervention (3 months) Self-compassion Scale(post-intervention (3 months))
- Change post-intervention (3 months) Serum Levels of Interleukins IL-6, IL-10(post-intervention (3 months))
- High-sensitivity C-reactive Protein(baseline)
- Change post-intervention (3 months) High-sensitivity C-reactive Protein(post-intervention (3 months))
- Change post-intervention (3 months) Euroqol Quality of Life Questionnaire(post-intervention (3 months))
- Change follow-up (6 months) Euroqol Quality of Life Questionnaire(follow-up (6 months))
- Change follow-up (6 months) Five Facets Mindfulness Questionaire FFMQ(follow-up (6 months))
- Serum Levels of Interleukins IL-6, IL-10(baseline)
- Serum levels of Brain Derived Neurotrophic Factor BDNF(baseline)
- Change post-intervention (3 months) Serum levels of Tumor Necrosis Factor TNF alpha(post-intervention (3 months))
- Change post-intervention (3 months) Serum levels of Brain Derived Neurotrophic Factor BDNF(post-intervention (3 months))
研究者
Javier Garcia Campayo
Medicine, Psychiatry
Hospital Miguel Servet