Efficacy of Amygdala Retraining With Mindfulness (ART+MF) vs Compassion Therapy (CT) for the Treatment of Patients With Fibromyalgia

Study Overview
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Brief Summary
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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.

Official Title
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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.

Conditions
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Fibromyalgia

Intervention / Treatment
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* Behavioral: ART with Mindfulness
* Behavioral: Mindfulness Compassion
* Behavioral: Relaxation


Participation Criteria
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Eligibility Criteria
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Inclusion criteria 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. Exclusion criteria 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).

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Amygdala Retraining Technique (ART) with Mindfulness<br>Consists of 10 weekly sessions, followed by 3 monthly sessions | Behavioral: ART with Mindfulness<br>* Introduction of ART with Mindfulness. Visualization of 100% recovery Developing Fibromyalgia and CFS. How stress triggers the central nervous system. The benefits of Mindfulness in chronic stress. Mindfulness Practice. Breathing meditation The ART. Breaking the negative thoughts related to the illness. Walking meditation Mindfulness and the Body Scan. Breaking the cycle of stress. Body-scan meditation Mindfulness and self-compassion. Kindly awareness meditation The accelerator of ART. Behaviors related to CFS and Fibromyalgia. Metta meditation Aware of negative thoughts related to stress stimulus. Mindfulness in daily activities Limiting beliefs, identity patterns. Motivation and sense of life. Meditation on values The recovery, cycles and stages. Fear of fail about recovery. Positive Visualization of future self Return to regular life. Mindfulness practice<br>|
| Experimental: Mindfulness Compassion<br>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 | Behavioral: Mindfulness Compassion<br>* Introduction.Definition of Compassion Self-Esteemed and Compassion Cultivate the understanding of the nature of inner experience. Working positive and negative thoughts.Connecting with difficult emotions Identifying the causes of suffering.How participants contribute to their own suffering. Attachments.Practice of Vulnerability Love,affection and self-compassion.How participants connect with the suffering of others Equanimity Forgiveness Interdependence. Gratitude.Affection to unknown people Developing affection and empathy.Empathy and burn out Review of the practices and meditations<br>|
| Active Comparator: Relaxation<br>Consists of 10 weekly sessions, followed by 3 monthly sessions | Behavioral: Relaxation<br>* 10 sessions based on relaxation techniques as active comparator intervention<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fibromyalgia Impact Questionnaire (FIQ) |  | baseline | 
| Change post-intervention (3 months) Fibromyalgia Impact Questionnaire (FIQ) |  | post-intervention (3 months) | 
| Change follow-up (6 months) Fibromyalgia Impact Questionnaire (FIQ) |  | follow-up (6 months) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sociodemographic Data |  | baseline | 
| Hospital Anxiety and Depression Scale (HADS) |  | baseline | 
| Change post-intervention (3 months) Hospital Anxiety and Depression Scale (HADS) |  | post-intervention (3 months) | 
| Change follow-up (6 months) Hospital Anxiety and Depression Scale (HADS) |  | follow-up (6 months) | 
| Fibrofatigue Scale (FFS) |  | baseline | 
| Change post-intervention (3 months) Fibrofatigue Scale (FFS) |  | post-intervention (3 months) | 
| Change follow-up (6 months) Fibrofatigue Scale (FFS) |  | follow-up (6 months) | 
| Euroqol Quality of Life Questionnaire |  | baseline | 
| 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) | 
| Pain Catastrophizing Scale |  | baseline | 
| Change post-intervention (3 months) Pain Catastrophizing Scale |  | post-intervention (3 months) | 
| Change follow-up (6 months) Pain Catastrophizing Scale |  | follow-up (6 months) | 
| 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) | 
| Five Facets Mindfulness Questionaire FFMQ |  | baseline | 
| Change post-intervention (3 months) Five Facets Mindfulness Questionaire FFMQ |  | post-intervention (3 months) | 
| Change follow-up (6 months) Five Facets Mindfulness Questionaire FFMQ |  | follow-up (6 months) | 
| Self-compassion Scale |  | baseline | 
| Change post-intervention (3 months) Self-compassion Scale |  | post-intervention (3 months) | 
| Change follow-up (6 months) Self-compassion Scale |  | follow-up (6 months) | 
| Serum Levels of Interleukins IL-6, IL-10 |  | baseline | 
| Change post-intervention (3 months) Serum Levels of Interleukins IL-6, IL-10 |  | post-intervention (3 months) | 
| Serum levels of Brain Derived Neurotrophic Factor BDNF |  | baseline | 
| Change post-intervention (3 months) Serum levels of Brain Derived Neurotrophic Factor BDNF |  | post-intervention (3 months) | 
| High-sensitivity C-reactive Protein |  | baseline | 
| Change post-intervention (3 months) High-sensitivity C-reactive Protein |  | post-intervention (3 months) | 
| Serum levels of Tumor Necrosis Factor TNF alpha |  | baseline | 
| Change post-intervention (3 months) Serum levels of Tumor Necrosis Factor TNF alpha |  | post-intervention (3 months) |