Overview

This trial is active, not recruiting.

Condition fibromyalgia
Treatments art with mindfulness, mindfulness compassion, relaxation
Sponsor Hospital Miguel Servet
Start date June 2015
End date December 2015
Trial size 60 participants
Trial identifier NCT02454244, PI15/0049

Summary

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking double blind (investigator, outcomes assessor)
Primary purpose treatment
Arm
(Experimental)
Consists of 10 weekly sessions, followed by 3 monthly sessions
art with mindfulness
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
(Experimental)
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
mindfulness compassion
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
(Active Comparator)
Consists of 10 weekly sessions, followed by 3 monthly sessions
relaxation
10 sessions based on relaxation techniques as active comparator intervention

Primary Outcomes

Measure
Fibromyalgia Impact Questionnaire (FIQ)
time frame: baseline
Change post-intervention (3 months) Fibromyalgia Impact Questionnaire (FIQ)
time frame: post-intervention (3 months)
Change follow-up (6 months) Fibromyalgia Impact Questionnaire (FIQ)
time frame: follow-up (6 months)

Secondary Outcomes

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

Eligibility Criteria

Male or female participants from 18 years up to 65 years old.

Inclusion criteria 1. Male or female aged between 18-65 years. 2. The patient needs to have the ability to read and understand Spanish 3. All the patients included in the study have been diagnosed with FM by a rheumatologist working for the Spanish National Health Service. 4. It is required that the patient does not modify during the trial the pharmacological treatment prescribed. 5. Signed informed consent. Exclusion criteria The patient should not meet any of the following criteria during the study: 1. Age <18 years or> 65 years. 2. 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 3. 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).

Additional Information

Official title 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.
Trial information was received from ClinicalTrials.gov and was last updated in May 2016.
Information provided to ClinicalTrials.gov by Hospital Miguel Servet.