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

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.

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.

Study Overview

• Status: Completed
• Conditions: Fibromyalgia
• Intervention / Treatment: Behavioral: ART with Mindfulness; Behavioral: Mindfulness Compassion; Behavioral: Relaxation

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Amygdala Retraining Technique (ART) with Mindfulness; Consists of 10 weekly sessions, followed by 3 monthly sessions	Behavioral: 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: 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	Behavioral: 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: Relaxation; Consists of 10 weekly sessions, followed by 3 monthly sessions	Behavioral: Relaxation; 10 sessions based on relaxation techniques as active comparator intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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	Time Frame
Hospital Anxiety and Depression Scale (HADS)	baseline
Sociodemographic Data	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)

Collaborators and Investigators

• Sponsor: Hospital Miguel Servet

Publications and helpful links

General Publications

• Montero-Marin J, Andres-Rodriguez L, Tops M, Luciano JV, Navarro-Gil M, Feliu-Soler A, Lopez-Del-Hoyo Y, Garcia-Campayo J. Effects of attachment-based compassion therapy (ABCT) on brain-derived neurotrophic factor and low-grade inflammation among fibromyalgia patients: A randomized controlled trial. Sci Rep. 2019 Oct 30;9(1):15639. doi: 10.1038/s41598-019-52260-z.
• Montero-Marin J, Navarro-Gil M, Puebla-Guedea M, Luciano JV, Van Gordon W, Shonin E, Garcia-Campayo J. Efficacy of "Attachment-Based Compassion Therapy" in the Treatment of Fibromyalgia: A Randomized Controlled Trial. Front Psychiatry. 2018 Jan 16;8:307. doi: 10.3389/fpsyt.2017.00307. eCollection 2017.

Study record dates

Study Major Dates

• Study Start: June 1, 2015
• Primary Completion (Actual): December 1, 2015
• Study Completion (Actual): September 1, 2016

Study Registration Dates

• First Submitted: May 18, 2015
• First Submitted That Met QC Criteria: May 21, 2015
• First Posted (Estimate): May 27, 2015

Study Record Updates

• Last Update Posted (Actual): August 10, 2017
• Last Update Submitted That Met QC Criteria: August 9, 2017
• Last Verified: August 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Muscular Diseases; Neuromuscular Diseases; Fibromyalgia; Myofascial Pain Syndromes
• Other Study ID Numbers: PI15/0049