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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-06-30

Study Completion Date

2016-09-30

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.

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Detailed Description

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Conditions

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Fibromyalgia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

Study Groups

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Amygdala Retraining Technique (ART) with Mindfulness

Consists of 10 weekly sessions, followed by 3 monthly sessions

Group Type EXPERIMENTAL

ART with Mindfulness

Intervention Type BEHAVIORAL

1. Introduction of ART with Mindfulness. Visualization of 100% recovery
2. Developing Fibromyalgia and CFS. How stress triggers the central nervous system. The benefits of Mindfulness in chronic stress. Mindfulness Practice. Breathing meditation
3. The ART. Breaking the negative thoughts related to the illness. Walking meditation
4. Mindfulness and the Body Scan. Breaking the cycle of stress. Body-scan meditation
5. Mindfulness and self-compassion. Kindly awareness meditation
6. The accelerator of ART. Behaviors related to CFS and Fibromyalgia. Metta meditation
7. Aware of negative thoughts related to stress stimulus. Mindfulness in daily activities
8. Limiting beliefs, identity patterns. Motivation and sense of life. Meditation on values
9. The recovery, cycles and stages. Fear of fail about recovery. Positive Visualization of future self
10. Return to regular life. Mindfulness practice

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

Group Type EXPERIMENTAL

Mindfulness Compassion

Intervention Type BEHAVIORAL

1. Introduction.Definition of Compassion
2. Self-Esteemed and Compassion
3. Cultivate the understanding of the nature of inner experience. Working positive and negative thoughts.Connecting with difficult emotions
4. Identifying the causes of suffering.How participants contribute to their own suffering. Attachments.Practice of Vulnerability
5. Love,affection and self-compassion.How participants connect with the suffering of others
6. Equanimity
7. Forgiveness
8. Interdependence. Gratitude.Affection to unknown people
9. Developing affection and empathy.Empathy and burn out
10. Review of the practices and meditations

Relaxation

Consists of 10 weekly sessions, followed by 3 monthly sessions

Group Type ACTIVE_COMPARATOR

Relaxation

Intervention Type BEHAVIORAL

10 sessions based on relaxation techniques as active comparator intervention

Interventions

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ART with Mindfulness

1. Introduction of ART with Mindfulness. Visualization of 100% recovery
2. Developing Fibromyalgia and CFS. How stress triggers the central nervous system. The benefits of Mindfulness in chronic stress. Mindfulness Practice. Breathing meditation
3. The ART. Breaking the negative thoughts related to the illness. Walking meditation
4. Mindfulness and the Body Scan. Breaking the cycle of stress. Body-scan meditation
5. Mindfulness and self-compassion. Kindly awareness meditation
6. The accelerator of ART. Behaviors related to CFS and Fibromyalgia. Metta meditation
7. Aware of negative thoughts related to stress stimulus. Mindfulness in daily activities
8. Limiting beliefs, identity patterns. Motivation and sense of life. Meditation on values
9. The recovery, cycles and stages. Fear of fail about recovery. Positive Visualization of future self
10. Return to regular life. Mindfulness practice

Intervention Type BEHAVIORAL

Mindfulness Compassion

1. Introduction.Definition of Compassion
2. Self-Esteemed and Compassion
3. Cultivate the understanding of the nature of inner experience. Working positive and negative thoughts.Connecting with difficult emotions
4. Identifying the causes of suffering.How participants contribute to their own suffering. Attachments.Practice of Vulnerability
5. Love,affection and self-compassion.How participants connect with the suffering of others
6. Equanimity
7. Forgiveness
8. Interdependence. Gratitude.Affection to unknown people
9. Developing affection and empathy.Empathy and burn out
10. Review of the practices and meditations

Intervention Type BEHAVIORAL

Relaxation

10 sessions based on relaxation techniques as active comparator intervention

Intervention Type BEHAVIORAL

Eligibility Criteria

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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).

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes