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

August 9, 2017 updated by: Javier Garcia Campayo, Hospital Miguel Servet

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
60

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Amygdala Retraining Technique (ART) with Mindfulness
Consists of 10 weekly sessions, followed by 3 monthly sessions
Behavioral: 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
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
  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
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Fibromyalgia Impact Questionnaire (FIQ)
Time Frame: baseline
baseline
Change post-intervention (3 months) Fibromyalgia Impact Questionnaire (FIQ)
Time Frame: post-intervention (3 months)
post-intervention (3 months)
Change follow-up (6 months) Fibromyalgia Impact Questionnaire (FIQ)
Time Frame: follow-up (6 months)
follow-up (6 months)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Hospital Anxiety and Depression Scale (HADS)
Time Frame: baseline
baseline
Sociodemographic Data
Time Frame: baseline
baseline
Change post-intervention (3 months) Hospital Anxiety and Depression Scale (HADS)
Time Frame: post-intervention (3 months)
post-intervention (3 months)
Change follow-up (6 months) Hospital Anxiety and Depression Scale (HADS)
Time Frame: follow-up (6 months)
follow-up (6 months)
Fibrofatigue Scale (FFS)
Time Frame: baseline
baseline
Change post-intervention (3 months) Fibrofatigue Scale (FFS)
Time Frame: post-intervention (3 months)
post-intervention (3 months)
Change follow-up (6 months) Fibrofatigue Scale (FFS)
Time Frame: follow-up (6 months)
follow-up (6 months)
Euroqol Quality of Life Questionnaire
Time Frame: baseline
baseline
Change post-intervention (3 months) Euroqol Quality of Life Questionnaire
Time Frame: post-intervention (3 months)
post-intervention (3 months)
Change follow-up (6 months) Euroqol Quality of Life Questionnaire
Time Frame: follow-up (6 months)
follow-up (6 months)
Pain Catastrophizing Scale
Time Frame: baseline
baseline
Change post-intervention (3 months) Pain Catastrophizing Scale
Time Frame: post-intervention (3 months)
post-intervention (3 months)
Change follow-up (6 months) Pain Catastrophizing Scale
Time Frame: follow-up (6 months)
follow-up (6 months)
Acceptance Questionaire AAQ-II
Time Frame: baseline
baseline
Change post-intervention (3 months) Acceptance Questionaire AAQ-II
Time Frame: post-intervention (3 months)
post-intervention (3 months)
Change follow-up (6 months) Acceptance Questionaire AAQ-II
Time Frame: follow-up (6 months)
follow-up (6 months)
Five Facets Mindfulness Questionaire FFMQ
Time Frame: baseline
baseline
Change post-intervention (3 months) Five Facets Mindfulness Questionaire FFMQ
Time Frame: post-intervention (3 months)
post-intervention (3 months)
Change follow-up (6 months) Five Facets Mindfulness Questionaire FFMQ
Time Frame: follow-up (6 months)
follow-up (6 months)
Self-compassion Scale
Time Frame: baseline
baseline
Change post-intervention (3 months) Self-compassion Scale
Time Frame: post-intervention (3 months)
post-intervention (3 months)
Change follow-up (6 months) Self-compassion Scale
Time Frame: follow-up (6 months)
follow-up (6 months)
Serum Levels of Interleukins IL-6, IL-10
Time Frame: baseline
baseline
Change post-intervention (3 months) Serum Levels of Interleukins IL-6, IL-10
Time Frame: post-intervention (3 months)
post-intervention (3 months)
Serum levels of Brain Derived Neurotrophic Factor BDNF
Time Frame: baseline
baseline
Change post-intervention (3 months) Serum levels of Brain Derived Neurotrophic Factor BDNF
Time Frame: post-intervention (3 months)
post-intervention (3 months)
High-sensitivity C-reactive Protein
Time Frame: baseline
baseline
Change post-intervention (3 months) High-sensitivity C-reactive Protein
Time Frame: post-intervention (3 months)
post-intervention (3 months)
Serum levels of Tumor Necrosis Factor TNF alpha
Time Frame: baseline
baseline
Change post-intervention (3 months) Serum levels of Tumor Necrosis Factor TNF alpha
Time Frame: post-intervention (3 months)
post-intervention (3 months)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Hospital Miguel Servet

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 1, 2015

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2015

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 1, 2016

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 18, 2015

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 21, 2015

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 27, 2015

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 10, 2017

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 9, 2017

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • PI15/0049

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Fibromyalgia

Clinical Trials on ART with Mindfulness

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings