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

Primary Purpose

Fibromyalgia

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
ART with Mindfulness
Mindfulness Compassion
Relaxation
Sponsored by
Hospital Miguel Servet
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Fibromyalgia

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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).

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Experimental

    Experimental

    Active Comparator

    Arm Label

    Amygdala Retraining Technique (ART) with Mindfulness

    Mindfulness Compassion

    Relaxation

    Arm Description

    Consists of 10 weekly sessions, followed by 3 monthly sessions

    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

    Consists of 10 weekly sessions, followed by 3 monthly sessions

    Outcomes

    Primary Outcome Measures

    Fibromyalgia Impact Questionnaire (FIQ)
    Change post-intervention (3 months) Fibromyalgia Impact Questionnaire (FIQ)
    Change follow-up (6 months) Fibromyalgia Impact Questionnaire (FIQ)

    Secondary Outcome Measures

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

    Full Information

    First Posted
    May 18, 2015
    Last Updated
    August 9, 2017
    Sponsor
    Hospital Miguel Servet
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02454244
    Brief Title
    Efficacy of Amygdala Retraining With Mindfulness (ART+MF) vs Compassion Therapy (CT) for the Treatment of Patients With Fibromyalgia
    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.
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2017
    Overall Recruitment Status
    Completed
    Study Start Date
    June 2015 (undefined)
    Primary Completion Date
    December 2015 (Actual)
    Study Completion Date
    September 2016 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Hospital Miguel Servet

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief 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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Fibromyalgia

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    InvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    60 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Amygdala Retraining Technique (ART) with Mindfulness
    Arm Type
    Experimental
    Arm Description
    Consists of 10 weekly sessions, followed by 3 monthly sessions
    Arm Title
    Mindfulness Compassion
    Arm Type
    Experimental
    Arm Description
    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
    Arm Title
    Relaxation
    Arm Type
    Active Comparator
    Arm Description
    Consists of 10 weekly sessions, followed by 3 monthly sessions
    Intervention Type
    Behavioral
    Intervention Name(s)
    ART with Mindfulness
    Intervention Description
    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
    Intervention Type
    Behavioral
    Intervention Name(s)
    Mindfulness Compassion
    Intervention Description
    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
    Intervention Type
    Behavioral
    Intervention Name(s)
    Relaxation
    Intervention Description
    10 sessions based on relaxation techniques as active comparator intervention
    Primary Outcome Measure Information:
    Title
    Fibromyalgia Impact Questionnaire (FIQ)
    Time Frame
    baseline
    Title
    Change post-intervention (3 months) Fibromyalgia Impact Questionnaire (FIQ)
    Time Frame
    post-intervention (3 months)
    Title
    Change follow-up (6 months) Fibromyalgia Impact Questionnaire (FIQ)
    Time Frame
    follow-up (6 months)
    Secondary Outcome Measure Information:
    Title
    Sociodemographic Data
    Time Frame
    baseline
    Title
    Hospital Anxiety and Depression Scale (HADS)
    Time Frame
    baseline
    Title
    Change post-intervention (3 months) Hospital Anxiety and Depression Scale (HADS)
    Time Frame
    post-intervention (3 months)
    Title
    Change follow-up (6 months) Hospital Anxiety and Depression Scale (HADS)
    Time Frame
    follow-up (6 months)
    Title
    Fibrofatigue Scale (FFS)
    Time Frame
    baseline
    Title
    Change post-intervention (3 months) Fibrofatigue Scale (FFS)
    Time Frame
    post-intervention (3 months)
    Title
    Change follow-up (6 months) Fibrofatigue Scale (FFS)
    Time Frame
    follow-up (6 months)
    Title
    Euroqol Quality of Life Questionnaire
    Time Frame
    baseline
    Title
    Change post-intervention (3 months) Euroqol Quality of Life Questionnaire
    Time Frame
    post-intervention (3 months)
    Title
    Change follow-up (6 months) Euroqol Quality of Life Questionnaire
    Time Frame
    follow-up (6 months)
    Title
    Pain Catastrophizing Scale
    Time Frame
    baseline
    Title
    Change post-intervention (3 months) Pain Catastrophizing Scale
    Time Frame
    post-intervention (3 months)
    Title
    Change follow-up (6 months) Pain Catastrophizing Scale
    Time Frame
    follow-up (6 months)
    Title
    Acceptance Questionaire AAQ-II
    Time Frame
    baseline
    Title
    Change post-intervention (3 months) Acceptance Questionaire AAQ-II
    Time Frame
    post-intervention (3 months)
    Title
    Change follow-up (6 months) Acceptance Questionaire AAQ-II
    Time Frame
    follow-up (6 months)
    Title
    Five Facets Mindfulness Questionaire FFMQ
    Time Frame
    baseline
    Title
    Change post-intervention (3 months) Five Facets Mindfulness Questionaire FFMQ
    Time Frame
    post-intervention (3 months)
    Title
    Change follow-up (6 months) Five Facets Mindfulness Questionaire FFMQ
    Time Frame
    follow-up (6 months)
    Title
    Self-compassion Scale
    Time Frame
    baseline
    Title
    Change post-intervention (3 months) Self-compassion Scale
    Time Frame
    post-intervention (3 months)
    Title
    Change follow-up (6 months) Self-compassion Scale
    Time Frame
    follow-up (6 months)
    Title
    Serum Levels of Interleukins IL-6, IL-10
    Time Frame
    baseline
    Title
    Change post-intervention (3 months) Serum Levels of Interleukins IL-6, IL-10
    Time Frame
    post-intervention (3 months)
    Title
    Serum levels of Brain Derived Neurotrophic Factor BDNF
    Time Frame
    baseline
    Title
    Change post-intervention (3 months) Serum levels of Brain Derived Neurotrophic Factor BDNF
    Time Frame
    post-intervention (3 months)
    Title
    High-sensitivity C-reactive Protein
    Time Frame
    baseline
    Title
    Change post-intervention (3 months) High-sensitivity C-reactive Protein
    Time Frame
    post-intervention (3 months)
    Title
    Serum levels of Tumor Necrosis Factor TNF alpha
    Time Frame
    baseline
    Title
    Change post-intervention (3 months) Serum levels of Tumor Necrosis Factor TNF alpha
    Time Frame
    post-intervention (3 months)

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    65 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    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).

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    31666651
    Citation
    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.
    Results Reference
    derived
    PubMed Identifier
    29387020
    Citation
    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.
    Results Reference
    derived

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

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