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NCT Number: NCT02454244

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

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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Key information

Conditions

Fibromyalgia Muscular Diseases Musculoskeletal Diseases Nervous System Diseases Neuromuscular Diseases Rheumatic Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

ART with Mindfulness

Behavioral
  • 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

Mindfulness Compassion

Behavioral
  • 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

Relaxation

Behavioral

10 sessions based on relaxation techniques as active comparator intervention

Primary outcomes

  1. Fibromyalgia Impact Questionnaire (FIQ)

    Time frame: baseline

  2. Change post-intervention (3 months) Fibromyalgia Impact Questionnaire (FIQ)

    Time frame: post-intervention (3 months)

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

    Time frame: follow-up (6 months)

Secondary outcomes

  1. Sociodemographic Data

    Time frame: baseline

  2. Hospital Anxiety and Depression Scale (HADS)

    Time frame: baseline

  3. Change post-intervention (3 months) Hospital Anxiety and Depression Scale (HADS)

    Time frame: post-intervention (3 months)

  4. Change follow-up (6 months) Hospital Anxiety and Depression Scale (HADS)

    Time frame: follow-up (6 months)

  5. Fibrofatigue Scale (FFS)

    Time frame: baseline

  6. Change post-intervention (3 months) Fibrofatigue Scale (FFS)

    Time frame: post-intervention (3 months)

  7. Change follow-up (6 months) Fibrofatigue Scale (FFS)

    Time frame: follow-up (6 months)

  8. Euroqol Quality of Life Questionnaire

    Time frame: baseline

  9. Change post-intervention (3 months) Euroqol Quality of Life Questionnaire

    Time frame: post-intervention (3 months)

  10. Change follow-up (6 months) Euroqol Quality of Life Questionnaire

    Time frame: follow-up (6 months)

  11. Pain Catastrophizing Scale

    Time frame: baseline

  12. Change post-intervention (3 months) Pain Catastrophizing Scale

    Time frame: post-intervention (3 months)

  13. Change follow-up (6 months) Pain Catastrophizing Scale

    Time frame: follow-up (6 months)

  14. Acceptance Questionaire AAQ-II

    Time frame: baseline

  15. Change post-intervention (3 months) Acceptance Questionaire AAQ-II

    Time frame: post-intervention (3 months)

  16. Change follow-up (6 months) Acceptance Questionaire AAQ-II

    Time frame: follow-up (6 months)

  17. Five Facets Mindfulness Questionaire FFMQ

    Time frame: baseline

  18. Change post-intervention (3 months) Five Facets Mindfulness Questionaire FFMQ

    Time frame: post-intervention (3 months)

  19. Change follow-up (6 months) Five Facets Mindfulness Questionaire FFMQ

    Time frame: follow-up (6 months)

  20. Self-compassion Scale

    Time frame: baseline

  21. Change post-intervention (3 months) Self-compassion Scale

    Time frame: post-intervention (3 months)

  22. Change follow-up (6 months) Self-compassion Scale

    Time frame: follow-up (6 months)

  23. Serum Levels of Interleukins IL-6, IL-10

    Time frame: baseline

  24. Change post-intervention (3 months) Serum Levels of Interleukins IL-6, IL-10

    Time frame: post-intervention (3 months)

  25. Serum levels of Brain Derived Neurotrophic Factor BDNF

    Time frame: baseline

  26. Change post-intervention (3 months) Serum levels of Brain Derived Neurotrophic Factor BDNF

    Time frame: post-intervention (3 months)

  27. High-sensitivity C-reactive Protein

    Time frame: baseline

  28. Change post-intervention (3 months) High-sensitivity C-reactive Protein

    Time frame: post-intervention (3 months)

  29. Serum levels of Tumor Necrosis Factor TNF alpha

    Time frame: baseline

  30. Change post-intervention (3 months) Serum levels of Tumor Necrosis Factor TNF alpha

    Time frame: post-intervention (3 months)

Sponsors and collaborators

Lead sponsor

Hospital Miguel Servet

Other

Registry information

Official study 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.

Important dates

Study start
2015
Primary completion
2015
Study completion
2016
First posted
May 27, 2015
Registry last updated
Aug 10, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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