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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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ClinicalTrials.gov Identifier: NCT02454244
Recruitment Status : Completed
First Posted : May 27, 2015
Last Update Posted : August 10, 2017
Sponsor:
Information provided by (Responsible Party):
Javier Garcia Campayo, Hospital Miguel Servet

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.

Condition or disease Intervention/treatment Phase
Fibromyalgia Behavioral: ART with Mindfulness Behavioral: Mindfulness Compassion Behavioral: Relaxation Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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 Start Date : June 2015
Actual Primary Completion Date : December 2015
Actual Study Completion Date : September 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Fibromyalgia

Arm Intervention/treatment
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




Primary Outcome Measures :
  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 Outcome Measures :
  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) ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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).

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Javier Garcia Campayo, Medicine, Psychiatry, Hospital Miguel Servet
ClinicalTrials.gov Identifier: NCT02454244     History of Changes
Other Study ID Numbers: PI15/0049
First Posted: May 27, 2015    Key Record Dates
Last Update Posted: August 10, 2017
Last Verified: August 2017

Additional relevant MeSH terms:
Fibromyalgia
Myofascial Pain Syndromes
Muscular Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Neuromuscular Diseases
Nervous System Diseases