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FibromyalgiaNCT02454244

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

A study testing ART with Mindfulness, Mindfulness Compassion and Relaxation in people with Fibromyalgia, run by Hospital Miguel Servet.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 65 yearsHealthy volunteers can take part
Conditions the study is for
Fibromyalgia
What is being tested?
ART with Mindfulness, Mindfulness Compassion and Relaxation
Could I receive a placebo?
No, everyone receives an active treatment
How many people
60 participants
Where
No sites listed yet
Study dates
Jun 2015to Sep 2016
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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).

About this study

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.

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.

Read more

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.
Conditions
Fibromyalgia
Being tested
ART with Mindfulness, Mindfulness Compassion, Relaxation
Medical subject headings
Fibromyalgia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ART with MindfulnessBehavioural

    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 CompassionBehavioural

    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

  • RelaxationBehavioural

    10 sessions based on relaxation techniques as active comparator intervention

Study groups in NCT02454244
Study groupRoleWhat they receive
Amygdala Retraining Technique (ART) with MindfulnessExperimentalConsists of 10 weekly sessions, followed by 3 monthly sessions
Receives: Behavioral: ART with Mindfulness
Mindfulness CompassionExperimentalIncludes 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
Receives: Behavioral: Mindfulness Compassion
RelaxationActive comparatorConsists of 10 weekly sessions, followed by 3 monthly sessions
Receives: Behavioral: Relaxation

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Fibromyalgia Impact Questionnaire (FIQ)

    Measured: baseline

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

    Measured: post-intervention (3 months)

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

    Measured: follow-up (6 months)

Secondary outcomes (30)

  1. Sociodemographic Data

    Measured: baseline

  2. Hospital Anxiety and Depression Scale (HADS)

    Measured: baseline

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

    Measured: post-intervention (3 months)

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

    Measured: follow-up (6 months)

  5. Fibrofatigue Scale (FFS)

    Measured: baseline

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

    Measured: post-intervention (3 months)

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

    Measured: follow-up (6 months)

  8. Euroqol Quality of Life Questionnaire

    Measured: baseline

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

    Measured: post-intervention (3 months)

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

    Measured: follow-up (6 months)

  11. Pain Catastrophizing Scale

    Measured: baseline

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

    Measured: post-intervention (3 months)

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

    Measured: follow-up (6 months)

  14. Acceptance Questionaire AAQ-II

    Measured: baseline

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

    Measured: post-intervention (3 months)

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

    Measured: follow-up (6 months)

  17. Five Facets Mindfulness Questionaire FFMQ

    Measured: baseline

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

    Measured: post-intervention (3 months)

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

    Measured: follow-up (6 months)

  20. Self-compassion Scale

    Measured: baseline

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

    Measured: post-intervention (3 months)

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

    Measured: follow-up (6 months)

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

    Measured: baseline

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

    Measured: post-intervention (3 months)

  25. Serum levels of Brain Derived Neurotrophic Factor BDNF

    Measured: baseline

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

    Measured: post-intervention (3 months)

  27. High-sensitivity C-reactive Protein

    Measured: baseline

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

    Measured: post-intervention (3 months)

  29. Serum levels of Tumor Necrosis Factor TNF alpha

    Measured: baseline

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

    Measured: post-intervention (3 months)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 May 2015 (estimated)
  2. Study startJun 2015
  3. Primary completionDec 2015
  4. Study completionSep 2016

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Investigator, Outcomes assessor
Enrolment
60 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02454244
Sponsor's protocol ID
PI15/0049
Status last verified
Aug 2017
First submitted
18 May 2015
Last updated
10 Aug 2017
Results posted
No
Data monitoring committee
No

Publications

  • 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.

    PubMed 31666651

  • 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.

    PubMed 29387020

Questions about this trial

What is this clinical trial studying?

A study testing ART with Mindfulness, Mindfulness Compassion and Relaxation in people with Fibromyalgia, run by Hospital Miguel Servet.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 10 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Fibromyalgia Impact Questionnaire (FIQ) (time frame: baseline). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02454244, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Aug 2017.

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