NCT02454244

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jun 2015

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 18, 2015

Completed
9 days until next milestone

First Posted

Study publicly available on registry

May 27, 2015

Completed
5 days until next milestone

Study Start

First participant enrolled

June 1, 2015

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2015

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2016

Completed
Last Updated

August 10, 2017

Status Verified

August 1, 2017

Enrollment Period

6 months

First QC Date

May 18, 2015

Last Update Submit

August 9, 2017

Conditions

Fibromyalgia

Outcome Measures

Primary Outcomes (3)

  • Fibromyalgia Impact Questionnaire (FIQ)

    baseline

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

    post-intervention (3 months)

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

    follow-up (6 months)

Secondary Outcomes (30)

  • Sociodemographic Data

    baseline

  • Hospital Anxiety and Depression Scale (HADS)

    baseline

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

    post-intervention (3 months)

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

    follow-up (6 months)

  • Fibrofatigue Scale (FFS)

    baseline

  • +25 more secondary outcomes

Study Arms (3)

Amygdala Retraining Technique (ART) with Mindfulness

EXPERIMENTAL

Consists of 10 weekly sessions, followed by 3 monthly sessions

Behavioral: ART with Mindfulness

Mindfulness Compassion

EXPERIMENTAL

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

Relaxation

ACTIVE COMPARATOR

Consists of 10 weekly sessions, followed by 3 monthly sessions

Behavioral: Relaxation

Interventions

ART with MindfulnessBEHAVIORAL

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

Amygdala Retraining Technique (ART) with Mindfulness
Mindfulness CompassionBEHAVIORAL

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

Mindfulness Compassion
RelaxationBEHAVIORAL

10 sessions based on relaxation techniques as active comparator intervention

Relaxation

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • The patient should not meet any of the following criteria during the study:
  • Age \<18 years or\> 65 years.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (2)

  • 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.

    PMID: 31666651DERIVED

  • 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.

    PMID: 29387020DERIVED

MeSH Terms

Conditions

Fibromyalgia

Interventions

Mindfulness

Condition Hierarchy (Ancestors)

Muscular DiseasesMusculoskeletal DiseasesRheumatic DiseasesNeuromuscular DiseasesNervous System Diseases

Intervention Hierarchy (Ancestors)

Cognitive Behavioral TherapyBehavior TherapyPsychotherapyBehavioral Disciplines and Activities

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Medicine, Psychiatry

Study Record Dates

First Submitted

May 18, 2015

First Posted

May 27, 2015

Study Start

June 1, 2015

Primary Completion

December 1, 2015

Study Completion

September 1, 2016

Last Updated

August 10, 2017

Record last verified: 2017-08