Trial record 8 of 125 for:    fibromyalgia | Open Studies | Interventional Studies

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

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified May 2015 by Hospital Miguel Servet
Sponsor:
Information provided by (Responsible Party):
Javier Garcia Campayo, Hospital Miguel Servet
ClinicalTrials.gov Identifier:
NCT02454244
First received: May 18, 2015
Last updated: May 27, 2015
Last verified: May 2015
  Purpose

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 Intervention
Fibromyalgia
Behavioral: ART with Mindfulness
Behavioral: Mindfulness Compassion
Behavioral: Relaxation

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (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.

Resource links provided by NLM:


Further study details as provided by Hospital Miguel Servet:

Primary Outcome Measures:
  • Fibromyalgia Impact Questionnaire (FIQ) [ Time Frame: baseline ] [ Designated as safety issue: No ]
  • Change post-intervention (3 months) Fibromyalgia Impact Questionnaire (FIQ) [ Time Frame: post-intervention (3 months) ] [ Designated as safety issue: No ]
  • Change follow-up (6 months) Fibromyalgia Impact Questionnaire (FIQ) [ Time Frame: follow-up (6 months) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Sociodemographic Data [ Time Frame: baseline ] [ Designated as safety issue: No ]
  • Hospital Anxiety and Depression Scale (HADS) [ Time Frame: baseline ] [ Designated as safety issue: No ]
  • Change post-intervention (3 months) Hospital Anxiety and Depression Scale (HADS) [ Time Frame: post-intervention (3 months) ] [ Designated as safety issue: No ]
  • Change follow-up (6 months) Hospital Anxiety and Depression Scale (HADS) [ Time Frame: follow-up (6 months) ] [ Designated as safety issue: No ]
  • Fibrofatigue Scale (FFS) [ Time Frame: baseline ] [ Designated as safety issue: No ]
  • Change post-intervention (3 months) Fibrofatigue Scale (FFS) [ Time Frame: post-intervention (3 months) ] [ Designated as safety issue: No ]
  • Change follow-up (6 months) Fibrofatigue Scale (FFS) [ Time Frame: follow-up (6 months) ] [ Designated as safety issue: No ]
  • Euroqol Quality of Life Questionnaire [ Time Frame: baseline ] [ Designated as safety issue: No ]
  • Change post-intervention (3 months) Euroqol Quality of Life Questionnaire [ Time Frame: post-intervention (3 months) ] [ Designated as safety issue: No ]
  • Change follow-up (6 months) Euroqol Quality of Life Questionnaire [ Time Frame: follow-up (6 months) ] [ Designated as safety issue: No ]
  • Pain Catastrophizing Scale [ Time Frame: baseline ] [ Designated as safety issue: No ]
  • Change post-intervention (3 months) Pain Catastrophizing Scale [ Time Frame: post-intervention (3 months) ] [ Designated as safety issue: No ]
  • Change follow-up (6 months) Pain Catastrophizing Scale [ Time Frame: follow-up (6 months) ] [ Designated as safety issue: No ]
  • Acceptance Questionaire AAQ-II [ Time Frame: baseline ] [ Designated as safety issue: No ]
  • Change post-intervention (3 months) Acceptance Questionaire AAQ-II [ Time Frame: post-intervention (3 months) ] [ Designated as safety issue: No ]
  • Change follow-up (6 months) Acceptance Questionaire AAQ-II [ Time Frame: follow-up (6 months) ] [ Designated as safety issue: No ]
  • Five Facets Mindfulness Questionaire FFMQ [ Time Frame: baseline ] [ Designated as safety issue: No ]
  • Change post-intervention (3 months) Five Facets Mindfulness Questionaire FFMQ [ Time Frame: post-intervention (3 months) ] [ Designated as safety issue: No ]
  • Change follow-up (6 months) Five Facets Mindfulness Questionaire FFMQ [ Time Frame: follow-up (6 months) ] [ Designated as safety issue: No ]
  • Self-compassion Scale [ Time Frame: baseline ] [ Designated as safety issue: No ]
  • Change post-intervention (3 months) Self-compassion Scale [ Time Frame: post-intervention (3 months) ] [ Designated as safety issue: No ]
  • Change follow-up (6 months) Self-compassion Scale [ Time Frame: follow-up (6 months) ] [ Designated as safety issue: No ]
  • Serum Levels of Interleukins IL-6, IL-10 [ Time Frame: baseline ] [ Designated as safety issue: No ]
  • Change post-intervention (3 months) Serum Levels of Interleukins IL-6, IL-10 [ Time Frame: post-intervention (3 months) ] [ Designated as safety issue: No ]
  • Serum levels of Brain Derived Neurotrophic Factor BDNF [ Time Frame: baseline ] [ Designated as safety issue: No ]
  • Change post-intervention (3 months) Serum levels of Brain Derived Neurotrophic Factor BDNF [ Time Frame: post-intervention (3 months) ] [ Designated as safety issue: No ]
  • High-sensitivity C-reactive Protein [ Time Frame: baseline ] [ Designated as safety issue: No ]
  • Change post-intervention (3 months) High-sensitivity C-reactive Protein [ Time Frame: post-intervention (3 months) ] [ Designated as safety issue: No ]
  • Serum levels of Tumor Necrosis Factor TNF alpha [ Time Frame: baseline ] [ Designated as safety issue: No ]
  • Change post-intervention (3 months) Serum levels of Tumor Necrosis Factor TNF alpha [ Time Frame: post-intervention (3 months) ] [ Designated as safety issue: No ]

Estimated Enrollment: 60
Study Start Date: June 2015
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: August 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
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).
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02454244

Contacts
Contact: Javier Garcia-Campayo, Doctor (+34)976506578 jgarcamp@gmail.com

Sponsors and Collaborators
Hospital Miguel Servet
  More Information

No publications provided

Responsible Party: Javier Garcia Campayo, Medicine, Psychiatry, Hospital Miguel Servet
ClinicalTrials.gov Identifier: NCT02454244     History of Changes
Other Study ID Numbers: PI15/0049
Study First Received: May 18, 2015
Last Updated: May 27, 2015
Health Authority: Spain: Ministry of Health

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

ClinicalTrials.gov processed this record on July 01, 2015