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

Fibromyalgia Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02454244
• Other study ID #: PI15/0049
• Status: Completed
• Phase: N/A
• First received: May 18, 2015
• Last updated: August 9, 2017
• Start date: June 2015
• Est. completion date: September 2016

Study information

• Verified date: August 2017
• Source: Hospital Miguel Servet
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: September 2016
• Est. primary completion date: December 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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).

Related Conditions & MeSH terms

• Fibromyalgia
• Myofascial Pain Syndromes

Intervention

Behavioral:
• ART with Mindfulness
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
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
10 sessions based on relaxation techniques as active comparator intervention

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hospital Miguel Servet

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Fibromyalgia Impact Questionnaire (FIQ)		baseline
Primary	Change post-intervention (3 months) Fibromyalgia Impact Questionnaire (FIQ)		post-intervention (3 months)
Primary	Change follow-up (6 months) Fibromyalgia Impact Questionnaire (FIQ)		follow-up (6 months)
Secondary	Sociodemographic Data		baseline
Secondary	Hospital Anxiety and Depression Scale (HADS)		baseline
Secondary	Change post-intervention (3 months) Hospital Anxiety and Depression Scale (HADS)		post-intervention (3 months)
Secondary	Change follow-up (6 months) Hospital Anxiety and Depression Scale (HADS)		follow-up (6 months)
Secondary	Fibrofatigue Scale (FFS)		baseline
Secondary	Change post-intervention (3 months) Fibrofatigue Scale (FFS)		post-intervention (3 months)
Secondary	Change follow-up (6 months) Fibrofatigue Scale (FFS)		follow-up (6 months)
Secondary	Euroqol Quality of Life Questionnaire		baseline
Secondary	Change post-intervention (3 months) Euroqol Quality of Life Questionnaire		post-intervention (3 months)
Secondary	Change follow-up (6 months) Euroqol Quality of Life Questionnaire		follow-up (6 months)
Secondary	Pain Catastrophizing Scale		baseline
Secondary	Change post-intervention (3 months) Pain Catastrophizing Scale		post-intervention (3 months)
Secondary	Change follow-up (6 months) Pain Catastrophizing Scale		follow-up (6 months)
Secondary	Acceptance Questionaire AAQ-II		baseline
Secondary	Change post-intervention (3 months) Acceptance Questionaire AAQ-II		post-intervention (3 months)
Secondary	Change follow-up (6 months) Acceptance Questionaire AAQ-II		follow-up (6 months)
Secondary	Five Facets Mindfulness Questionaire FFMQ		baseline
Secondary	Change post-intervention (3 months) Five Facets Mindfulness Questionaire FFMQ		post-intervention (3 months)
Secondary	Change follow-up (6 months) Five Facets Mindfulness Questionaire FFMQ		follow-up (6 months)
Secondary	Self-compassion Scale		baseline
Secondary	Change post-intervention (3 months) Self-compassion Scale		post-intervention (3 months)
Secondary	Change follow-up (6 months) Self-compassion Scale		follow-up (6 months)
Secondary	Serum Levels of Interleukins IL-6, IL-10		baseline
Secondary	Change post-intervention (3 months) Serum Levels of Interleukins IL-6, IL-10		post-intervention (3 months)
Secondary	Serum levels of Brain Derived Neurotrophic Factor BDNF		baseline
Secondary	Change post-intervention (3 months) Serum levels of Brain Derived Neurotrophic Factor BDNF		post-intervention (3 months)
Secondary	High-sensitivity C-reactive Protein		baseline
Secondary	Change post-intervention (3 months) High-sensitivity C-reactive Protein		post-intervention (3 months)
Secondary	Serum levels of Tumor Necrosis Factor TNF alpha		baseline
Secondary	Change post-intervention (3 months) Serum levels of Tumor Necrosis Factor TNF alpha		post-intervention (3 months)