NCT02454244

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

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.

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: Hospital Miguel Servet · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

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.

Conditions

• Fibromyalgia

Interventions

Type	Name	Description
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
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
BEHAVIORAL	Relaxation	10 sessions based on relaxation techniques as active comparator intervention

Timeline

• Start date: 2015-06-01
• Primary completion: 2015-12-01
• Completion: 2016-09-01
• First posted: 2015-05-27
• Last updated: 2017-08-10