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

University Hospital Miguel Servet

Status: Completed

Conditions: Fibromyalgia

Treatments: Behavioral: ART with Mindfulness; Behavioral: Mindfulness Compassion; Behavioral: Relaxation

Study type: Interventional

Funder types: Other

Identifiers

NCT02454244

PI15/0049

Details and patient eligibility

About

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.

Enrollment: 60 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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60 participants in 3 patient groups

Amygdala Retraining Technique (ART) with Mindfulness

Experimental group

Description:

Consists of 10 weekly sessions, followed by 3 monthly sessions

Treatment:

Behavioral: ART with Mindfulness

Mindfulness Compassion

Experimental group

Description:

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

Treatment:

Behavioral: Mindfulness Compassion

Relaxation

Active Comparator group

Description:

Consists of 10 weekly sessions, followed by 3 monthly sessions

Treatment:

Behavioral: Relaxation