Clinical trial NCT02454244: Efficacy of Amygdala Retraining With Mindfulness (ART+MF) vs Compassion Therapy (CT) for the Treatment of Patients With Fibromyalgia
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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Fibromyalgia
Lead sponsor: Hospital Miguel Servet
Sponsor class: OTHER
First posted: 2015-05-27
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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).

Primary outcomes:
measure: Fibromyalgia Impact Questionnaire (FIQ)
timeFrame: baseline
measure: Change post-intervention (3 months) Fibromyalgia Impact Questionnaire (FIQ)
timeFrame: post-intervention (3 months)
measure: Change follow-up (6 months) Fibromyalgia Impact Questionnaire (FIQ)
timeFrame: follow-up (6 months)
Secondary outcomes:
measure: Sociodemographic Data
timeFrame: baseline
measure: Hospital Anxiety and Depression Scale (HADS)
timeFrame: baseline
measure: Change post-intervention (3 months) Hospital Anxiety and Depression Scale (HADS)
timeFrame: post-intervention (3 months)
measure: Change follow-up (6 months) Hospital Anxiety and Depression Scale (HADS)
timeFrame: follow-up (6 months)
measure: Fibrofatigue Scale (FFS)
timeFrame: baseline
measure: Change post-intervention (3 months) Fibrofatigue Scale (FFS)
timeFrame: post-intervention (3 months)
measure: Change follow-up (6 months) Fibrofatigue Scale (FFS)
timeFrame: follow-up (6 months)
measure: Euroqol Quality of Life Questionnaire
timeFrame: baseline
measure: Change post-intervention (3 months) Euroqol Quality of Life Questionnaire
timeFrame: post-intervention (3 months)
measure: Change follow-up (6 months) Euroqol Quality of Life Questionnaire
timeFrame: follow-up (6 months)
measure: Pain Catastrophizing Scale
timeFrame: baseline
measure: Change post-intervention (3 months) Pain Catastrophizing Scale
timeFrame: post-intervention (3 months)
measure: Change follow-up (6 months) Pain Catastrophizing Scale
timeFrame: follow-up (6 months)
measure: Acceptance Questionaire AAQ-II
timeFrame: baseline
measure: Change post-intervention (3 months) Acceptance Questionaire AAQ-II
timeFrame: post-intervention (3 months)
measure: Change follow-up (6 months) Acceptance Questionaire AAQ-II
timeFrame: follow-up (6 months)
measure: Five Facets Mindfulness Questionaire FFMQ
timeFrame: baseline
measure: Change post-intervention (3 months) Five Facets Mindfulness Questionaire FFMQ
timeFrame: post-intervention (3 months)
measure: Change follow-up (6 months) Five Facets Mindfulness Questionaire FFMQ
timeFrame: follow-up (6 months)
measure: Self-compassion Scale
timeFrame: baseline
measure: Change post-intervention (3 months) Self-compassion Scale
timeFrame: post-intervention (3 months)
measure: Change follow-up (6 months) Self-compassion Scale
timeFrame: follow-up (6 months)
measure: Serum Levels of Interleukins IL-6, IL-10
timeFrame: baseline
measure: Change post-intervention (3 months) Serum Levels of Interleukins IL-6, IL-10
timeFrame: post-intervention (3 months)
measure: Serum levels of Brain Derived Neurotrophic Factor BDNF
timeFrame: baseline
measure: Change post-intervention (3 months) Serum levels of Brain Derived Neurotrophic Factor BDNF
timeFrame: post-intervention (3 months)
measure: High-sensitivity C-reactive Protein
timeFrame: baseline
measure: Change post-intervention (3 months) High-sensitivity C-reactive Protein
timeFrame: post-intervention (3 months)
measure: Serum levels of Tumor Necrosis Factor TNF alpha
timeFrame: baseline
measure: Change post-intervention (3 months) Serum levels of Tumor Necrosis Factor TNF alpha
timeFrame: post-intervention (3 months)
Other outcomes:
Locations:
Study officials:
References:
citation: 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.
citation: 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.