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.
Verified date | August 2017 |
Source | Hospital Miguel Servet |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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). |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Hospital Miguel Servet |
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) |
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