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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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Amygdala Retraining Technique (ART) with Mindfulness | Experimental | Consists of 10 weekly sessions, followed by 3 monthly sessions |
|
| Mindfulness Compassion | Experimental | 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 |
|
| Relaxation | Active Comparator | Consists of 10 weekly sessions, followed by 3 monthly sessions |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ART with Mindfulness | Behavioral |
|
| Measure | Description | Time Frame |
|---|---|---|
| Fibromyalgia Impact Questionnaire (FIQ) | baseline | |
| Change post-intervention (3 months) Fibromyalgia Impact Questionnaire (FIQ) | post-intervention (3 months) | |
| Change follow-up (6 months) Fibromyalgia Impact Questionnaire (FIQ) | follow-up (6 months) |
| Measure | Description | Time Frame |
|---|---|---|
| Sociodemographic Data | baseline | |
| Hospital Anxiety and Depression Scale (HADS) | baseline | |
| Change post-intervention (3 months) Hospital Anxiety and Depression Scale (HADS) |
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Inclusion criteria
Exclusion criteria
The patient should not meet any of the following criteria during the study:
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31666651 | Derived | 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. | |
| 29387020 |
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| ID | Term |
|---|---|
| D005356 | Fibromyalgia |
| ID | Term |
|---|---|
| D009135 | Muscular Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
| D009468 | Neuromuscular Diseases |
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| ID | Term |
|---|---|
| D064866 | Mindfulness |
| ID | Term |
|---|---|
| D015928 | Cognitive Behavioral Therapy |
| D001521 | Behavior Therapy |
| D011613 | Psychotherapy |
| D004191 | Behavioral Disciplines and Activities |
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|
| Mindfulness Compassion | Behavioral |
|
|
| Relaxation | Behavioral | 10 sessions based on relaxation techniques as active comparator intervention |
|
| post-intervention (3 months) |
| Change follow-up (6 months) Hospital Anxiety and Depression Scale (HADS) | follow-up (6 months) |
| Fibrofatigue Scale (FFS) | baseline |
| Change post-intervention (3 months) Fibrofatigue Scale (FFS) | post-intervention (3 months) |
| Change follow-up (6 months) Fibrofatigue Scale (FFS) | follow-up (6 months) |
| Euroqol Quality of Life Questionnaire | baseline |
| Change post-intervention (3 months) Euroqol Quality of Life Questionnaire | post-intervention (3 months) |
| Change follow-up (6 months) Euroqol Quality of Life Questionnaire | follow-up (6 months) |
| Pain Catastrophizing Scale | baseline |
| Change post-intervention (3 months) Pain Catastrophizing Scale | post-intervention (3 months) |
| Change follow-up (6 months) Pain Catastrophizing Scale | follow-up (6 months) |
| Acceptance Questionaire AAQ-II | baseline |
| Change post-intervention (3 months) Acceptance Questionaire AAQ-II | post-intervention (3 months) |
| Change follow-up (6 months) Acceptance Questionaire AAQ-II | follow-up (6 months) |
| Five Facets Mindfulness Questionaire FFMQ | baseline |
| Change post-intervention (3 months) Five Facets Mindfulness Questionaire FFMQ | post-intervention (3 months) |
| Change follow-up (6 months) Five Facets Mindfulness Questionaire FFMQ | follow-up (6 months) |
| Self-compassion Scale | baseline |
| Change post-intervention (3 months) Self-compassion Scale | post-intervention (3 months) |
| Change follow-up (6 months) Self-compassion Scale | follow-up (6 months) |
| Serum Levels of Interleukins IL-6, IL-10 | baseline |
| Change post-intervention (3 months) Serum Levels of Interleukins IL-6, IL-10 | post-intervention (3 months) |
| Serum levels of Brain Derived Neurotrophic Factor BDNF | baseline |
| Change post-intervention (3 months) Serum levels of Brain Derived Neurotrophic Factor BDNF | post-intervention (3 months) |
| High-sensitivity C-reactive Protein | baseline |
| Change post-intervention (3 months) High-sensitivity C-reactive Protein | post-intervention (3 months) |
| Serum levels of Tumor Necrosis Factor TNF alpha | baseline |
| Change post-intervention (3 months) Serum levels of Tumor Necrosis Factor TNF alpha | post-intervention (3 months) |
| 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. |
| D009422 |
| Nervous System Diseases |