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Cost-utility and Biological Underpinnings of MBSR in Fibromyalgia Syndrome (EUDAIMON)

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ClinicalTrials.gov Identifier: NCT02561416
Recruitment Status : Completed
First Posted : September 28, 2015
Last Update Posted : September 6, 2018
Sponsor:
Collaborators:
Carlos III Health Institute
Preventive Services and Health Promotion Research Network
Parc Sanitari Sant Joan de Déu
Information provided by (Responsible Party):
Juan Vicente Luciano, Fundació Sant Joan de Déu

Brief Summary:

Purpose:

Fibromyalgia syndrome (FMS) is a disabling condition mainly characterized by chronic widespread pain, disturbed sleep, fatigue, and distress. The estimated overall prevalence of FMS in Europe is 2.9% and it incurs in high personal, social and healthcare costs. Available treatments in FMS are not curative and there is some evidence of positive effects of mindfulness-based stress reduction (MBSR) in patients with chronic pain and FMS. Nevertheless, although promising, the positive findings obtained in previous studies implementing mindfulness-based interventions in patients with FMS have to be interpreted with caution due to important methodological limitations (e.g. absence of randomization, high attrition rates, or small sample sizes). Therefore, further research in larger studies using more adequate methodologies is warranted. Furthermore, little is known about putative neurobiological processes underpinning the effects of mindfulness training in patients with chronic pain.

Aims: The aim of this randomized, controlled trial (RCT) is two-fold: firstly, to assess the effectiveness and cost-utility of MBSR added to treatment as usual (TAU); and secondly, to evaluate the effects of the compared interventions on neurobiological parameters. Specifically, MBSR will be compared to an active control which was previously reported as a cost-effective intervention (TAU + FibroQol psycho-educational program; Luciano et al., 2013) and also vs. TAU alone (in a 12-month follow-up RCT). Brain structure and function of pain-relevant areas and levels of inflammation markers (cytokines) will be assessed pre-post interventions in half of the study participants.

Methods:

Design: RCT with three arms:

  1. TAU + MBSR,
  2. TAU + FibroQoL and
  3. TAU.

Sample: 180 adults with FMS according to the ACR 1990 criteria (N=60 for each study arm) will be recruited from from the Parc Sanitari Sant Joan de Déu Rheumatology Service, Sant Boi de Llobregat, Spain. Half of the participants will be randomly selected to participate in the neurobiological pre-post evaluation (N= 30 each group). All patients will be assessed at baseline, post-intervention and 12-month follow-up for clinical variables, prep-post intervention for biomarkers study, and baseline and 12-month follow-up for cost-related variables.


Condition or disease Intervention/treatment Phase
Fibromyalgia Syndrome Behavioral: MBSR Behavioral: FibroQol Drug: TAU Phase 3

Detailed Description:

Detailed description of the study protocol has been published elsewhere (in an open-access journal):

http://bmccomplementalternmed.biomedcentral.com/articles/10.1186/s12906-016-1068-2


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 225 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Cost-utility and Biological Underpinnings of Mindfulness-Based Stress Reduction (MBSR) in Fibromyalgia Syndrome: A Three-arm Randomized, Controlled Trial (EUDAIMON Project)
Actual Study Start Date : January 1, 2016
Actual Primary Completion Date : June 30, 2018
Actual Study Completion Date : August 31, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Fibromyalgia

Arm Intervention/treatment
Experimental: Mindfulness-Based Stress Reduction
Mindfulness-Based Stress Reduction (MBSR) The MBSR consists in eight 2-h group sessions and an all-day mindfulness retreat, and offers intensive and structured training in mindfulness meditation to help patients to relate to their physical and psychological conditions in more accepting and nonjudgmental ways. Participants will be encouraged to engage in home mindfulness practices. Sessions will be lead by 4 MBSR accredited instructors.
Behavioral: MBSR
Session 1: Recognising the present moment Session 2: Engaging with the breath Session 3: Practice, practice, practice Session 4: Stress and the flow of emotions Session 5: Stress and thoughts: finding another place to stand Session 6: Interpersonal mindfulness / mindful communication. Session 7: Applying mindfulness Session 8: Making mindfulness a part of your life

Drug: TAU
In Spain the treatment as usual provided in FMS is mainly pharmacological and adjusted to the symptomatic profile of the patient. Counselling about aerobic exercise adjusted to patients' physical limitations is usually also provided.
Other Name: Usual care

Active Comparator: Psycho-educational Program
Psycho-educational Program (FibroQol) It consists of eight 2-h group sessions including information about FMS (4 sessions) based on a consensus document of the Health Department of Catalonia + autogenic relaxation (4 sessions).
Behavioral: FibroQol

Session 1: General information. Expectations of the patients. History of the illness. Principal and secondary symptoms in FM. Physiological mechanisms involved in the genesis of pain.

Session 2: Relaxation training-I. Session 3: Diagnosis. Pharmacological and non-pharmacological treatments. Prognosis. Current model of health care in Catalonia. Units specialized in the treatment of FM.

Session 4: Relaxation training-II. Session 5: Strategies to increase self-esteem and regulate emotions. Pain experience and recurrent invalidation. Social support (family and friends).

Session 6: Relaxation training-III Session 7: Benefits of physical exercise in FM. Session 8: Relaxation training-IV.


Drug: TAU
In Spain the treatment as usual provided in FMS is mainly pharmacological and adjusted to the symptomatic profile of the patient. Counselling about aerobic exercise adjusted to patients' physical limitations is usually also provided.
Other Name: Usual care

Treatment As Usual
Treatment As Usual.
Drug: TAU
In Spain the treatment as usual provided in FMS is mainly pharmacological and adjusted to the symptomatic profile of the patient. Counselling about aerobic exercise adjusted to patients' physical limitations is usually also provided.
Other Name: Usual care




Primary Outcome Measures :
  1. Effectiveness Evaluation: Revised Fibromyalgia Impact Questionnaire (FIQR) [ Time Frame: Change from baseline scores at 12 months ]
  2. Cost-utility: Client Service Receipt Inventory (CSRI) [ Time Frame: Change from baseline scores at 12 months ]
  3. Inflammatory markers: pro- and anti-inflammatory cytokines & hs-CRP [ Time Frame: Change from baseline values at 2 months ]
  4. EuroQoL questionnaire (EQ-5D-5L) [ Time Frame: Change from baseline scores at 12 months ]
  5. Structural neuroimaging: Voxel-Based Morphometry (VBM) [ Time Frame: Change from baseline brain gray matter concentration at 2 months ]
    Analysis of morphometric changes associated with participation in the three study arms voxel-by-voxel across the brain and in functionally-defined brain regions of interest relating to meta-awareness, body awareness, memory consolidation-reconsolidation, and emotion regulation.

  6. Functional neuroimaging: pulsed continuous arterial spin labeling (pCASL) [ Time Frame: Change from baseline regional cerebral blood flow at 2 months ]
    Analysis of changes in regional cerebral blood flow representing response to treatment throughout the brain and in a priori-specified network of brain regions postulated to underpin the sensory-discriminative, cognitive-evaluative and affective-motivational aspects of the pain experience.


Secondary Outcome Measures :
  1. Hamilton Anxiety and Depression Scale (HADS) [ Time Frame: Baseline, 2-month & 12-month follow-up ]
  2. Perceived Stress Scale (PSS-10) [ Time Frame: Baseline, 2-month & 12-month follow-up ]
  3. Multidimensional Inventory of Subjective Cognitive Impairment (MISCI) [ Time Frame: Baseline, 2-month & 12-month follow-up ]
  4. Pain Catastrophising Scale (PCS) [ Time Frame: Baseline, 2-month & 12-month follow-up ]
  5. Fibromyalgia Survey Diagnostic Criteria (FSDC) [ Time Frame: Baseline, 2-month & 12-month follow-up ]

Other Outcome Measures:
  1. Five Facets Mindfulness Questionnaire (FFMQ) [ Time Frame: Baseline, 2-month & 12-month follow-up ]
    Process variable

  2. Self-Compassion Scale (SCS-12) [ Time Frame: Baseline, 2-month & 12-month follow-up ]
    Process variable

  3. Psychological Inflexibility in Pain Scale (PIPS) [ Time Frame: Baseline, 2-month & 12-month follow-up ]
    Process variable

  4. Checklist - Adverse events of the interventions [ Time Frame: 2-month ]
    Control variable

  5. Credibility/Expectancy Questionnaire (CEQ) [ Time Frame: Baseline (MBSR & FibroQol groups) ]
    Control variable

  6. Mini-Mental State Examination (MMSE) [ Time Frame: Baseline ]
    Screening measure

  7. Structured Clinical Interview for DSM Axis I Disorders (SCID-I) [ Time Frame: Baseline ]
    Screening measure



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

General Inclusion Criteria:

  • Patients of both genders between 18-65 years old.
  • Verified diagnosis of FMS according to the American College of Rheumatology criteria (ACR 1990).
  • Ability to understand Spanish language.
  • Written informed consent.

General Exclusion Criteria:

  • Participation in other clinical trials
  • Cognitive impairment according to MINI (total score ≤ 24)
  • Receiving psychological treatment during the last or the current year
  • Previous experience with meditation or mind-body therapies.
  • Physical/psychiatric comorbidity that interferes with treatment (any severe medical illness, psychotic symptoms, substance abuse).
  • Not being able to attend to group sessions.
  • Being involved in ongoing litigation relating to the FMS.

Additional Inclusion Criteria for the biomarkers sub-study (90 participants in total):

  • Female gender
  • Right-handed

Additional Exclusion Criteria for the biomarkers sub-study:

  • Neoplastic illnesses (diagnosed from the medical history), infection, cardiopulmonary, vascular or other internal medical conditions
  • Use of oral or local corticosteroids or anti-cytokine therapy
  • Needle-phobia
  • Impossibility of being scanned in MRI (due to agoraphobia, metal implants, pace-marker…)
  • BMI> 36kg/m2 or >110Kg
  • Consuming > 8 caffeine units per day
  • Smoking > 5 cigarettes per day
  • Acute pain not related to the FMS at the day of biomarkers evaluation
  • Being pregnant or breastfeeding.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02561416


Locations
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Spain
Teaching, Research & Innovation Unit - Parc Sanitari Sant Joan de Déu
Sant Boi de Llobregat, Barcelona, Spain, 08830
Sponsors and Collaborators
Fundació Sant Joan de Déu
Carlos III Health Institute
Preventive Services and Health Promotion Research Network
Parc Sanitari Sant Joan de Déu
Investigators
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Principal Investigator: Juan V. Luciano, PhD Teaching, Research & Innovation Unit - Parc Sanitari Sant Joan de Déu

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Juan Vicente Luciano, PhD, Fundació Sant Joan de Déu
ClinicalTrials.gov Identifier: NCT02561416     History of Changes
Other Study ID Numbers: CP14/00087
PI15/00383 ( Other Grant/Funding Number: Institute of Health Carlos III )
First Posted: September 28, 2015    Key Record Dates
Last Update Posted: September 6, 2018
Last Verified: September 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Juan Vicente Luciano, Fundació Sant Joan de Déu:
Fibromyalgia syndrome
Mindfulness (MBSR)
Neuroimaging
Cytokines
Randomized Controlled Trial
Cost-effectiveness
Psychoeducation (FibroQol)

Additional relevant MeSH terms:
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Syndrome
Fibromyalgia
Myofascial Pain Syndromes
Disease
Pathologic Processes
Muscular Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Neuromuscular Diseases
Nervous System Diseases