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

October 11, 2019 updated by: Juan Vicente Luciano, Fundació Sant Joan de Déu

Cost-utility and Biological Underpinnings of Mindfulness-Based Stress Reduction (MBSR) in Fibromyalgia Syndrome: A Three-arm Randomized, Controlled Trial (EUDAIMON Project)

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Study Type

Interventional

Enrollment (Actual)

225

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
    • Barcelona
      • Sant Boi de Llobregat, Barcelona, Spain, 08830
        • Teaching, Research & Innovation Unit - Parc Sanitari Sant Joan de Déu

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / 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 Names:
  • 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).
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 Names:
  • Usual care
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.
Other: 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 Names:
  • Usual care

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Effectiveness Evaluation: Revised Fibromyalgia Impact Questionnaire (FIQR)
Time Frame: Change from baseline scores at 12 months
Change from baseline scores at 12 months
Cost-utility: Client Service Receipt Inventory (CSRI)
Time Frame: Change from baseline scores at 12 months
Change from baseline scores at 12 months
Inflammatory markers: pro- and anti-inflammatory cytokines & hs-CRP
Time Frame: Change from baseline values at 2 months
Change from baseline values at 2 months
EuroQoL questionnaire (EQ-5D-5L)
Time Frame: Change from baseline scores at 12 months
Change from baseline scores at 12 months
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.
Change from baseline brain gray matter concentration at 2 months
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.
Change from baseline regional cerebral blood flow at 2 months

Secondary Outcome Measures

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

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Five Facets Mindfulness Questionnaire (FFMQ)
Time Frame: Baseline, 2-month & 12-month follow-up
Process variable
Baseline, 2-month & 12-month follow-up
Self-Compassion Scale (SCS-12)
Time Frame: Baseline, 2-month & 12-month follow-up
Process variable
Baseline, 2-month & 12-month follow-up
Psychological Inflexibility in Pain Scale (PIPS)
Time Frame: Baseline, 2-month & 12-month follow-up
Process variable
Baseline, 2-month & 12-month follow-up
Checklist - Adverse events of the interventions
Time Frame: 2-month
Control variable
2-month
Credibility/Expectancy Questionnaire (CEQ)
Time Frame: Baseline (MBSR & FibroQol groups)
Control variable
Baseline (MBSR & FibroQol groups)
Mini-Mental State Examination (MMSE)
Time Frame: Baseline
Screening measure
Baseline
Structured Clinical Interview for DSM Axis I Disorders (SCID-I)
Time Frame: Baseline
Screening measure
Baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fundació Sant Joan de Déu

Collaborators

Parc Sanitari Sant Joan de Déu
Carlos III Health Institute
Preventive Services and Health Promotion Research Network

Investigators

  • Principal Investigator: Juan V. Luciano, PhD, Teaching, Research & Innovation Unit - Parc Sanitari Sant Joan de Déu

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2016

Primary Completion (Actual)

June 30, 2018

Study Completion (Actual)

December 31, 2018

Study Registration Dates

First Submitted

September 23, 2015

First Submitted That Met QC Criteria

September 24, 2015

First Posted (Estimate)

September 28, 2015

Study Record Updates

Last Update Posted (Actual)

October 14, 2019

Last Update Submitted That Met QC Criteria

October 11, 2019

Last Verified

October 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CP14/00087
  • PI15/00383 (Other Grant/Funding Number: Institute of Health Carlos III)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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