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NCT Number: NCT02561416

Cost-utility and Biological Underpinnings of MBSR in Fibromyalgia Syndrome

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.

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Key information

Conditions

Fibromyalgia Syndrome Fibromyalgia Muscular Diseases Musculoskeletal Diseases Nervous System Diseases Neuromuscular Diseases Rheumatic Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Teaching, Research & Innovation Unit - Parc Sanitari Sant Joan de Déu

Sant Boi de Llobregat, Barcelona, 08830, Spain

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

MBSR

Behavioral

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

FibroQol

Behavioral

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.

TAU

Drug

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

Primary outcomes

  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 outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Fundació Sant Joan de Déu

Other

Collaborators

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

Registry information

Official study title

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

Acronym: EUDAIMON

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
Sep 28, 2015
Registry last updated
Oct 14, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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