Trial record 15 of 101 for:    fibromyalgia | Open Studies | Exclude Unknown

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

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified September 2015 by Fundació Sant Joan de Déu
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
ClinicalTrials.gov Identifier:
NCT02561416
First received: September 23, 2015
Last updated: September 24, 2015
Last verified: September 2015
  Purpose

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 Intervention Phase
Fibromyalgia Syndrome
Behavioral: MBSR
Behavioral: FibroQol
Other: TAU
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (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)

Resource links provided by NLM:


Further study details as provided by Fundació Sant Joan de Déu:

Primary Outcome Measures:
  • Effectiveness Evaluation: Revised Fibromyalgia Impact Questionnaire (FIQR) [ Time Frame: Change from baseline scores at 12 months ] [ Designated as safety issue: No ]
  • Cost-utility: Client Service Receipt Inventory (CSRI) [ Time Frame: Change from baseline scores at 12 months ] [ Designated as safety issue: No ]
  • Inflammatory markers: pro- and anti-inflammatory cytokines & hs-CRP [ Time Frame: Change from baseline values at 2 months ] [ Designated as safety issue: No ]
  • EuroQoL questionnaire (EQ-5D-5L) [ Time Frame: Change from baseline scores at 12 months ] [ Designated as safety issue: No ]
  • Structural neuroimaging: Voxel-Based Morphometry (VBM) [ Time Frame: Change from baseline brain gray matter concentration at 2 months ] [ Designated as safety issue: No ]
    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.

  • Functional neuroimaging: pulsed continuous arterial spin labeling (pCASL) [ Time Frame: Change from baseline regional cerebral blood flow at 2 months ] [ Designated as safety issue: No ]
    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:
  • Pain threshold assessed with sphygmomanometer [ Time Frame: Baseline, 2-month & 12-month follow-up ] [ Designated as safety issue: No ]
  • Patient Global Impression of Change (PGIC) [ Time Frame: Baseline, 2-month & 12-month follow-up ] [ Designated as safety issue: No ]
  • Pain Specific Impression of Change (PSIC) [ Time Frame: Baseline, 2-month & 12-month follow-up ] [ Designated as safety issue: No ]
  • Hamilton Anxiety and Depression Scale (HADS) [ Time Frame: Baseline, 2-month & 12-month follow-up ] [ Designated as safety issue: No ]
  • Perceived Stress Scale (PSS-10) [ Time Frame: Baseline, 2-month & 12-month follow-up ] [ Designated as safety issue: No ]
  • Multidimensional Inventory of Subjective Cognitive Impairment (MISCI) [ Time Frame: Baseline, 2-month & 12-month follow-up ] [ Designated as safety issue: No ]

Other Outcome Measures:
  • Pain Catastrophising Scale (PCS) [ Time Frame: Baseline, 2-month & 12-month follow-up ] [ Designated as safety issue: No ]
    Process variable

  • Five Facets Mindfulness Questionnaire (FFMQ) [ Time Frame: Baseline, 2-month & 12-month follow-up ] [ Designated as safety issue: No ]
    Process variable

  • Self-Compassion Scale (SCS-12) [ Time Frame: Baseline, 2-month & 12-month follow-up ] [ Designated as safety issue: No ]
    Process variable

  • Scale of Body Connection (SBC) [ Time Frame: Baseline, 2-month & 12-month follow-up ] [ Designated as safety issue: No ]
    Process variable

  • Psychological Inflexibility in Pain Scale (PIPS) [ Time Frame: Baseline, 2-month & 12-month follow-up ] [ Designated as safety issue: No ]
    Process variable

  • Checklist - Adverse events of the interventions [ Time Frame: 2-month ] [ Designated as safety issue: Yes ]
    Control variable

  • Credibility/Expectancy Questionnaire (CEQ) [ Time Frame: Baseline (MBSR & FibroQol groups) ] [ Designated as safety issue: No ]
    Control variable

  • Fibromyalgia Survey Diagnostic Criteria (FSDC) [ Time Frame: Baseline, 2-month & 12-month follow-up ] [ Designated as safety issue: No ]
    Screening & Primary outcome measure

  • Mini-Mental State Examination (MMSE) [ Time Frame: Baseline ] [ Designated as safety issue: No ]
    Screening measure

  • Structured Clinical Interview for DSM Axis I Disorders (SCID-I) [ Time Frame: Baseline ] [ Designated as safety issue: No ]
    Screening measure

  • Chronic Medical Conditions Checklist (CMCC) [ Time Frame: Baseline ] [ Designated as safety issue: No ]
    Screening measure


Estimated Enrollment: 180
Study Start Date: January 2016
Estimated Study Completion Date: December 2018
Estimated Primary Completion Date: June 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: MBSR
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
Other: 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.
Active Comparator: FibroQol
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.

Other: 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.
TAU
Treatment As Usual.
Other: 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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02561416

Contacts
Contact: Juan V. Luciano, PhD +34936406350 ext 2540 jvluciano@pssjd.org
Contact: Albert Feliu, PhD +936406350 ext 2546 a.feliu@pssjd.org

Locations
Spain
Teaching, Research & Innovation Unit - Parc Sanitari Sant Joan de Déu Not yet recruiting
Sant Boi de Llobregat, Barcelona, Spain, 08830
Contact: Juan V. Luciano, PhD    +936406350 ext 2540    jvluciano@pssjd.org   
Contact: Albert Feliu, PhD    +936406350 ext 2546    a.feliu@pssjd.org   
Sub-Investigator: Xavier Borràs, PhD         
Sub-Investigator: Maite Peñarrubia, MD         
Sub-Investigator: Antoni Rozadilla, MD         
Sub-Investigator: Jaume Aguado, MSC         
Sub-Investigator: Nicolás Fayed, MD         
Sub-Investigator: Marta Puebla, MSC         
Sub-Investigator: Matthew A. Howard, PhD         
Sub-Investigator: Francesco D'Amico, PhD         
Sub-Investigator: Rona Moss-Morris, PhD         
Sub-Investigator: James Shearer, PhD         
Sub-Investigator: Albert Feliu-Soler, PhD         
Principal Investigator: Juan V. Luciano, PhD         
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
Principal Investigator: Juan V. Luciano, PhD Teaching, Research & Innovation Unit - Parc Sanitari Sant Joan de Déu
  More Information

Additional Information:
No publications provided

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 
Study First Received: September 23, 2015
Last Updated: September 24, 2015
Health Authority: Spain: Ministry of Health

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

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

ClinicalTrials.gov processed this record on February 08, 2016