Cost-utility and Biological Underpinnings of MBSR in Fibromyalgia Syndrome

NCT02561416 | Completed Phase 3

• 2 other identifiers: CP14/00087PI15/00383
• Study Type: interventional
• Target: 225
• Locations: 1 country
• Sites: 1

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

Conditions

Fibromyalgia Syndrome

Keywords

Fibromyalgia syndrome; Mindfulness (MBSR); Neuroimaging; Cytokines; Randomized Controlled Trial; Cost-effectiveness; Psychoeducation (FibroQol)

Outcome Measures

Primary Outcomes (6)

• Effectiveness Evaluation: Revised Fibromyalgia Impact Questionnaire (FIQR)

  Change from baseline scores at 12 months

• Cost-utility: Client Service Receipt Inventory (CSRI)

  Change from baseline scores at 12 months

• Inflammatory markers: pro- and anti-inflammatory cytokines & hs-CRP

  Change from baseline values at 2 months

• EuroQoL questionnaire (EQ-5D-5L)

  Change from baseline scores at 12 months

• Structural neuroimaging: Voxel-Based Morphometry (VBM)

  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)

  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 Outcomes (5)

• Hamilton Anxiety and Depression Scale (HADS)

  Baseline, 2-month & 12-month follow-up

• Perceived Stress Scale (PSS-10)

  Baseline, 2-month & 12-month follow-up

• Multidimensional Inventory of Subjective Cognitive Impairment (MISCI)

  Baseline, 2-month & 12-month follow-up

• Pain Catastrophising Scale (PCS)

  Baseline, 2-month & 12-month follow-up

• Fibromyalgia Survey Diagnostic Criteria (FSDC)

  Baseline, 2-month & 12-month follow-up

Other Outcomes (7)

• Five Facets Mindfulness Questionnaire (FFMQ)

  Baseline, 2-month & 12-month follow-up

• Self-Compassion Scale (SCS-12)

  Baseline, 2-month & 12-month follow-up

• Psychological Inflexibility in Pain Scale (PIPS)

  Baseline, 2-month & 12-month follow-up

Study Arms (3)

Mindfulness-Based Stress Reduction

EXPERIMENTAL

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; Drug: TAU

Psycho-educational Program

ACTIVE COMPARATOR

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; Drug: TAU

Treatment As Usual

OTHER

Treatment As Usual.

Drug: TAU

Interventions

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

Mindfulness-Based Stress Reduction

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.

Psycho-educational Program

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.

Also known as: Usual care

Mindfulness-Based Stress Reduction; Psycho-educational Program; Treatment As Usual

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• Female gender
• Right-handed
• 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

Sponsors & Collaborators

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

Study Sites (1)

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

Sant Boi de Llobregat, Barcelona, 08830, Spain

Location

Related Publications (3)

• Medina S, O'Daly OG, Howard MA, Feliu-Soler A, Luciano JV. Differential Brain Perfusion Changes Following Two Mind-Body Interventions for Fibromyalgia Patients: an Arterial Spin Labelling fMRI Study. Mindfulness (N Y). 2022;13(2):449-461. doi: 10.1007/s12671-021-01806-2. Epub 2022 Jan 5.

  PMID: 35222735 DERIVED

• Perez-Aranda A, Feliu-Soler A, Montero-Marin J, Garcia-Campayo J, Andres-Rodriguez L, Borras X, Rozadilla-Sacanell A, Penarrubia-Maria MT, Angarita-Osorio N, McCracken LM, Luciano JV. A randomized controlled efficacy trial of mindfulness-based stress reduction compared with an active control group and usual care for fibromyalgia: the EUDAIMON study. Pain. 2019 Nov;160(11):2508-2523. doi: 10.1097/j.pain.0000000000001655.

  PMID: 31356450 DERIVED

• Feliu-Soler A, Borras X, Penarrubia-Maria MT, Rozadilla-Sacanell A, D'Amico F, Moss-Morris R, Howard MA, Fayed N, Soriano-Mas C, Puebla-Guedea M, Serrano-Blanco A, Perez-Aranda A, Tuccillo R, Luciano JV. Cost-utility and biological underpinnings of Mindfulness-Based Stress Reduction (MBSR) versus a psychoeducational programme (FibroQoL) for fibromyalgia: a 12-month randomised controlled trial (EUDAIMON study). BMC Complement Altern Med. 2016 Feb 27;16:81. doi: 10.1186/s12906-016-1068-2.

  PMID: 26921267 DERIVED

MeSH Terms

Conditions

Fibromyalgia

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Neuromuscular Diseases; Nervous System Diseases

Study Officials

• Juan V. Luciano, PhD

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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD

Study Record Dates

• First Submitted: September 23, 2015
• First Posted: September 28, 2015
• Study Start: January 1, 2016
• Primary Completion: June 30, 2018
• Study Completion: December 31, 2018
• Last Updated: October 14, 2019

Record last verified: 2019-10

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)