Clinical trial NCT02561416: Cost-utility and Biological Underpinnings of MBSR in Fibromyalgia Syndrome
Official title: Cost-utility and Biological Underpinnings of Mindfulness-Based Stress Reduction (MBSR) in Fibromyalgia Syndrome: A Three-arm Randomized, Controlled Trial (EUDAIMON Project)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Fibromyalgia Syndrome
Keywords: Fibromyalgia syndrome
Mindfulness (MBSR)
Neuroimaging
Cytokines
Randomized Controlled Trial
Cost-effectiveness
Psychoeducation (FibroQol)
Lead sponsor: Fundació Sant Joan de Déu
Sponsor class: OTHER
Collaborators: name: Carlos III Health Institute
name: Preventive Services and Health Promotion Research Network
name: Parc Sanitari Sant Joan de Déu
First posted: 2015-09-28
Enrollment: 225
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Eligibility 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.

Primary outcomes:
measure: Effectiveness Evaluation: Revised Fibromyalgia Impact Questionnaire (FIQR)
timeFrame: Change from baseline scores at 12 months
measure: Cost-utility: Client Service Receipt Inventory (CSRI)
timeFrame: Change from baseline scores at 12 months
measure: Inflammatory markers: pro- and anti-inflammatory cytokines & hs-CRP
timeFrame: Change from baseline values at 2 months
measure: EuroQoL questionnaire (EQ-5D-5L)
timeFrame: Change from baseline scores at 12 months
measure: Structural neuroimaging: Voxel-Based Morphometry (VBM)
timeFrame: Change from baseline brain gray matter concentration at 2 months
measure: Functional neuroimaging: pulsed continuous arterial spin labeling (pCASL)
timeFrame: Change from baseline regional cerebral blood flow at 2 months
Secondary outcomes:
measure: Hamilton Anxiety and Depression Scale (HADS)
timeFrame: Baseline, 2-month & 12-month follow-up
measure: Perceived Stress Scale (PSS-10)
timeFrame: Baseline, 2-month & 12-month follow-up
measure: Multidimensional Inventory of Subjective Cognitive Impairment (MISCI)
timeFrame: Baseline, 2-month & 12-month follow-up
measure: Pain Catastrophising Scale (PCS)
timeFrame: Baseline, 2-month & 12-month follow-up
measure: Fibromyalgia Survey Diagnostic Criteria (FSDC)
timeFrame: Baseline, 2-month & 12-month follow-up
Other outcomes:
measure: Five Facets Mindfulness Questionnaire (FFMQ)
timeFrame: Baseline, 2-month & 12-month follow-up
measure: Self-Compassion Scale (SCS-12)
timeFrame: Baseline, 2-month & 12-month follow-up
measure: Psychological Inflexibility in Pain Scale (PIPS)
timeFrame: Baseline, 2-month & 12-month follow-up
measure: Checklist - Adverse events of the interventions
timeFrame: 2-month
measure: Credibility/Expectancy Questionnaire (CEQ)
timeFrame: Baseline (MBSR & FibroQol groups)
measure: Mini-Mental State Examination (MMSE)
timeFrame: Baseline
measure: Structured Clinical Interview for DSM Axis I Disorders (SCID-I)
timeFrame: Baseline
Locations:
city: Sant Boi de Llobregat
country: Spain
facility: Teaching, Research & Innovation Unit - Parc Sanitari Sant Joan de Déu
state: Barcelona
Study officials:
affiliation: Teaching, Research & Innovation Unit - Parc Sanitari Sant Joan de Déu
name: Juan V. Luciano, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.