Cost-utility and Biological Underpinnings of MBSR in Fibromyalgia Syndrome

Fibromyalgia Syndrome Clinical Trial

— EUDAIMON  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02561416
• Other study ID #: CP14/00087
• Secondary ID: PI15/00383
• Status: Completed
• Phase: Phase 3
• Start date: January 1, 2016
• Est. completion date: December 31, 2018

Study information

• Verified date: October 2019
• Source: Fundació Sant Joan de Déu
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 225
• Est. completion date: December 31, 2018
• Est. primary completion date: June 30, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Fibromyalgia
• Fibromyalgia Syndrome
• Myofascial Pain Syndromes
• Syndrome

Intervention

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
• 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.

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.

Locations

Country	Name	City	State
Spain	Teaching, Research & Innovation Unit - Parc Sanitari Sant Joan de Déu	Sant Boi de Llobregat	Barcelona

Sponsors (4)

Lead Sponsor	Collaborator
Fundació Sant Joan de Déu	Carlos III Health Institute, Parc Sanitari Sant Joan de Déu, Preventive Services and Health Promotion Research Network

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Five Facets Mindfulness Questionnaire (FFMQ)	Process variable	Baseline, 2-month & 12-month follow-up
Other	Self-Compassion Scale (SCS-12)	Process variable	Baseline, 2-month & 12-month follow-up
Other	Psychological Inflexibility in Pain Scale (PIPS)	Process variable	Baseline, 2-month & 12-month follow-up
Other	Checklist - Adverse events of the interventions	Control variable	2-month
Other	Credibility/Expectancy Questionnaire (CEQ)	Control variable	Baseline (MBSR & FibroQol groups)
Other	Mini-Mental State Examination (MMSE)	Screening measure	Baseline
Other	Structured Clinical Interview for DSM Axis I Disorders (SCID-I)	Screening measure	Baseline
Primary	Effectiveness Evaluation: Revised Fibromyalgia Impact Questionnaire (FIQR)		Change from baseline scores at 12 months
Primary	Cost-utility: Client Service Receipt Inventory (CSRI)		Change from baseline scores at 12 months
Primary	Inflammatory markers: pro- and anti-inflammatory cytokines & hs-CRP		Change from baseline values at 2 months
Primary	EuroQoL questionnaire (EQ-5D-5L)		Change from baseline scores at 12 months
Primary	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
Primary	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	Hamilton Anxiety and Depression Scale (HADS)		Baseline, 2-month & 12-month follow-up
Secondary	Perceived Stress Scale (PSS-10)		Baseline, 2-month & 12-month follow-up
Secondary	Multidimensional Inventory of Subjective Cognitive Impairment (MISCI)		Baseline, 2-month & 12-month follow-up
Secondary	Pain Catastrophising Scale (PCS)		Baseline, 2-month & 12-month follow-up
Secondary	Fibromyalgia Survey Diagnostic Criteria (FSDC)		Baseline, 2-month & 12-month follow-up

External Links

•   Juan V. Luciano - profile in Researchgate