Fibromyalgia SyndromePhase 3EUDAIMONNCT02561416

Cost-utility and Biological Underpinnings of MBSR in Fibromyalgia Syndrome

A Phase 3 study testing MBSR, FibroQol and TAU in people with Fibromyalgia Syndrome, run by Fundació Sant Joan de Déu at 1 site in Spain.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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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. Read more about this study

Who is it for?: Ages 18 to 65 years
Conditions the study is for: Fibromyalgia Syndrome
What is being tested?: MBSR, FibroQol and TAU
Type of treatment: Injection or infusion, Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 225 participants
Where: 1 siteSpain
Study dates: 1 Jan 2016to 31 Dec 2018
Phase: Phase 3
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 65 years
All sexes
No healthy volunteers
Adult, Older adult

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.

Trial locations and contacts

1 site in 1 country.

Spain1 site

Teaching, Research & Innovation Unit - Parc Sanitari Sant Joan de Déu
Sant Boi de Llobregat, Barcelona, 08830

Other trials in Spain

About this study

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

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:

TAU + MBSR,
TAU + FibroQoL and
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.

Read the 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

Conditions: Fibromyalgia Syndrome
Being tested: MBSR, FibroQol, TAU
Keywords: Fibromyalgia syndrome, Mindfulness (MBSR), Neuroimaging, Cytokines, Randomized Controlled Trial, Cost-effectiveness, Psychoeducation (FibroQol)
Medical subject headings: Fibromyalgia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

MBSRBehavioural
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
FibroQolBehavioural
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.
TAUDrug
Also called Usual care
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.

Study groups in NCT02561416
Study group	Role	What they receive
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. Receives: 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). Receives: Behavioral: FibroQol; Drug: TAU
Treatment As Usual	Other	Treatment As Usual. Receives: Drug: TAU

What is being measured

The primary outcome is the main question the study is designed to answer.

Effectiveness Evaluation: Revised Fibromyalgia Impact Questionnaire (FIQR)
Measured: Change from baseline scores at 12 months
Cost-utility: Client Service Receipt Inventory (CSRI)
Measured: Change from baseline scores at 12 months
Inflammatory markers: pro- and anti-inflammatory cytokines & hs-CRP
Measured: Change from baseline values at 2 months
EuroQoL questionnaire (EQ-5D-5L)
Measured: 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.
Measured: 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.
Measured: Change from baseline regional cerebral blood flow at 2 months

Secondary outcomes (5)

Hamilton Anxiety and Depression Scale (HADS)
Measured: Baseline, 2-month & 12-month follow-up
Perceived Stress Scale (PSS-10)
Measured: Baseline, 2-month & 12-month follow-up
Multidimensional Inventory of Subjective Cognitive Impairment (MISCI)
Measured: Baseline, 2-month & 12-month follow-up
Pain Catastrophising Scale (PCS)
Measured: Baseline, 2-month & 12-month follow-up
Fibromyalgia Survey Diagnostic Criteria (FSDC)
Measured: Baseline, 2-month & 12-month follow-up

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Jan 201631 Dec 2018

First posted28 Sep 2015 (estimated)
Study start1 Jan 2016
Primary completion30 Jun 2018
Study completion31 Dec 2018

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (3)Papers the sponsor has linked to this study.
Other trials for Fibromyalgia SyndromeStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Investigator, Outcomes assessor
Enrolment: 225 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02561416
Sponsor's protocol ID: CP14/00087
Other IDs: PI15/00383
Acronym: EUDAIMON
Status last verified: Oct 2019
First submitted: 23 Sep 2015
Last updated: 14 Oct 2019
Results posted: No
Data monitoring committee: No
Individual data sharing: No

Publications

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.
PubMed 35222735
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.
PubMed 31356450
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.
PubMed 26921267

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Objective Measurement of Pain Regulation in Individuals Who Have Received Internet-delivered Exposure-based Cognitive Behavior Therapy
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Exercise Interventions and Dietary Advice in Fibromyalgia and IBS
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All Fibromyalgia Syndrome trials

Study at a glance

From the registry record, last updated by the sponsor on 14 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Cost-utility and Biological Underpinnings of Mindfulness-Based Stress Reduction (MBSR) in Fibromyalgia Syndrome: A Three-arm Randomized, Controlled Trial (EUDAIMON Project)
ClinicalTrials.gov ID: NCT02561416
Acronym / sponsor ID: EUDAIMON / CP14/00087
Conditions: Fibromyalgia Syndrome
Keywords: Fibromyalgia syndrome, Mindfulness (MBSR), Neuroimaging, Cytokines, Randomized Controlled Trial, Cost-effectiveness, Psychoeducation (FibroQol)
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 225 participants (actual)
Lead sponsor: Fundació Sant Joan de DéuUniversity, hospital or other
Collaborators: Carlos III Health Institute, Preventive Services and Health Promotion Research Network, Parc Sanitari Sant Joan de Déu
Study start: 1 Jan 2016 (actual)
Primary completion: 30 Jun 2018 (actual)
Study completion: 31 Dec 2018 (actual)
First posted: 28 Sep 2015 (estimated)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Purpose:

Methods:

Design: RCT with three arms:

TAU + MBSR,
TAU + FibroQoL and
TAU.

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

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (investigator, outcomes assessor)
Number of arms: 3

Arm	Type	Receives
Mindfulness-Based Stress Reduction	Experimental	Behavioral: MBSR, Drug: TAUMindfulness-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.
Psycho-educational Program	Active comparator	Behavioral: FibroQol, Drug: TAUPsycho-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).
Treatment As Usual	Other	Drug: TAUTreatment As Usual.

Who may qualify

Ages: 18 to 65 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
MBSRSession 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	Behavioural	Mindfulness-Based Stress Reduction
FibroQolSession 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.	Behavioural	Psycho-educational Program
TAUAlso: Usual careIn 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.	Drug	Mindfulness-Based Stress Reduction, Psycho-educational Program, Treatment As Usual

Primary outcome

Effectiveness Evaluation: Revised Fibromyalgia Impact Questionnaire (FIQR)
Time frame: Change from baseline scores at 12 months
Cost-utility: Client Service Receipt Inventory (CSRI)
Time frame: Change from baseline scores at 12 months
Inflammatory markers: pro- and anti-inflammatory cytokines & hs-CRP
Time frame: Change from baseline values at 2 months
EuroQoL questionnaire (EQ-5D-5L)
Time frame: Change from baseline scores at 12 months
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.
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.

5 secondary outcomes

Hamilton Anxiety and Depression Scale (HADS)
Time frame: Baseline, 2-month & 12-month follow-up
Perceived Stress Scale (PSS-10)
Time frame: Baseline, 2-month & 12-month follow-up
Multidimensional Inventory of Subjective Cognitive Impairment (MISCI)
Time frame: Baseline, 2-month & 12-month follow-up
Pain Catastrophising Scale (PCS)
Time frame: Baseline, 2-month & 12-month follow-up
Fibromyalgia Survey Diagnostic Criteria (FSDC)
Time frame: Baseline, 2-month & 12-month follow-up

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 14 Oct 2019.
Derived from this study: PubMed 35222735Medina 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.
Derived from this study: PubMed 31356450Perez-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.
Derived from this study: PubMed 26921267Feliu-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.
Individual participant dataSharing planned: No

Related trials for Fibromyalgia Syndrome

Active, not recruiting
Objective Measurement of Pain Regulation in Individuals Who Have Received Internet-delivered Exposure-based Cognitive Behavior Therapy
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Open-Label Safety Study of AXS-14 in Subjects With Fibromyalgia
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Juan V. Luciano, PhD principal investigator

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

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing MBSR, FibroQol and TAU in people with Fibromyalgia Syndrome, run by Fundació Sant Joan de Déu at 1 site in Spain.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 14 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Effectiveness Evaluation: Revised Fibromyalgia Impact Questionnaire (FIQR) (time frame: Change from baseline scores at 12 months). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02561416, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Oct 2019.