Cost-utility and Biological Underpinnings of MBSR in Fibromyalgia Syndrome

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

225 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-01-01

Study Completion Date

2018-12-31

Brief Summary

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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.

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Detailed Description

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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

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Fibromyalgia Syndrome

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

Study Groups

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Mindfulness-Based Stress Reduction

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.

Group Type EXPERIMENTAL

MBSR

Intervention Type 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

TAU

Intervention Type 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.

Psycho-educational Program

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).

Group Type ACTIVE_COMPARATOR

FibroQol

Intervention Type 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.

TAU

Intervention Type 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.

Treatment As Usual

Treatment As Usual.

Group Type OTHER

TAU

Intervention Type 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.

Interventions

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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

Intervention Type 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.

Intervention Type BEHAVIORAL

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.

Intervention Type DRUG

Other Intervention Names

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Usual care

Eligibility Criteria

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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.

* Female gender
* Right-handed

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.

* 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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No