Cost-utility and Biological Underpinnings of MBSR in Fibromyalgia Syndrome
Status:
Completed
Trial end date:
2018-12-31
Target enrollment:
Participant gender:
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.
Phase:
Phase 3
Details
Lead Sponsor:
Fundació Sant Joan de Déu
Collaborators:
Carlos III Health Institute Parc Sanitari Sant Joan de Déu Preventive Services and Health Promotion Research Network