Cost–Utility of Mindfulness-Based Stress Reduction for Fibromyalgia versus a Multicomponent Intervention and Usual Care: A 12-Month Randomized Controlled Trial (EUDAIMON Study)

Abstract

Fibromyalgia (FM) is a prevalent, chronic, disabling, pain syndrome that implies high healthcare costs. Economic evaluations of potentially effective treatments for FM are needed. The aim of this study was to analyze the cost–utility of Mindfulness-Based Stress Reduction (MBSR) as an add-on to treatment-as-usual (TAU) for patients with FM compared to an adjuvant multicomponent intervention (“FibroQoL”) and to TAU. We performed an economic evaluation alongside a 12 month, randomized, controlled trial; data from 204 (68 per study arm) of the 225 patients (90.1%) were included in the cost–utility analyses, which were conducted both under the government and the public healthcare system perspectives. The main outcome measures were the EuroQol (EQ-5D-5L) for assessing Quality-Adjusted Life Years (QALYs) and improvements in health-related quality of life, and the Client Service Receipt Inventory (CSRI) for estimating direct and indirect costs. Incremental cost-effectiveness ratios (ICERs) were also calculated. Two sensitivity analyses (intention-to-treat, ITT, and per protocol, PPA) were conducted. The results indicated that MBSR achieved a significant reduction in costs compared to the other study arms (p < 0.05 in the completers sample), especially in terms of indirect costs and primary healthcare services. It also produced a significant incremental effect compared to TAU in the ITT sample (ΔQALYs = 0.053, p < 0.05, where QALYs represents quality-adjusted life years). Overall, our findings support the efficiency of MBSR over FibroQoL and TAU specifically within a Spanish public healthcare context.

Effectiveness of a Multicomponent Treatment for Fibromyalgia Based on Pain Neuroscience Education, Exercise Therapy, Psychological Support, and Nature Exposure (NAT-FM): A Pragmatic Randomized Controlled Trial

“…To our knowledge, this is also the first study to demonstrate the effectiveness of a multicomponent treatment that specifically integrates nature exposure in patients with FM. There are a number of studies supporting the effectiveness of each or a combination of two or more components of the intervention that constitute this multicomponent approach [ 19 , 20 , 21 , 22 , 23 , 24 , 25 , 26 , 29 , 30 , 31 , 32 , 33 , 34 , 36 ]. Although integrating the different therapeutic interventions was a complex process, the TAU + NAT-FM approach was designed with a clear and replicable methodology [ 27 , 28 , 36 ] and it is based on an empirically validated framework.…”

“…Use of the following therapeutic components have received empirical support and are considered to be optimal elements in multicomponent interventional packages: pain neuroscience education (PNE), exercise therapy (ET), cognitive behavioral therapy (CBT), and mindfulness training (MT) [ 20 , 21 , 22 , 23 , 24 , 25 , 26 , 27 ]. A recent randomized controlled trial (RCT) [ 27 ], which integrated, for the first time, the aforementioned four therapeutic approaches, PNE, ET, CBT and MT, found moderate to large effect sizes in the improvement of the core FM symptoms.…”

Mindfulness-based interventions: an overall review

“… 92 However, more studies are needed to confirm their cost-effectiveness. Preliminary evidence support its cost-effectiveness, 93 including but not limited to pain in breast cancer, 94 fibromyalgia, 95 low back pain 96 and caregiver training. 97 It is also a cost-saving treatment for improving quality of life for distressed cancer patients using both online or face-to-face MBCT.…”

Efficacy of the FIBROWALK Multicomponent Program Moved to a Virtual Setting for Patients with Fibromyalgia during the COVID-19 Pandemic: A Proof-of-Concept RCT Performed Alongside the State of Alarm in Spain

“…Current therapeutic strategies in FM usually combine pharmacological and non-pharmacological approaches [ 10 , 11 , 12 , 13 ], and multicomponent non-pharmacological treatments are currently considered the gold standard [ 12 , 14 , 15 , 16 , 17 ]. Regarding therapy components proved to be effective in FM, Pain Neuroscience Education (PNE) [ 18 , 19 , 20 , 21 , 22 , 23 , 24 , 25 , 26 , 27 , 28 ] is aimed at changing patients’ pain beliefs, emphasizing how overprotective behaviors can modulate pain experience [ 29 , 30 , 31 ], and it has been found to be effective for reducing pain disability, catastrophizing, avoidance behaviors and physical inactivity in patients with FM [ 32 ].…”

“…On the other hand, Cognitive Behavioral Therapy (CBT) and therapeutic exercise are also core pillars of intervention in FM [ 33 , 34 , 35 ], and combining both has been seen to be particularly effective at treating several FM symptoms [ 36 , 37 , 38 ] (e.g., relieving pain, fatigue, depression, and improving psychological well-being and physical functioning [ 12 , 33 ]). Furthermore, mindfulness training [ 39 ] has also been found to be an efficacious and cost-effective treatment for improving functional impairment, anxiety, depression, and quality of life in patients with FM [ 13 , 37 ]. The FIBROWALK program is an evidence-based multicomponent strategy based on the combination of the aforementioned therapeutic components with positive results in two recent RCTs in FM [ 40 , 41 ].…”