Mindfulness-based and acceptance-based interventions and physical activity in the management of fibromyalgia - evaluation of a multicomponent rehabilitation programme

Background: Fibromyalgia (FM) is a heterogeneous and complex musculoskeletal pain disorder characterised by multiple symptoms. The often unpredictable remission and recurrence of FM symptoms further impair social and physical function and reduce overall quality of life. No curative treatment is available for FM, and pharmacological treatment is inadequate. In Norway, treatment is usually limited to general practitioner (GP) consultations and physiotherapy. Traditionally, health care services have been based on a biomedical approach focusing on pathogenesis, diagnosis, and treatment of diseases. This approach is less likely to benefit patients with FM who have complex symptoms and no effective treatments to access. This condition calls for a broader perspective on health and more holistic management approaches. For optimal management, the European League Against Rheumatism (EULAR) has developed evidence-based recommendations including prompt diagnosis and patient education as first-line treatment. Furthermore, nonpharmacological treatment, such as physical exercise and psychological interventions, should be initiated with the aim of improving patient quality of life. According to Norwegian health authorities, FM treatment is to be provided at the primary care level. However, the treatment modalities described in the EULAR recommendations are available in Norwegian primary health care only to a limited degree. Aims: The main aim of this thesis was to evaluate the effects of a multicomponent rehabilitation programme combining two nonpharmacological treatment modalities for patients with newly diagnosed FM delivered in primary health care. The specific objectives were 1) to analyse the health effects of mindfulness- and acceptance-based interventions for patients with FM, with an exploration of the content and delivery components in the interventions; 2) to design and implement a randomised controlled trial and to evaluate health effects of a Norwegian mindfulness- and acceptance-based intervention followed by physical activity; and 3) to identify groups of patients with different symptom severity trajectories and to explore differences in baseline characteristics among these groups. Materials and methods: This thesis comprises a systematic review with meta-analyses, a randomised controlled trial (RCT), and an observational exploratory study. The systematic review included RCTs investigating the effects of mindfulness- and acceptance-based interventions for patients with FM. Furthermore, the Template for Intervention Description and Replication checklist was used to specifically extract, describe, and explore the reported content and delivery components in each study’s intervention. In the RCT, eligible patients were invited to a 3-hour FM patient education programme before randomisation. A multicomponent programme, including a 10-session mindfulness- and acceptance-based group programme followed by 12 weeks of physical activity, was evaluated in comparison to a control group that received treatment as usual, i.e., no treatment or any other treatment of their choice. We collected data using patient-reported questionnaires, with the Patient Global Impression of Change (PGIC) as the primary outcome measure. Secondary outcomes evaluated at the 12-month follow-up were pain, fatigue, sleep quality, psychological distress, physical activity, health-related quality of life, motivation for and barriers to physical activity, mindfulness, and work ability. In the observational exploratory study, to identify groups of patients with different symptom severity trajectories, we evaluated Polysymptomatic Distress Scale (PDS) scores using latent class growth analysis. The study participants were those included in the RCT. We also explored differences in baseline characteristics between groups with different trajectories. Results: The systematic review included nine RCTs and 750 patients with FM. The metaanalyses, giving standardised mean differences (SMDs) with 95% confidence intervals (CIs), showed small to moderate effects in favour of mindfulness- and acceptance-based interventions at the end of treatment for pain (SMD -0.46 [95% CI -0.75, -0.17]), depression (SMD -0.49 [95% CI -0.85, -0.12]), anxiety (SMD -0.37 [95% CI -0.71, -0.02]), sleep quality (SMD -0.33 [95% CI -0.70, 0.04]), health-related quality of life (SMD -0.74 [95% CI -2.02, 0.54]), and mindfulness (SMD -0.40 [95% CI -0.69, -0.11]). At follow-up, all effect sizes decreased except for anxiety, for which there was a small increase in effect size. We graded the certainty of evidence as very low to moderate. The included studies reported and assessed adherence and fidelity differently. In the RCT, 170 patients were randomised, 85 to the intervention group and 85 to the control group. Our main analysis was the dichotomised PGIC, and we found no statistically significant differences between the intervention and control groups at the 3- and 12-month follow-ups. Additional analyses of the distribution of PGIC showed statistically significant differences between groups in favour of the intervention group at the 3-month follow-up (p=0.01) but not at the 12-month follow-up (p=0.06). For secondary outcomes, we found no statistically significant differences between the groups at the 12-month follow-up, except for a tendency to be mindful (p=0.016) and perception of the benefits of exercise (p=0.033) in favour of the intervention group. We intended to capture patients with FM at an early stage of their disease, but the included patients reported a median symptom duration of 8 years. In the observational study, we identified two distinct groups of PDS trajectories: one group defined by having no improvement and another defined by having some improvement. The analyses showed no statistically significant differences in baseline characteristics between these two groups. Conclusion: In the systematic review, we found overall small to moderate uncertain effects of mindfulness- and acceptance-based interventions for patients with FM. The RCT demonstrated no enhanced benefit over treatment as usual with the addition of a multicomponent rehabilitation programme that added a mindfulness- and acceptance-based intervention followed by physical activity to patient education. In the observational exploratory study, analyses identified two groups of FM trajectories, one group that improved slightly and one group that experienced no improvements, but the two groups did not differ in baseline characteristics