Improved management of patients with fibromyalgia: Implementation and evaluation of an integrated care model

INTERVENTION: Participants will be randomised one of two groups: Intervention group: Participants take part in a multicomponent rehabilitation programme in their home municipality. The programme comprises a 10‐session mindfulness‐based Vitality Training Programme (VTP) followed by 8 weeks tailored physical exercise supervised by a physiotherapist at a Healthy Life Center. Control group: Participants will receive treatment as usual in primary care, i.e. GP consultations and any physical activity as usual. They will be offered the VTP after completion of the last data collection, i.e. one year after inclusion. Participants in both groups are followed up at 4 months (end of VTP) and 12 months post‐randomisation. CONDITION: Fibromyalgia/widespread musculoskeletal pain ; Musculoskeletal Diseases ; Fibromyalgia/widespread musculoskeletal pain PRIMARY OUTCOME: Patient global impression of change (PGIC) measured by a 7‐point self‐reported Likert scale ranging from 1 (“I feel very much worse”) through 4 (“no change”) to 7 (“I feel very much better”) one year after inclusion. Scores of 6 and 7 are considered clinically relevant improvement. The primary outcome will be measured after completion of the VTP (4 months) and at 12 months follow‐up. SECONDARY OUTCOME: All outcomes will be measured at baseline (before randomisation), at 4 months and 12 months:; 1. Pain, measured by Numeric Rating Scale (NRS, 0‐10); 2. Fatigue, measured by Numeric Rating Scale (NRS, 0‐10); 3. Sleep quality, measured by Numeric Rating Scale (NRS, 0‐10); 4. Psychological distress, measured by General Health Questionnaire‐12 (GHQ‐12); 5. Physical activity, measured by 4 questions from the Norwegian HUNT‐study ; 6. Work ability, measured by the Work Productivity and Activity Impairment Questionnaire (WPAI) INCLUSION CRITERIA: 1. Rheumatologist confirmed diagnosis of fibromyalgia according to the American College of Rheumatology 2011 criteria 2. Aged between 20 and 50