Can mindfulness have long-term impact on patients with fibromyalgia? A two-year prospective follow-up study of a mindfulness-based intervention.

To examine changes in symptoms and health status in patients with fibromyalgia (FM) 24 months after participating in the mindfulness-based group-program, the Vitality Training (VTP), followed by physical exercise counselling. Seventy-six participants, mean age (range) 43 (26-52), females 69 (91%), diagnosed with FM according to the ACR 2011-criteria received the VTP in a previous randomised controlled trial. Control group participants could receive the VTP after a 12-month observation period, therefore only data from the intervention group were analysed in the present study. Self-reported data were collected electronically at baseline, 3, 12 and 24 months. Outcomes were patient global impression of change (PGIC), FM-severity, i.e. widespread pain (WPI) and symptom severity (SSS), pain, fatigue, sleep quality, psychological distress, motivation and barriers for physical activity, mindfulness and work participation. Trends across time-points were analysed using mixed models for repeated measurements. At 24-months, 48 (56.5%) participants responded, 94% female, median (range) age 46 (28-54), symptom duration 12 (5-33) years. Seven participants reported much/very much better on the PGIC; 21 (44%) reported no change/minimal improvement. Improvements were observed in WPI (-1.9, ES 0.4), SSS (-1.2, ES 0.6), fatigue (-0.8, p =.014) and self-efficacy for physical activity (1.4, ES 0.4). There was a significant trend of reduced WPI, SSS, pain and fatigue across the four time-points, but no additional improvements from 12 to 24-month follow-up. Participants who had completed the VTP demonstrated small to moderate improvements in symptom burden and FM-severity from baseline to 24-month follow-up. Trial registration number: ISRCTN96836577 https://doi.org/10.1186/ISRCTN96836577 , prospectively registered 12.07.2016.