Effectiveness of a Multicomponent Program for Fibromyalgia Patients in a Primary Care Setting (FIBROCARE Program): A Pragmatic Randomized Controlled Trial.

: Multicomponent, non-pharmacological therapies are the preferred first-line treatments for fibromyalgia (FM), but little is known about them in primary care settings. Our study assessed the effectiveness of the FIBROCARE Program in improving the quality of life, functional impact, mood, and pain of people with FM. : We conducted a pragmatic, randomized controlled trial that was not blinded for both patients and the professionals delivering the treatments in the study groups. We compared a group receiving non-pharmacological multicomponent group therapy (MT) based on health education, physical exercise, and cognitive-behavioral therapy with another group receiving the usual clinical care. The MT group was treated in the primary care context in Catalonia (Spain) through 12 consecutive weekly sessions. Both groups were followed up with at the end of the MT group sessions and 6 and 12 months after the group sessions with the Short-Form 36 (SF-36) v2 Health Survey questionnaire, the Hospital Anxiety and Depression Scale (HADS-A and HADS-D), the Visual Analog Scale, and the Revised Fibromyalgia Impact Questionnaire (ClinicalTrials.gov: NCT04049006). : Improvements in pain intensity, functional impact, physical health, fatigue, and emotional problems that affect daily activities in the MT group lasted up to 12 months. Benefits measured by the SF-36 Mental Health dimension and the HADS-A subscale were lost after 6 months. Effects on the SF-36 Social Functioning dimension and HADS-D present at 6 months persisted for up to 12 months. Generally, the longer the time since the FM diagnosis, the better was a patient's mood. : The FIBROCARE Program effectively improves all the studied health outcomes except patient mood, since anxiety symptoms persist. The program should reinforce patient psychological support overall, focusing particularly on the years initially after diagnosis.