Objective: The treatment of patients with fibromyalgia (FM), a high-prevalence chronic pain condition with a high impact on both patients and society, poses a great challenge to clinicians due to a lack of effective treatments. In view of the large individual variability in outcome, selecting patients at risk of long-term dysfunction and offering tailored treatment may be promising for beneficial treatment effects.
Methods: High-risk patients were selected and classified into 2 groups (pain-persistence and pain-avoidance groups) and subsequently randomized in groups to either a treatment condition (TC) or a waiting list control condition (WLC). Treatment consisted of 16 sessions of cognitive-behavioral therapy (CBT) and exercise training in groups, tailored to the patient's specific cognitive-behavioral pattern, delivered within 10 weeks. Physical and psychological functioning and impact of FM were assessed at baseline, posttreatment, and 6-month followup. Treatment effects were evaluated using a linear mixed model.
Results: The treatment effects were significant for all primary outcomes, showing significant differences in physical (pain, fatigue, and functional disability) and psychological (negative mood and anxiety) functioning, and impact of FM for the TC in comparison with the WLC. Effect sizes in the TC were overall large, and reliable change indices indicated a clinically relevant improvement among the TC.
Conclusion: The presented results demonstrate for the first time that tailored CBT and exercise training for high-risk patients with FM is effective in improving short- and long-term physical and psychological functioning, indicating that tailoring treatment is likely to promote beneficial outcomes in FM and reduce the burden for patients and society.
Trial registration: ClinicalTrials.gov NCT00268606.