• Marta Alda, Juan V Luciano, Eva Andrés, Antoni Serrano-Blanco, Baltasar Rodero, Yolanda López del Hoyo, Miquel Roca, Sergio Moreno, Rosa Magallón, and Javier García-Campayo.
• Servicio de Psiquiatría, Hospital Miguel Servet y Universidad de Zaragoza, Instituto Aragonés de Ciencias de la Salud (I+CS), Red de Actividades Preventivas y de Promoción de la Salud (REDIAPP) (G06/170 and RD06/0018/0017), Avda Isabel La Catolica 1, 5009 Zaragoza, Spain.
• Arthritis Res. Ther. 2011 Jan 1;13(5):R173.

IntroductionNo randomised, controlled trials have been conducted to date on the efficacy of psychological and pharmacological treatments of pain catastrophising (PC) in patients with fibromyalgia. Our aim in this study was to assess the effectiveness of cognitive-behaviour therapy (CBT) and the recommended pharmacological treatment (RPT) compared with treatment as usual (TAU) at the primary care level for the treatment of PC in fibromyalgia patients.MethodsWe conducted a six-month, multicenter, randomized, blinded, parallel group, controlled trial in which patients were randomly assigned to one of three study arms: CBT (n = 57), RPT (n = 56) and TAU at the primary care level (n = 56). The major outcome of this study was PC in patients with fibromyalgia. The secondary variables were pain acceptance, depression, anxiety, pain, global function and quality of life.ResultsCBT significantly decreased global PC at the six-month follow-up examination with effect sizes of Cohen's d = 0.73 and 1.01 compared with RPT and TAU, respectively. CBT was also more effective than RPT and TAU at increasing pain acceptance at the six-month follow-up examination (effect sizes of Cohen's d = 0.77 and 0.80, respectively). Compared with RPT and TAU, CBT was more effective at improving global function based on the Fibromyalgia Impact Questionnaire (six-month effect sizes Cohen's d = 0.44 and 0.53, respectively) and quality of life based on the European Quality of Life Scale (six-month effect sizes Cohen's d = 0.11 and 0.40, respectively). There were no differences among the three treatments with regard to pain and depression.ConclusionsCBT shows higher efficacy than RPT and TAU not only in key outcomes in FM, such as function and quality of life, but also in relevant mediators of treatment effects, such as pain catastrophising and pain acceptance.Trial RegistrationISRCTN: ISRCTN10804772.

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