Ope, USA and Canada. There is currently no cure for FMS nor is there a “gold standard” of treatment. Management of this disorder is therefore aimed at reducing symptoms and maintaining optimal functioning [7,8]. Interventions such as medication alone or the use of a single non-pharmacological treatment produce, at best, modest effects on patients’ condition [9,10]. Results of a meta-analysis of 49 studies published 15 years ago [11] suggest that non-pharmacological treatments are more effective than drug interventions. A recent meta-analysis of 23 studies assessing the efficacy of psychological interventions for fibromyalgia showed small to medium positive effects on short and long-term pain, quality of sleep, functional status, depression, and tendency to catastrophize in the face of pain [12]. Other recent literature reviews on the use of patient education, exercise activities, cognitive behavioural therapy (CBT), and multidisciplinary treatment [13?6] suggest that a multimodal approach which combines at least one educational/ psychological intervention with at least one exercise treatment can be effective for improving FMS symptoms including pain, fatigue, mood and/or quality of life (QOL). However, many of the reviewed studies suffer from methodological deficiencies (e.g., small sample size, single site study, unstandardized outcomes, short follow-up, etc), and well-designed trials are still needed. Based on the Interactional School of Low Back Pain [17,18], Barcellos de Souza et al. [19] developed in 2007 a multimodal group intervention–the Interactional School of Fibromyalgia (ISF)–which combines exercise therapy and educational/psychological tools for self-management of FMS. Patient empowerment is an integral component of the intervention as is active patient participation. The authors [19] conducted a randomized controlled trial (RCT) to assess the efficacy of their intervention and found positive effects on pain intensity and perceivedPLOS ONE | DOI:10.1371/journal.pone.0126324 May 15,2 /Multicomponent Group Intervention for Self-Management of Fibromyalgiaoverall capacity to manage FMS symptoms. Although promising, these results remain preliminary and need to be replicated in a RCT involving more than one site, and using a comprehensive set of well-validated outcome measures such as those recommended by the IMMPACT (Initiative on Methods, Measurement, and Pain Assessment in Clinical Trials) Group [20?2]. Furthermore, adding a qualitative research component to the study would be an asset to further capture the patients’ experience during the intervention. Finally, some aspects of the ISF needed to be Trichostatin A chemical information updated and somewhat reorganized. We therefore adapted the ISF into a more structured intervention program entitled PASSAGE whose French acronym is Programme d’Apprentissage de Strat ieS ACY 241 site d’Auto-Gestion Efficaces (Training Program of Efficient SelfManagement Strategies). The aim of the present study was thus to evaluate, quantitatively and qualitatively, the efficacy of the PASSAGE Program–a multicomponent interdisciplinary group intervention for the self-management of FMS. It was expected that the Program will lead to improvements in the clinical condition of patients suffering from this disorder.MethodsThe French version protocol for this trial (as well as the English translation of the Methods section) and supporting CONSORT checklist are available as supporting information; see S1 CONSORT Checklist, S1 and S2 Protocols.Ethics.Ope, USA and Canada. There is currently no cure for FMS nor is there a “gold standard” of treatment. Management of this disorder is therefore aimed at reducing symptoms and maintaining optimal functioning [7,8]. Interventions such as medication alone or the use of a single non-pharmacological treatment produce, at best, modest effects on patients’ condition [9,10]. Results of a meta-analysis of 49 studies published 15 years ago [11] suggest that non-pharmacological treatments are more effective than drug interventions. A recent meta-analysis of 23 studies assessing the efficacy of psychological interventions for fibromyalgia showed small to medium positive effects on short and long-term pain, quality of sleep, functional status, depression, and tendency to catastrophize in the face of pain [12]. Other recent literature reviews on the use of patient education, exercise activities, cognitive behavioural therapy (CBT), and multidisciplinary treatment [13?6] suggest that a multimodal approach which combines at least one educational/ psychological intervention with at least one exercise treatment can be effective for improving FMS symptoms including pain, fatigue, mood and/or quality of life (QOL). However, many of the reviewed studies suffer from methodological deficiencies (e.g., small sample size, single site study, unstandardized outcomes, short follow-up, etc), and well-designed trials are still needed. Based on the Interactional School of Low Back Pain [17,18], Barcellos de Souza et al. [19] developed in 2007 a multimodal group intervention–the Interactional School of Fibromyalgia (ISF)–which combines exercise therapy and educational/psychological tools for self-management of FMS. Patient empowerment is an integral component of the intervention as is active patient participation. The authors [19] conducted a randomized controlled trial (RCT) to assess the efficacy of their intervention and found positive effects on pain intensity and perceivedPLOS ONE | DOI:10.1371/journal.pone.0126324 May 15,2 /Multicomponent Group Intervention for Self-Management of Fibromyalgiaoverall capacity to manage FMS symptoms. Although promising, these results remain preliminary and need to be replicated in a RCT involving more than one site, and using a comprehensive set of well-validated outcome measures such as those recommended by the IMMPACT (Initiative on Methods, Measurement, and Pain Assessment in Clinical Trials) Group [20?2]. Furthermore, adding a qualitative research component to the study would be an asset to further capture the patients’ experience during the intervention. Finally, some aspects of the ISF needed to be updated and somewhat reorganized. We therefore adapted the ISF into a more structured intervention program entitled PASSAGE whose French acronym is Programme d’Apprentissage de Strat ieS d’Auto-Gestion Efficaces (Training Program of Efficient SelfManagement Strategies). The aim of the present study was thus to evaluate, quantitatively and qualitatively, the efficacy of the PASSAGE Program–a multicomponent interdisciplinary group intervention for the self-management of FMS. It was expected that the Program will lead to improvements in the clinical condition of patients suffering from this disorder.MethodsThe French version protocol for this trial (as well as the English translation of the Methods section) and supporting CONSORT checklist are available as supporting information; see S1 CONSORT Checklist, S1 and S2 Protocols.Ethics.