http://annals.org/ en-us Tue, 19 Apr 2011 00:00:00 GMT Tue, 09 Apr 2013 13:46:45 GMT Silverchair editor@annals.org webmaster@annals.org http://annals.org/article.aspx?articleID=746843 Tue, 19 Apr 2011 00:00:00 GMT Engel CC. <span class="paragraphSection"><div class="boxTitle">Question</div>Does tailored cognitive-behavioral therapy (CBT) plus exercise training (ET) improve physical and psychological outcomes in high-risk patients with fibromyalgia?<div class="boxTitle">Methods</div><div class="boxTitle">Design</div>Cluster randomized controlled trial. ClinicalTrials.gov NCT00268606.<div class="boxTitle">Allocation</div>Not concealed.*<div class="boxTitle">Blinding</div>Unblinded.*<div class="boxTitle">Follow-up period</div>6 months.<div class="boxTitle">Setting</div>6 hospitals in the area of Nijmegen, The Netherlands.<div class="boxTitle">Patients</div>158 patients ≥ 18 years of age (mean age 41 y, 94% women) who were diagnosed with fibromyalgia in the past 5 years and had high levels of distress (negative mood and/or anxiety) and dysfunction (pain, fatigue, functional disability, and effect on daily living). Exclusion criteria included severe physical or psychological comorbid conditions, current psychological treatments, fibromyalgia secondary to another rheumatic condition, and pregnancy.<div class="boxTitle">Intervention</div>CBT-ET, tailored to patients’ cognitive-behavioral pattern (pain persistence [PP] group, <span style="font-style:italic;">n</span> = 39; pain avoidance [PA] group, <span style="font-style:italic;">n</span> = 29) and given by cognitive-behavioral therapists and physiotherapists in 16 twice-weekly group sessions (CBT, 2 h, followed by ET, 2 h) with 1 booster session 3 months after treatment; or wait-list control (PP group, <span style="font-style:italic;">n</span> = 45; PA group, <span style="font-style:italic;">n</span> = 45).<div class="boxTitle">Outcomes</div>Physical functioning, including pain (Impact of Rheumatic Diseases on General Health and Lifestyle [IRGL] pain scale), fatigue (Checklist Individual Strength fatigue scale), and functional disability (IRGL mobility scale); and psychological functioning, including negative mood (IRGL negative mood scale), anxiety (IRGL anxiety scale), and effect on daily life (Fibromyalgia Impact Questionnaire).<div class="boxTitle">Patient follow-up</div>87% (intention-to-treat analysis).<div class="boxTitle">Main results</div>Tailored CBT-ET reduced pain, fatigue, functional disability, negative mood, anxiety, and effect on daily living more than a wait-list condition (Table). The effect of CBT-ET for reducing pain was greater in the PA than in the PP group (<span style="font-style:italic;">P</span> < 0.05 for interaction).<div class="boxTitle">Conclusion</div>Tailored cognitive-behavioral therapy and exercise training improved physical and psychological functioning in fibromyalgia.Tailored cognitive-behavioral therapy plus exercise training (CBT-ET) vs wait-list control (WLC) in high-risk patients with fibromyalgia†OutcomesMean effect size at 6 mo follow-up‡<span style="font-style:italic;">P</span> value§CBT-ETWLCPain (IRGL scale)0.950.06<0.001Fatigue (Checklist Individual Strength scale)1.430.16<0.001||Functional disability (IRGL mobility scale)1.360.28<0.001Negative mood (IRGL scale)0.780.15<0.001Anxiety (IRGL scale)0.930.210.001Impact on daily life (Fibromyalgia Impact Questionnaire)1.240.18<0.001†IRGL = Impact of Rheumatic Diseases on General Health and Lifestyle.‡Positive effect size indicates decreased symptoms.§For linear mixed-model analysis with posttreatment and 6-mo follow-up assessments as dependent variables.||Author confirmed for posttreatment and 6-mo follow-up.</span> http://annals.org/article.aspx?articleID=746843