Cognitive Behavior Therapy, Exercise, or Both for Treating Chronic Widespread Pain

BACKGROUND: The clinical impact of telephone-delivered cognitive behavioral therapy (TCBT), exercise, or a combined intervention in primary care patients with chronic widespread pain (CWP) is unclear. METHODS: A total of 442 patients with CWP (meeting the American College of Rheumatology criteria) were randomized to receive 6 months of TCBT, graded exercise, combined intervention, or treatment as usual (TAU). The primary outcome, using a 7-point patient global assessment scale of change in health since trial enrollment (range: very much worse to very much better), was assessed at baseline and 6 months (intervention end) and 9 months after randomization. A positive outcome was defined as "much better" or "very much better." Data were analyzed using logistic regression according to the intention-to-treat principle. RESULTS: The percentages reporting a positive outcome at 6 and 9 months, respectively, were TAU group, 8% and 8%; TCBT group, 30% and 33%; exercise group, 35% and 24%; and combined intervention group, 37% and 37% (P < .001). After adjustment for age, sex, center, and baseline predictors of outcome, active interventions improved outcome compared with TAU: TCBT (6 months: odds ratio OR, 5.0 95% CI, 2.0-12.5; 9 months: OR, 5.4 95% CI, 2.3-12.8), exercise (6 months: OR, 6.1 95% CI, 2.5-15.1; 9 months: OR, 3.6 95% CI, 1.5-8.5), and combined intervention (6 months: OR, 7.1 95% CI, 2.9-17.2; 9 months: OR, 6.2 95% CI, 2.7-14.4). At 6 and 9 months, combined intervention was associated with improvements in the 36-Item Short Form Health Questionnaire physical component score and a reduction in passive coping strategies. Conclusions on cost-effectiveness were sensitive to missing data. CONCLUSION: TCBT was associated with substantial, statistically significant, and sustained improvements in patient global assessment. TRIAL REGISTRATION: clinicaltrials.gov Identifier: ISRCTN67013851.