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 < 0.001). 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 to 12.5); 9 months: OR 5.4 (95% CI 2.3 to 12.8)), exercise (6 months OR 6.1 (95% CI 2.5 to 15.1); 9 months OR 3.6 (95% CI 1.5 to 8.5)), and combined intervention (6 months OR 7.1 (95% CI 2.9 to 17.2); 9 months OR 6.2 (95% CI 2.7 to 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: http://www.isrctn.com identifier ISRCTN67013851.

Full text (sometimes free) may be available at these link(s):      help

• DOI
• PubMed
• PDF locator
• publisher