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Randomized Controlled Trial
. 2012 Jan;64(1):297-305.
doi: 10.1002/art.30644.

Cognitive behavioral therapy for the treatment of juvenile fibromyalgia: a multisite, single-blind, randomized, controlled clinical trial

Susmita Kashikar-Zuck  1 , Tracy V Ting, Lesley M Arnold, Judy Bean, Scott W Powers, T Brent Graham, Murray H Passo, Kenneth N Schikler, Philip J Hashkes, Steven Spalding, Anne M Lynch-Jordan, Gerard Banez, Margaret M Richards, Daniel J Lovell
Affiliations
Randomized Controlled Trial

Cognitive behavioral therapy for the treatment of juvenile fibromyalgia: a multisite, single-blind, randomized, controlled clinical trial

Susmita Kashikar-Zuck et al. Arthritis Rheum. 2012 Jan.

Abstract

Objective: Juvenile fibromyalgia syndrome (FMS) is a chronic musculoskeletal pain disorder in children and adolescents for which there are no evidence-based treatments. The objective of this multisite, single-blind, randomized clinical trial was to test whether cognitive-behavioral therapy (CBT) was superior to fibromyalgia (FM) education in reducing functional disability, pain, and symptoms of depression in juvenile FMS.

Methods: Participants were 114 adolescents (ages 11-18 years) with juvenile FMS. After receiving stable medications for 8 weeks, patients were randomized to either CBT or FM education and received 8 weekly individual sessions with a therapist and 2 booster sessions. Assessments were conducted at baseline, immediately following the 8-week treatment phase, and at 6-month followup.

Results: The majority of patients (87.7%) completed the trial per protocol. Intent-to-treat analyses showed that patients in both groups had significant reductions in functional disability, pain, and symptoms of depression at the end of the study, and CBT was significantly superior to FM education in reducing the primary outcome of functional disability (mean baseline to end-of-treatment difference between groups 5.39 [95% confidence interval 1.57, 9.22]). Reduction in symptoms of depression was clinically significant for both groups, with mean scores in the range of normal/nondepressed by the end of the study. Reduction in pain was not clinically significant for either group (<30% decrease in pain). There were no study-related adverse events.

Conclusion: In this controlled trial, CBT was found to be a safe and effective treatment for reducing functional disability and symptoms of depression in adolescents with juvenile FMS.

Trial registration: ClinicalTrials.gov NCT00086047.

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Figures

Figure 1
Figure 1
Study flow diagram. † = reasons for dropout included time constraints, family reasons, loss to followup, and 1 psychiatric hospitalization for non-study-related reasons. * = 2 subjects were randomized to fibromyalgia education but dropped out before attending any sessions and were therefore excluded from intent-to-treat analyses.
Figure 2
Figure 2
Percentage improvement in group means of Functional Disability Inventory score over time. Tx = treatment.
See this image and copyright information in PMC

References

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