Fibromyalgia is a debilitating pain condition for which treatment effects are typically modest. The most evaluated psychological treatment is traditional cognitive behavior therapy (T-CBT), but promising effects have recently been seen in exposure-based cognitive behavior therapy (Exp-CBT). We investigated whether Exp-CBT was superior to T-CBT in a randomized controlled trial. Self-referred participants with fibromyalgia (N = 274) were randomized (1:1) to 10 weeks of Exp-CBT or T-CBT. Treatments were delivered online and presented as "CBT for fibromyalgia." Participants were assessed at baseline, weekly during treatment, posttreatment, and at 6- and 12-month follow-up. Primary outcome was the difference in reduction in fibromyalgia severity as measured using the Fibromyalgia Impact Questionnaire (FIQ) over 11 assessment points from baseline to posttreatment, modelled within an intention-to-treat framework using linear mixed effects models fitted on multiple imputed data. Approximately 91% of weekly FIQ scores were collected over the main phase. There was no significant difference between Exp-CBT and T-CBT in the mean reduction of fibromyalgia severity from pretreatment to posttreatment (b = 1.3, 95% CI -3.0 to 5.7, P = 0.544, d = -0.10). Minimal clinically important improvement was seen 60% in Exp-CBT vs 59% in T-CBT. Effects were sustained up to 12 months posttreatment. This well-powered randomized trial indicated that Exp-CBT was not superior to T-CBT for fibromyalgia. Both treatments were associated with a marked reduction in fibromyalgia severity, and the online treatment format might be of high clinical utility. T-CBT can still be regarded a reference standard treatment that remains clinically relevant when compared to novel treatment approaches.
Although this study did not show any differences, it is an important subject to be tested so we can adequately inform our patients.
This study has no placebo treatment arm, making it a priori poor. The patient selection was biased, selected by advertisement, etc and self-referred; diagnosis 'by physician' is not reliable, not confirmed (e.g., by ACR criteria). No data on concurrent medication given (opioids?); the large effect in both groups is remarkable and makes this reviewer uneasy. In this setting, I cannot make conclusions about the difference between groups either.
This is a worthwhile confirmation of a significant benefit. There is good evidence that benefit is a function of the basic treatment protocol.