An internet-based cognitive behavioral therapy (iCBT) program significantly reduced depressive symptoms in individuals with multiple sclerosis (MS) compared with care as usual, results from a multisite, phase 3, randomized trial show.
Between May 2017 and November 2020, investigators enrolled 279 participants in a randomized, controlled, phase 3 trial at five sites within the United States and Germany to reduce depressive symptoms in people with multiple sclerosis (MS) using the Amiria iCBT program.
The iCBT program used a simulated dialogue approach to lead users through a path consisting of 10 modules, including psychoeducation, behavioral activation, cognitive modification, mindfulness, and positive psychology, for instance.
The primary endpoint was severity of depressive symptoms as measured by the Beck Depression Inventory-II (BDI-II) at week 12 after randomization.
Among participants with MS, 101 were randomly assigned to receive stand-alone iCBT, 85 received guided iCBT, and 93 participants in the control group received treatment as usual.
The stand-alone form of the iCBT program significantly reduced depressive symptoms as measured by the BDI-II as compared with those in the control group: the difference was 6.32 points (95% CI, 3.37 – 9.27; P < .0001); effect size d = 0.97 (95% CI, 0.64 – 1.30).
The guided form of the iCBT program also significantly reduced depressive symptoms as measured by the BDI-II as compared with care as usual: the difference was 5.80 points (95% CI, 2.71 – 8.88]; P < .0001); effect size d = 0.96 (95% CI, 0.62 – 1.30).
Clinically relevant worsening was observed in three participants in the control group, one in the stand-alone iCBT group, and none in the guided iCBT group.
“This trial provides evidence for safety and efficacy of this multiple sclerosis-specific online tool as a stand-alone or guided application to reduce depressive symptoms in multiple sclerosis over a 12-week period. This remote-access, scalable intervention increases the therapeutic options in this patient group and could help to overcome treatment barriers,” the investigators write.
Stefan M Gold, PhD, of the Charité–Berlin University of Medicine in Berlin, Germany, led the study, which was published online September 27 in Lancet Digital Health. The study was funded by the National Multiple Sclerosis Society.
Investigators were unable to reach the planned sample size of 375 participants at least in part due to the difficulties associated with recruitment during the COVID-19 pandemic.
Gold reports receiving honoraria from Hexal and research grants from Biogen, the German Ministry for Education and Research, the German Ministry of Health, Deutsche Forschungsgemeinschaft, and the National Multiple Sclerosis Society (NMSS). Full disclosures in article.
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