The clinical effects of digital cognitive behavioral therapy for insomnia in a heterogenous study sample: results from a randomized controlled trial

Abstract

Study Objectives Numerous studies worldwide have reported beneficial effects of digital cognitive behavioral therapy for insomnia (dCBT-I). However, few focus on real-world study samples that reflect people in regular care. To test whether dCBT-I is suitable within German regular care, we designed a randomized controlled trial recruiting a heterogenous insomnia population. Methods Participants aged 18+ who met the criteria for insomnia disorder were randomized to 8-weeks dCBT-I + care-as-usual (CAU) or they were set on a waitlist + CAU. The intervention group was followed up at six and 12-months. Primary outcome was self-reported insomnia severity, assessed with the Insomnia Severity Index (ISI) at eight-weeks post-randomization. A one-way ANCOVA with baseline score as covariate was fitted to determine group-differences. Secondary outcomes included measures on daytime functioning, quality of life, depression, anxiety, dreams, and nightmares. Results Of the N = 238 participants (67.6% female), age range 19 to 81 years, n = 118 were randomized to dCBT-I and n = 120 to the control group. At post-treatment, the use of dCBT-I was associated with a large reduction on the ISI (Diffadj = -7.60) in comparison to WLC (d = - 2.08). This clinical improvement was also reflected in responder and remission rates. Treatment effects were also observed for daytime functioning, quality of life, symptoms of depression and anxiety (ds = 0.26 - 1.02) and at long-term follow-up (intervention group only; ds = 0.18 – 1.65). No effects were found for dream and nightmare frequency. Conclusions This study showed that dCBT-I reduces insomnia symptoms and improves daytime functioning in a heterogenous insomnia population in Germany with sustained long-term treatment effects in the intervention group. Our results underscore the potential of digital health applications, their suitability within regular care, and their role in facilitating widespread implementation of CBT-I as first-line treatment for insomnia.