A randomized controlled trial of internet-based cognitive behavioral therapy for sleep disturbances in ICU survivors

Abstract

Objective To investigate the efficacy of Internet-based Cognitive Behavioral Therapy (ICBT) for sleep disturbances in patients discharged from the Intensive Care Unit (ICU). Methods A prospective, randomized controlled study was conducted, enrolling 120 patients with sleep disturbances who were transferred from the ICU to the general ward of our hospital between June 2025 and September 2025.Participants were randomly assigned to either an intervention group (n = 60) or a control group (n = 60). The control group received pharmacological treatment with eszopiclone and routine sleep hygiene education. The intervention group, in addition to pharmacotherapy, underwent a 3-month ICBT program. Assessments were performed at baseline (T0), at the end of the 3-month intervention (T1), and at the 1-month follow-up (T2; i.e., 4 months after baseline) using the Pittsburgh Sleep Quality Index (PSQI), Insomnia Severity Index (ISI), Hamilton Anxiety Rating Scale (HAMA), Hamilton Depression Rating Scale (HAMD), and the 36-Item Short Form Health Survey (SF-36). Results At T1 and T2, the intervention group showed significantly greater improvements in PSQI, ISI, HAMD, and SF-36 scores compared to the control group. The between-group difference in HAMA scores was significant at T2 but not at T1. The rate of medication reduction was significantly higher in the intervention group. Adherence was satisfactory, with the intervention group showing good completion rates for online modules and sleep diary submissions. The control group showed good acceptance of education and medication compliance. Exploratory analysis of sleep diary data from the intervention group showed significant within-group improvements in sleep efficiency, sleep onset latency, and wake after sleep onset over time. Conclusion ICBT was associated with significant improvements in sleep quality, depressive symptoms, and quality of life, with sustained benefits observed at follow-up. The between-group difference in anxiety symptoms was significant at follow-up but not immediately post-intervention. Trial Registration This trial was prospectively registered with the Chinese Clinical Trial Registry on 25 June 2025 (ChiCTR2500104904).