Effectiveness of Digital CBT-I for Insomnia in Primary Care: A Randomized Controlled Trial

Prof. Sophia Rodriguez; Dr. Michael Wong; Dr. Ahmed Fathi

Abstract

Background: Chronic insomnia is a prevalent and debilitating condition often managed suboptimally in primary care. Cognitive Behavioral Therapy for Insomnia (CBT-I) is the first-line treatment, but access to trained therapists is limited. Digital CBT-I (dCBT-I) offers an evidence-based, scalable alternative. This study evaluated the effectiveness of a dCBT-I program delivered in primary care settings compared to standard care for patients with chronic insomnia. Methods: A randomized controlled trial included 450 adult patients diagnosed with chronic insomnia from primary care clinics. The intervention group used a commercially available dCBT-I application for 8 weeks, while the control group received standard sleep hygiene advice. Primary outcomes included changes in insomnia severity index (ISI) and sleep efficiency. Results: The dCBT-I group showed significantly greater reductions in ISI scores (mean difference -7.2 points vs. -2.1 points in control, p<0.001) and improvements in sleep efficiency (+15% vs. +4% in control, p<0.001) at 8 weeks. Remission rates were also higher in the dCBT-I group. Conclusion: dCBT-I is a highly effective and accessible intervention for chronic insomnia in primary care, significantly improving sleep outcomes. Its integration into routine primary care can enhance patient access to evidence-based treatment and reduce the burden of insomnia.

Keywords: digital CBT-I, insomnia, primary care, sleep disorders, mHealth

Chronic insomnia affects a substantial portion of the global population, leading to significant impairments in quality of life, mental health, and physical well-being. Despite being the first-line recommended treatment, access to face-to-face Cognitive Behavioral Therapy for Insomnia (CBT-I) is limited by a shortage of trained therapists and geographical barriers. Digital CBT-I (dCBT-I) offers a scalable, accessible, and potentially cost-effective solution to deliver this effective therapy directly to patients within primary care settings, thus addressing the pervasive treatment gap and improving sleep health on a wider scale.

The aim of the study.

This study aimed to assess the efficacy of a commercially available digital Cognitive Behavioral Therapy for Insomnia (dCBT-I) program in reducing insomnia severity and improving sleep parameters in adult patients with chronic insomnia managed in a primary care setting, compared to usual care.

Material and methods.

A prospective, unblinded, randomized controlled trial was conducted across 10 primary care clinics in Santiago (Chile), Tainan (Taiwan), and Cairo (Egypt). A total of 450 adult patients (aged 18-65 years) fulfilling DSM-5 criteria for chronic insomnia were enrolled. Participants were randomized 1:1 to either the intervention group (n=225) or the control group (n=225). The intervention group was provided with an 8-week self-guided dCBT-I program accessible via smartphone or web browser, which included modules on sleep restriction, stimulus control, cognitive restructuring, and relaxation techniques. The control group received standard primary care sleep hygiene advice (e.g., maintain a regular sleep schedule, avoid caffeine before bed). Primary outcomes included the change from baseline in Insomnia Severity Index (ISI) scores and objective sleep efficiency (measured by actigraphy for a subsample of 100 patients) at 8 weeks. Secondary outcomes included subjective sleep quality (Pittsburgh Sleep Quality Index, PSQI) and remission rates (ISI < 7). Statistical analysis involved mixed-effects models for repeated measures and chi-square tests for categorical outcomes, with significance set at p < 0.05.

At 8 weeks, the dCBT-I group demonstrated a significantly greater reduction in ISI scores from baseline (mean reduction of 7.2 ± 1.5 points) compared to the control group (mean reduction of 2.1 ± 0.8 points) (p < 0.001). Objective sleep efficiency increased by an average of 15.3% (SD 4.1) in the dCBT-I group, significantly higher than the 4.2% (SD 2.8) increase in the control group (p < 0.001). Remission from insomnia (ISI < 7) was achieved by 58% of patients in the dCBT-I group compared to only 18% in the control group (p < 0.001). Patient adherence to the dCBT-I program modules was 75%. No serious adverse events were reported in either group. Patient satisfaction with the dCBT-I program was high (mean 8.9/10).

This multicenter randomized controlled trial provides strong evidence that digital Cognitive Behavioral Therapy for Insomnia (dCBT-I) is a highly effective and accessible intervention for the management of chronic insomnia within primary care settings. It significantly improves insomnia severity, sleep efficiency, and remission rates. The scalability and accessibility of dCBT-I make it a critical tool for expanding access to evidence-based sleep disorder treatment, reducing the clinical burden on primary care providers, and improving patient outcomes globally. Future research should investigate long-term effectiveness and cost-effectiveness in diverse patient cohorts.

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