A prescription digital therapeutic (PDT) for insomnia, delivering cognitive behavioral therapy (CBT-I), has shown significant improvements in sleep and mental health, particularly for individuals with severe insomnia. The findings, published in Frontiers in Psychiatry, highlight the potential of digital interventions in addressing chronic sleep disorders.
Efficacy of Digital CBT-I
The study, a pragmatic, prospective, single-arm clinical trial (NCT04325464), assessed the impact of a prescription digital therapeutic on insomnia, anxiety, and depression. Participants accessed the therapeutic via a mobile device over nine weeks, engaging with six interactive treatment cores and daily sleep diaries to personalize their treatment.
Study Design and Patient Population
Researchers recruited 1565 adults (aged 22-75 years) with chronic insomnia from across the United States. The study leveraged referrals from sleep clinicians, a waiting list for a mobile adaptation of a browser-based CBT-I intervention, and individuals identified through insomnia-related internet searches. The average age of participants was 46 years (SD=13.28), and 74.7% were women. Baseline insomnia severity, as measured by the Insomnia Severity Index (ISI), was subthreshold in 16.3% of participants, moderate in 55.3%, and severe in 28.3%.
Key Findings
Participants who completed all six treatment cores (48.4%) experienced a significant reduction in mean ISI score, from 18.8 at baseline to 9.9 at the end of treatment. These improvements sustained at immediate post-intervention (mean=11.0) and at 6-month (mean=11.6) and 12-month (mean=12.2) follow-ups (all P < .001). The PDT was also associated with significant decreases in Generalized Anxiety Disorder-7 scale (GAD-7) and 8-item Patient Health Questionnaire (PHQ-8) scores at all measured time points following treatment (all P < .001).
Implications and Limitations
The study's results suggest that the benefits of digital CBT-I extend beyond controlled clinical trials and are applicable in real-world settings among a diverse group of adults in the US. However, the study's limitations include the absence of a comparator group, low adherence to the full CBT-I program, and participant attrition during longer follow-up periods.
Current Treatment Landscape
Cognitive behavioral therapy for insomnia (CBT-I) is considered the first-line treatment for chronic insomnia, typically delivered over 4 to 8 sessions. The FDA cleared this prescription digital therapeutic in March 2020. This study supports the use of digital therapeutics as an accessible and effective intervention for managing insomnia and related mental health symptoms.
