Effect of Herbal Medicine (Hwanglyeonhaedok-tang) on Insomnia Patients with Bedtime Procrastination: study protocol for a randomized controlled trial

Objectives: Insomnia, characterized by difficulty initiating or maintaining sleep, affects a significant portion of the global population. Bedtime procrastination, which is a voluntary delay in going to bed, is a major contributing factor to the prevalence of sleep deprivation in modern societies. Hwanglyeonhaedok-tang (HJD decoction) has shown promise in improving the symptoms of insomnia. This study aimed to evaluate the efficacy of HJD decoction in patients with insomnia and bedtime procrastination.

Methods: This study employs a parallel-group design, comparing HJD decoction to usual care in a 11 ratio. Sixty participants with insomnia and bedtime procrastination will be enrolled. The experimental group will receive HJD decoction for 4 weeks, while both groups will undergo a brief behavioral treatment for insomnia. The primary outcome will be the change in the Insomnia Severity Index score (ISI) from baseline to 4 weeks. Secondary outcomes include sleep diary metrics, the Pittsburgh Sleep Quality Index (PSQI), and Bedtime Procrastination Scale (BPS). The exploratory outcomes include perceived stress, anxiety, smartphone use, and heart rate variability.

Conclusion: This trial examines the role of herbal medicine in treating a specific type of insomnia that is increasingly common in modern society. The combination of HJD decoction with behavioral intervention offers a comprehensive approach to treating insomnia complicated by bedtime procrastination. The results will provide valuable insights into integrative treatment strategies for sleep disorders in the digital age.