Effectiveness of Stepped-Care Chinese Herbal Medicine and Psychotherapy on Improving Sleep in Adults with Insomnia: A Stepped-Wedge Cluster Randomized Trial

INTRODUCTION: Insomnia is one of the most common sleep disorders in adults, with global prevalence rates ranging between 2.3% and 25.5%. Cognitive behavioral therapy for insomnia (CBT-I) and pharmacotherapy are recognized as common treatments for managing insomnia. However, access to CBT-I is often limited, while low acceptance rate of pharmacotherapy is also a well-known limitation. Therefore, it is imperative to identify alternative treatments that are accessible, effective and acceptable. Traditional Chinese medicine (TCM), including Chinese herbal medicine (CHM), has been proved to be effective for treating insomnia and is particularly popular in Eastern Asia. In Hong Kong (HK), 34.5% of insomnia patients choose TCM, making it the leading treatment option and reflecting strong cultural acceptance. However, most previous Chinese medicine studies on insomnia were well-controlled randomized trials, and real-world evaluations are lacking. This study aims to examine the effectiveness of stepped-care CHM and psychotherapy intervention in treating insomnia in adults in four clinical centers. MATERIALS AND METHODS: (1) Study design This stepped-wedge, cluster randomized trial recruited 366 adults with insomnia in HK between April and November 2024. The 18 geographic districts in HK are grouped into 4 clusters of 4 to 6 districts each, with randomization conducted at cluster level. The intervention was implemented sequentially in one cluster at a time based on a pre-generated random number, while the other clusters remained unexposed. After four steps, all clusters received the intervention. The study was approved by HK Baptist University Research Ethics Committee and prospectively registered with the Chinese Clinical Trial Registry (ChiCTR2400083685). (2) Population Adults with an insomnia severity index (ISI) score ≥ 14. (3) Stepped-care intervention The intervention consists of two levels. In level 1, the CHM treatment was based on TCM syndrome differentiation, classifying participants into three subtypes : excess syndrome, treated with Jia Wei Xiao Yao powder; deficiency syndrome, treated with Gui Pi decoction; and excess-deficiency complex syndrome, addressed with Huang Lian E Jiao decoction and Jiao Tai bolus. This level lasted 6 weeks, with participants taking a 5-gram herbal formula twice daily. Those without sleep improvement (ISI score≥ 14 after level 1 treatment) progressed to level 2, which involved an 8-week personalized CHM intervention and 8-session psychotherapy. (4) Outcome Outcome assessments were conducted at baseline and post-intervention. The primary outcome was ISI. The acceptance rate was operationalized as adherence rate by counting unconsumed sachets. Participants' self-management skills for handling insomnia and awareness of sleep health were also measured. RESULTS: All participants (age [SD]: 45.50 [13.08]; FEMALE: 282 [77.05%]) received the level 1 treatment, among whom, 49 (age [sd] : 47.61 [12.83]; female : 34 [69.39%]) progressed to the level 2 treatment. Only level 1 treatment significantly reduced insomnia severity (mean difference [95% ci] : -3.38 [-4.03 to -2.73]; p<0.0001; level 2: -0.90 [-2.49 to 0.69]; p=0.26). The adherence rate was high, at 84.8%. 98.4% of participants reported improved self-management skills for handling insomnia, while 97.3% expressed increased awareness of their sleep health. CONCLUSIONS: The stepped-care CHM and psychotherapy is effective and acceptable in treating insomnia, empowering participants in self-managing insomnia and increasing awareness of sleep health.