Effectiveness of Chinese herbal medicine on improving sleep and mental health in adults: Study protocol for a stepped-wedge cluster randomized trial

Background: Depression, anxiety, and insomnia significantly impact global health and impose substantial health burdens worldwide. Conventional treatments including pharmacotherapy and psychotherapy face limitations in efficacy, side effects, and accessibility. Despite preliminary evidence suggesting the potential of Chinese herbal medicine (CHM) in managing these conditions, large-scale evaluations are lacking. This study aims to examine the effectiveness of CHM for the treatment of adults experiencing mild-to-moderate symptoms of depression, anxiety, and insomnia. Methods: This study will be a multicenter, pragmatic stepped-wedge cluster randomized trial. Districts will be randomized to receive the CHM intervention sequentially in four steps based on a computer-generated number, while control districts remain unexposed until their respective intervention phase. The intervention consists of a three-level stepped-care approach: Level 1 involves herbal tisane for mild symptoms, Level 2 offers standardized CHM for moderate symptoms or non-responders to Level 1, and Level 3 combines personalized CHM with psychotherapy for those not improved by Level 2. Symptom severity will be assessed using validated scales, Patient Health Questionnaire-9 for depression, Generalized Anxiety Disorder-7 for anxiety, and Insomnia Severity Index for insomnia, with primary outcomes measured at baseline, post-intervention, and follow-up. The study was approved by the Hong Kong Baptist University Research Ethics Committee (Approval No.: REC/22-23/0709). Discussion: This study will provide significant insights into the effectiveness of a stepped-care CHM intervention for alleviating depression, anxiety, and insomnia. The results could guide future decision-making regarding the integration of CHM into mainstream healthcare systems in Hong Kong and beyond. Trial registration: Chinese Clinical Trial Registry, ChiCTR2400083685, April 30, 2024, https://www.chictr.org.cn/hvshowprojectEN.html?id=251238&v=1.0