SPIRIT Checklist: Study Protocol for a Stepped-Wedge Cluster Randomized Trial on the Effectiveness of Chinese Herbal Medicine in Improving Sleep and Mental Health in Adults

This study will be a multicenter, assessor-blinded, pragmatic stepped-wedge cluster randomized trial. Districts will be randomized to receive the Chinese herbal medicine (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).