Efficacy and safety of laser acupuncture for treating insomnia in major depressive disorder: study protocol for a randomized controlled trial.

Background: Effective options for managing insomnia in major depressive disorder (MDD) remain limited. This randomized, single-blind, three-arm parallel trial will compare low-dose laser acupuncture (LA), sham laser acupuncture (SLA), and standard care, evaluating changes in sleep and mood alongside serum biomarkers at three time points (t0 = pre-treatment; t1 = post-treatment, 6 weeks; t2 = follow-up, 12 weeks after treatment). Methods: A total of 120 inpatients meeting all eligibility criteria will be randomized (1:1:1) to LA, SLA, or control. The primary outcome is the Pittsburgh Sleep Quality Index (PSQI). Secondary outcomes include the Insomnia Severity Index (ISI), the 17-item Hamilton Depression Rating Scale (HAMD-17), serum 5-hydroxytryptamine (5-HT) and cortisol (CORT), and actigraphy. Outcomes are assessed at t0, t1, and t2. Safety will be evaluated by adverse events (AEs) and discontinuations due to adverse effects. Analyses will follow the intention-to-treat principle. Discussion: By integrating validated clinical endpoints with biomarker assessments, this trial will provide rigorous evidence on the efficacy and safety of low-dose LA for insomnia comorbid with MDD and help clarify potential mechanisms of action. If effective, LA could offer a non-invasive adjunct or alternative to current therapies. Registration Details: ClinicalTrials.gov, identifier NCT06443242.