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

ABSTRACT:

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

SUBMITTER: Qiu Q 

PROVIDER: S-EPMC12676490 | biostudies-literature | 2025

REPOSITORIES: biostudies-literature