JMIR Publications

ABSTRACT

Background:

The comorbidity of insomnia and subclinical mood disorders markedly impairs circadian rhythms and daily functioning. Multiple randomized controlled trials (RCTs) have shown that acupuncture can significantly improve symptoms such as low mood, anxiety, and sleep disorders, especially in individuals with mild-to-moderate symptoms. However, few multicenter studies have investigated the therapeutic effects of acupuncture for this comorbid condition from the perspective of immune-related microRNAs (miRNAs).

Objective:

This study aims to evaluate the efficacy of acupuncture in patients comorbid with insomnia and subclinical mood disorders, and to explore its potential mechanisms from the perspective of immune-related miRNAs by conducting a multicenter randomized controlled trial.

Methods:

This multicenter RCT will be conducted across 8 research centers from August 2025 to December 2026, enrolling 200 subjects diagnosed with insomnia and subclinical mood disorders. All enrolled participants will be divided into the acupuncture group or the non-meridian and non-acupoint group randomly. The treatment frequency of the two groups is three times per week, lasting for 4 weeks. The primary outcome measure is the treatment response rate, defined as the proportion of participants whose PSQI score at the end of treatment decreased by ≥3 points from baseline. Secondary outcomes include longitudinal scores on validated sleep, mood, and somatic symptom scales at each follow-up time point, as well as serum levels of 5-HT, DA, NE, TNF-α, IFN-γ, IL-2, IL-4, IL-6, and IL-10, and miRNA expression levels.

Results:

none.

Conclusions:

This multicenter RCT aims to systematically evaluate the clinical efficacy and safety of acupuncture for insomnia with subclinical mood disorders, and to explore the underlying neuroimmune regulatory mechanisms via miRNA sequencing technology. The findings of this trial will provide high-quality evidence for the clinical application of acupuncture in the management of insomnia and mood disorders, and will offer novel insights into its biological mechanisms. Clinical Trial: This study has received approval from the Medical Ethics Committee of Shandong Provincial Third Hospital Shandong University (approval number: KYLL-2024124-1) with registration at the International Traditional Medicine Clinical Trials Registry (Registration Number: ITMCTR2026000680).