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STUDY PROTOCOL article

Front. Psychiatry

Sec. Mood Disorders

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

Provisionally accepted
Qiyue QiuQiyue Qiu1Mun Fei YamMun Fei Yam2Weiwei YangWeiwei Yang3Fei GuoFei Guo1Chenxi LiuChenxi Liu1Mohammad Farris Iman Leong Bin AbdullahMohammad Farris Iman Leong Bin Abdullah4*Shichang YangShichang Yang1*
  • 1The Second Affiliated Hospital of Xinxiang Medical University, Xinxiang, China
  • 2Universiti Sains Malaysia, Minden Heights, Malaysia
  • 3The Fifth People's Hospital of Lingbao City, Lingbao, China
  • 4Universiti Sultan Zainal Abidin Fakulti Perubatan, Kuala Terengganu, Malaysia

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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. Trial registration: ClinicalTrials.gov, NCT06443242 (registered June 5, 2024).

Keywords: Low-dose laser acupuncture, insomnia, Major Depressive Disorder, randomizedcontrolled trial, protocol

Received: 04 Sep 2025; Accepted: 31 Oct 2025.

Copyright: © 2025 Qiu, Yam, Yang, Guo, Liu, Leong Bin Abdullah and Yang. This is an open-access article distributed under the terms of the Creative Commons Attribution License (CC BY). The use, distribution or reproduction in other forums is permitted, provided the original author(s) or licensor are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. No use, distribution or reproduction is permitted which does not comply with these terms.

* Correspondence:
Mohammad Farris Iman Leong Bin Abdullah, farrisiman@unisza.edu.my
Shichang Yang, yangshch2000@163.com

Disclaimer: All claims expressed in this article are solely those of the authors and do not necessarily represent those of their affiliated organizations, or those of the publisher, the editors and the reviewers. Any product that may be evaluated in this article or claim that may be made by its manufacturer is not guaranteed or endorsed by the publisher.

Supplementary Material