Guu Ta-Wei, Cassano Paolo, Li Wan-Jing, Tseng Yu-Hsiung, Ho Wen-Yu, Lin Yi-Ting, Lin Sheng-Yu, Chang Jane Pei-Chen, Mischoulon David, Su Kuan-Pin
Division of Psychiatry, Departments of Internal Medicine, China Medical University Beigang Hospital, Yunlin, Taiwan; Centre for Healthy Brain Ageing, Department of Psychological Medicine, Institute of Psychiatry, Psychology and Neuroscience, King's College London, UK; Mind-Body Interface Research Centre (MBI-Lab), China Medical University Hospital, Taichung, Taiwan.
Harvard Medical School, Boston, MA, USA; MGH Division of Neuropsychiatry, Massachusetts General Hospital, Boston, MA, USA.
J Affect Disord. 2025 Mar 1;372:635-642. doi: 10.1016/j.jad.2024.12.065. Epub 2024 Dec 18.
Device-based treatments exist in psychiatry for decades, but are usually operated by clinicians and require multiple office visits. Near-infrared transcranial photobiomodulation (tPBM) is a safe neurostimulation modality with potential antidepressant and hypnotic effects. We investigated the feasibility and efficacy of adjunctive tPBM treatment, self-administered by a wearable headband.
We randomized 48 outpatients with major depressive disorder (MDD) into tPBM or sham with 1:1 ratio. All participants were advised to receive the device-based intervention for at least 20 min daily at their preferred time and place for 8 weeks. The compliance and adverse events were monitored throughout the trial. The Hamilton Depression Rating Scale (HAMD), Beck's Depression Inventory (BDI) and Pittsburgh Sleep Quality Index (PSQI) were used to evaluate the symptoms from baseline until week-12.
Participants reported this self-administered intervention well-tolerated. Treatment compliance was equally good between various group-comparisons, and the adverse effects were minimal and transient. Post-treatment, the HAMD and BDI scores of patients in both tPBM group and sham group significantly decreased compared to baseline, with no between-group difference. However, a significant PSQI score reduction was only found in tPBM group from week-2 onward compared with baseline, with significant between-group difference lasting until week-12 (F = 6.16, p = 0.017).
This smaller sample size and short treatment and follow-up durations.
Self-administered wearable tPBM appears to be a feasible and well-tolerated in MDD patients. The low-level dosimetry appeared insufficient to produce an antidepressant effect but effective in improving sleep quality. Further studies should investigate different dosimetry and intervention time. CLINICAL TRIALS REGISTRATION NUMBER IN CLINICALTRIAL.GOV: NCT04619121.
基于设备的治疗方法在精神病学领域已存在数十年，但通常由临床医生操作，且需要多次门诊就诊。近红外经颅光生物调节（tPBM）是一种安全的神经刺激方式，具有潜在的抗抑郁和催眠作用。我们研究了可穿戴头带自我管理的辅助tPBM治疗的可行性和疗效。
我们将48名重度抑郁症（MDD）门诊患者按1:1的比例随机分为tPBM组或假治疗组。建议所有参与者在他们喜欢的时间和地点每天接受基于设备的干预至少20分钟，持续8周。在整个试验过程中监测依从性和不良事件。使用汉密尔顿抑郁量表（HAMD）、贝克抑郁量表（BDI）和匹兹堡睡眠质量指数（PSQI）评估从基线到第12周的症状。
参与者报告这种自我管理的干预耐受性良好。在不同组间比较中，治疗依从性同样良好，且不良反应轻微且短暂。治疗后，tPBM组和假治疗组患者的HAMD和BDI评分与基线相比均显著降低，组间无差异。然而，与基线相比，仅在tPBM组中从第2周起发现PSQI评分显著降低，组间差异显著持续至第12周（F = 6.16，p = 0.017）。
本研究样本量较小，治疗及随访时间较短。
自我管理的可穿戴tPBM在MDD患者中似乎是可行的且耐受性良好。低剂量照射似乎不足以产生抗抑郁作用，但对改善睡眠质量有效。进一步的研究应调查不同的剂量和干预时间。临床试验注册编号在CLINICALTRIAL.GOV：NCT04619121。
