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一款整合应激生物标志物与综合心理测量学的抑郁症诊断软件的探索性临床试验。

Exploratory Clinical Trial of a Depression Diagnostic Software That Integrates Stress Biomarkers and Composite Psychometrics.

作者信息

Jang Sooah, Kim In-Young, Choi Sun-Woo, Lee Anna, Lee Ju-Yeal, Shin Hyunkyung, Lee Junwoo, Lee Mikyeong, Lee Kyoung-Ryul, Jung Saeeun, Ryu Jin Sun, Oh Jihee, Kwon Manjae, Kim Joohan, Ahn Ryunsup, Jung Young-Chul, Seok Jeong-Ho

机构信息

Research Institute of Minds.AI, Co. Ltd., Seoul, Republic of Korea.

Institue of Behavioral Sciences in Medicine, Yonsei University College of Medicine, Seoul, Republic of Korea.

出版信息

Psychiatry Investig. 2024 Mar;21(3):230-241. doi: 10.30773/pi.2023.0253. Epub 2024 Mar 25.

DOI:10.30773/pi.2023.0253
PMID:38569581
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC10990624/
Abstract

OBJECTIVE

This study evaluated the clinical effectiveness of Minds.NAVI, a depression screening kit combining psychometric measures and stress hormone biomarkers, in a prospective clinical trial. The objective was to assess its potential as a depression screening tool and investigate the associations between psychological assessments, salivary hormone staging, and depression severity.

METHODS

Thirty-five participants with major depressive disorder and 12 healthy controls (HCs) were included. The Minds.NAVI software, utilizing the PROtective and Vulnerable factors battEry Test (PROVE) and salivary cortisol/dehydroepiandrosterone (DHEA) analysis, was employed. The PROVE test is a comprehensive self-report questionnaire that assesses depressive symptoms, suicide risk, attachment style, adverse childhood experiences, mentalization capacity, and resilience. In addition, salivary cortisol and DHEA levels were measured to evaluate the functional stage of the hypothalamic-pituitary-adrenal (HPA) axis.

RESULTS

Minds.NAVI exhibited 100% sensitivity, 91.7% specificity, and 97.9% accuracy in distinguishing depression from HCs within an exploratory small group. Salivary stress hormone phases showed changes with depression stage (p=0.030), and the proportion of patients with "adrenal exhaustion stage" was higher in the moderate/severe depression group (p=0.038). Protective/vulnerable factors differed significantly between controls and depressed groups (p<0.001). Cortisol awakening response inversely correlated with depressive symptom severity (r=-0.31, p=0.034).

CONCLUSION

This study suggested possible clinical effectiveness of Minds.NAVI, a depression screening tool that integrates psychometric measures and stress hormone biomarkers. The findings support the potential association between depression, chronic stress, and HPA axis hyporesponsiveness.

摘要

目的

本研究在一项前瞻性临床试验中评估了Minds.NAVI（一种结合心理测量方法和应激激素生物标志物的抑郁症筛查工具）的临床有效性。目的是评估其作为抑郁症筛查工具的潜力，并研究心理评估、唾液激素分期与抑郁症严重程度之间的关联。

方法

纳入35名重度抑郁症患者和12名健康对照者（HCs）。使用了Minds.NAVI软件，该软件采用了保护性和易损性因素电池测试（PROVE）以及唾液皮质醇/脱氢表雄酮（DHEA）分析。PROVE测试是一份全面的自我报告问卷，用于评估抑郁症状、自杀风险、依恋风格、童年不良经历、心理化能力和恢复力。此外，测量唾液皮质醇和DHEA水平以评估下丘脑 - 垂体 - 肾上腺（HPA）轴的功能阶段。

结果

在一个探索性小样本组中，Minds.NAVI在区分抑郁症患者和健康对照者方面表现出100%的敏感性、91.7%的特异性和97.9%的准确性。唾液应激激素阶段随抑郁阶段而变化（p = 0.030），中度/重度抑郁症组中“肾上腺耗竭阶段”患者的比例更高（p = 0.038）。对照组和抑郁症组之间的保护/易损因素存在显著差异（p < 0.001）。皮质醇觉醒反应与抑郁症状严重程度呈负相关（r = -0.31，p = 0.034）。

结论

本研究表明Minds.NAVI（一种整合心理测量方法和应激激素生物标志物的抑郁症筛查工具）可能具有临床有效性。研究结果支持了抑郁症、慢性应激和HPA轴反应性降低之间的潜在关联。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/7a2b/10990624/f83e843cef58/pi-2023-0253f6.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/7a2b/10990624/b411f3fdc080/pi-2023-0253f1.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/7a2b/10990624/c6f0096a4cc8/pi-2023-0253f2.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/7a2b/10990624/601fa8829a1d/pi-2023-0253f3.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/7a2b/10990624/19380d93db10/pi-2023-0253f4.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/7a2b/10990624/b4c8c7e0dc2b/pi-2023-0253f5.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/7a2b/10990624/f83e843cef58/pi-2023-0253f6.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/7a2b/10990624/b411f3fdc080/pi-2023-0253f1.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/7a2b/10990624/c6f0096a4cc8/pi-2023-0253f2.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/7a2b/10990624/601fa8829a1d/pi-2023-0253f3.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/7a2b/10990624/19380d93db10/pi-2023-0253f4.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/7a2b/10990624/b4c8c7e0dc2b/pi-2023-0253f5.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/7a2b/10990624/f83e843cef58/pi-2023-0253f6.jpg

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