Clinical Trials Study
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World J Psychiatry. Mar 19, 2025; 15(3): 99408
Published online Mar 19, 2025. doi: 10.5498/wjp.v15.i3.99408
Using the THINC-integrated tool to compare the characteristics of cognitive dysfunction in patients with unipolar and bipolar depression
Na Zhu, Qi Zhang, Jia Huang, Jie Tong, Heng-Fen Gong, Ming-Huan Zhu, Wei Lu, Jie Zhang, Xi-Rong Sun
Na Zhu, Qi Zhang, Jie Tong, Heng-Fen Gong, Ming-Huan Zhu, Wei Lu, Jie Zhang, Xi-Rong Sun, Clinical Research Center for Mental Disorders, Shanghai Pudong New Area Mental Health Center, School of Medicine, Tongji University, Shanghai 200124, China
Jia Huang, Clinical Research Center, Shanghai Mental Health Center, Shanghai Jiao Tong University School of Medicine, Shanghai 200030, China
Co-first authors: Na Zhu and Qi Zhang.
Co-corresponding authors: Jie Zhang and Xi-Rong Sun.
Author contributions: Zhu N and Zhang Q conceptualized and designed the research; Tong J, Zhu MH, Gong HF, and Lu W screened patients and acquired clinical data; Zhu N performed data analysis and writing-original draft preparation and revising; All the authors have read and approved the final manuscript. Zhu N proposed, designed and conducted THINC-integrated tool analysis, performed data analysis and prepared the first draft of the manuscript. Zhang Q was responsible for patient screening, enrollment, and collection of clinical data. Both authors have made crucial and indispensable contributions towards the completion of the project and thus qualified as the co-first authors of the paper. Both Sun XR and Zhang J have played important and indispensable roles in the experimental design, data interpretation and manuscript preparation as the co-corresponding authors. Sun XR applied for and obtained the funds for this research project. Zhang J conceptualized, designed, and supervised the whole process of the project. She searched the literature, revised the early version of the manuscript. Sun XR was instrumental and responsible for data re-analysis and re-interpretation, figure plotting, comprehensive literature search, preparation and submission of the manuscript. This collaboration between Sun XR and Zhang J is crucial for the publication of this manuscript and other manuscripts still in preparation.
Supported by Science and Technology Development Fund of Shanghai Pudong New Area, No. PKJ2023-Y20; Key Discipline Construction Fund of the Shanghai Pudong New Area Municipal Commission of Health and Family Planning, No. PWZxk2022-18; and Pudong New Area Construction Project of National Traditional Chinese Medicine Development Comprehensive Reform Pilot Zone, No. PDZY-2022-0501.
Institutional review board statement: This research was conducted under the approval of the Institutional Review Board (IRB) of the Shanghai Pudong Area Mental Health Centre. The IRB carefully evaluated the research protocol, which encompassed the study design, methods of data collection, and procedures for participant recruitment and consent. The review process ensured that the study adhered to ethical guidelines and protected the rights and welfare of the participants. Informed consent was obtained from all participants after they were fully informed about the nature, purpose, and potential risks of the study. The confidentiality of participant information was maintained throughout the research process. The study was approved under IRB protocol number [PDJWLL2020037].
Clinical trial registration statement: This clinical trial was prospectively registered with ClinicalTrials.gov under the registration number [NCT 05053204]. The details provided in the registration encompassed the trial's primary and secondary objectives, study design, inclusion and exclusion criteria for participants, interventions and comparator treatments, outcome measures, planned sample size, and the estimated trial duration. This registration process is in line with the requirements and guidelines set forth to ensure transparency and reproducibility in clinical research. It allows for public access to key trial information, enabling other researchers, healthcare providers, and the general public to be informed about the trial's progress and results. The investigators of this trial are committed to following the protocol as registered and to reporting the trial outcomes in a timely and accurate manner.
Informed consent statement: All participants in this study were provided with comprehensive information regarding the nature, purpose, procedures, potential benefits, and possible risks of the research. This information was presented in a clear and understandable manner, either verbally and in written form. Before their inclusion in the study, participants were given sufficient time to review and consider the details. They were informed that their participation was entirely voluntary and that they could withdraw at any time without penalty or negative consequences. Written informed consent was obtained from each participant. The consent forms were signed and dated, and a copy was provided to the participants for their records. The research team ensured that all questions and concerns raised by the participants were addressed promptly and satisfactorily. The privacy and confidentiality of the participants were protected throughout the study, and any identifiable information was handled in accordance with applicable privacy laws and ethical guidelines. This process of obtaining informed consent was carried out in strict accordance with the requirements and recommendations of the Institutional Review Board of Shanghai Pudong Area Mental Health Centre to safeguard the rights and well-being of the individuals involved in the research.
Conflict-of-interest statement: The authors declare no conflict of interest.
CONSORT 2010 statement: The authors have read the CONSORT 2010 Statement, and the manuscript was prepared and revised according to the CONSORT 2010 Statement.
Data sharing statement: Data used in this research can be shared upon request. please contact the first author at zhuna1987524@aliyun.com. The requester must provide a detailed research plan explaining how the data will be used and must sign a data use agreement which ensures that the data will not be used for commercial purposes and that the privacy of the participants will be protected.
Open Access: This article is an open-access article that was selected by an in-house editor and fully peer-reviewed by external reviewers. It is distributed in accordance with the Creative Commons Attribution NonCommercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited and the use is non-commercial. See: https://creativecommons.org/Licenses/by-nc/4.0/
Corresponding author: Xi-Rong Sun, MD, Clinical Research Center for Mental Disorders, Shanghai Pudong New Area Mental Health Center, School of Medicine, Tongji University, No. 165 Sanlin Road, Pudong New Area, Shanghai 200124, China. sunxr1807@163.com
Received: July 22, 2024
Revised: December 16, 2024
Accepted: January 22, 2025
Published online: March 19, 2025
Processing time: 219 Days and 1.4 Hours
Abstract
BACKGROUND

Major depressive disorder (MDD) and bipolar depression (BD-D) are both intricate, enduring, and profound psychiatric conditions characterized primarily by depressive episodes and cognitive dysfunction. However, distinguishing the characteristics and influencing factors of cognitive impairment in unipolar and BD-D is crucial for identification and intervention.

AIM

To compare neurocognitive characteristics and investigate associations between cognitive function and clinical features in unipolar and BD-D.

METHODS

The THINC-integrated tool (THINC-it) as a cognitive assessment tool was applied to 295 individuals: 75 patients with depressive disorders (MDD), 120 individuals with BD-D, and 100 healthy controls. The Hamilton Depression Scale-17 (HAMD), Hamilton Anxiety Scale-14 (HAMA), and Pittsburgh Sleep Quality Index (PSQI) were employed to assess depression, anxiety, and sleep. Neurocognitive function characteristics and the relationships between cognitive impairment and general clinical attributes were analyzed.

RESULTS

There were no statistically significant differences in the overall THINC-it with each objective subscale. However, the subjective subscale (Perceived Deficits Questionnaire for Depression-5-item) showed significant differences between MDD and BD-D (P < 0.001). Linear regression analyses were explored to determine associations. Age, years of education, age at onset, and HAMD were significantly co-associated with the overall THINC-it and each subscale in both MDD and BD-D (P < 0.05). Furthermore, years of education showed a positive correlation with objective cognitive impairment (e.g., Codebreaker, Trails) (P < 0.05). There was a notable difference in that the number of depressive episodes, disease duration, hospitalizations, HAMA, and PSQI were significantly associated with the overall THINC-it with each subscale between MDD and BD-D (P < 0.05).

CONCLUSION

Although both unipolar and BD-D showed similar objective cognitive impairments, there was a significant difference in subjective cognitive impairment. Our findings suggest that factors like age, years of education, age at onset, and depression severity might not be significantly difference in the influence of cognitive impairment. Furthermore, we found that education was a protective factor for cognitive impairment in both unipolar and BD-D. Our analysis revealed that distinct factors including disease duration, number of depressive episodes, hospitalizations, anxiety levels, and sleep quality influenced cognitive impairment between unipolar and BD-D. Therefore, it was important to investigate the specific characteristics of cognitive impairment and influencing factors to identify differentiating unipolar and BD-D.

Keywords: Unipolar and bipolar depression; THINC-integrated tool; Objective cognitive impairments; Subjective cognitive impairment; Depression; Influencing factor

Core Tip: The THINC-integrated tool was applied to 75 patients with depressive disorders, 120 individuals with bipolar depression, and 100 healthy controls. In our study, neurocognitive function characteristics were analyzed as well as the relationships between cognitive impairment and general clinical attributes. We found that objective cognitive impairment exhibited similarities between individuals with unipolar and bipolar depression, whereas subjective cognitive impairment showed differences. Additionally, there were no disparities in the impacts of age, age at onset, years of education, and depression level on cognitive impairment in individuals with unipolar and bipolar depression. Furthermore, years of education emerged as a protective factor against objective cognitive impairment. Interestingly, other clinical features had different effects on cognitive impairment varying between the two depression groups. These provide some theoretical support for the identification of unipolar and bipolar depression.