Mental Disorders Research Articles

Analysing Depressive Symptoms during Pregnancy Period: A Cross Sectional Study

Background: Depression is a mental health disorder characterized by persistent sadness, hopelessness, and loss of interest in activities. During pregnancy, it is referred to as antenatal depression, which can impact both maternal and fetal health. Untreated prenatal depression can lead to complications during pregnancy and childbirth, as well as long-term emotional and behavioral issues in the child. The Beck Depression Inventory (BDI) is widely used to assess the severity of depressive symptoms, and early diagnosis and treatment are important for managing this condition effectively. Aim: To analyze the prevalence of depressive symptoms during the pregnancy period. Objectives: To determine the prevalence of depressive symptoms during pregnancy. To compare the prevalence of depressive symptoms across the first, second, and third trimesters. To educate patients and caregivers about the prevention of depressive conditions during pregnancy. Methodology: A cross-sectional study was carried out at NIMS Medicity, Thiruvananthapuram, over a 6-month period. A total of 138 pregnant women were assessed for depressive symptoms using the Beck Depression Inventory (BDI). Data was collected in a structured form and analyzed using Microsoft Excel and SPSS version 24. Result and Discussion: Out of the 138 participants, most were in the age group of 25-28 years. 52.7% had planned pregnancies, while 47.83% had unplanned pregnancies. 12.32% of the participants experienced obstetric complications such as thyroid issues, PCOD (Polycystic Ovarian Disease), or IVF (In-vitro Fertilisation), while 87.68% did not. The classification of depression was based on the BDI score, and mild mood disturbance was most common (35.51%). 61.59% of the participants had depressive symptoms, with the highest incidence observed in the third trimester. Conclusion: This study highlighted the significant prevalence of depressive symptoms during pregnancy. Factors such as age, unplanned pregnancies, trimester, and obstetric complications were found to influence the occurrence of depressive symptoms. The study underscores the importance of early detection and intervention for managing depression during pregnancy.

Monitoring System for Patients with Mental Disorders based on RFID Technology

Based on the low efficiency of the supervision of patients with mental disorders in China, and the frequent occurrence of harm caused by mental disorders to caregivers and medical staff, the idea of using RFID technology combined with database and artificial intelligence technology to solve the problem of supervision of patients with mental disorders is proposed. By allowing patients with mental disorders to wear RFID tags, real-time positioning and tracking of patients with mental disorders can be achieved. Combined with a data collection and processing platform, their behavioral data can be analyzed to provide decision support for medical staff. At the same time, RFID and related technologies can also be used for drug management to ensure that patients take their medication on time and in the appropriate amount, avoiding missed or excessive medication. This system not only improves the supervision efficiency of patients with mental disorders, but also enhances the personal safety protection level of guardians and medical staff for patients with mental disorders, providing more efficient and comprehensive support and services for patients with mental disorders.

Voices that matter: The impact of patient-reported outcome measures on clinical decision-making

The critical role of patient-reported outcome measures (PROMs) in enhancing clinical decision-making and promoting patient-centered care has gained a profound significance in scientific research. PROMs encapsulate a patient's health status directly from their perspective, encompassing various domains such as symptom severity, functional status, and overall quality of life. By integrating PROMs into routine clinical practice and research, healthcare providers can achieve a more nuanced understanding of patient experiences and tailor treatments accordingly. The deployment of PROMs supports dynamic patient-provider interactions, fostering better patient engagement and adherence to treatment plans. Moreover, PROMs are pivotal in clinical settings for monitoring disease progression and treatment efficacy, particularly in chronic and mental health conditions. However, challenges in implementing PROMs include data collection and management, integration into existing health systems, and acceptance by patients and providers. Overcoming these barriers necessitates technological advancements, policy development, and continuous education to enhance the acceptability and effectiveness of PROMs. The paper concludes with recommendations for future research and policy-making aimed at optimizing the use and impact of PROMs across healthcare settings.

The Influence of Different Kidney Replacement Modalities on Health-Related Quality of Life in ESKD Patients.

Health-related quality of life (HRQOL) has gained increasing emphasis on the long-term outcome of patients taking sustained kidney replacement therapy (KRT). However, the influence of KRT modalities on patients' quality of life and their comparison needs further investigation. This study included 267 patients: 101 under hemodialysis (HD), 87 under peritoneal dialysis (PD) and 79 received kidney transplantation (KT). HRQOL of patients were evaluated by KDQOL-36 and EQ-5D-3L scales. Inverse probability of treatment weighting (IPTW) was used to balance patients' demographic characteristics. KT improved physical activity of patients and reduce effect of kidney disease, as shown by the higher physical composite score (KT: 43.927±8.370 vs HD: 38.101±8.567 vs PD: 37.446±8.626, P<0.001) and effects of kidney disease (KT: 71.917±24.469 vs HD: 57.654±16.722 vs PD: 53.169±17.960, P<0.001), but did not improve mental composite score (MCS), burden of kidney disease (BKD) and symptoms/problems of kidney disease (SPKD). No differences were found between HD and PD. Patients under different KRT modalities had different symptom distribution, but had close overall score in symptom evaluation. SPKD had the strongest association with MCS among all dimensions (r=0.398, 95%CI: 0.274 to 0.509), explaining 15.8% variation in MCS. KT recipients had significantly improved overall and physical aspect quality of life, meanwhile they still suffered similar mental problems and multiple discomforts like fatigue and skin problems, just as HD and PD patients. HD and PD patients' quality of life was similar. The impact of comorbidities and the underlying disease leading to end-stage kidney diseases on patients' quality of life should not be neglected.

Development and Validation of Psychosocial Immunity Scale for Job Professionals

Background: In the context of increasing occupational stress and burnout, the need for comprehensive assessment tools that capture both psychological resilience and social coping mechanisms has become critical. Existing scales often address these domains in isolation, failing to account for their dynamic interaction in shaping professional well-being and performance. Objective: This study aimed to develop and validate the Psychosocial Immunity Scale for Job Professionals (PSIS), designed to assess the dual dimensions of psychological and social immunity in the workplace, with the goal of identifying protective factors against burnout and stress-related dysfunction. Methods: A cross-sectional study was conducted across multiple professional sectors in urban Pakistan. A total of 153 participants were recruited for Exploratory Factor Analysis (EFA), followed by 238 participants for Confirmatory Factor Analysis (CFA). Inclusion criteria included adults aged ≥18 years with at least one year of continuous job experience; those with known psychiatric illness were excluded. Items were generated via systematic literature review and validated by subject matter experts. Statistical analysis was performed using SPSS v26 and AMOS v28, evaluating construct validity, internal consistency, and model fit. Ethical approval was granted by the GIFT University IRB in accordance with the Helsinki Declaration. Results: EFA revealed a two-factor structure (psychological and social immunity) with 16 retained items, explaining 50.5% variance (KMO=0.82, α=0.817). CFA confirmed model fit with CFI=0.936, TLI=0.925, RMSEA=0.056. PSIS scores showed positive correlations with cognitive crafting (r=0.46) and flow state (r=0.53), and negative correlation with work-life imbalance (r=–0.34), all statistically significant (p&lt;0.001). Conclusion: The PSIS is a valid, reliable tool for assessing psychosocial resilience among professionals. Its application can enhance early identification of stress vulnerability and support evidence-based interventions in occupational health and mental well-being.

Refining smart healthcare care for mental health and substance use disorders: A patient-centred, evidence-based approach

In this article, we comment on the article by Zhang et al , which explores the familiarity, awareness, and usage of smart medical care and its correlation with mental health and personality traits. The use of intelligent healthcare technologies in treating mental disorders and substance use disorders shows significant promise, but involves certain challenges, such as limited access, low technological literacy, and privacy concerns. These barriers disproportionately affect deprived populations and individuals with severe mental health conditions. We highlight the positive impact of smart healthcare solutions, such as telemedicine and wearable technologies, on patient engagement, remote monitoring, and treatment adherence. To overcome these challenges, we propose strategies, such as improving user-friendliness, ensuring equitable access to digital interventions, enhancing cybersecurity, and integrating smart healthcare into clinical workflows. Training healthcare providers and developing policies to ensure the ethical use of patient data are essential. When implemented thoughtfully, smart healthcare technologies can revolutionize mental health and substance use disorder treatment, improve patient outcomes, and reduce healthcare inequities.

Closer look at the cardiovascular and metabolic predictors of postpartum depression

Postpartum depression (PPD) is a severe mental health disorder affecting 10% to 15% of postpartum women worldwide. Pre-eclampsia is a hypertensive disorder of pregnancy that has been identified as a significant factor for PPD due to its vascular dysfunction, systemic inflammation and neurobiological alterations. The neuroinflammatory mechanisms common to both pre-eclampsia and PPD, that contribute to depressive symptoms include elevated proinflammatory cytokines (interleukin-6, tumor necrosis factor-alpha), activation of the kynurenine pathway, and oxidative stress. To critically evaluate Wu et al 's study, which investigates blood pressure variability (BPV) and gestational body mass index (BMI) as independent predictors of PPD. To integrate recent findings on the metabolic and cardiovascular links between depression, pre-eclampsia, and postpartum mental health outcomes. Pre-pregnancy BMI is found to be a stronger predictor of PPD than gestational weight gain. A vascular-neuropsychiatric connection has been indicated in pre-eclamptic women, indicating a significant correlation between BPV and depressive postpartum symptoms. There is increased susceptibility to depression due to neuroinflammation contributed by blood pressure fluctuations and metabolic dysregulation. The incidence of PPD could be reduced by early identification and intervention for BP fluctuations. Early detection and intervention in high-risk pregnancies should be conducted through public health strategies that prioritize awareness, education, and accessibility to mental health care.

Cerebral hemodynamic characteristics of patients with auditory verbal hallucinations and the construction of nomogram models

BACKGROUND The characteristics of cerebral hemodynamic indexes of patients with different types of auditory verbal hallucinations (AVHs) was not clear. AIM To explore the characteristics of cerebral hemodynamic indexes of patients with different types of AVHs and construct the risk nomogram prediction model of patients with different types of AVHs. METHODS Patients with different types of verbal hallucinations who visited Wenzhou Seventh People’s Hospital were retrospectively selected from March 2021 to March 2023, and these patients were classified into 117 cases of schizophrenia (SCZ) with AVHs, 108 cases of post-traumatic stress disorder (PTSD) with AVHs, and 105 cases of recurrent depressive disorder with AVHs according to type. Transcranial doppler was performed to measure the hemodynamic parameters of the anterior cerebral artery (ACA), middle cerebral artery (MCA), posterior cerebral artery (PCA), basilar artery (BA) and vertebral artery (VA). Logistic regression modelling was used to explore the factors affecting patients with different types of AVHs and odds ratio, 95% confidence interval (CI). A clinical prediction model was constructed, and the efficacy of the clinical prediction model was evaluated by using receiver operating characteristic, Hosmer-Lemeshow Goodness-of-Fit test, calibration curves and decision curve analysis. RESULTS The differences between the three groups of patients in mean velocity (Vm)-MCA, end-diastolic velocity (Vd)-MCA, Vm-ACA, pulsatility index (PI)-ACA, Vm-PCA, peak systolic velocity (Vs)-PCA, Vd-PCA, Vm-BA, Vs-BA, Vd-BA, PI-BA, resistance index (RI)-BA, Vm-VA, Vs-VA, Vd-VA, PI-VA, and RI-VA indexes were statistically significant. Rising Vm-ACA is an independent risk factor for SCZ with AVHs, and falling Vm-VA, Vd-MCA, and Vd-VA are independent risk factors for SCZ with AVHs. Rising Vm-ACA, Vm-PCA, Vs-PCA, Vd-PCA, Vm-BA, and Vs-BA are independent risk factors for PTSD with AVHs, and Vm-MCA, Vs-MCA, Vd-MCA, PI-PCA, and RI-BA are independent protective factors for PTSD with AVHs. Elevated Vm-MCA, Vd-MCA, RI-BA, Vm-VA, and Vd-VA were independent risk factors, and elevated Vm-ACA, Vs-ACA, Vm-PCA, Vs-PCA, and Vd-PCA were independent protective factors. The areas under the curve of the three models were 0.82 (95%CI: 0.76-0.87), 0.88 (95%CI: 0.83-0.92), and 0.81 (95%CI: 0.77-0.86), respectively; the Hosmer-Lemeshow Goodness-of-Fit test of the calibration curves of the three models suggests that P &gt; 0.05. CONCLUSION Monitoring the cerebral hemodynamic indexes of patients with AVHs is of practical significance in determining the type of mental disorder, which helps clinicians identify the type of AVHs and adopt more efficient treatment strategies to help patients recover.

Sleep, Health Care-Seeking Behaviors, and Perceptions Associated With the Use of Sleep Wearables in Canada: Results From a Nationally Representative Survey.

The popularity of sleep-tracking wearables has surged worldwide. Yet, there are significant gaps in understanding the real-life implications of this phenomenon. While wearables may offer insights about sleep and promote sleep health awareness, evidence remains mixed on whether they lead to improved sleep outcomes or fuel sleep anxiety. This study aims to (1) determine the prevalence and sociodemographic predictors of using sleep wearables in Canada, (2) evaluate the perceived effects of wearable use on sleep and stress, (3) compare sleep and health care-seeking behaviors in users and nonusers, and (4) investigate the moderating effects of wearable use on the association between sleep and anxiety. An online survey investigating sleep and mental health was distributed to a representative sample of 1200 Canadians. The survey included questions on demographics, wearables use, sleep patterns, health care-seeking behaviors, insomnia (ISI-3 [Insomnia Severity Index-3]), and anxiety (GAD-7 [Generalized Anxiety Disorder-7]) symptoms. Analyses relied on descriptive statistics and logistic regression (aims 1 and 2), multivariate analyses of covariance and chi-squared analyses (aim 3), and multiple regression (aim 4). Among the 1200 respondents (n=636, 53% female; aged 16 to 88 years), 19.3% (n=231) reported using a wearable device to monitor sleep. Several sociodemographic variables were associated with an increased likelihood of using wearables including: youth, being retired, being part of a racialized minority group, earning a higher income, having greater health care coverage, having a sleep disorder, and having a mental disorder (χ214=110.2, P<.001). Of all wearable users, nearly 45% felt that using sleep wearables had a positive effect on their sleep (n=102) and stress levels (n=97), while 4.5% (n=10) noted a negative effect. Compared to nonusers, wearable users reported 13 minutes longer sleep onset latency (F1,1151=5.21, P=.02, ƞp2=0.005), slept about 1 hour less (F1,1143=31.60, P<.001, ƞp2=0.027), and endorsed more severe insomnia symptoms (F1,1119=4.04, P<.05, ƞp2=0.004). After adjusting for the presence of sleep disorders, only the differences in sleep duration remained. The proportion of wearable users was almost twice as high in those having informed a health care provider about sleep difficulties (χ22=35.4, P<.001) and in those having used sleep medications (χ23=38.7, P<.001). Wearable use was identified as a moderator of the effect of anxiety symptoms on sleep duration, with wearable users showing a steeper decline in total sleep time as anxiety increased compared to nonusers (F1,1165=17.5, P<.001). One in 5 Canadians acknowledged having used sleep wearables. Predictors include younger age, higher income, and having a sleep or mental disorder. Although many individuals reported positive effects of sleep wearables, wearables use strengthened the link between short sleep and anxiety. Expanding our understanding of the factors associated with beneficial versus detrimental use of sleep wearables may help support more informed applications.

Identifying and Taking Action on the Protective and Risk Factors of Black Maternal Mental Health: Protocol for Community-Based Participatory Study.

Maternal mental health disorders are associated with adverse maternal and infant health outcomes. Despite advances in screening and treatment, disparities in maternal mental health disorders continue to disproportionately affect Black mothers and birthing persons. While there are studies that have examined maternal mental health, a gap in research remains in understanding the protective and risk factors of Black maternal mental health in Canada. Identifying the risks and protective factors is critical for advancing equitable and inclusive policies and practices that promote maternal well-being and optimal outcomes for Black perinatal populations. This paper presents an outline of a study protocol that seeks to identify the protective and risk factors of Black maternal mental health and to engage Black mothers and birthing persons from the Greater Toronto Area in codesigning a culturally safe and inclusive best practices model to inform policy and interventions. The proposed study will use an exploratory 3-phase sequential mixed methods approach underpinned by the principles of health equity and community-based participatory research. Phase 1 will involve engaging Black mothers and birth persons (n=300) in a survey to examine the psychosocial determinants of Black maternal mental health, including depression, anxiety, discrimination, strong Black women trope, attitude toward seeking mental health, support, and stigma. In phase 2, we will conduct 6 focus groups and individual interviews (n=60) to explore the stressors in the context of Black mothers and birth persons' everyday lives, psychosocial and support needs, and conditions that promote their resilience.Finally, phase 3 will engage Black women and birthing persons (n=30) in a codesign session using the concept mapping method to identify priority areas for action to inform policy and programming.We will use SPSS version 26 (IBM Corp) to analyze the survey data, drawing on both descriptive and inferential statistics. NVivo (Lumivero), a qualitative data analysis software, will be used to organize the data from phase 2 into meaningful themes informed by Braun and Clarke's thematic analysis approach. Ethics approval was granted in July 2024. Data collection for phase 1 started in December 2024 and will be completed in April 2025. Findings from phase 1 will inform phases 2 and 3 of this study, which will be conducted in the third quarter of 2025. We will disseminate the results of this study in the second and third quarters of 2025. The findings will generate the much-needed knowledge to shift policy, practice, and research and support capacity building among Black mothers and birthing persons. In addition, the proposed study will contribute to informing policy initiatives and interventions at the health system and community level to advance mental health equity and build capacity among service providers to provide culturally safe and equitable mental health care. PRR1-10.2196/70076.

Shaping the Future of Psychiatric Neurosurgery: From Connectomic Precision to Technological Integration

Psychiatric neurosurgery is undergoing a profound transformation, propelled by advances in neurotechnology, connectomics, and personalized medicine. Once controversial, surgical interventions are now guided by detailed functional brain mapping and precise neuromodulation techniques, such as deep brain stimulation (DBS), which offer therapeutic options for patients with severe, treatment-resistant psychiatric disorders. This manuscript reviews the current techniques, including lesion-based procedures and DBS, and explores their mechanisms of action, from synaptic plasticity to large-scale network modulation. It highlights recent progress in neuroimaging, connectomic targeting, and artificial intelligence applications for surgical planning and the prediction of treatment responses. Ethical considerations—including informed consent, identity, and long-term follow-up—are critically examined in light of these advances. Furthermore, the growing role of minimally invasive procedures and wearable integrated neurotechnologies is discussed as part of a shift toward dynamic and adaptive interventions. Although still investigational, psychiatric neurosurgery is emerging as a technologically sophisticated field that demands rigorous clinical evaluation, ethical accountability, and an individualized approach to restoring function and autonomy in some of the most disabling mental illnesses.

Stress &amp; Thyroid Function – From Bench to Bedside

Abstract Experimental animal and human studies illustrate the effect of various stress forms on the thyroid gland and the regulation of thyroid hormones (TH) through the thyrotropic multi-loop control circuit. The hypothalamic–pituitary–thyroid axis (HPT) axis is part of the physiological stress system and mediates key regulators of metabolic activity during stress response. Genetically characterized individuals are more affected in their response to stressors, and their psychological response is extremely amplified. This leads to significant increases in TH serum levels as soon as a negative stressor appears. Physical stressors are used to induce psychological stress, e.g., physical exercise, starvation, sleep deprivation, hypoxia, and cold temperatures, all of which impact thyroid function. In addition, somatic illnesses may also affect the thyroid gland or may be related to a thyroidal dysfunction. As a psychosocial stressor in animal models, neonatal separation from the mother was used, affecting energy homeostasis and causing an increase in thyroliberin (TRH) expression in female rats and an increase in TRH degrading ectoenzyme in male rats. In mice with restrained stress, TH are important mediators of accelerated tumor growth. In human studies, isolated sexual abuse in childhood doubles the risk of thyroid dysfunction, with puerperal depression after sexual abuse in childhood increasing the risk for HPT axis disorders and elevated thyroid autoantibodies four-fold. In addition, psychological illnesses influence thyroid function. In the future, laboratory studies with standardized induction of various stress forms are warranted to better understand stress-induced effects on the HPT axis and their corresponding mechanisms.

The Care Experiences of Pregnant Women With Serious Mental Illness: A Scoping Review [Formula: see text

Serious mental illness (SMI) in pregnancy is a public health concern due to associated poor maternal-child outcomes. There is a gap in the literature about the healthcare experiences of pregnant women with SMI and the experiences of providers who care for this population. The purpose of this scoping review is to examine the current state of the science regarding the experiences of pregnant women with SMI and the experiences of providers when treating this population. The aim of this review was to fill a knowledge gap that is needed to facilitate paradigm shifts in the treatment of pregnant women with SMI. We conducted a systematic search for published, peer-reviewed, English-language literature addressing the experiences of pregnant women with SMI receiving care and the experiences of those providing care to the population. The databases searched were OVID MEDLINE, Embase (OVID), CINAHL, PsycINFO (EBSCO), and Sociological Abstracts (ProQuest). Sixteen qualitative and mixed-method articles focused on pregnant women with SMI were included in this review. Key themes emerged regarding patients' desire for specialized providers for treatment, preparedness in pregnancy, access to quality guidance and information, special attention to issues/concerns, guidance in medication, and care integration. Providers reported a desire for better interdisciplinary communication and specialized knowledge and expertise regarding SMI. This review provides insight into areas where interprofessional collaboration can be vital in helping improve health outcomes; however, more research is needed surrounding the perspectives of providers and their support and resources when treating this population.

Implementation of Structured Suicide Risk Screening in a State Physician Health Monitoring Program

Background This study examined the implementation of structured suicide risk screening by a large state physician health monitoring program (PHP). Methods Physicians (n = 363; 87 women; 44.78 years-old, SD = 13.75) were screened for suicide risk with the Columbia Suicide Severity Rating Scale (C-SSRS) at PHP intake and at 2-weeks, 3-months, 1-year, 2-years, 3-years after initiating monitoring, and following any sentinel events. The PHP response was recorded at each timepoint. Results At intake, female physicians reported higher current (p = .025, Cramer’s V = .178) and lifetime suicide risk (p = .010, Cramer’s V = .163) compared to male physicians. Physicians monitored for substance use disorders (SUD) were more likely to deny any lifetime suicide risk than those monitored for co-occurring SUD and psychiatric disorders (p = .017, Cramer’s V = .171), and had lower rates of “moderate” lifetime suicide risk than those monitored for psychiatric disorders only (p = .017, Cramer’s V = .171). The PHP offered behavioral health referrals for physicians reporting “low” risk (n = 2) plus safety measures for those with “moderate” (n = 2) and “high” risk (n = 1). One physician reporting “low” risk and four physicians reporting “high” risk were already in-treatment. At 2-weeks and 3-months into monitoring, suicide risk remained “very low” (99.4% and 98.8%) or “low.” At 1-year, risk was “very low” for 99.3% of physicians, with two at “moderate” risk. At 2 and 3 years, 100% reported “very low” suicide risk. No suicides occurred among monitored physicians. Conclusion PHPs offer support to mitigate suicide risk among physicians. The observed decrease in suicide risk across monitoring may reflect the recovery processes that monitoring is intended to support.

HIV-related Stigma among People with HIV in Denmark and its Association with Psychosocial and Sexual Health: a cross-sectional Nationwide Study.

HIV-related stigma remains a major barrier to improving the lives of people with HIV (PWH) and curbing the epidemic globally. This cross-sectional study assessed HIV-related stigma, based on The HIV Stigma Framework, among PWH in Denmark, and examined its potential associations with sociodemographic characteristics, as well as with HIV-related, psychosocial and sexual health measures. Data from 630 participants (486 men and 144 women) in the SHARE study-a nationwide survey on psychosocial and sexual health among PWH in Denmark conducted from 2021 to 2022-were analysed using sex-stratified linear and logistic regression models adjusted for relevant confounders. Results showed that anticipated stigma was the most commonly reported stigma mechanism, with 68% of men and 77% of women expressing high levels of concern about HIV status sharing. In contrast, enacted stigma was reported by 9% of men and 22% of women. The multivariate regression analyses revealed that higher stigma levels were associated with originating from low- or middle-income countries and with a history of mental health problems, whereas non-heterosexual identity and a longer time since HIV diagnosis were linked to lower stigma. In both men and women, stigma was significantly associated with fewer close friends, loneliness, anxiety and reduced sexual desire. Among men, stigma was also significantly associated with sharing one's HIV status with fewer people, depression, suicidal tendencies and erectile dysfunction. In conclusion, HIV-related stigma, notably stigma related to anticipated stigma, remains prevalent among PWH in Denmark and it is significantly associated with a range of psychosocial and sexual challenges.

Abstract P5-08-28: Randomized phase 2 window of opportunity trial comparing the effect of preoperative atirmociclib (PF-07220060) plus letrozole versus letrozole alone on Ki-67 tumor expression in postmenopausal women with HR+/HER2+ breast cancer

Abstract Background: In previous clinical trials, complete cell cycle arrest (CCCA, defined as Ki-67 ≤2.7%) in the neoadjuvant setting was correlated with relapse-free survival after definitive surgical resection. Cyclin-dependent kinase 4/6 inhibitors (CDK4/6is), in combination with endocrine therapy (ET), have consistently shown progression-free survival and/or overall survival benefits for patients with HR+/HER2− metastatic breast cancer (BC). High and/or continuous CDK4/6i dosing may result in dose-limiting cytopenia-related toxicity; neutropenia is believed to be mediated mainly by inhibition of CDK6 rather than CDK4. Atirmociclib (PF-07220060) is a novel, highly potent and selective inhibitor of CDK4. In preclinical studies, atirmociclib induced G1 cell cycle arrest in BC cell lines and significantly inhibited the growth of HR+/HER2− tumors, which are known to have a high degree of CDK4 dependency. Preliminary results from a phase 1/2a multi-part trial assessing atirmociclib in patients with HR+/HER2− metastatic BC have demonstrated encouraging efficacy, safety, and tolerability (Yap et al, JCO. 2023;41:3009; Giordano et al, JCO. 2024;42:3108). Based on these findings, this study aims to evaluate the potential impact of atirmociclib in combination with letrozole in the preoperative treatment of patients with HR+/HER2− early BC. Methods: This international (16 countries, &amp;gt;80 proposed sites), phase 2, open-label, randomized clinical trial will evaluate the effects of atirmociclib plus letrozole versus letrozole alone on Ki-67 expression in tumors after 14 days of treatment in the preoperative setting. Postmenopausal women aged ≥18 years with newly diagnosed and treatment naïve HR+/HER2− BC will be enrolled. Additional inclusion criteria include primary tumor size ≥1.5 cm amenable to surgical resection, ECOG PS 0 or 1, and a baseline tumor Ki-67 score ≥10%. Exclusion criteria include any prior systemic therapy for the treatment of BC, inadequate bone marrow, renal, and liver function, any other active malignancy within 3 years prior to enrollment, certain severe medical conditions within 6 months of enrollment, known allergy to the study drug, inability to take oral medications, and certain psychiatric conditions. Approximately 118 patients will be randomly assigned 1:1 to receive atirmociclib (300 mg, orally, twice daily) plus letrozole (2.5 mg, orally, once daily) or letrozole alone (2.5 mg, orally, once daily), continuously for 14 days. After the 14-day treatment period, participants will come off study treatment and continue on standard-of-care therapy (eg, ET, surgery, radiotherapy, chemotherapy) per physician’s choice. Participants will have both a baseline biopsy and an on-treatment biopsy (Day 14). The primary endpoint will be CCCA (Ki-67 ≤2.7%) rates at Day 14 (based on centrally assessed post-treatment tumor biopsies). Secondary endpoints will be incidence of all adverse events (AEs), serious AEs, AEs leading to study drug discontinuation, circulating tumor DNA measurements at baseline and Day 14, Ctrough and peri-biopsy plasma concentrations of atirmociclib, and centrally-assessed Ki-67 immunohistochemistry. Assessment of changes in the tumor microenvironment using spatial omics, and evaluation of the association between tumor gene expression profiles and treatment outcomes will be exploratory objectives. Enrollment is to begin July 2024 (NCT06465368). Citation Format: Shom Goel, Khalil Zaman, Seock-Ah Im, Ahmed Elkhanany, Chiun-Sheng Huang, Cristian Villanueva, Sara Lopez Tarruella, Chin-Hee Chung, Ann Alcasid, Yuan Liu, Cynthia Basu, Michail Ignatiadis. Randomized phase 2 window of opportunity trial comparing the effect of preoperative atirmociclib (PF-07220060) plus letrozole versus letrozole alone on Ki-67 tumor expression in postmenopausal women with HR+/HER2+ breast cancer [abstract]. In: Proceedings of the San Antonio Breast Cancer Symposium 2024; 2024 Dec 10-13; San Antonio, TX. Philadelphia (PA): AACR; Clin Cancer Res 2025;31(12 Suppl):Abstract nr P5-08-28.

Influence on Consultation Behavior of Pregnant and Postpartum Women in Japan: Insights from a Nation-Wide Survey

Background: In Japan, new challenges are emerging, such as declining birth rates, an increase in age at childbirth, postpartum depression, and child abuse. Methods: This study examines the factors influencing maternal consultation behavior at public institutions using some of the data from the Japan COVID-19 and Society Internet Survey (JACSIS). A total of 6227 women (1380 pregnant and 4847 postpartum) were analyzed through logistic regression. Results: The results showed different factors influencing consultations between pregnant women and postpartum women. Among pregnant women, different trends were observed between primigravidae and multigravidae, indicating that primigravidae aged ≥40 years and multigravidae with multiple childbirths tend to seek consultations more frequently. In postpartum women, psychological distress (K6), adverse childhood experiences (ACEs), and social support networks significantly influenced consultation behavior. Postpartum women with extensive support networks (≥3 confidants) exhibited higher consultation rates. In contrast, those with elevated Edinburgh Postnatal Depression Scale (EPDS) and Mother-to-Infant Bonding Scale (MIBS-J) scores were less likely to seek help, potentially due to mental health stigma. Conclusions: This study showed that pregnant and postpartum women facing physical, mental, family, or relationship issues are seeking consultations and receiving thorough support. On the other hand, since some pregnant and postpartum women refrained from seeking consultation, it is necessary to further consider support measures that make it easier for all pregnant and postpartum women to seek advice in the future.

Short-form video addiction and depression: a comparative network analysis between left-behind children and non-left-behind children

Introduction Left-behind children (LBC) often exhibit higher levels of mental health problems and behavioral issues compared to non-left-behind children (NLBC). This study aims to investigate the differences between LBC and NLBC in terms of short-form video addiction and depression. Methods A total of 1839 adolescents (LBC:876) from middle and high schools were involved in the study. EBICglasso network analysis was used to explore the interaction between two disorders in LBC and NLBC. Results The network analysis of symptom networks revealed robust connections between short-form video addiction and depression among LBC and NLBC. The most central symptom in the LBC network was Academic functional impairment, while Mood change emerged as the most central symptom in the NLBC network. The inertia symptom of depression was identified as bridge symptoms in both networks. Comparing the two networks, significant differences were found in nodes including anhedonia, mood change and overuse. Conclusions The study shows complex links between short-form video addiction and depression, with variations seen between LBC and NLBC. Academic functional impairment and Mood change were central symptoms in LBC and NLBC networks, respectively. Differences were also noted in anhedonia, mood change, and overuse. This underscores the necessity for tailored interventions to tackle mental health concerns in both LBC and NLBC.

Effectiveness of Mindfulness and Qigong Training for Self-Healing in patients with Hwabyung and depressive disorder: a randomized controlled trial

BackgroundHwabyung is a Korean culture-bound syndrome characterized by anger-related physical and psychological symptoms. Depressive disorder is a common mental disorder that occurs worldwide and is highly comorbid with Hwabyung. In traditional East Asian medicine, both Hwabyung and depression are associated with an imbalance in vital energy termed qi. Mindfulness induces psychosomatic balance, and qigong facilitates the cultivation and regulation of qi, which may be effective treatments for Hwabyung and depression. This study aimed to investigate whether Mindfulness and Qigong Training for Self-Healing (MQT-SH) could improve psychosomatic symptoms in patients with Hwabyung and depressive disorders.MethodsThis was a two-arm, randomized controlled trial. Patients diagnosed with both Hwabyung and depressive disorder were included in the trial. A total of 64 participants were recruited and randomly assigned to either the experimental (n=32) or control group (n=32). The experimental group underwent MQT-SH that consisted of mindfulness and qigong for the first six weeks, whereas the control group received no treatment. During the next six weeks, the control group performed MQT-SH for ethical equity. Assessments were conducted at baseline, post-intervention (6-week), and follow-up (12-week).ResultsMQT-SH significantly decreased Hwabyung, depression, anxiety, and anger while increasing subjective vitality, and the effectiveness of the intervention were maintained at a short-term follow-up of 6 weeks. Physical vitality mediated the effectiveness of the MQT-SH on Hwabyung, whereas psychological vitality mediated the effectiveness of the MQT-SH on depression. Only one adverse event was reported during the intervention period. Home practice was not significantly associated with any intervention change.DiscussionThis study demonstrated that MQT-SH is an effective and safe intervention for patients with Hwabyung and depressive disorders. This study explored the possibility that subjective vitality may serve as a mechanism for treating psychosomatic and mood symptoms. Future studies should control for placebo effects and conduct long-term follow-ups.Ethics and disseminationThis study was approved by the Institutional Review Board of Kyung-Hee University Oriental Medicine Hospital in Gangdong (KHNMCOH 2023-09-003).Clinical trial registrationhttps://cris.nih.go.kr/cris/search/detailSearch.do?seq=26882&amp;amp;status=5&amp;amp;seq_group=25511&amp;amp;search_page=M, identifier KCT0008937.

Socioeconomic status, antidepressant use, and return to work after disability due to common mental disorders.

Socioeconomic status, antidepressant use, and return to work after disability due to common mental disorders.