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Does a program‐based cognitive behavioral therapy affect insomnia and depression in menopausal women? A randomized controlled trial

Abstract

Background

Menopausal women often complain of a range of physical and psychological symptoms known as menopausal syndrome. These symptoms are associated with fluctuating hormone levels, sleep disturbances, and mood swings.

Aim

This study aimed to examine the efficacy of a program-based cognitive behavioral group therapy (CBT) for insomnia and depression among women experiencing menopause.

Methods

A randomized controlled trial of 88 women experiencing menopause was conducted in Egypt from June to September 2022 in outpatient clinics at Mansoura University Hospitals in Egypt. Participants were randomly assigned to a control group (45 women) and an intervention group (43 women). The intervention group received 7 weeks of CBT sessions. Insomnia Severity Index (ISI), Pittsburgh Sleep Quality Index (PSQI), and Beck Depression Inventory 2nd Edition (BDI-II) were administered before and after the intervention.

Results

In the intervention group, there was a significant difference in scores of the subdomains of PSQI, including sleep efficiency, daytime dysfunction, subjective sleep quality, and sleep disturbance (t = 8.911, 11.77, 7.638, and 11.054, respectively), while no significant difference in domains of using sleep medication, sleep duration, and sleep latency. Significant improvements were observed between pre-and-post-intervention in the intervention group for the total scores of PSQI, ISI, and BDII-II (t = 12.711, 16.272, and 12.384, respectively), indicating a large effect size for the three studied variables (r = .81, .87, .8, respectively).

Linking Evidence to Action

This study demonstrated the efficacy of group CBT for lowering insomnia and depression in women experiencing menopause. Thus, results indicated the need of considering prompt and appropriate interventions such as CBT as a safe treatment option to prevent the aggravation of sleep and emotional problems for menopausal women.

Trial Registration

ClinicalTrials.gov Identifier: NCT05920460.

Sepsis policy, guidelines and standards in Canada: a jurisdictional scoping review protocol

Por: Sheikh · F. · Chechulina · V. · Daneman · N. · Garber · G. E. · Hendrick · K. · Kissoon · N. · Loubani · O. · Russell · K. · Fox-Robichaud · A. · Schwartz · L. · Barrett · K.
Introduction

To our knowledge, this study is the first to identify and describe current sepsis policies, clinical practice guidelines, and health professional training standards in Canada to inform evidence-based policy recommendations.

Methods and analysis

This study will be designed and reported according to the Arksey and O’Malley framework for scoping reviews and the Preferred Reporting Items for Systematic Review and Meta-Analyses Extension for Scoping Reviews. EMBASE, CINAHL, Medline, Turning Research Into Practice and Policy Commons will be searched for policies, clinical practice guidelines and health professional training standards published or updated in 2010 onwards, and related to the identification, management or reporting of sepsis in Canada. Additional sources of evidence will be identified by searching the websites of Canadian organisations responsible for regulating the training of healthcare professionals and reporting health outcomes. All potentially eligible sources of evidence will be reviewed for inclusion, followed by data extraction, independently and in duplicate. The included policies will be collated and summarised to inform future evidence-based sepsis policy recommendations.

Ethics and dissemination

The proposed study does not require ethics approval. The results of the study will be submitted for publication in a peer-reviewed journal and presented at local, national and international forums.

Trends in inequalities in avoidable hospitalisations across the COVID-19 pandemic: a cohort study of 23.5 million people in England

Objective

To determine whether periods of disruption were associated with increased ‘avoidable’ hospital admissions and wider social inequalities in England.

Design

Observational repeated cross-sectional study.

Setting

England (January 2019 to March 2022).

Participants

With the approval of NHS England we used individual-level electronic health records from OpenSAFELY, which covered ~40% of general practices in England (mean monthly population size 23.5 million people).

Primary and secondary outcome measures

We estimated crude and directly age-standardised rates for potentially preventable unplanned hospital admissions: ambulatory care sensitive conditions and urgent emergency sensitive conditions. We considered how trends in these outcomes varied by three measures of social and spatial inequality: neighbourhood socioeconomic deprivation, ethnicity and geographical region.

Results

There were large declines in avoidable hospitalisations during the first national lockdown (March to May 2020). Trends increased post-lockdown but never reached 2019 levels. The exception to these trends was for vaccine-preventable ambulatory care sensitive admissions which remained low throughout 2020–2021. While trends were consistent by each measure of inequality, absolute levels of inequalities narrowed across levels of neighbourhood socioeconomic deprivation, Asian ethnicity (compared with white ethnicity) and geographical region (especially in northern regions).

Conclusions

We found no evidence that periods of healthcare disruption from the COVID-19 pandemic resulted in more avoidable hospitalisations. Falling avoidable hospital admissions has coincided with declining inequalities most strongly by level of deprivation, but also for Asian ethnic groups and northern regions of England.

External validation of the QCovid 2 and 3 risk prediction algorithms for risk of COVID-19 hospitalisation and mortality in adults: a national cohort study in Scotland

Por: Kerr · S. · Millington · T. · Rudan · I. · McCowan · C. · Tibble · H. · Jeffrey · K. · Fagbamigbe · A. F. · Simpson · C. R. · Robertson · C. · Hippisley-Cox · J. · Sheikh · A.
Objective

The QCovid 2 and 3 algorithms are risk prediction tools developed during the second wave of the COVID-19 pandemic that can be used to predict the risk of COVID-19 hospitalisation and mortality, taking vaccination status into account. In this study, we assess their performance in Scotland.

Methods

We used the Early Pandemic Evaluation and Enhanced Surveillance of COVID-19 national data platform consisting of individual-level data for the population of Scotland (5.4 million residents). Primary care data were linked to reverse-transcription PCR virology testing, hospitalisation and mortality data. We assessed the discrimination and calibration of the QCovid 2 and 3 algorithms in predicting COVID-19 hospitalisations and deaths between 8 December 2020 and 15 June 2021.

Results

Our validation dataset comprised 465 058 individuals, aged 19–100. We found the following performance metrics (95% CIs) for QCovid 2 and 3: Harrell’s C 0.84 (0.82 to 0.86) for hospitalisation, and 0.92 (0.90 to 0.94) for death, observed-expected ratio of 0.24 for hospitalisation and 0.26 for death (ie, both the number of hospitalisations and the number of deaths were overestimated), and a Brier score of 0.0009 (0.00084 to 0.00096) for hospitalisation and 0.00036 (0.00032 to 0.0004) for death.

Conclusions

We found good discrimination of the QCovid 2 and 3 algorithms in Scotland, although performance was worse in higher age groups. Both the number of hospitalisations and the number of deaths were overestimated.

PAKistan Study of prEmature coronary atHerosclerosis in young AdulTs (PAK-SEHAT): a prospective longitudinal study protocol investigating the prevalence, severity and determinants of atherosclerotic cardiovascular disease in the young adult Pakistani popu

Por: Hanif · B. · Sheikh · S. · Peerwani · G. · Cainzos-Achirica · M. · Javed · W. · Baqar · J. B. · Samad · Z. · Bashir · F. · S Virani · S. · Nasir · K. · Aijaz · S.
Introduction

Atherosclerotic cardiovascular disease (ASCVD) is a major cause of morbidity, mortality and health expenditures worldwide. Despite having higher ASCVD in the Pakistani population, data on subclinical coronary atherosclerosis in young Pakistanis remain scarce. The PAKistan Study of prEmature coronary atHerosclerosis in young AdulTs (PAK-SEHAT) aims to assess the prevalence, severity and determinants of subclinical coronary atherosclerosis among Pakistani men (35–60 years) and women (35–65 years) free of clinically symptomatic ASCVD and will assess 5-year rates of ASCVD events.

Methods and analysis

PAK-SEHAT is an ongoing prospective cohort study with 2000 participants from all provinces of Pakistan who will be interviewed at the baseline along with phlebotomy, measurement of carotid intima-media thickness (CIMT) and coronary CT angiography (CCTA). Phlebotomy will be repeated at 2.5 years, whereas CIMT and CCTA will be repeated at 5 years. We will report the frequency of maximal coronary stenosis ≥50% and ≥70%, number of coronary vessels with plaque and the number of coronary segments affected per participant on CCTA. We will use Cox proportional hazards regression models to evaluate the association between baseline characteristics and incident ASCVD events during follow-up. These associations will be presented as HRs with 95% CIs.

Ethics and dissemination

The study protocol was approved by the Tabba Heart Institute Institutional Review Board (THI/IRB/FQ/22-09-2021/016). All study procedures are consistent with the principles of the Declaration of Helsinki. Findings of the study will be disseminated via peer-reviewed publications and conference presentations.

Trial registration number

NCT05156736.

Altered serum TNF-α and MCP-4 levels are associated with the pathophysiology of major depressive disorder: A case-control study results

by Jannatul Nayem, Rapty Sarker, A. S. M. Roknuzzaman, M. M. A. Shalahuddin Qusar, Sheikh Zahir Raihan, Md. Rabiul Islam, Zobaer Al Mahmud

Background

Major Depressive Disorder (MDD) is a debilitating mental health condition with complex etiology, and recent research has focused on pro-inflammatory cytokines and chemokines as potential contributors to its pathogenesis. However, studies investigating the roles of TNF-α and MCP-4 in MDD within the Bangladeshi population are scarce. This study aimed to assess the association between serum TNF-α and MCP-4 levels and the severity of MDD, exploring their potential as risk indicators for MDD development.

Methods

This case-control study enrolled 58 MDD patients from Bangabandhu Sheikh Mujib Medical University (BSMMU) Hospital, Dhaka, Bangladesh, alongside 30 age, sex, and BMI-matched healthy controls. MDD diagnosis followed DSM-5 criteria and disease severity using the 17-item Hamilton Depression Rating Scale (Ham-D). We measured serum TNF-α and MCP-4 levels using ELISA assays according to the supplied protocols.

Results

The study revealed significantly elevated serum TNF-α levels in MDD patients (47±6.6 pg/ml, mean±SEM) compared to controls (28.06±1.07 pg/ml). These increased TNF-α levels positively correlated with Ham-D scores (Pearson’s r = 0.300, p = 0.038), suggesting a potential association between peripheral TNF-α levels and MDD pathology. Additionally, MDD patients exhibited significantly higher serum MCP-4 levels (70.49±6.45 pg/ml) than controls (40.21±4.08 pg/ml). However, serum MCP-4 levels showed a significant negative correlation (r = -0.270, P = 0.048) with Ham-D scores in MDD patients, indicating a more complex role for MCP-4 in MDD pathogenesis.

Conclusion

This study highlights that Bangladeshi MDD patients exhibit heightened inflammatory and immune responses compared to controls, supporting the cytokine hypothesis in MDD pathogenesis. Serum TNF-α, but not MCP-4, shows promise as a potential biomarker for assessing the risk of MDD development, which could aid in early detection. Future investigations involving larger populations and longitudinal studies are essential to confirm the utility of these cytokines as biomarkers for MDD.

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