Protocol for 'Re: CBT Dialysis: a realist evaluation–why, for whom and in what circumstances does cognitive behaviour therapy work for people with depressive symptoms receiving dialysis?

Introduction
Nearly 40% of adults receiving life-saving dialysis for kidney failure report depressive symptoms. With more than 40 000 Canadians on dialysis, this is a significant health burden. Cognitive behavioural therapy (CBT) has been shown to be effective for treating depressive symptoms; however, it is rarely considered or used for people receiving dialysis. The aim of this realist study is to evaluate and explain how, why, for whom and in what circumstances therapist-guided and remotely delivered CBT works in order to provide equitable mental healthcare to individuals with depressive symptoms receiving dialysis.

Methods and analysis
The project will include a realist synthesis, a quantitative cohort study and a realist evaluation. Realist methodology is a theory-driven approach that seeks to explain how generative mechanisms are shaped by contextual features, giving rise to outcome patterns. We will begin by developing an initial programme theory (IPT) from the literature and interviews with CBT therapists to understand how CBT is intended to work and for whom. We will use data from the quantitative cohort study to identify contexts that may shape outcome patterns in CBT for people receiving dialysis. This includes previously collected survey data and data from a longitudinal cohort study, both sourced from people across Canada undergoing dialysis. We will test and refine the IPT using data from a realist evaluation and existing literature. The realist evaluation will involve participants from the quantitative cohort study who received therapist-guided, remotely delivered CBT.

Ethics and dissemination
Ethical approvals have been granted. We have planned a wide range of dissemination strategies: journal manuscripts and conference presentations, executive memos for administrators of renal programmes in Canada, an online inventory of resources for depressive symptoms and presentations of findings together with patient partners at all participating sites.

PROSPERO registration number
CRD42023476184.

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Remote ischaemic preconditioning in cemented hip arthroplasty (the PRINCIPAL study)–randomised controlled trial: study protocol

Introduction
Total hip arthroplasty (THA) is an effective treatment for severe osteoarthritis. However, THA has a high surgical risk for patients with concomitant diseases and is associated with several serious complications, such as myocardial infarction, acute kidney injury and cognitive dysfunction. This study will explore the potential protective effects of remote ischaemic preconditioning (RIPC) in cemented THA patients.

Methods and analysis
The PRINCIPAL study is designed as a randomised, controlled, parallel-group, blinded trial to assess the impact of RIPC in cemented THA patients. The study will compare two patient groups—one group will have the RIPC procedure, and the second will have the sham procedure. The primary outcome is the peak troponin T concentration during the three postoperative days. Secondary outcomes include markers of arterial stiffness (augmentation index (AIx), carotid-femoral pulse wave velocity, central blood pressures), neural (neuron-specific enolase, S100B) and renal injury biomarkers (estimated glomerular filtration rate, creatinine, cystatin C), markers of systemic inflammation (hypoxia-inducible factor 1-alpha, interleukin (IL)-6, IL-1β, tumour necrosis factor-alpha, IL-10) and oxidative stress (total peroxide concentration, total antioxidant capacity), as well as clinical outcome measures such as major adverse cardiovascular events and all-cause mortality.

Ethics and dissemination
The ethical board of the University of Tartu has granted approval for the study (no. 384T-26). The results of this study will be disseminated in international peer-reviewed journals.

Trial registration number
NCT06323018.

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Exploring cognitive function and postoperative neurocognitive recovery after cardiac surgery in older adults (ECPON): a protocol for an observational study

Introduction
Cardiovascular disease is one of the most common health issues facing the older population, and the number of older adults undergoing cardiac surgery is expected to increase. Postoperative neurocognitive impairment is a frequent and often unrecognised complication that can adversely affect a patient’s recovery, quality of life and daily activities, as well as impact the lives of their family members. Patients may express cognitive difficulties as a feeling of ‘not being the same since the operation’. This study aims to investigate the factors that influence neurocognitive function and patient-reported cognitive symptoms among patients aged 65 and older following cardiac surgery, and explore the impact on the overall postoperative recovery. Additionally, the study aims to describe the perspectives of close relatives on the recovery process.

Methods and analysis
A longitudinal observational study with a mixed-methods approach will be conducted in two thoracic surgical departments in Sweden. A total of 220 patients and 1 close relative for each patient will participate. Neurocognitive function will be assessed preoperatively and at 1, 3 and 6 months postoperatively using a digitalised neurocognitive test battery. We will also evaluate postoperative patient-reported cognitive symptoms and signs, delirium, frailty, health-related quality of life, depression, perceived self-efficacy, fatigue and functional capacity. Each patient’s close relative will assess the observed cognitive function and report on caregiver burden. At the 6-month mark, a purposive sample of patients and their close relatives will be interviewed to explore their experiences of postoperative cognitive recovery.

Ethics and dissemination
The study has been approved by the Swedish Ethical Review Authority (Reference number: 2024-03380-01) and will adhere to the Helsinki Declaration and its amendments. The results will be disseminated through peer-reviewed journals and scientific conferences, as well as presented in various popular science forums and patient organisations.

Trial registration number
NCT06469515; Pre-results.

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Effect of perioperative haemodynamic management based on cerebral autoregulation monitored by Cerebral Oximetry Index during carotid endarterectomy: protocol of a randomised trial

Introduction
Impaired cerebral autoregulation is associated with postoperative ischaemic brain injury and often occurs in patients with carotid artery stenosis. Adequate cerebral perfusion should therefore be maintained during carotid endarterectomies. Whether guiding intraoperative blood pressure to the Cerebral Oximetry Index (a measure of cerebral perfusion adequacy) reduces postoperative cerebral ischaemia remains unclear.

Methods and analysis
We plan a dual-centre randomised blinded trial. A total of 560 patients having elective carotid endarterectomy will be randomly assigned to guided versus routine haemodynamic management. In patients randomised to guided management, mean arterial pressure will be titrated to maintain a normal cerebral oximetry index. In the routine care group, mean arterial pressure will be targeted to within 20% of individual preoperative baseline values. The primary outcome will be the incidence of new ischaemic brain injury within 3 days after surgery assessed by brain imaging, with or without clinical symptoms. Secondary outcomes include the incidence of postoperative delirium, cognitive function and pain severity.

Ethics approval and dissemination
The study protocol (V.1.2, 1 January 2025) has been approved by the Medical Ethics Committee of Beijing Tiantan Hospital, Capital Medicine University (KY2024-049-03) and Xuanwu Hospital, Capital Medical University (LYS2025-023-001). The findings of the study will be disseminated in a peer-reviewed journal and at a scientific conference.

Trial registration number
NCT06406842.

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Skills for adolescent WELLbeing (SWELL): protocol for a preventive effectiveness randomised controlled trial for young people at high-familial risk of depression with treatment optimisation for parents with depression at study entry comparing online group cognitive behavioural therapy (CBT) with treatment as usual

Introduction
Young people (YP) whose parents have depression are at elevated risk for developing depression themselves and could benefit from preventive interventions. However, when parents are in a depressive episode, this reduces the effects of psychological interventions for depression in YP. Moreover, parental depression is often managed suboptimally in usual care. There is, therefore, a case for identifying and optimising parental depression treatment to enhance the effectiveness of psychological preventive interventions for depression in YP.

Methods and analysis
This is a randomised controlled trial (Skills for adolescent WELLbeing) to determine the effectiveness of a cognitive behavioural therapy (CBT) intervention compared with usual care in increasing the time to a major depressive episode in YP by 9-month follow-up (primary outcome). The intervention offers a 12-week treatment-optimisation phase for parents depressed at study entry, followed by randomisation of the young person to a small group manualised online CBT programme facilitated by a therapist. YP allocated to the intervention will receive eight weekly sessions plus three monthly continuation sessions. Secondary outcomes include the number of depression-free weeks, mental health symptoms and functioning. Mechanisms of intervention action will be assessed with mediation analysis of quantitative data and thematic analysis of qualitative interviews. Participants (parents/carers with depression and their children aged 13–19 years) will be identified through existing cohorts of adults with depression, from primary care through health boards in Wales and England, UK, schools and advertising including via social media.

Ethics and dissemination
The trial has received ethical approval from Wales NHS Research Ethics Committee (REC) 5, the Health Research Authority and Health and Care Research Wales (IRAS 305331; REC 22/WA/0254). This manuscript is based on V.5.7 of the protocol (17 January 2025). Findings will be disseminated in peer-reviewed journals and conferences. Reports and social media messages will be used to disseminate findings to the wider public.

Trial registration number
ISRCTN13924193 (date registered: 15 March 2023).

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Arterial, Venous, and Cerebrospinal Fluid Flow and Pulsatility in Stroke-Related Cerebral Small Vessel Disease: A Longitudinal Analysis

Stroke, Ahead of Print. BACKGROUND:Cerebral small vessel disease (SVD) causes up to 45% of dementias and 25% of ischemic strokes, but the understanding of vascular pathophysiology is limited. We aimed to investigate the contribution of pulsatility of intracranial arteries, veins, and cerebrospinal fluid (CSF) and cerebral blood flow to long-term imaging and clinical outcomes in SVD.METHODS:We prospectively recruited participants in Edinburgh/Lothian, Scotland, with lacunar or nonlacunar ischemic stroke (modified Rankin Scale score ≤2, as controls) and assessed medical and brain magnetic resonance imaging characteristics at baseline and 1 year (2018–2022). We used phase-contrast magnetic resonance imaging to measure flow and pulsatility in major cerebral vessels and CSF to investigate independent associations with baseline white matter hyperintensity (WMH) and perivascular space (PVS) volumes and their progression, as well as with recurrent stroke, functional, and cognitive outcomes at 1 year. We applied linear, logistic, and ordinal regression models in our analysis.RESULTS:We recruited 210 participants; 205 (66.8% male; aged 66.4±11.1 years) had useable data. In covariate-adjusted analyses, higher baseline arterial pulsatility was associated with larger volumes of baseline WMH (B=0.26 [95% CI, 0.08–0.44];P=0.01) and basal ganglia PVS (B=0.12 [95% CI, 0.04–0.20];P

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Understanding medical students transition to clinical training: a qualitative study of transformative learning and professional identity formation

Introduction
The transition from preclinical to clinical training represents a pivotal stage in medical education, offering opportunities for transformative learning and professional identity formation. This study aims to explore how medical students reflect on their initial clinical learning experiences during the first week of clinical training, and how these reflections reveal early shifts in their professional identity, using Mezirow’s transformational learning framework.

Method
A qualitative descriptive study was conducted at VinUniversity, Hanoi, Vietnam. 47 fourth-year medical students from a single cohort submitted reflective writings after their first week of clinical training. Thematic analysis was performed, with emergent themes mapped against the dominant phases of Mezirow’s transformational learning framework.

Results
Thematic analysis revealed four main themes: (1) disorientation and emotional adaptation, (2) bridging theory and practice, (3) learning from the clinical environment and (4) personal and professional growth. Reflections revealed both emotional and cognitive shifts, highlighting students’ early adaptation and growth. Findings emphasised the need for enhanced mentorship, emotional resilience training and tailored bilingual communication strategies to optimise the transition.

Conclusions
Reflective writing captured students’ first impressions of clinical training and highlighted the critical role of emotional adaptation, mentorship and experiential learning in supporting identity formation. These insights offer practical implications for enhancing student support strategies and curriculum design in medical education.

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Effectiveness of music with auditory beat stimulation in reducing state anxiety in Canadian students with trait anxiety: protocol for a randomised controlled trial

Introduction
Undergraduate students report a high level of trait anxiety, which is a risk factor for further psychological decline if unmanaged. Music-based interventions are cost-effective and have been found to improve indices of anxiety. More recently, music with auditory beat stimulation (ABS) has been shown to improve symptoms of anxiety to a greater extent than music alone. While there is limited empirical evidence, music interventions with ABS may also be effective at targeting neurophysiological markers of anxiety. The aim of this study is to evaluate the effectiveness of a novel music with ABS intervention on self-report and neurophysiological indices of anxiety in undergraduate students with trait anxiety. It is hypothesised that relative to a pink noise control, listening to music with ABS will lower self-reported anxiety, reduce salivary cortisol, increase heart rate variability, increase theta and alpha-band electroencephalography (EEG) power and decrease beta and gamma-band EEG power.

Methods and analysis
Fifty Canadian undergraduate students who self-report experiencing anxiety will be recruited for this two-arm randomised controlled trial. Participants will be randomised to a single music session with ABS or pink noise; each intervention ranges from 24 min to 27 min. Outcomes will be assessed at baseline and immediately following the intervention and will be self-reported anxiety and affect (the State-Trait Inventory of Cognitive and Somatic Anxiety and the Self-Assessment Manikin), salivary cortisol, heart rate variability measured by ECG and cortical measures of anxiety (measured by EEG). Repeated measures analyses of covariance will be performed to evaluate the effect of condition assignment on outcome measures.

Ethics and dissemination
This study will be conducted under the Declaration of Helsinki. This study was approved by the Toronto Metropolitan University Research Ethics Board (REB-2020-068) and registered on ClinicalTrials.gov (NCT05442086). The findings of this study will be published in a peer-reviewed journal.

Trial registration number
NCT05442086.

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Implementing innovative technology promoting self-awareness of brain health and self-determination in obtaining a timely dementia diagnosis: protocol for a multimethods, concurrent, two-part observational study

Introduction
Diagnosis in the early stages of dementia can lead to successful delay in associated cognitive decline. However, up to 76% of Australians diagnosed with dementia have already advanced beyond the early stage of disease. BrainTrack is an evidence-based mobile application (app) designed in Australia to promote brain health self-awareness, self-determination to promote help-seeking and, ultimately, a timelier dementia diagnosis. We will evaluate user experience, implementation and social return-on-investment outcomes of BrainTrack and will report dementia-related concerns, dementia literacy, knowledge, stigma and motivation for behaviour change and explore their associations with demographic characteristics.

Methods and analysis
A multimethods, concurrent, two-study observational design will be used. Study 1 will evaluate BrainTrack user experience and implementation outcomes, changes in users’ dementia literacy, dementia knowledge, perceptions of dementia-related stigma and help-seeking at five time points (baseline, 1, 3, 6 and 12 months). People residing in all states and territories of Australia will be recruited to the study via the BrainTrack app. Data collection will occur online and through teleconferencing. Approximately 1000 participants will complete all five surveys. Google Analytics data will measure adoption. App usage data will identify app use patterns. A sample of continuing app users (~n=80) and those who cease app use within 6 months (~n=20) will be interviewed to obtain in-depth information about their app use and help-seeking experience. Dementia Australia Helpline data will quantify help-seeking calls triggered by BrainTrack use. In Study 1, longitudinal outcomes will be analysed using mixed models. The economic and social value of BrainTrack will be assessed using social return on investment analysis. In Study 2, general practitioners (~n=20) currently practising in Australia will participate in semi-structured interviews conducted via online teleconferencing. Interviews will elicit perceptions of the usefulness of BrainTrack for initiating and facilitating discussions with patients about cognition and dementia. Qualitative data will be analysed thematically, followed by deductive analysis guided by the Theoretical Domains Framework.

Ethics and dissemination
This study has received Human Research Ethics Committee approval from Deakin University Human Research Ethics Committee (Study 1: HREC Reference Number 2022–220) and Deakin University Human Ethics Advisory Group, Faculty of Health (Study 2: Reference Number 202_2022). Informed consent will be obtained prior to participation, either verbally for interviews or online for surveys. Study findings will be published in peer-reviewed journals and communicated to key stakeholders.

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Randomised controlled trial to compare the efficacy of integrated cognitive-behavioural therapy (COPE-A) for substance use and traumatic stress among adolescents and young adults delivered via telehealth versus in person: trial protocol

Introduction
Emerging research indicates that integrated treatment of co-occurring post-traumatic stress disorder (PTSD) and substance use disorder can be effective among adolescents and young people. However, various barriers exist to young people accessing evidence-based treatments. Telehealth offers an opportunity to address these barriers and provide a scalable and accessible alternative to inperson treatment. This paper describes the study protocol for a randomised controlled trial (RCT) examining the efficacy, safety and cost-effectiveness of an integrated trauma-focused cognitive-behavioural treatment for traumatic stress and substance use among adolescents and young adults (Concurrent Treatment of PTSD and Substance Use Disorders Using Prolonged Exposure – Adolescent and Young Adult version (COPE-A)) when delivered in person compared with via telehealth.

Methods and analysis
A two-arm, parallel group, single-blind, non-inferiority RCT with follow-up at 4 months and 12 months post study entry will be conducted in Sydney, Australia. Participants (170 adolescents and young adults aged 12–25 years) will be allocated to receive COPE-A either in person or via telehealth (allocation ratio 1:1) using minimisation. Project psychologists will administer treatment via both modes of delivery over a maximum of 16 sessions of 60–90 min. The primary outcome will be between-group differences in change in the severity of PTSD symptoms from baseline to 4-month follow-up, as measured by the Clinician-Administered PTSD Scale for Children and Adolescents for the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition.

Ethics and dissemination
This study has been approved by the Sydney Children’s Hospitals Network Human Research Ethics Committee (2024/ETH01050). Research findings will be published in peer-reviewed journals and presented at scientific conferences.

Trial registration number
ACTRN12624000776505.

Protocol version
V.2.3, 20 March 2025.

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Protocol for a prospective cohort study to determine the multimodal biomarkers of delirium and new dementia after acute illness in older adults: ORCHARD-PS

Introduction
Delirium is common in the older hospital population and is often precipitated by acute illness. Delirium is associated with poor outcomes including subsequent cognitive decline and dementia and may therefore be a modifiable risk factor for dementia. However, the mechanisms underpinning the delirium–dementia relationship and the role of coexisting acute illness factors remain uncertain. Current biomarker studies of delirium have limitations including lack of detailed delirium characterisation with few studies on neurodegenerative or neuroimaging biomarkers especially in the acute setting. The Oxford and Reading Cognitive Health After Recovery from acute illness and Delirium—Prospective Study (ORCHARD-PS) aims to elucidate the pathophysiology of delirium and subsequent cognitive decline after acute illness in older adults, through acquisition of multimodal biomarkers for deep phenotyping of delirium and acute illness, and follow-up for incident dementia.

Methods and analysis
ORCHARD-PS is a bi-centre, prospective cohort study. Consecutive eligible patients requiring acute hospital admission or assessment are identified by the relevant acute clinical care team. All patients age >65 years without advanced dementia, nursing home residence, end-stage frailty or terminal illness are eligible. Details of potential participants are communicated to the research team and written informed consent or consultee agreement is obtained. Participants are interviewed as soon as possible after admission/assessment using a structured proforma.
Data are collected on demographics, diagnosis and comorbidities, social and functional background. Delirium is assessed using the 4A’s test, Confusion Assessment Method (long-form), Observational Scale of Level of Arousal, Richmond Agitation-Sedation Scale and Memorial Delirium Assessment Scale and diagnosed using the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition criteria. Delirium is categorised by time of onset (prevalent vs incident), dementia status, motoric subtype, severity and duration. Cognitive tests include the 10-point Abbreviated Mental Test and Montreal Cognitive Assessment. Participants are reassessed every 48–72 hours if remaining in hospital. Informant questionnaire data and interview are supplemented by hand searching of medical records and linkage to electronic patient records for nursing risk assessments, vital observations, laboratory results and International Classification of Diseases, Tenth Revision diagnostic and procedure codes.
In-person follow-up with more detailed cognitive testing and informant interview is undertaken at 3 months, and 1 and 3 years supplemented with indirect follow-up using medical records. Blood banking is performed at baseline and all follow-ups for future biomarker analyses. CT-brain and MRI-brain imaging acquired as part of standard care is obtained for quantification of brain atrophy and white matter disease/stroke supplemented by research CT-brain imaging. Outcomes include length of hospitalisation, change in care needs, institutionalisation, mortality, readmission, longitudinal changes in cognitive and functional status and incident dementia. Biomarker associations with delirium, and with incident dementia on follow-up, will be determined using logistic or Cox regression as appropriate, unadjusted and adjusted for covariates including demographics, baseline cognition, frailty, comorbidity and apolipoprotein E genotype.

Ethics and dissemination
ORCHARD-PS is approved by the South Central—Berkshire Research Ethics Committee (REC Reference: 23/SC/0199). Results will be disseminated through peer-reviewed publications and conference presentations.

Trial registration number
ISRCTN24171810.

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Effects of work cessation on cognitive functioning in rural older adults in China: a cross-sectional study based on CHARLS

Objectives
This study investigated the effects of work cessation on cognitive function among older adults in rural China. Given that cognitive disorders affect 6.04% of individuals aged 60 and above—with higher prevalence in rural areas—understanding this relationship is critical.

Design
A cross-sectional study was employed, using data from the 2020 wave of the China Health and Retirement Longitudinal Study (CHARLS). Regression analysis assessed the impact of work cessation on cognitive function and the moderating effects of social activities, health behaviours and internet use.

Setting
Data were collected from 150 districts, 450 villages, and urban community units in China.

Participants
The study included 6,318 participants, with 4,045 currently employed and 2,273 no longer working.

Main outcome measures
Cognitive function was evaluated using measures of mathematical computation, temporal and image cognition, and situational memory was tested through 20 memory-related questions. Explanatory variables included work cessation status, while moderating variables encompassed social activities, health behaviours (smoking and alcohol consumption) and internet use.

Results
Work cessation has a negative impact on cognitive function, particularly situational memory and overall cognitive ability. Stopping work was associated with a decrease in cognitive functioning by 0.796 SD (p

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Effectiveness of cognitive stimulation for individuals with mild cognitive impairment: a systematic review and meta-analysis

Objective
Cognitive stimulation (CS) is a non-pharmacological intervention aimed at enhancing cognitive function. However, the effectiveness of CS in individuals diagnosed with mild cognitive impairment (MCI) remains inconclusive. Therefore, this study aimed to assess the effectiveness of CS in improving cognitive function, psychological well-being, instrumental activities of daily living (IADL) and quality of life (QoL) in individuals with MCI, based on randomised controlled trials (RCTs).

Design
Systematic review and meta-analysis.

Data sources
Six English databases were systematically searched, including PubMed, Web of Science, Embase, Cumulative Index to Nursing and Allied Health Literature, American Psychological Association PsycInfo and Academic Search Premier.

Eligibility criteria
RCTs about CS for individuals with MCI, published between January 2003 and December 2024.

Data extraction and synthesis
Data were extracted and assessed using the revised Cochrane risk of bias tool for randomised trials by independent researchers. The meta-analysis was conducted using the standardised mean difference (SMD) and 95% CIs of the included studies.

Results
The meta-analysis included five eligible studies for the primary outcomes of cognitive function and three eligible studies for the secondary outcomes of psychological wellness. In the pooled samples, the CS intervention had a significant effect on cognitive function (SMD=0.63, 95% CI 0.25 to 1.01; p=0.001) and depression symptoms (SMD=–0.29, 95% CI –0.55 to –0.03; p=0.03) in individuals with MCI. However, no significant improvements in anxiety symptoms were identified after the CS intervention (SMD=–0.05; 95% CI –0.31 to 0.21; p=0.71).

Conclusion
The CS intervention can effectively improve cognitive function and alleviate depression symptoms. Although a meta-analysis was not conducted for IADL and QoL due to the limited number of included studies, positive trends in enhancing IADL performance and augmenting QoL were observed in individuals with MCI. However, due to the scarcity of relevant studies in this research field, more comprehensive RCTs are warranted to provide a better understanding of the potential benefits of CS and to guide its clinical application in the future.

PROSPERO registration number
CRD42023494685.

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