Cost-effectiveness of massed versus spaced trauma-focused treatment as first-line treatment for post-traumatic stress disorder in adults with multiple trauma exposure: protocol for a single-blind non-inferiority randomised controlled trial

Introduction
Post-traumatic stress disorder (PTSD) is a serious disorder that burdens individuals and society. The current standard of first-line treatment for PTSD is spaced trauma-focused treatment (S-TFT), involving weekly sessions. While effective, S-TFT may take relatively long to complete, especially in patients exposed to multiple potentially traumatic events (PTEs). Massed trauma-focused treatment (M-TFT), involving increased session frequency, potentially results in faster symptom reduction and restoration of quality of life, as well as in a reduction of societal costs. However, M-TFT is not recommended as first-line treatment. This paper describes the research protocol of a single-blind, multicentre randomised controlled trial (RCT) aimed at investigating: (1) the clinical and cost-effectiveness of M-TFT versus S-TFT in employed, multiply traumatised patients who seek first-line treatment for PTSD and (2) predictive and moderating factors related to treatment response.

Methods and analysis
186 participants are recruited from five centres and will be included if they are ≥18 years old, meet criteria for a Diagnostic and Statistical Manual of Mental Disorders Fifth Edition PTSD diagnosis based on ≥two PTEs, seek treatment for the first time and are employed. Patients with specified comorbid disorders and insufficient Dutch language proficiency are excluded. Participants are randomised to 800 min of either M-TFT or S-TFT. M-TFT consists of two once-weekly preparatory sessions, 10 twice-daily sessions of prolonged exposure, eye movement desensitisation and reprocessing therapy for 2 weeks and two once-weekly closing sessions. S-TFT consists of weekly sessions of one of five evidence-based treatment interventions. Outcomes are assessed at baseline and at 7 weeks, 17 weeks, 6 months and 9 months after baseline. Primary outcomes are clinical effectiveness in terms of PTSD symptom severity and cost-effectiveness based on quality of life measures and societal costs. Data will be analysed with linear mixed models.

Ethics and dissemination
This study protocol was approved by the Medical Ethics Review Board of the Amsterdam University Medical Center (NL86057.018.24). Participants will provide informed consent before enrolment in the trial. Results will be published in peer-reviewed journals and will be released to clinicians, patient groups and the general community.

Trial registration number
This protocol is registered at Overview of Medical Research in the Netherlands (OMON; trial register number 56960) and ClinicalTrials.gov (NCT06700590).

Read More

Assessment of the prevalence of stress, anxiety and depression in healthcare workers providing services related to communicable diseases in primary-level health units in Maputo city, Mozambique: an observational cross-sectional study protocol

Introduction
Mental health is essential for well-being and critical to the quality of care delivered by healthcare professionals. Health workers face increased risks of mental health disorders due to long hours, high emotional and physical demands, and exposure to communicable diseases, which exacerbate stress and anxiety levels. Evidence from low-income countries, including Mozambique, is scarce, yet health professionals in these regions frequently deal with the dual burden of communicable diseases and resource constraints. This study addresses a critical evidence gap by focusing on the mental health of healthcare professionals in Mozambique who are frequently exposed to psychological stress while managing communicable diseases. It aims to assess the prevalence of stress, anxiety and depression among healthcare workers providing services related to communicable diseases in primary-level health units (PHUs) in Maputo City, Mozambique. The study also seeks to identify personal and professional factors associated with these mental health disorders.

Methods and analysis
This is an observational cross-sectional study targeting healthcare workers in PHUs who provide services related to communicable diseases in Maputo City. Using convenience sampling, 382 participants will be recruited, stratified by health unit type. This sample size was calculated manually using the formula by Wang and Ji (2020). Data will be collected through a questionnaire, including demographic and professional information and a validated tool (Depression, Anxiety and Stress Scale, DASS-21), using the Research Electronic Data Capture (REDCap) Software for secure data capture. Descriptive and inferential statistical analyses will be performed using IBM SPSS Statistics to estimate prevalence rates and explore associated factors.

Ethics and dissemination
The study was approved by the Interinstitutional Committee on Bioethics in Health of the Faculty of Medicine/Maputo Central Hospital (CIBS FM&HCM/117/2024). Written informed consent will be obtained, and participants experiencing significant discomfort will be referred for mental health support. Findings will be disseminated via academic theses, peer-reviewed publications, national conferences, and reports shared with the Ministry of Health to inform mental health interventions for healthcare workers.

Registration
This protocol is registered with the Interinstitutional Committee on Bioethics in Health of the Faculty of Medicine/Maputo Central Hospital (CIBS FM&HCM).

Read More

Augmentation of trauma-focused psychotherapy for post-traumatic stress disorder: a protocol for a systematic review and meta-analysis

Introduction
Despite the established status of trauma-focused psychotherapy (TFP) as a first-line treatment for post-traumatic stress disorder (PTSD), a substantial proportion of individuals do not achieve clinically significant improvement or discontinue treatment. Exploring augmentation strategies to enhance treatment outcomes is essential to reduce the overall burden PTSD puts on individuals and society. This protocol outlines a systematic review and meta-analysis of randomised controlled trials (RCTs) evaluating the efficacy of non-pharmacological augmentation strategies in addition to TFP for PTSD treatment.

Methods and Analysis
We comprehensively searched PubMed, Embase, CENTRAL, PTSDpubs, PsycArticles, PsycINFO, PSYNDEX and CINAHL for RCTs without restrictions on publication dates or languages in October 2024. Study screening is currently ongoing. Additionally, we will perform forward and backward searches of the included studies and relevant reviews. Two reviewers will independently screen and select studies, extract data and assess the risk of bias. We will conduct a narrative review to qualitatively synthesise data and a meta-analysis to quantitatively compare the treatment efficacy of augmented TFP with TFP alone or TFP plus placebo. Primary outcomes will be both symptom severity and response rates. The secondary outcome will be dropout rates. We will explore sources of between-study heterogeneity and potential moderators through subgroup and meta-regression analyses. We will assess the overall quality of the included studies with the Grading of Recommendations Assessment, Development, and Evaluation system.

Ethics and dissemination
Ethical approval is not required. We intend to publish results in a peer-reviewed journal and provide materials and data through the Open Science Framework.

PROSPERO registration number
CRD42024549435.

Read More

Stepped wedge cluster randomised controlled trial to assess the impact of a decision support tool for physical restraint use in intensive care units (ARBORea Study): a study protocol

Introduction
Intensive care units (ICUs) manage patients with or likely to have one or more life-threatening acute organ failures that might require the use of invasive supportive therapies. The use of physical restraint is frequent, with rates up to 50%, and usually initiated to maintain patient safety especially if the patient is agitated. Physical restraints have been associated with delirium, post-traumatic stress disorder and physical injuries while restricting patients’ individual freedom. Moreover, the incidence of invasive therapeutic devices’ self-removal by patients might not be decreased by physical restraint use. No recommendation is available concerning ICU patients and physical restraint management, despite being a daily practice. The main objective is to evaluate whether a strategy aimed at decreasing physical restraint use in ICU patients with that of a strategy based on routine and subjective caregivers’ decision is safe and efficient.

Methods and analysis
ARBORea is a multicentre randomised, stepped-wedge trial testing an innovative, dedicated web-based, multiprofessionally developed, experts validated, nursing management strategy in comparison with standard care. The primary outcome is physical restraint use rate (effectiveness) measured at least every 8 hours and incidents’ rate (tolerance) defined as the rate of incidents attributable to non-compliance, corresponding to the deterioration or self-removal of critical devices, a fall or self-aggressive or heteroaggressive behaviours. Planned enrolment is 4000 ICU adult participants at 20 French academic and non-academic centres. Safety and long-term outcomes will be evaluated.

Ethics and dissemination
Trial results will be reported according to the Consolidated Standards of Reporting Trials 2010 guidelines. Findings will be published in peer-reviewed journals and presented at local, national and international meetings and conferences to publicise and explain the research to clinicians, commissioners and service users. The trial is funded by the French Ministry of Health and has been approved by the French local ethics committee (Comité de Protection des Personnes Sud-Ouest et Outre-Mer 2, Toulouse, France with registration number: 2020-A02904-35).

Trial registration number
(ClinicalTrials.gov) NCT04957238 on 12 July 2021 before first inclusion in study.

Read More

Association between problematic social media use and psychological distress among college students: a cross-sectional study in China exploring the mediating role of eating disorders

Objectives
This study aimed to examine the mediating role of eating disorders in the association between problematic social media use (PSMU) and psychological distress, including anxiety, depression and stress, among Chinese college students. The primary hypothesis was that eating disorders would partially mediate the relationship between PSMU and psychological distress.

Design
A cross-sectional study.

Setting
Participants were recruited from a vocational college in Jiangxi, China.

Participants
A total of 454 college students aged 18 years or older participated in the study. The median age was 19 years (IQR=18, 20), and 73.4% were male. Participants were included if they were enrolled in college and able to provide informed consent. Students undergoing psychological treatment or taking psychiatric medications were excluded.

Primary outcome measures
PSMU was assessed using the Bergen Social Media Addiction Scale, psychological distress was assessed using the Depression Anxiety Stress Scales-21 and eating disorder symptoms were assessed using the SCOFF questionnaire.

Results
PSMU was significantly associated with higher levels of psychological distress (r=0.321, p

Read More

Novel Perivascular Macrophage Mechanism to Promote Glymphatic Aβ Clearance After Stroke

Stroke, Ahead of Print. BACKGROUND:Parenchymal border macrophages (PBMs) reside at the interface between the central nervous system and the periphery. They are known to mediate the accessibility of the substances to the brain. However, no one has examined their role in poststroke Aβ (amyloid-β) clearance.METHODS:Permanent focal cerebral ischemia was induced in 8- to 10-week-old C57/Bl6 male mice by distal middle cerebral artery occlusion. The clodronate liposomes were administered into the cerebral spinal fluid at 7 days before stroke to deplete the PBM population. Sensorimotor and cognitive functions, glymphatic system, and Aβ accumulation were assessed for up to 34 days after stroke.RESULTS:The Aβ accumulated along brain blood vessels after stroke in both the ipsilateral and contralateral hemispheres. When PBMs were depleted, glymphatic drainage of Aβ was markedly reduced, and this was accompanied by deterioration of cognitive function, highlighting a critical role for PBMs in poststroke Aβ disposal. A possible mechanism relates to MANF (mesencephalic astrocyte-derived neurotrophic factor). MANF derived from PBMs suppressed astrocytic stress and maintained glymphatic drainage when supplemented into the cerebral spinal fluid. In the chronic phase of stroke, MANF production in PBMs was downregulated, and consequently, glymphatic impairments were exacerbated, which led to ongoing Aβ accumulation and cognitive decline.CONCLUSIONS:In summary, supplementation of MANF not only mitigates the adverse impacts of PBM depletion but also exerts therapeutic effects that improve glymphatic system function. We thus propose that this represents a promising strategy to prevent poststroke cognitive impairment.

Read More

“Broken Heart Syndrome” Tied to High Rehospitalization Rates

Takotsubo cardiomyopathy, nicknamed “broken heart syndrome,” is often triggered by intense emotional or physical stress and is characterized by temporary left ventricular dysfunction. Although the syndrome occurs in the absence of obstructive coronary artery disease and the left ventricular ejection fraction recovers after the acute phase, a cohort study showed that patients had a similar likelihood of hospital readmission to those with incident coronary artery disease.

Read More

Cardiac Arrest in Long-Distance Running

Millions of people participate in long-distance running, particularly marathons and half-marathons, annually. While the health benefits of regular exercise are well established, long-distance running can cause significant cardiovascular stress, potentially increasing the risk of cardiac arrest in individuals with underlying heart conditions. This concern is particularly notable as the number of middle-aged and elderly runners—a population at higher average cardiovascular risk than younger runners—continues to rise. Understanding the incidence, causes, and outcomes of cardiac arrest in long-distance runners is crucial for informing risk, identifying prevention strategies, and optimizing race-day medical preparedness.

Read More

Outcomes of participating in the Lets Play programme on 0-5-year-old autistic childrens engagement and caregivers stress: study protocol for a parallel randomised controlled trial

Introduction
Vast empirical evidence highlights the importance of early identification, diagnosis and support for autistic children. Caregivers of autistic children often experience high levels of psychological distress; hence there is a need for parallel child and caregiver support. Autism New Zealand’s Let’s Play programme is a caregiver-mediated, community-based programme based on the principles of developmental and relational interventions (henceforth, developmental). Developmental interventions are evidence-based supports designed to enhance children’s learning within the context of developmentally appropriate, naturalistic settings (eg, everyday routines, play). We aim to evaluate the effects of the Let’s Play programme on autistic children’s engagement and caregiver stress.

Methods and analysis
This study will be a single-blind (rater) randomised controlled trial with two parallel arms: immediate programme access (intervention) versus a waitlist control. Participants will be 64 caregivers of children aged 0–5 years with diagnosed or suspected autism, allowing for 20% attrition, based on power calculations. The Let’s Play programme will be delivered over 9 weeks using a combination of small group workshops and in-home coaching. Primary outcome variables include child engagement and caregiver stress. Caregivers will complete measures at three time points (baseline, immediately post-programme and at the 6-month follow-up), and effectiveness will be analysed using generalised estimating equation models and intention-to-treat and per protocol analyses.

Ethics and dissemination
This trial was approved by Aotearoa New Zealand Ministry of Health’s Health and Disability Ethics Committee (2022 FULL 13041). Findings will be communicated nationally and internationally via conferences, journal publications and stakeholder groups (eg, service providers for autistic children). Results will be shared regardless of magnitude or direction of effect.

Trial registration number
ACTRN12622001139763.

Read More

Prevalence of common mental disorders and sleep disorder among adolescents and young adults with HIV: a systematic review and meta-analysis

Objective
Adolescents and young adults (AYA) with HIV are a population at high risk of experiencing mental issues and sleep disorder. We aim to summarise the global prevalence and risks of depression, anxiety, post-traumatic stress disorder (PTSD) and sleep disorder among AYA with HIV.

Design
Systematic review and meta-analysis.

Data sources
PubMed, Web of Science, Embase and PsycINFO were searched from inception to 3 August 2024.

Eligibility criteria
Observational studies reporting the prevalence of depression, anxiety, PTSD or sleep disorder among AYA with HIV and published in English were included. Reviews, case reports, conference papers, notes, editorials and non-observational research were excluded.

Data extraction and synthesis
Titles, abstracts and full texts were reviewed and screened, and data were independently extracted. A modified Newcastle-Ottawa Quality Assessment Scale (NOS) was used to evaluate study quality. Heterogeneity was assessed by I2 statistics, and subgroup analysis was performed to identify the source of heterogeneity. The pooled prevalence and the risks of depression, anxiety, PTSD and sleep disorder by comparison with HIV-uninfected peers were measured with random-effects and fixed-effects models. Publication bias was examined using Egger’s correlation tests and funnel plot. The Grading of Recommendations Assessment, Development and Evaluation was used to assess the certainty of evidence.

Results
56 articles were included in the final analysis. According to the modified NOS, 13 (23.2%) studies were considered good, 38 (67.9%) were satisfactory and 5 (8.9%) were unsatisfactory. 51 studies including 21 735 AYA with HIV contributed data for the pooled prevalence of depression (28%, 95% CI 24% to 32%, I2=98.68%; low certainty evidence); 21 studies including 8021 cases contributed data for the pooled prevalence of anxiety (22%, 95% CI 17% to 27%, I2=98.35%; low certainty evidence); 9 studies including 3691 cases contributed data for the pooled prevalence of PTSD (12%, 95% CI 8% to 17%, I2=95.60%; low certainty evidence); and 4 studies including 1909 cases contributed data for the pooled prevalence of sleep disorder (51%, 95% CI 31% to 70%, I2=98.37%; low certainty evidence). Compared with AYA without HIV, those with HIV had a higher risk of depression (OR=2.67, 95% CI 1.63 to 5.90, I2=84.0%), anxiety (OR=1.89, 95% CI 1.32 to 2.69, I2=50.3%), PTSD (OR=1.58, 95% CI 1.23 to 2.04, I2=40.1%) and sleep disorder (OR=2.11, 95% CI 1.51 to 2.95, I2=0.0%). A subgroup analysis found that studies conducted in Asia had a lower prevalence of depression (21.7% vs 29.6%, p

Read More

Opioid-free anaesthesia and postoperative quality of recovery in patients undergoing supratentorial tumour resection: protocol for a randomised controlled trial

Introduction
Opioids play a pivotal role in being capable of effectively blocking the pain and stress responses triggered by procedures such as surgery and intubation. However, it should not be overlooked that opioids have numerous side effects, such as respiratory depression, postoperative nausea and vomiting. These effects can raise intracranial pressure, posing a life-threatening risk in neurosurgical patients. Opioid-free anaesthesia can prevent or significantly reduce opioid usage. The aim of this study is to investigate the effect of opioid-free anaesthesia on the quality of recovery in patients undergoing supratentorial tumour resection in neurosurgery.

Methods and analysis
This is a single-centre, randomised controlled clinical trial. A total of 170 patients receiving general anaesthesia will be randomised in a 1:1 ratio into two groups, one receiving opioid-free anaesthesia and the other receiving opioid-based anaesthesia. The primary outcome measure is the Quality of Recovery-15 Score on the second day after surgery. The secondary outcomes include the Quality of Recovery Score on the fifth day, the incidence of nausea and vomiting within 48 hours, the NRS Pain Score on the second and fifth days, the sleep quality on the second and fifth days after surgery, and the incidence of chronic pain at 3 months and 6 months after surgery.

Ethics and dissemination
This study received official approval from the Ethics Committee of Beijing Tiantan Hospital, Capital Medical University, on 9 September 2024 (KY2024-219-02). The findings of this study are intended to be disseminated through publications in international peer-reviewed journals, presentations at national and international academic conferences, and broad distribution via online platforms.

Trial registration number
ClincalTrials.gov, NCT06607029 (15 September 2024)

Read More

Prevalence of urinary incontinence among nulliparous women and its association with underweight body mass index: a secondary analysis of a nationwide cross-sectional study in China

Objectives
To estimate the prevalence of urinary incontinence (UI) and its subtypes among nulliparous Chinese women with associated risk factors. The prevalence of UI among those living in urban or rural communities was also analysed with potential risk factors.

Design
This is a secondary analysis of epidemiological survey data on UI in Chinese women. The original study was designed as a nationwide cross-sectional study involving 56 460 adult women conducted from October 2019 to December 2021.

Setting
Seven geographic regions of China.

Participants
Nulliparous women who were aged ≥20 years old and were permanent residents were included in this secondary analysis. Participants who had severe mental or physical disorders or were pregnant were excluded. Data on demographic characteristics, health status and medical history were collected.

Primary and secondary outcome measures
The primary outcome was the prevalence of UI, whereas secondary outcome measures were adjusted odds ratios (aOR) for risk factor analysis.

Results
A total of 6244 nulliparous women were included in the analysis. The prevalence of UI was 1.9% for nulliparous Chinese women, with stress, urgency and mixed UI being prevalent at 0.9%, 0.3% and 0.7%, respectively. The prevalence of UI was 2.1% and 1.6% for urban and rural subgroups. Abnormal body mass index was significantly associated with UI in the nulliparous group (underweight, aOR: 1.88, 95% CI: 1.03 to 3.45, p=0.041; overweight, aOR: 2.26, 95% CI: 1.37 to 3.73, p=0.001; and obesity, aOR: 3.64, 95% CI: 1.86 to 7.15, p

Read More