Study protocol for a pre-registered randomised open-label trial of ten-session cognitive behaviour therapy (CBT-T) for eating disorders: does stratified augmented treatment lead to better outcomes?

Introduction
Further improvement of cognitive–behavioural therapy for eating disorders (CBT-ED) is required that can provide better outcomes. Recent work showed that the length of therapy is not critical in improving outcomes. Rather, stratifying the treatment to individual needs is required to produce significant improvements. The current study adopts the approach of evaluating augmentations to ten-session CBT (CBT-T) where initial response to therapy is gradual rather than rapid.

Methods and analysis
Clients aged 15 years and over presenting to the Flinders University Services for Eating Disorders between January 2025 and June 2028 will be randomised to receive either CBT-T as usual or CBT-T augmented with therapy modules (CBT-TA) matched to obstacles to progress for gradual responders. Rapid response, assessed using the Eating Disorder Examination Questionnaire, is defined as ≥1.13 decrease in global ED psychopathology at session 4. In CBT-TA, the therapist and gradual responder will collaboratively choose at least one of nine augmentations to incorporate into therapy. Rapid responders in this group will be given access to the augmentations for use in their own time. Data for the main intent-to-treat analyses will be collected on five occasions: baseline assessment (T1), immediately preceding session 4 (T2), end of treatment (T3) and 3-month and 6-month follow-up (T4 and T5). The primary outcome is ED psychopathology, and secondary outcomes include behavioural indicators of the ED, impairment caused by the ED, general negative emotion, self-harm and hope. Analyses will be undertaken on an intention-to-treat basis and will include all participants in the group to which they were randomised.

Ethics and dissemination
Ethics approval was provided by the Social and Behavioural Research Ethics Committee at Flinders University (7992). This trial was prospectively registered with the Australian New Zealand Clinical Trials Registry (ACTRN12624001495516). The findings arising from the study protocol will be reported to participants and presented at scientific conferences and disseminated by publications submitted to peer-reviewed journals.

Trial registration number
Australian New Zealand Clinical Trials Registry (ACTRN12624001495516).

Leggi
Aprile 2025

[Articles] Interaction of brain imaging features and effects of intensive blood pressure lowering after endovascular treatment for acute ischaemic stroke: the pre-specified secondary analyses of ENCHANTED2/MT trial

Our study indicates that collateral status may help identify patients at risk from intensive blood pressure lowering treatment to a systolic target of 120 mm Hg or lower, in patients undergoing endovascular therapy for acute ischaemic stroke from large-vessel occlusion.

Leggi
Aprile 2025

Association of severity features and laboratory biomarkers with adverse maternal outcomes in pre-eclamptic women: a retrospective cohort study in an Ethiopian tertiary hospital

Objective
To examine the association between clinical severity features, laboratory biomarkers and adverse maternal outcomes in women diagnosed with pre-eclampsia–eclampsia syndrome.

Design
A retrospective cohort study design.

Setting
Ayder Comprehensive Specialized Hospital, a tertiary care hospital in Tigray, Ethiopia.

Participants
A total of 1095 women diagnosed with pre-eclampsia–eclampsia syndrome between 2015 and 2021 were consecutively included.

Outcomes
Adverse maternal outcomes, defined as a composite of intensive care unit (ICU) admission, need for haemodialysis, pulmonary oedema or death.

Methods
A multivariable binary logistic regression model was used to assess the association between pre-eclampsia severity features, laboratory biomarkers and adverse maternal outcomes. Adjusted odds ratios (AORs) were estimated with 95% CIs.

Results
Adverse maternal outcomes occurred in 100 (9.1%) of cases. Eclampsia (AOR=8.85, 95% CI 4.08 to 19.20), lower extremity oedema (AOR=2.28, 95% CI 1.06 to 4.90) and elevated creatinine levels (AOR=5.07, 95% CI 2.21 to 11.61) were significant predictors. Additionally, increasing maternal age was associated with a higher risk (AOR=1.07, 95% CI 1.00 to 1.13).

Conclusions
Clinical severity features (eclampsia and lower extremity oedema), laboratory biomarkers (elevated creatinine) and increasing maternal age were associated with unfavourable maternal outcomes. These findings highlight the importance of integrating clinical signs and laboratory biomarkers into risk assessment for pre-eclampsia patients.

Leggi
Aprile 2025

Predictors of HIV testing and status disclosure among young adolescents in postconflict settings: findings from a pre-post study design in Nimule per-urban town of South Sudan

Objective
To assess HIV testing and status disclosure rates and explore their associated predictors among young adolescents (10–17 years) who received health education through the Orphans and Vulnerable Children programme in Nimule, South Sudan.

Design
A pre–post evaluation study with data collected at baseline (December 2020) and at the endline (December 2022).

Setting
The study was conducted in Nimule, a densely populated periurban town characterised by high HIV prevalence and substantial cross-border movement between Uganda and South Sudan, making it a relevant setting for an HIV prevention project.

Intervention
The primary intervention was HIV risk education delivered through forty peer-led health clubs. Adolescents were screened for HIV risk factors and referred for HIV and other sexually transmitted infection testing at health facilities.

Participants
The study included young adolescents aged 10–17 years recruited from HIV-affected households within 17 neighbourhoods in Nimule periurban town. Informed consent was obtained from both caregivers and adolescents.

Primary and secondary outcome measures
The primary outcome was self-reported HIV testing and status disclosure. Binary logistic regression was used to assess the association between the study outcome variables and associated sociodemographic factors.

Results
A total of 557 (73.0%) of the 768 enrolled adolescents were surveyed at baseline and endline, including 301 (54.0%) females and 276 (46.0%) males. The median age was 14 years (IQR: 11–16) at baseline and 15 years (IQR: 12–17) at endline.
HIV testing increased from 315 (56.7%) at baseline to 557 (100%). The odds of undisclosed HIV status were 49% lower at endline adjusted OR (aOR) 0.51 (95% CI 0.92, 0.67; p

Leggi
Aprile 2025

Digital gamification-based pursed lip breathing exercises driven by Behaviour Change Wheel in patients with COPD: a feasibility trial protocol using pre-post study design

Introduction
Effective chronic obstructive pulmonary disease (COPD) interventions require intensive and repetitive exercises, yet their monotonous nature can reduce adherence. Innovative rehabilitation devices that are safe, user-friendly, engaging and cost-effective are crucial. This study introduces a digital gamification-based approach to pursed lip breathing (PLB) exercises, guided by the Behaviour Change Wheel (BCW) framework. The digital platform transforms traditional PLB into an interactive and enjoyable experience, enhancing motivation and adherence. Using a pre-post study design, this feasibility trial aims to assess the safety, feasibility and acceptability of the digital gamification PLB intervention protocol driven by the BCW framework installed on WeChat (DT-PLB) for home-based COPD management.

Methods and analysis
The methodology of this study is divided into two phases. Phase 1 refers to the development of the DT-PLB system based on research evidence, behavioural analysis from the insight of the BCW and stakeholders’ perspectives, and phase 2 points to present the pre-post trial design for the DT-PLB system consisting of five smartphone-based software interface modules: Ranking, Report, Daily PLB Tasks, Social Community and Mine. Eligible patients with COPD will be recruited from a university hospital in Sichuan Province, Mainland China. The DT-PLB will be conducted in non-hospital settings for patients with COPD for 10 min per session, three times a day on a daily basis for 8 weeks. Data collection will be conducted at two time points: baseline and post-intervention.
Demographic data (eg, age, gender and marital status) will be collected only at baseline. The primary outcome measures in this study will be a series of feasibility outcomes involving participant recruitment and completion of the DT-PLB intervention. Additionally, several clinical outcomes in terms of the effects of the DT-PLB intervention on dyspnoea, exercise capability, quality of life, and pulmonary function index will be evaluated as secondary outcomes.

Ethics and dissemination
This study has received Manchester Metropolitan University ethical approval (REC reference 56631) and the Affiliated Hospital of Southwest Medical University ethical approval (REC reference KY2023105). The findings from DT-PLB will be disseminated widely through peer-reviewed publications, scientific conferences and workshops. If successful, DT-PLB will be directly applied to the Affiliated Hospital of Southwest Medical University to manage PLB exercises.

Trial registration number
NCT06063733.

Leggi
Marzo 2025

Digital gamification-based pursed lip breathing exercises driven by Behaviour Change Wheel in patients with COPD: a feasibility trial protocol using pre-post study design

Introduction
Effective chronic obstructive pulmonary disease (COPD) interventions require intensive and repetitive exercises, yet their monotonous nature can reduce adherence. Innovative rehabilitation devices that are safe, user-friendly, engaging and cost-effective are crucial. This study introduces a digital gamification-based approach to pursed lip breathing (PLB) exercises, guided by the Behaviour Change Wheel (BCW) framework. The digital platform transforms traditional PLB into an interactive and enjoyable experience, enhancing motivation and adherence. Using a pre-post study design, this feasibility trial aims to assess the safety, feasibility and acceptability of the digital gamification PLB intervention protocol driven by the BCW framework installed on WeChat (DT-PLB) for home-based COPD management.

Methods and analysis
The methodology of this study is divided into two phases. Phase 1 refers to the development of the DT-PLB system based on research evidence, behavioural analysis from the insight of the BCW and stakeholders’ perspectives, and phase 2 points to present the pre-post trial design for the DT-PLB system consisting of five smartphone-based software interface modules: Ranking, Report, Daily PLB Tasks, Social Community and Mine. Eligible patients with COPD will be recruited from a university hospital in Sichuan Province, Mainland China. The DT-PLB will be conducted in non-hospital settings for patients with COPD for 10 min per session, three times a day on a daily basis for 8 weeks. Data collection will be conducted at two time points: baseline and post-intervention.
Demographic data (eg, age, gender and marital status) will be collected only at baseline. The primary outcome measures in this study will be a series of feasibility outcomes involving participant recruitment and completion of the DT-PLB intervention. Additionally, several clinical outcomes in terms of the effects of the DT-PLB intervention on dyspnoea, exercise capability, quality of life, and pulmonary function index will be evaluated as secondary outcomes.

Ethics and dissemination
This study has received Manchester Metropolitan University ethical approval (REC reference 56631) and the Affiliated Hospital of Southwest Medical University ethical approval (REC reference KY2023105). The findings from DT-PLB will be disseminated widely through peer-reviewed publications, scientific conferences and workshops. If successful, DT-PLB will be directly applied to the Affiliated Hospital of Southwest Medical University to manage PLB exercises.

Trial registration number
NCT06063733.

Leggi
Marzo 2025

Consequences of loneliness/isolation and visitation restrictions on the mood of long-term care residents without severe dementia pre-COVID-19 and during COVID-19: a scoping review

Background
Mental health disorders are common among residents of long-term care (LTC). Despite depression being the most common type of mental illness, it is often undiagnosed in LTC. Due to its prevalence, chronicity and associated morbidity, depression poses a considerable service use burden. The COVID-19 pandemic has brought needed attention to the mental health challenges faced by older adults in LTC.

Objectives
To explore the effects of isolation on the mood of LTC residents and compare between both the pre-COVID-19 and COVID-19 periods.

Design
A scoping review.

Methods
PubMed, CINAHL, PsycINFO, SCOPUS, Google Scholar and medRxiv were searched for studies that met the eligibility criteria: (1) articles assessing mood or mental health status of LTC residents; (2) mood disturbance resulting from visitation restrictions/isolation or loneliness; (3) residents were without severe dementia or moderate/severe cognitive impairment and (4) studies were available in English. Studies were excluded if their entire sample was residents with severe cognitive impairment or severe dementia. A total of 31 studies were included in this review. The total number of articles retrieved from the databases searched was 3652 articles, of which 409 duplicates were removed. 3242 article titles and abstracts were screened for eligibility, of which 3063 were excluded. The remaining 180 full-text studies were reviewed for eligibility, where an additional 149 studies were excluded. Data were then extracted from all full-length pieces for analysis, and findings were summarised.

Results
The review identified contradictory views with a diversity of findings highlighting the complexity of factors influencing residents’ mood during a global health crisis such as that of COVID-19. Studies highlighted the importance of quality interactions with others for the well-being of LTC residents. Significant correlations were found between social isolation, loneliness and depression. During COVID-19, visitation restrictions led to increased loneliness, depression and mood problems, especially among residents without cognitive impairment. However, some studies reported no significant adverse effects or even a decrease in depression symptoms during COVID-19 restrictions, possibly due to implemented strategies to maintain social engagement.

Conclusion
The COVID-19 pandemic had a substantial impact on LTC homes, influencing the physical and mental well-being of residents. This highlighted pre-existing challenges in the LTC system, emphasising the importance of comprehensive strategies to safeguard resident mental health. It is important to combine measures to ensure both physical safety and mental well-being.

Leggi
Marzo 2025