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Efficacy, moderators and mediators of cognitive behavioural analysis system of psychotherapy (CBASP) versus behavioural activation (BA) in persistently depressed treatment-resistant inpatients: study protocol for the multicentre, randomised controlled cha

Por: Brakemeier · E.-L. · Klein · J. P. · Zimmermann · J. · Hollandt · M. · Reinhard · M. A. · Boger · S. · Daldrup · L. · Eldem · L. · Gebhardt · P. · Heinrich · S. · Hirsmueller · M. · Millerowski · J. · Richter · M. · Ridderbusch · I. C. · Suerig · S. · Schroeter · L. · Velten-Schurian
Introduction

Up to 30% of individuals with depression develop persistent depressive disorder (PDD), an often disabling and difficult to treat condition. The Cognitive Behavioural Analysis System of Psychotherapy (CBASP) is the only psychotherapy developed specifically for treating individuals with PDD. While several randomised controlled trials (RCTs) have demonstrated its efficacy in outpatient settings, evidence for its use in inpatient settings remains limited. Pilot studies of CBASP inpatient programmes in Germany have shown promising feasibility and effectiveness; however, no RCTs to date have systematically evaluated their outcomes. This study represents the first RCT to compare the short- and long-term efficacy and safety of CBASP with Behavioural Activation (BA), a first-line psychotherapy for depression, within an intensive multimodal inpatient setting.

Methods and analysis

In this prospective, multicentre, rater-blinded RCT with an active control group, we aim to recruit 396 adults (aged 18–70 years) with treatment-resistant PDD at eight German university hospitals. Participants will be randomly assigned to receive either (1) CBASP or (2) BA within an intensive treatment programme consisting of 10 weeks acute treatment in an inpatient and/or day clinic setting, followed by 6 weeks of outpatient continuation treatment. Primary and secondary outcome assessments will be conducted at multiple time points: baseline (T0), treatment onset (T1), after 5 and 10 weeks of acute treatment (T2, T3), at the end of continuation treatment (T4, week 16) and every 2 months up to week 64 (T5, naturalistic follow-up).

The primary outcome measure will be the change in depression severity, as assessed by the Hamilton Depression Rating Scale (24-item version), after 16 weeks of treatment (from T0 to T4). Secondary outcomes will include response, remission, deterioration and relapse rates, self-reported depression and anxiety symptoms and additional psychological variables. A cost-benefit analysis will evaluate the health-economic benefits of both interventions. Additionally, this RCT will explore personalised treatment selection and mechanisms of change, including potential moderators and mediators of treatment effects. The findings from this trial are expected to provide clinicians with evidence-based guidance on choosing CBASP versus BA for inpatients with treatment-resistant PDD.

Ethics and dissemination

This study has received ethical approval from the ethics committees of all participating university hospitals. All participants will provide written informed consent before enrolment. Study findings will be published in peer-reviewed journals and presented at national and international conferences. We have involved people with lived experience from the earliest pilots onward, using their feedback to refine our study design. Ongoing consultation at conferences and public events has further ensured that our research remains grounded in patient perspectives.

Trial registration number

NCT04996433.

Telerehabilitation versus face-to-face programme on electrical stimulation and neck exercises for non-specific neck pain: a study protocol for a randomised controlled trial

Introduction

Neck pain is a common issue among the working-age population, with a high recurrence rate and one of the highest healthcare costs globally. Exercise is proposed as one of the key components in managing this condition, and electrotherapy is established as a safe and proven analgesic measure. Telemedicine improves access to healthcare by removing geographical barriers and reducing costs, allowing consultations from any location and supporting the work-life balance of the patient.

Objective

The aim of this study is to compare the efficacy of e-Health versus a face-to-face programme in the therapeutic management of non-specific neck pain through exercise and analgesic electrotherapy.

Methods and analysis

A randomised clinical trial with 100 participants suffering from non-specific neck pain will be conducted. Participants will be evenly divided into two groups to receive analgesic electrotherapy combined with a cervical exercise programme delivered either via an e-Health programme or face-to-face programme. A total of 24 sessions will be administered over 8 weeks. Data collected will include demographic and clinical information, disability, pain intensity, fear of movement, sleep quality, catastrophising, quality of life and range of motion. Assessments will be conducted at the start of the study (baseline), at 8 weeks (post-treatment), and 2 months after completing the intervention (follow-up).

Ethics and dissemination

This protocol has been approved by the Andalusian Biomedical Research Ethics Coordinating Committee (SICEIA) with number register (SICEIA-2024-000820) on 25 September 2024. Findings will be disseminated through publications in peer-reviewed journals and presentations at international and national conferences.

Trial registration number

ClinicalTrials.gov (NCT06842381).

Validity, Reliability and Responsiveness of Wound‐QoL‐14 Quality of Life Questionnaire in Patients With Diabetes Related Foot Ulcers

ABSTRACT

Diabetes related foot ulcers (DFU) are associated with significant physical, psychological and social dysfunction. Measuring the impact of treatments on patients' overall well-being is vital to ensure care is holistic. This study aimed to validate the Wound-Qol-14 quality of life assessment tool in people with a DFU. A single centre longitudinal prospective validation study in people with DFUs was conducted. Wound-Qol-14, Diabetic Foot Ulcer Scale—Short Form (DFS-SF) and EuroQol 5 dimensions 5 levels (EQ-5D-5L) were completed by people with DFUs at baseline and 6 months. Wound-Qol-14 was repeated within 7 days of the first questionnaire. Correlation coefficients with a cut off of ≥ 0.7 were used to assess convergent validity, divergent validity and responsiveness to changes in DFU severity. Reliability was assessed using Cronbach's α. The study aimed to recruit 100 people. One hundred and seven people were recruited. The mean age was 62 (SD 13) years and 85 (79.4%) were male. The mean DFU duration was 30 (SD 83) days and the mean DFU area was 6.2 (SD 10.7) cm2. Convergent validity was demonstrated in all domains of Wound-Qol-14 and DFS-SF (r − 0.695 to −0.799) except burden/bothered about ulcer care domains (r = −0.443). There was moderate correlation between Wound-Qol-14 domains and EQ-5D-5L dimensions (r = 0.477–0.501). Cronbach's α ranged from 0.683 to 0.919 for the domains of Wound-Qol-14. Wound-Qol-14 was not responsive to changes in DFU severity (r = −0.291; 95% CI −0.501 to −0.048) but was responsive to healing status (healed 1.14 [IQR 0.86] vs. unhealed 1.86 [IQR 1.47]; p = 0.017). Wound-Qol-14 is a valid and reliable tool to measure disease-specific quality of life in people with DFUs. Further work is needed to refine the responsiveness. EQ-5D-5L should be used to measure generic quality of life in people with DFUs.

Assessment of knowledge, attitudes and practices regarding antimicrobial resistance among primary health care prescribers in Imo State, Nigeria: implications for digital health readiness

Por: Basil · I. C. · Ekeleme · U. G. · Udujih · O. G. · Dozie · U. W. · Iwuala · C. · Ibe · S. · Nwoke · E. · Mbakwem · B. · Okoro · L. I. · Uzoma · F. C. · Okoroama · C. L. · Uzoma · M.-J.
Introduction

Antimicrobial resistance (AMR) is one of the most urgent global health threats, responsible for an estimated 4.95 million deaths annually, including 1.27 million directly linked to drug-resistant infections. Nigeria is particularly affected, ranking 19th globally in AMR-related mortality, with an estimated 64 500 attributable and 263 400 associated deaths in 2019. These estimates are likely conservative due to limited surveillance. Economically, AMR could cost Nigeria 5%–7% of its GDP by 2050.

Despite this burden, antibiotic misuse remains widespread, with 42% of adults and over 46% of children under 5 receiving antibiotics without prescriptions. At the primary healthcare (PHC) level, where most antibiotics are prescribed, challenges such as limited diagnostics, inconsistent prescription and poor access to digital tools hinder effective antimicrobial stewardship (AMS).

Objectives

The primary objective of this study is to assess the knowledge, attitudes and practices regarding antimicrobial resistance (AMR) among PHC prescribers in Imo State, Nigeria. A secondary objective is to explore preliminary indicators of their digital readiness to inform future technological interventions for AMS.

Design

A cross-sectional study using an online questionnaire.

Setting

PHC facilities across all 27 local government areas of Imo State, Nigeria.

Participants

A purposive sample of 547 facility-based public PHC prescribers included 84% of all facility Officers-in-Charge of health facilities in the state and 16% of other PHC workers who were involved in prescription.

Primary and secondary outcome measures

The primary outcome measures were composite scores for knowledge (adequate/inadequate), attitude (positive/negative) and prescribing practice (good/poor), derived from a validated questionnaire. Secondary measures included sources of AMR information and indicators of digital readiness.

Results

While 77.1% demonstrated adequate knowledge, only 32.7% exhibited positive attitudes and 88.5% reported poor prescribing practices. Attitude was the strongest predictor of good practice (OR=17.585, p

Conclusions

These findings underscore a critical gap between knowledge and practice, driven in part by limited access to digital decision-support tools. To address the documented gaps in tool access and training, strengthening digital inclusion through context-adapted e-learning, offline-compatible AMS tools and simplified digital antibiograms is a necessary implication for improving antibiotic stewardship and clinical outcomes at the PHC level.

Functional decline and social support in older patients during hospitalisation: a cross-sectional study of some determinants of care in a poor resource setting, Southeast Nigeria

Por: Anyigor-Ogah · C. S. · Ekechi · A. N. · Chukwuonye · M. E. · Nweke · I. C. · Idika · I. M. · Ovuoba · C. M.
Introduction

There is a high level of older people neglect in Nigeria, especially in the rural setting, and they did not receive much attention in terms of their overall health and well-being. Government social interventions are usually geared towards the children, adolescents, pregnant women and lactating mothers. Evaluating the level of functional decline and social support among these groups and how it affects their overall well-being will enable policy formulations geared towards holistic care for them. This study aimed to determine the level of functional dependence in some basic activities of daily living (ADLs: mobility, dressing, grasp and bathing) and social support in older people to enhance evidence-based advocacy to all stakeholders in older people care.

Methods

This was a hospital-based cross-sectional study of 160 (75 males and 85 females) older people aged 65–98 years selected through systematic random sampling. The 2 test, t-test and logistic regression were used for analysis.

Results

The response rate was 100%. The mean age of male respondents was 76.31±8.34 years and that of the female respondents was 76.87±7.47 years. A statistically significant association was found between age >75 years, absence of a spouse, low education level and functional dependence in all ADLs studied. Although age independently predicted dependence in all studied ADLs, except dressing and grasp, marital status predicted dependence in dressing and bathing, and availability of care also predicted dependence in mobility.

Conclusion

Age is an independent risk factor for functional dependence in mobility and bathing, and marital status independently predicted dependence in dressing and bathing. Not receiving care also independently predicted dependence in mobility. Thus, improvements in the biopsychosocial, biomedical and economic well-being of older people will ameliorate the impact of poor care on functional status and ADLs.

Gender- and sex-sensitive psychopharmacotherapy of alcohol use disorder: a systematic review and meta-analysis protocol

Por: Hiss · I. C. · Hoffmann · S. · Reinhard · I. · Siegmann · E.-M. · Bach · P. · Kiefer · F. · Fischer · R. · Jäger · K. · Lenz · B.
Introduction

Alcohol use disorder (AUD) is a prevalent, chronic condition generating considerable global morbidity, mortality and socioeconomic burden. Despite the availability of established pharmacotherapies, overall treatment uptake remains low and effect sizes are moderate at best. Emerging evidence highlights substantial differences in treatment response between sexes and genders, yet these factors are rarely systematically considered in clinical trials or routine care. Existing reviews have limited scope and often exclude gender-diverse populations. This project aims to (1) Synthesise evidence on gender- and sex-specific efficacy, safety and adherence in AUD pharmacotherapies, (2) Evaluate the consideration of sex and gender beyond binary classifications in existing research and (3) Develop recommendations for gender- and sex-sensitive treatment strategies.

Methods and analysis

A systematic review and meta-analysis will be conducted using (PubMed, Web of Science, Scopus, Google Scholar, German Clinical Trials Register and ClinicalTrials.gov). We will include randomised controlled trials of pharmacotherapies for AUD with a minimum treatment duration of 4 weeks, reporting gender-specific and/or sex-specific results. The literature search will cover studies published up to October 2025, with inclusion restricted to articles published in English or German, regardless of setting. Two reviewers will independently screen records and assess risk of bias (Cochrane RoB), with evidence certainty evaluated using Grading of Recommendations Assessment, Development and Evaluation and aligned to Preferred Reporting Items for Systematic Reviews and Meta-Analyses 2020 and Sex and Gender Equity in Research guidelines.

Ethics and dissemination

Ethics approval is not required as only data from already completed studies and supplementary information directly provided by study authors are used. Findings and recommendations will be disseminated in peer-reviewed journals and presented at conferences and workshops.

PROSPERO registration number

CRD420251079160.

Extracorporeal Shockwave Therapy for Diabetes Related Foot Ulcers: A Pilot Three‐Arm Double‐Blinded Randomised Controlled Trial

ABSTRACT

There is an urgent need for effective interventions to aid diabetes-related foot ulcer (DFU) healing. This study aimed to test the deliverability of a proposed trial of extracorporeal shockwave therapy (ESWT) for DFU healing. A pilot double-blinded randomised controlled trial. Patients with a DFU present for ≥ 4 weeks were randomised to high dose (500 shocks/cm2), low dose (100 shocks/cm2) or sham (0 shocks/cm2) ESWT, plus standard care. Follow-up was for 24 weeks. Primary outcome was deliverability of the trial. Secondary outcomes were healing, quality of life and healthcare resource use. One-hundred and forty-one (15.6%) screened patients were eligible and 74 (52.5%) patients were recruited. Follow-up attendance was 97.3% (72/74), 93.2% (69/74) and 87.8% (65/74) at 6, 12 and 24 weeks. The median DFU healing time was high dose: 54.0 (IQR 119.0), low dose: 78.5 (IQR 61.0) and sham: 83.0 (IQR 85.0) days. The mean EQ-5D-5L utility value at 24 weeks was high dose: 0.621 (95% CI 0.438–0.804), low dose: 0.779 (95% CI 0.683–0.876) and sham: 0.806 (95% CI 0.717–0.895). Healthcare resource use was lowest in the low-dose ESWT arm. The pilot trial has demonstrated that patients with a DFU are willing to engage in the proposed trial and suggest the optimal way to deliver the definitive trial.

Global mapping of oral health plans, programmes and policies in countries with universal health coverage: a scoping review protocol

Introduction

This review aims to map oral health plans, programmes and policies worldwide in countries with universal health coverage.

Methods and analysis

This protocol describes a scoping review that will follow the Joanna Briggs Institute methodology and the Preferred Reporting Items for Systematic Reviews and Meta-Analyses-Scoping Review checklist, guided by the PCC framework: Population—countries with universal health coverage (78 globally recognised); Concept—oral health plans, programmes and policies; Context—integration into health systems. Searches will be conducted in MEDLINE (PubMed), Scopus, Web of Science, Embase, Health System Evidence and Epistemonikos, with no restrictions on date, language or study type. Grey literature will be accessed through Google Scholar, OpenThesis and the Brazilian Digital Library of Theses and Dissertations. Official documents from ministries of health and international bodies, including the WHO and the International Monetary Fund, will also be reviewed. Two independent reviewers will screen titles and abstracts; a third will resolve disagreements. Eligible records will undergo full-text review. Data will be extracted into predefined categories reflecting health system components: population, structure, services, governance and oral health indicators. Results will be presented using tables, charts and figures to illustrate strategies and innovations.

Ethics and dissemination

This review does not involve primary data collection and does not require ethical approval. Results will be disseminated through a peer-reviewed publication and presentations at academic conferences and scientific events.

Study registration

Open Science Framework (DOI 10.17605/OSF.IO/RCP8N).

Characterisation of a clinical trial-like population of high cardiovascular risk patients prior to myocardial infarction or stroke in the real world: design and protocol for a multidatabase retrospective cohort study

Por: Ochs · A. · Chan · Q. · Dhalwani · N. N. · Duxbury · M. · Shannon · E. · OKelly · J. · Paiva da Silva Lima · G. · Avcil · S. · Chan · A. Y. · Chui · C. S. · Lai · E. C.-C. · Cars · T. · Shin · J.-Y. · Heintjes · E. M. · Wong · I. C.
Introduction

Cardiovascular (CV) disease is the leading cause of morbidity and mortality globally. Low-density lipoprotein cholesterol (LDL-C) is an important modifiable risk factor of major adverse cardiovascular events. Patients without prior myocardial infarction (MI) or stroke but with established risk factors and elevated LDL-C may benefit from intensive lipid-lowering therapy (LLT); however, the size and potential healthcare burden of this population globally are not known. The benefits of evolocumab, a proprotein convertase subtilisin/kexin type 9 inhibitor, in these patients, are currently being studied in the phase 3 Effect of Evolocumab in Patients at High Cardiovascular Risk Without Prior Myocardial Infarction or Stroke (VESALIUS-CV) trial. To characterise the high-risk pre–CV-event (VESALIUS-CV–like) individuals in the real world, an observational study is being conducted across multiple countries.

Methods and analysis

This retrospective cohort study will use a common protocol and an analytical common data model approach to characterise VESALIUS-CV–like individuals in the real world across different geographical regions and healthcare settings. The study period will be from 2010 to 2022, subject to data availability in study sites. Patients aged 50 years and older at high risk of CV disease but without prior MI or stroke will be included in this study. VESALIUS-CV–like individuals are defined through a combination of the following: (1) one diagnosis of coronary artery disease, cerebrovascular disease, peripheral artery disease or diabetes with microvascular complications or chronic insulin use; (2) an elevated LDL-C measurement and (3) other high-risk factors. The objectives of this study are to estimate the prevalence of VESALIUS-CV–like individuals, describe their characteristics and care pathways and estimate their incidence rates of CV events and healthcare costs. The prevalence of VESALIUS-CV–like individuals will be expressed as annual prevalence; patient characteristics at index date will be presented using summary statistics; care pathways will be summarised as LLT prescription across time; and the incidence of defined CV events will be expressed as events per person-years as well as at certain time periods. Healthcare costs will be presented as CV-related costs in different time periods.

Ethics and dissemination

Approvals of the study protocol were obtained from relevant local ethics and regulatory frameworks for each participating database. The results of the study will be submitted to peer-reviewed scientific publications and presented at scientific conferences.

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