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.

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.

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.

NCT04996433.

Postdischarge surveys are critical in collecting patient-reported experience measures (PREMs) and patient-reported outcome measures (PROMs), but response rates vary and are often low.

To assess determinants that are associated with survey completion by phone in a complex medical care setting.

Secondary analysis of a prospective controlled interrupted time series analysis.

As part of the non-randomised controlled In-HospiTOOL trial, a survey was conducted to gather data on PREMs and PROMs in multimorbid patients from seven hospitals in Switzerland.

31 103 medical acute care hospitalisations among seven intervention hospitals who were eligible for the survey.

Over a 6-month pre-intervention phase (August 2017 through January 2018) and a subsequent 12-month intervention phase (February 2018 through January 2019), patients were contacted by phone 30 days after hospital admission.

The primary outcome was responsiveness to the survey. We assessed group differences between responders and non-responders, and associations of patient characteristics with survey completion were estimated using generalised estimating equations.

Of 31 103 eligible patients, 25 557 (82.2%) completed the survey 30 days after hospital admission. Responders were marginally older than non-responders (median (IQR) age, 73 (60–82) years vs 72 (57–82); standardised mean difference (SMD), –0.08), were more likely to be Swiss (81.9% vs 74.4%; SMD, –0.18), to have private healthcare insurance (22.9% vs 17.9%; SMD, 0.12), to be living at home before admission (85.7% vs 78.6%; SMD, 0.18) and to be less frail (67.4% vs 59.1%; SMD, 0.18). A longer length of stay (OR 0.98; 95% CI 0.97 to 0.99), discharge to a non-home institution (OR 0.50; 95% CI 0.46 to 0.54) and rehospitalisation within 30 days (OR 0.78; 95% CI 0.68 to 0.89) is associated with a decreased responsiveness.

The study shows that achieving a high survey response rate among vulnerable acute care patients is feasible, which in turn allows for the effective identification of key determinants and enhances the collection of information on patients’ experiences and outcomes.

ISRCTN83274049.

Prescribing high-dose antipsychotics is typically reserved for individuals with treatment-resistant severe mental illnesses, such as schizophrenia, bipolar disorder and psychotic depression. It carries an increased risk of adverse drug effects, necessitating regular monitoring. Non-mental health specialist clinicians may not always be aware when the maximum recommended dose of antipsychotics is exceeded, leading to unintentional high-dose prescribing without recognising the need for additional monitoring or understanding the associated risks. Therefore, providing clinical decision support (CDS) tools to support clinicians and improve the appropriate prescribing of antipsychotics is important. The aim of this study is to understand current prescribing practices and assess the impact of high-dose antipsychotic prescribing on clinical outcomes among hospitalised patients. The findings from this study will shape a future project focused on developing an integrated computerised CDS tool.

This retrospective cohort study will examine antipsychotic prescribing among hospitalised patients using Hospital Electronic Prescribing and Medicines Administration data in Scotland from 2019 to 2023, in linkage with hospital records, Scottish Morbidity Records and primary care prescribing (Prescribing Information System). Patients will be grouped into those prescribed high-dose (exposed), defined as exceeding the 100% maximum recommended British National Formulary dose and normal-dose (unexposed) antipsychotics, followed from their first ever antipsychotic prescription date (index date) until the end of the study, study outcomes or death, whichever happens first. We will quantify high-dose antipsychotic prescribing, profile patient characteristics and use machine learning techniques to assess associations of high-dose antipsychotic prescribing with clinical outcomes, including harms and benefits, but will not attempt to establish causality.

The Health and Social Care Public Benefit and Privacy Policy Panel (HSC-PBPP) has granted ethical approval (ref. 2024-0239) following a Data Protection Impact Assessment, with data securely held and accessed in the National Safe Haven. The results will be published in international peer-reviewed journals and will be shared with clinicians.

Internationally, the vision of a ‘Digital Trustworthy Evidence Ecosystem’ is being pursued with clinical practice guidelines (CPGs) as one element of such a system. Consequently, CPGs and CPG repositories need to be digitalised.

The objective of this prospective, before-after study is to evaluate the impact of digitalising a quality-assured CPG registry using the international data format standard ‘Fast Healthcare Interoperability Resources’ (FHIR). This includes the architecture of the registry, the format of individual guidelines and application programming interfaces to import and export CPG content. The study is guided by a scoping review.

The primary outcome is the usability of the digitalised CPG registry and CPG content for different user groups comprising CPG developers, CPG administrators, health care professionals and patients—including at the point of care in in- and outpatient settings—and technical professionals as users of CPG content in digital applications.

For the before-after comparison, semi-quantitative (surveys) and qualitative (focus groups) methods are applied. All user groups will be involved in a baseline analysis to assess user expectations and technical requirements. According to the results, the digitalised guideline registry will be implemented. The intervention comprises the testing of the digitalised registry with guideline content by all user groups. Analysis of outcomes will include formative and summative evaluation. Final results and further research needs will be discussed in a World Café with all stakeholders.

The Ethics Committee of the Berlin chamber of physicians, in accordance with its code of conduct §15 section 1 (Eth-KB-24-11) confirmed that no ethical approval is needed for this study. The study is registered in the German Clinical Trials Registry (No: DRKS00034111). Results will be presented at national and international conferences, published in peer-reviewed journals and on the website of the funding institution.

German Clinical Trials Registry (No: DRKS00034111).