To explore the acceptability of the Community Outpatient Psychotherapy Engagement Service for Self-harm (COPESS) intervention and trial procedures for participants.

A mixed-method approach and a single-blind randomised controlled trial design with 1:1 allocation to either COPESS plus treatment as usual or treatment as usual alone.

Primary care.

Fifteen semistructured interviews were conducted with participants in the COPESS trial; eight were randomised to the intervention arm, and seven were randomised to the treatment-as-usual arm. Interviews lasted 30–60 min.

COPESS is a brief, relational psychotherapy delivered over 4 weekly sessions plus a follow-up, focusing on understanding difficult emotional states and their links to self-harm through here-and-now relational and emotional processes.

Thematic analysis allowed exploration of themes important to participants in their experiences in the COPESS trial and their experiences of care for self-harm more generally.

Five themes were identified as associated with the acceptability of the COPESS intervention and trial: self-harm as a primary problem, what I needed when I needed it, being heard and understood, online delivery of the intervention and lasting impacts. Participants generally expressed positive views about the intervention, citing a need for services that specifically target self-harm and an appreciation of the rapid access to help. Strong relationships with the therapist were highly valued and not diminished by online delivery of the intervention. Positive impacts continued post therapy sessions.

These results support the acceptability of the COPESS intervention, the need for self-harm specific services and support moving forward to a full trial.

Pre-registered on clinicaltrials.gov (NCT04191122) on 9 December 2019.

Miscarriage, defined in the UK as loss of pregnancy prior to 24 weeks gestation, can have long-term psychological implications. Clinical guidelines for perinatal bereavement care do not provide guidance on how best to support the mental health of women, and their partners, after miscarriage. Peer support (support from those who share common characteristics) is often sought, but there is little understanding of its access and use. We conducted a systematic review to understand the barriers to and facilitators of the implementation of peer support to improve mental health outcomes for parents after miscarriage.

Systematic review and thematic synthesis.

A comprehensive systematic search across nine databases (MEDLINE, CINAHL, APA PsycINFO, Web of Science (all databases), EMBASE, CENTRAL, LENS.org, British Nursing Index and Health Management Information Consortium) was conducted in June 2025. Grey literature was identified through website searching, contact with topic experts and a national Call for Evidence.

Qualitative and mixed-methods studies exploring motivations, experiences and preferences for peer support after miscarriage were included.

Two independent reviewers used standardised methods to search, screen, extract and code included studies. Suitable studies were evaluated using the Critical Appraisal Skills Programme Qualitative Research Checklist. Findings were extracted and subjected to a thematic synthesis.

Across nine studies included in the review, three overarching themes were developed, with seven subthemes, capturing both barriers and facilitators. ‘Engaging in relational recognition’ reflects the validation and connection that arise through experiential resonance, often heightened by the context of exclusion from broader social or clinical support. ‘Mechanisms of Communality’ describe how communality is enacted through dynamic peer interactions, including modelling and facilitating grief, benchmarking physical change and mattering through reciprocity, highlighting mutual support and shared coping. ‘Dynamics of Access’ consider factors which shape engagement, including changing needs of individuals across time and modalities of support and their effects.

These findings form the first synthesis of peer support after miscarriage and bring a nuanced service user perspective of barriers and facilitators by examining evidence from diverse studies. Peer support after miscarriage was seen to be a dynamic, relational process shaped by shared experience, mutual exchange and context-specific factors. Findings underscore key policy and practice considerations, including the use of trauma-informed, loss-sensitive approaches and consideration of intersectionality, that should be reflected when offering peer support services, with and for, those who have experienced miscarriage.

CRD42024518248.

Congenital malformations (CMs) are the leading cause of infant mortality. Still, the aetiology remains unknown in 70% of cases. The most accepted hypothesis is that hereditary and environmental elements concur in altering embryo-fetal development. Recently, the role of the environment has been emphasised.

Women are exposed to several xenobiotics during pregnancy. This review aims to study the available literature on the exposure of pregnant women to pesticides through drinking water to see if there is any evidence of correlation to the onset of any kind of congenital anomalies.

We will conduct a systematic literature review in The Cochrane Library, Embase and PubMed for studies published between 1 January 2005 and 31 January 2026. Articles will be included if they examine pregnant women as the study population, exposure to pesticide active ingredients and metabolites present in drinking water, and any type of CM in their children as the main outcome. The screening of title, abstract and full text as well as the data extraction will be conducted independently through two investigators. A third investigator will resolve any eventual conflicts. Each included study will be evaluated according to the NIH’s quality assessment tools. Grading of Recommendations Assessment, Development and Evaluation approach will be used for summarising and assessing certainty in the bodies of evidence produced by the review. This study is registered with PROSPERO, CRD420251063011.

The completed work will be published in a scientific journal for dissemination. Due to the nature of the study, an ethical approval is not necessary since no patient data or other information will be directly collected.

Burn injuries constitute a significant health concern, requiring immediate first aid to mitigate further tissue damage and complications. Most countries worldwide recommend application of 20 min of cool running water (20CRW) within 3 hours of the burn as the cornerstone in burn first aid management. Despite its widespread acceptance and proven benefits in reducing the severity of burns and subsequent interventions, concerns regarding the risk of hypothermia following this intervention persist, representing at least a perceived barrier to the delivery of 20CRW. When it does occur, hypothermia in patients with burns has been associated with higher mortality rates, even after controlling for burn injury severity. Developing an understanding of the incidence of post-burn hypothermia following 20CRW, with a specific focus on potential predictive and/or causative factors, is quintessential.

A retrospective cohort study of all adult and paediatric patients with thermal burn injuries presenting to one of 11 participating Australian or New Zealand hospitals between 1 January 2024 and 31 December 2024 will be conducted. The primary outcome is the incidence of hypothermia in patients with burns following their arrival at the emergency department (ED). Secondary outcomes include influence of burn first aid cooling, risk factors influencing hypothermia, impact of hypothermia on clinical patient outcomes and incidence of hypothermia in patients with burns in non-ED settings.

Ethical approval was granted by the Children’s Health Queensland Human Research Ethics Committee (CHQHREC; HREC Ref No: HREC/25/QCHQ/114285) as well as Health and Disability Ethics Committees, New Zealand (HDEC; Ref No: 2026 EXP 23892). The study findings will be formally disseminated through peer-reviewed journals and conference presentations.

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.

Clinical psychology interventions for reducing obesity have developed alongside pharmacological and surgical treatments, but usually as interventions for individual patients. Any healthcare intervention rests on a logic model: assumptions that through specific physical and social mechanisms, it will produce certain intended outcomes, provided that conducive background conditions (‘contexts’) exist. Using evidence from the feasibility trial preceding a full randomised controlled trial (RCT), this paper assesses the empirical validity of the initial logic model of a new group-based weight management intervention: PROGROUP, designed for patients with body mass index (BMI) ≥40 kg/m² or ≥35 kg/m² with comorbidities. We aimed to test whether:

Multimethod proof-of-concept study by means of realist evaluation of the initial PROGROUP logic model. We:

Specialised ambulatory mental health services in the English NHS.

Adults with severe obesity (BMI ≥40 kg/m² or ≥35 kg/m² with comorbidities).

Group-building techniques to enhance group members’ adoption of evidence-based methods of behaviour change affecting their dietary behaviour and physical activity.

Qualitative outcomes. What kinds of:

Quantitative measures not used.

The initial logic model assumed that the following sequence of mechanisms would produce weight loss: referral from GP to specialist weight management services; further referral to PROGROUP; preparatory individual consultation; facilitated group sessions produce a group identity; group identity reinforces weight management capability and motivation; further individual consultations adjust for individual circumstances; behaviour change outside the treatment setting, producing weight loss. Contexts necessary for these mechanisms to work included: sufficient catchment population; group size, continuity and membership retention; suitable location; facilitator training; and practical support outside the treatment setting.

The findings suggested revisions to the logic model, but more in the delivery components and contextual assumptions than the core therapeutic mechanisms. There was scope to simplify the referral mechanisms. Different professions could implement the model. A realist evaluation of a pre-RCT feasibility study can be used to make the intervention’s logic model more securely evidence-based, serving as a proof-of-concept test for the intervention. It indicated the conditions under which such group psychological interventions might be more widely used.

ISRCTN22088800.

Long-term brain health profiles following exposure to repetitive head impacts and/or concussions in contact sports are a public health focus and the subject of a national debate. The true prevalence rates of mild cognitive impairment (MCI) or neurobehavioural dysregulation are unknown in the nearly 20 000 current/living former professional football players. Here, we describe the procedures and methodology of the prevalence study of cognitive function in former professional football players from the Brain Health Initiative at the University of Pittsburgh. The objective is to define the prevalence of normal cognitive function versus neurodegeneration in former professional football players through clinical, neuroimaging and biomarker assessments.

Participants include former professional football players aged 29–59 years at study onset who played a minimum of three professional football games in three professional seasons and non-exposed controls. Participants are recruited by two mechanisms, a random and non-random sample. The full study protocol includes a 3–4-day, multidomain assessment (eg, neurological, neurocognitive, psychiatric, sleep, vestibular, orthopaedic and cardiovascular) for neurodegenerative disease and overall health and function, including MRI, positron emission tomography scans, analysis of blood plasma and cerebrospinal fluid, neurocognitive assessments, applanation tonometry, overnight sleep study and informant interview. A multidisciplinary clinical panel conducts a blinded diagnostic consensus conference to adjudicate the presence of MCI and/or traumatic encephalopathy syndrome, which serve as the study’s primary and secondary outcomes, respectively. Point prevalence of these for both the exposed and unexposed cohorts will be calculated as the primary statistical analysis.

The University of Pittsburgh Institutional Review Board approved the study prior to recruiting human subjects (protocol numbers STUDY19010008: sIRB - Brain Health Initiative (Part 1) and STUDY19030211: sIRB - Brain Health Initiative (Part 2)). The results will be disseminated in peer-reviewed journals and as presentations at national and international scientific conferences.

The primary objective of this clinical trial is to determine the clinical and cost-effectiveness of psychoeducation and emotional stabilisation (PES), together with eye movement desensitisation and reprocessing (EMDR) plus treatment-as-usual (TAU) in reducing symptoms of post-traumatic stress disorder (PTSD) among adults with intellectual disabilities compared with TAU. Secondary objectives include: (1) determining whether PES/EMDR plus TAU is superior to TAU in improving mental health problems and quality of life (QoL) among adults with intellectual disabilities who had a diagnosis of PTSD and (2) completing a process evaluation to examine intervention implementation and acceptability.

This is a two-arm parallel single-blind randomised controlled trial comparing PES-EMDR+TAU to TAU including an internal pilot phase. Outcome data will be captured prior to randomisation, and at 4 (after PES), 8 (after EMDR) and 14 months postrandomisation by masked assessors. 144 adults with intellectual disabilities with a diagnosis of PTSD will be allocated (1:1) randomly using minimisation from National Health Service (NHS) community and inpatients services for adults with intellectual disabilities in England. Participants are eligible to take part in this trial if: (1) they are aged 18 or older, but younger than 66, (2) have a Full Scale IQ

The primary outcome will be assessed using an intention-to-treat analysis. Baseline characteristics will be compared between arms to determine whether any potentially influential imbalance occurred. The primary outcome will be analysed by analysis of covariance, adjusting for baseline values of the outcome and any variables used in the randomisation process. Secondary outcomes will be analysed using linear or logistic regression models as appropriate reflecting the distribution of the outcome variable. The treatment effect will be estimated as an adjusted difference between sample means, presented with 95% CIs and p values. A complier average causal effect analysis will be considered should the data availability be sufficient to estimate the impact of non-compliance. A series of subgroup analyses on the primary outcomes will be considered considering differences in the Impact of Event Scale–Intellectual Disabilities scores at 14 months for (1) differing levels of general intellectual functioning and (2) PTSD versus complex PTSD.

This clinical trial was designed to allow for conclusions about whether PES/EMDR+TAU is efficacious in reducing symptoms of PTSD, relative to TAU, for adults with intellectual disabilities. A favourable ethical opinion has been received from an NHS ethics committee in the UK. The findings from this trial will be published within peer-reviewed journals and shared at national and international conferences. We will also aim to record and distribute podcasts detailing our findings together with our partners.

ISRCTN35167485.

Growing evidence suggests that vaccines targeting respiratory pathogens have non-specific and broader effects. We aimed to investigate the non-specific effects of respiratory vaccines on acute lower respiratory infection (ALRI) hospitalisations and associated outcomes in children

Systematic review and meta-analysis.

We searched online databases including Medline, Embase, CINAHL, Scopus and Clinical Trials.gov from inception to 24 January 2024.

We included human studies involving non-specific/off-target effects of respiratory vaccines (including maternal, infant and childhood vaccines) and excluded studies investigating the Bacille Calmette-Guérin vaccine and non-pathogen-confirmed outcomes following pneumococcal conjugate vaccination (PCV).

We used Research Screener, a machine learning tool, to semi-automate the abstract screening process and Covidence, a management and streamlining software for full-text reviews and data extraction. A meta-analysis was conducted if four or more studies reported on the same outcome and the same exposure vaccine.

After removing duplicates, 9727 articles were identified. After screening and full-text reviews, 20 articles were eligible. Of those, four met the requirements for a meta-analysis which showed a 21% vaccine effectiveness (VE) (95% CI 8.0% to 32.0%) of maternal influenza vaccine against all-cause ALRI hospitalisations in infants

Our review demonstrated both protective and neutral non-specific effects of respiratory vaccines against ALRI-hospitalisations and related outcomes in young children. Such effects should be considered as part of the full value of a vaccine and how vaccine investments are prioritised. Further research on the impact of respiratory vaccines on antibiotic prescribing rates is essential as consistent reductions may help contribute to reducing the global burden of antimicrobial resistance.

CRD 42023476038.

VALTIVE1 is a multi-centre, single-arm, non-interventional biomarker study for patients with advanced ovarian cancer. Plasma samples (Tie2 concentration) are collected to detect vascular control in tumours during standard treatment with chemotherapy and bevacizumab. This qualitative study embedded in VALTIVE1 aimed to assess the acceptability and feasibility of a potential VALTIVE2 trial. It explored the participants’ perceptions of the study and treatments and how they might feel if bevacizumab were discontinued based on the results from the biomarker test.

This qualitative study used semi-structured telephone interviews, which were analysed using deductive and inductive thematic analysis.

Cancer treatment sites in the UK.

Participants recruited to VALTIVE1 were invited to take part in qualitative interviews. 11 female participants took part from four clinical sites.

Participants reported that they experienced side effects attributed to bevacizumab, including stiffness, pain, fatigue, nose bleeds and muscle aches. Participants felt that combining chemotherapy and bevacizumab may have increased the severity of the side effects they experienced. Most participants felt that it was acceptable, if not preferable, to be allocated to a group in a future VALTIVE2 study where bevacizumab may be discontinued according to the results from the biomarker test. A clear preference of participants was to be informed of the biomarker test results, health status and treatment side effects.

A future trial should consider ensuring all participants have access to test results, as participants indicated a preference to know whether bevacizumab was working and to discontinue bevacizumab if it had not prevented tumour growth based on the biomarker results. Comprehensive and ongoing information and support regarding treatment side effects should be provided to all participants throughout their cancer pathways and trials.

NCT04523116.