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ObjectivesThe current study aimed to explore participants’ views on the acceptability, impact and mechanisms of change of Augmented Depression Therapy (ADepT), a novel wellbeing-focused and recovery-oriented psychological therapy for depression.DesignA semi-structured qualitative interview design was used, with data analysed using the framework approach.Participants20 participants with anhedonic depression who had received up to 20 sessions of ADepT, sampled from a pilot randomised controlled trial of ADepT versus Cognitive Behavioural Therapy (CBT).SettingA primary care psychological therapy clinic in Devon, UK, with interviews occurring between May 2018 and February 2020.ResultsParticipants found the wellbeing focus of ADepT acceptable. Helpful aspects of therapy were a positive therapeutic bond, the structure and flow of therapy scaffolding the learning journey, the tools and techniques of therapy helping building wellbeing and booster sessions supporting long-term recovery. Negative aspects for some participants were therapy feeling too intense and triggering feelings of failure. Participants reported significant positive impacts of treatment on wellbeing, functioning and hope. Perceived mechanisms of change were reorienting to the positive, engaging with valued goals, taking a proactive life stance, gaining confidence and motivation for change, breaking down tasks into small steps, cultivating self-care and self-compassion, enhancing help seeking and interpersonal effectiveness, changing the relationship to depression, and rediscovering the self beyond depression.ConclusionsFindings suggest that the wellbeing focus of ADepT is acceptable and leads to positive impacts, supports the logic model underpinning the intervention, and warrants continuation to a definitive trial.Trial registration numberISRCTN85278228.

IntroductionAttention deficit/hyperactivity disorder (ADHD) is a prevalent and impairing cluster of traits affecting 2%–5% of children. These children are at risk of negative health, social and educational outcomes and often experience severe difficulties at school, so effective psychosocial interventions are needed. There is mixed evidence for existing school-based interventions for ADHD, which are complex and resource-intensive, contradicting teachers’ preferences for short, flexible strategies that suit a range of ADHD-related classroom-based problems. They are also poorly evaluated. In this study, a prototype intervention comprising a digital ‘toolkit’ of behavioural strategies will be tested and refined. We aim to refine the prototype so that its use is feasible and acceptable within school settings, and to establish whether a future definitive, appropriately powered, trial of effectiveness is feasible. This novel iterative study aims to pre-emptively address implementation and evaluation challenges that have hampered previous randomised controlled trials of non-pharmacological interventions.Methods and analysisA randomised iterative mixed-methods case-series design will be used. Schools will be randomised to the time (school term) they implement the toolkit. Eight primary schools and 16–32 children with impairing traits of ADHD will participate, along with school staff and parents. The toolkit will be refined after each term, or more frequently if needed. Small, theory-based and data driven changes hypothesised as relevant across school contexts will be made, as well as reactive changes addressing implementation barriers. Feasibility and acceptability will be assessed through quantitative and qualitative data collection and analyses in relation to study continuation criteria, and ADHD symptoms and classroom functioning will be tracked and visually evaluated to assess whether there are early indications of toolkit utility.Ethics and disseminationEthical approval has been obtained. Results will be presented in journal articles, conferences and through varied forms of media to reach policymakers, stakeholders and the public.

IntroductionAbout 30% of depressed patients suffer from a protracted course in which the disorder continues to cause significant burden despite treatment efforts. While originally developed for relapse prevention, mindfulness-based cognitive therapy (MBCT) has increasingly been investigated in depressed patients with such ‘difficult-to-treat’ courses. This is a protocol for an individual participant data (IPD) meta-analysis aiming to determine efficacy and potential moderators of MBCT treatment effects in this group based on evidence from randomised controlled trials.Methods and analysisSystematic searches in PubMed, Web of Science, Scopus, PsycINFO, EMBASE and the Cochrane Controlled Trials Register for randomised controlled trials were completed on 17 June 2024. Authors of identified studies have contributed IPD, and data extractions have been completed. An update search will be conducted immediately before the start of data analyses. We will investigate the following outcomes: (a) self-reported and observer-reported severity of depression symptomatology, (b) remission and (c) clinically meaningful improvement and deterioration. One-stage and two-stage IPD-MA will be conducted with one-stage models using the observed IPD from all studies simultaneously as the primary approach. One-stage IPD models will include stratified study intercepts and error terms as well as random effects to capture between-study heterogeneity. Moderator analyses will test treatment-covariate interactions for both individual patient-level and study-level characteristics.Ethics and disseminationThe results will inform understanding of the use of MBCT in patients with current ‘difficult-to-treat’ depression and will contribute to arguments in favour of or against implementing MBCT as a treatment for this group. They will be published in a peer-reviewed journal and made available to stakeholders in accessible formats. No local ethical review was necessary following consultation with the Ethics and Governance Board of the University of Surrey. Guidance on patient data storage and management will be adhered to throughout.PROSPERO registration numberCRD42022332039.

Background In bipolar spectrum disorder, some individuals experience ongoing, frequent fluctuations in mood outside of affective episodes. There are currently no evidence-based psychological interventions designed to address this. This feasibility study is a phase II evaluation of a dialectical behavioural therapy-informed approach (Therapy for Inter-episode mood Variability in Bipolar [ThrIVe-B]). It seeks to examine the feasibility and acceptability of a future definitive trial evaluating the clinical and cost effectiveness of the ThrIVe-B programme. Methods/design Patients will be randomised 1:1 to either treatment as usual only (control arm) or the ThrIVe-B intervention plus treatment as usual (intervention arm). Follow-up points will be at 3, 6, 9 and 15 months after baseline, with 9 months as the primary end point for the candidate primary outcome measures. We aim to recruit 48 individuals meeting diagnostic criteria for a bipolar spectrum disorder and reporting frequent mood swings outside of acute episodes, through primary and secondary care services and self-referral. To evaluate feasibility and acceptability, we will examine recruitment and retention rates, completion rates for study measures and feedback from participants on their experience of study participation and therapy. Discussion Proceeding to a definitive trial will be indicated if the following criteria are met: (1) trial participation does not lead to serious negative consequences for our participants; (2) any serious concerns about the acceptability and feasibility of the trial procedures can be rectified prior to a definitive trial; (3) follow-up data at 9 months are available for at least 60% of participants; (4) at least 60% of patients in the ThrIVe-B arm complete treatment. Trial registration ISRCTN, ISRCTN54234300 . Registered on 20 July 2017.

In bipolar spectrum disorder, some individuals experience ongoing, frequent fluctuations in mood outside of affective episodes. There are currently no evidence-based psychological interventions designed to address this. This feasibility study is a phase II evaluation of a dialectical behavioural therapy-informed approach (Therapy for Inter-episode mood Variability in Bipolar [ThrIVe-B]). It seeks to examine the feasibility and acceptability of a future definitive trial evaluating the clinical and cost effectiveness of the ThrIVe-B programme. Proceeding to a definitive trial will be indicated if the following criteria are met: (1) trial participation does not lead to serious negative consequences for our participants; (2) any serious concerns about the acceptability and feasibility of the trial procedures can be rectified prior to a definitive trial; (3) follow-up data at 9 months are available for at least 60% of participants; (4) at least 60% of patients in the ThrIVe-B arm complete treatment.

Abstract Background Although mother-to-child human immunodeficiency virus (HIV) transmission has dramatically decreased with maternal antiretroviral therapy, breast milk transmission accounts for most of the 180 000 new infant HIV infections annually. Broadly neutralizing antibodies (bNAb) may further reduce transmission. Methods A Phase 1 safety and pharmacokinetic study was conducted: a single subcutaneous (SC) dose of 20 or 40 mg/kg (Dose Groups 1 and 2, respectively) of the bNAb VRC01 was administered to HIV-exposed infants soon after birth. Breastfeeding infants (Dose Group 3) received 40 mg/kg SC VRC01 after birth and then 20 mg/kg/dose SC monthly. All infants received appropriate antiretroviral prophylaxis. Results Forty infants were enrolled (21 in the United States, 19 in Africa). Subcutaneous VRC01 was safe and well tolerated with only mild-to-moderate local reactions, primarily erythema, which rapidly resolved. For multiple-dose infants, local reactions decreased with subsequent injections. VRC01 was rapidly absorbed after administration, with peak concentrations 1–6 days postdose. The 40 mg/kg dose resulted in 13 of 14 infants achieving the serum 50 micrograms (mcg)/mL target at day 28. Dose Group 3 infants maintained concentrations greater than 50 mcg/mL throughout breastfeeding. Conclusions Subcutaneous VRC01 as single or multiple doses is safe and well tolerated in very young infants and is suitable for further study to prevent HIV transmission in infants. Safety and pharmacokinetics of VRC01, a broadly neutralizing monoclonal antibody, was evaluated in HIV-exposed neonates. VRC01 was well tolerated with frequent mild local reactions. Birth dose of 40 mg/kg and monthly dose of 20 mg/kg achieved target trough serum levels.

Age less than 55 years, normal Glasgow Coma Score (GCS), and absence of hypotension are traditional criteria for the selection of adult patients with blunt splenic trauma for observation. The objective of this study is to challenge these criteria. Two hundred twelve patients who presented with blunt splenic injury between 1992 and 1997 were identified from the Trauma Registry at our Level I trauma center. The patients were divided into three groups: 100 patients (47%) were observed, 108 (51%) underwent immediate splenorrhaphy or splenectomy, and 4 (2%) failed observation. The three groups were compared by participants’ ages, GCSs, and histories of hypotension. No statistical differences were noted between the successfully observed patients and those requiring immediate surgery with respect to these criteria. Of the 4 patients who failed observation, all were younger than 55 years, all had a GCS >12, and all were normotensive. Our findings suggest that traditional criteria used to select patients for splenic trauma observation are not absolute indicators and should be liberalized: patients can be successfully observed despite having criteria that, in the past, would have led to immediate operative intervention.