This concurrent, exploratory, mixed-methods process evaluation, embedded within a randomised controlled trial, investigates how the ‘active prevention in people at risk of dementia through lifestyle behaviour change and technology to build resilience’ (APPLE-Tree) secondary dementia prevention intervention might support behavioural and lifestyle goal attainment, through determining the contexts influencing engagement and testing intervention theoretical assumptions.

We aimed to investigate (a) intervention reach, dose and fidelity, (b) contexts influencing engagement and (c) alignment of findings with theoretical assumptions about how the intervention might have supported participants to meet personalised behavioural and lifestyle goals.

We measured intervention reach and dose. We selected interviewees for setting, gender and ethnic diversity from the 374 APPLE-Tree trial participants randomised to the intervention arm. We interviewed 25 intervention participants, 12 facilitators and 3 study partners. Additionally, we analysed 11 interviews previously conducted during or after intervention delivery for an ethnography, and 233 facilitator-completed participant goal records. We thematically analysed data, combining inductive/deductive approaches informed by the ‘capability, opportunity and motivation-behaviour’ (COM-B) behaviour change model. We video-recorded a randomly selected tenth of sessions and rated fidelity.

A total of 346 of 374 (92.5%) intervention arm participants received some intervention (reach), and 305 of 374 (81.6%) attended ≥5 main sessions (predefined as adhering: dose). According to facilitator records, participants met a mean of 5.1 of 7.5 (68.3%) goals set. We generated three themes around (a) building capability and motivation, (b) connecting with other participants and facilitators and (c) flexibility and a tailored approach.

The intervention supported behaviour change, through increasing knowledge and providing space to plan, implement and evaluate new strategies and make social connections. Feedback indicated that the intervention was flexible and inclusive of diverse preferences and needs.

Mental health awareness efforts are increasing, especially for ADHD. There is growing evidence that such efforts may also cause unnecessary self-diagnosis and worsening symptoms for some disorders; however, there are no validated approaches to avoid these potential harms without reducing the awareness efforts themselves. We developed a multifaceted intervention, called nocebo education. The intervention was based on the principles of the nocebo effect, where negative expectations may cause symptom misattribution and worsening. We tested whether teaching about the nocebo effect could mitigate the potential false self-diagnosis and symptom worsening from ADHD awareness.

In a double-blind randomized controlled trial with a week-long follow-up (NCT06638411), 215 healthy young adults (77% women) were randomized to participate in a group workshop on either ADHD awareness, ADHD combined with nocebo education, or control (sleep). We measured changes in self-diagnosis and ADHD symptoms immediately after the workshop (self-diagnosis), and 1-week later (self-diagnosis and symptoms).

ADHD group reported substantially higher self-diagnosis scores immediately $ ({\beta}_{\mathrm{standardised}}=0.80\;\left[0.58,1.02\right],p<.001 $) and 1 week after the workshop $ (\beta =0.50\;\left[0.28,0.72\right],p<.001 $) compared to controls. These effects persisted despite no changes in reported symptoms. Nocebo education halved the false self-diagnosis scores immediately after the workshop ($ \beta =0.45\;\left[0.23,0.67\right],p<.001 $) and eliminated the false self-diagnosis entirely at follow-up $ (\beta =0.16\;\left[-0.06,0.38\right],p=.08 $).

We show that being exposed to ADHD awareness reliably increases false self-diagnosis among healthy young adults for at least one week; a brief nocebo education intervention is efficacious in substantially reducing and later eliminating it. Nocebo education is a promising adjunct for balanced awareness efforts that could be applied in various contexts.

Neonatal aortic thrombosis, though rare, is a critical condition with high morbidity and mortality. Spontaneous thrombosis is uncommon, complicating diagnosis due to its similarity to aortic coarctation. Standard treatments include heparinisation and thrombolysis, but severe cases may require interventional or surgical thrombectomy.

This case series examines interventional therapy in neonates with spontaneous aortic thrombosis, focusing on reduced systolic function or organ failure, and evaluates off-label thrombectomy devices.

Three neonates with spontaneous abdominal aortic thrombosis treated at Hannover Medical School between 2017 and 2023 were reviewed. Clinical presentation, diagnostics, treatments, and outcomes were analysed. Treatment involved therapeutic anticoagulation, systemic thrombolysis and interventional thrombectomy using off-label devices. A literature review on interventional thrombectomy in neonates was conducted.

The first neonate, with severe multi-organ failure, died after thrombectomy. The second recovered fully with systemic thrombolysis. The third, critically ill, recovered following successful thrombectomy and thrombolysis. Off-label use of the Amplatzer Vascular Plug II proved more effective than the Amplatzer Piccolo PDA Occluder for managing organised thrombus. A literature review identified seven cases of neonatal aortic thrombectomy using various devices, highlighting interventional thrombectomy as a promising treatment for neonates with cardiac decompensation or imminent organ failure.

We propose a diagnostic approach for newborns with diminished or absent femoral pulses without structural heart or vascular disease. Interventional thrombectomy is a viable option for neonates with spontaneous aortic thrombosis in life-threatening situations involving decreased systolic function or organ failure. Further studies are needed to evaluate safety and long-term outcomes of catheter-based interventions.

Recruiting and retaining racial/ethnic minorities in research remains a significant challenge, often due to mistrust in clinical research and cultural misconceptions related to specific conditions. Despite the anonymity provided by technology-based intervention studies, difficulties in participant recruitment and retention in these studies remain. This paper addresses practical issues in recruiting and retaining Asian American breast cancer survivors with pain and depressive symptoms in a technology-based intervention study.

To identify practical issues in participant recruitment and retention, a content analysis was conducted on all recorded materials, including research diaries of individual research team members, weekly team meeting minutes, and research team members’ posts on Microsoft Teams.

Analysis identified six practical issues: (a) strict inclusion/exclusion criteria; (b) multiple stigmas associated with cancer, depressive symptoms, and pain; (c) lack of interest in research participation; (d) closed Asian American communities/groups; (e) frequent technological issues; and (f) potential unauthentic cases.

Addressing these recruitment and retention issues can inform the design of future culturally tailored, technology-based intervention studies for racial and ethnic minority populations.

Bipolar disorders are a major cause of disability worldwide, with most of the disease burden attributed to those in low- and middle-income countries, including Nigeria. There is limited evidence on culturally appropriate interventions for bipolar disorders in Nigeria.

The study aims to examine the feasibility, and acceptability of culturally adapted psychoeducation (CaPE) for treating bipolar disorders.

A randomised controlled trial (RCT) compared CaPE plus treatment as usual (TAU) with TAU alone among 34 persons with bipolar disorders in Jos, Nigeria. CaPE comprised 12 group sessions of in-person psychoeducation lasting approximately 90 min each, delivered on a weekly basis by clinical researchers supervised by clinical psychologists and consultant psychiatrists. The primary outcome was feasibility, measured by participants’ recruitment and retention rates. Other outcomes included acceptability as measured by the Service Satisfaction Scale (SSS), Brief Bipolar Disorder Symptom Scale (BBDSS), Patient Health Questionnaire (PHQ-9) and Quality-of-Life scale (EQ5D). Outcomes were assessed at baseline and weeks 12 and 24. Focus group (n = 10) and individual interviews (n = 5) were conducted with the CaPE + TAU group, recorded, transcribed verbatim and analysed using interpretative phenomenological analysis.

The CaPE+TAU group (n = 17) recorded a high participant recruitment and retention rate of 86% across 12 sessions, and also recorded a higher level of satisfaction with SSS compared with the TAU alone group; 87.5% indicated very satisfied compared with 66.7% indicated not sure in the TAU group. In terms of clinical outcomes, for PHQ-9 scores the intervention group showed a reduction from baseline to end of intervention (EOI) and follow-up, with differences of −12.01 and −7.39, respectively (both P < 0.001). The EQ5D index showed a notable improvement in the intervention group at both EOI and follow-up (P < 0.001). Lastly, BBDS scores decreased significantly in the CaPE+TAU group at both EOI and follow-up, with differences of −21.45 and −15.76 (both P < 0.001).

The RCT of CaPE is a feasible, acceptable and culturally appropriate treatment option for bipolar disorders in Nigeria. Further adequately powered RCTs evaluating the intervention’s clinical and cost-effectiveness are warranted.

Binge-eating disorder (BED) is characterized by highly distressing episodes of loss-of-control over-eating. We have examined the use of repetitive transcranial magnetic stimulation (rTMS) for the treatment of people with BED and associated obesity. Such non-invasive brain stimulation (NIBS) techniques are used therapeutically in several psychiatric conditions and there is an associated scientific rationale.

Sixty participants were randomly allocated to receive 20 sessions of neuronavigated 10 Hz rTMS administered to the left dorsolateral prefrontal cortex (dlPFC) or sham treatment. Primary outcomes were the frequency of binge eating episodes (BEE) and the ‘urge to eat’ (craving) evaluated at baseline and end-of-treatment (8 weeks post-randomization). Secondary outcomes included body mass index (BMI), hunger, general and specific eating disorder psychopathology. Follow-up analyses were conducted for most outcomes at 16 weeks post-randomization. Multilevel models were used to evaluate group, time, and group-by-time interactions for the association between rTMS exposure and outcomes.

The real rTMS group (compared with sham treatment), showed a significantly greater decrease in the number of BEE at the end of treatment (Estimated Mean [EM]: 2.41 95% CI: 1.84–3.15 versus EM: 1.45 95% CI: 1.05–1.99, p = 0.02), and at follow-up (EM: 3.79 95% CI: 3–4.78 versus EM: 2.45 95% CI: 1.88–3.17, p = 0.02; group × time interaction analysis p = 0.02). No group differences were found for other comparisons.

rTMS was associated with reduced BEE during and after treatment: it suggests rTMS is a promising intervention for BED.

To evaluate and synthesize research that has investigated interventions to train registered health professionals to effectively communicate with patients in acute settings who are establishing their goals of care, to develop an understanding of current practices and their effectiveness.

Integrative review.

Medline, Embase, PsycINFO, SCOPUS, CINAHL, and ProQuest, searched from the date each database was available to December 2023. Forty-seven (n = 47) research studies investigating interventions to train registered health professionals to effectively communicate with patients in acute settings who are establishing their goals of care were critically appraised for methodological quality using the Joanna Briggs Institute Quality Appraisal Framework. Minimum essential criteria and scores were agreed prior to appraisal.

Twenty-eight studies were excluded due to methodological quality. The 19 studies included comprised quasi experimental (n = 9), qualitative (n = 4), RCT (n = 2), text and opinion (n = 1), and mixed methods (n = 3). From these included studies 4 themes with embedded sub-themes were derived: (a) delivery of training programs, (b) clinician outcomes, (c) patient outcomes, and (d) system outcomes.

Communication training is essential and beneficial however its effectiveness depends on overcoming existing barriers, providing continuous learning opportunities, and embedding these into clinical practice. Addressing these factors will ensure that clinicians and healthcare organizations can improve patient and system outcomes. When clinicians and organizations prioritize regular, context-specific communication training, which promotes the use of conversation guides and available technologies, Goals of Patient Care conversations are more likely to be embedded in practice, promoting effective and patient-centered communication.