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Malnutrition remains a major public health challenge in low- and middle-income countries and disproportionately affecting children under five. Eggs, given their high nutrient density and relative physical or economic accessibility, have been tested for their effect on improving nutritional outcomes in children under five. However, findings from scientific exercises to test the impact of egg-based trials on child growth have not been systhematically pooled and synthesised. Therefore, this meta-analysis aimed to synthesise evidence on the impact of egg-based interventions on the nutritional status of children underfive as determined by weight-for-height Z-score (WHZ), weight-for-age z-score (WAZ), and height-for-age z-score (HAZ). Research articles of randomised controlled trials published between 2013 and 2023 were identified through a comprehensive search of PubMed/MEDLINE, Web of Science, CINAHL, Embase, Science Direct, Google Scholar, and African Index Medicus data bases. Articles evaluated the effect of egg-based interventions against alternative diets, behaviour-change education, or no alternative intervention were included. Primary outcomes are WHZ, WAZ, and HAZ. Random-effects models were used to pool effect sizes (mean difference), and subgroup analyses and meta-regression explored sources of heterogeneity. Publication bias was assessed using funnel plots and Egger’s test. Seven studies involving 3673 children met the inclusion criteria. Egg-based intervention significantly improved WAZ (MD: 0.33; 95% CI: 0.11–0.55) and WHZ (MD: 0.30; 95% CI: 0.12–0.48). However, no significant effect was observed on HAZ (MD: 0.05; 95% CI: –0.05–0.14). It is figuredout that egg-based interventions can improve weight-related nutritional outcomes (WHZ and HAZ) among children underfive in sub-Saharan Africa, but not linear growth (HAZ).
People with intellectual disability experience substantial health inequities, including higher multimorbidity, increased healthcare utilisation and markedly reduced life expectancy. High-quality research is essential to address these disparities. The National Institute for Health and Care Research (NIHR) funded Research Delivery Network provides the infrastructure/expertise/support needed to deliver NIHR-funded studies, and supports studies funded by a non-commercial/industry partner. However, the effectiveness of NIHR-funded studies versus those supported in driving impactful intellectual disability research remains unclear.
Aims
To evaluate and compare the outcomes of NIHR-funded and supported intellectual disability research.
Method
All NIHR studies (funded/supported) relating to intellectual disability (2010–2020) were identified through systematic register searches. Primary outcomes included publication rates and impact on local, national and international clinical guidelines. Data collection was supplemented with a questionnaire to chief investigators and literature searches. Quantitative analyses examined associations between funding status, study design, publication and guideline impact, whereas qualitative responses explored implementation challenges.
Results
In total, 88 projects were identified, and 42% (37/88) were NIHR-funded. Overall, 81% of studies generated at least one publication and 28% informed clinical guidelines. NIHR funding was not significantly associated with publication or guideline impact. Randomised controlled trials (RCTs) were significantly more likely to be published and more likely to influence non-UK national and international guidelines than non-RCTs. The amount of funding showed no association with impact. Qualitative findings highlighted funding constraints, staff capacity and stakeholder engagement as key determinants of implementation.
Conclusions
NIHR-funded intellectual disability research was no more likely than NIHR-supported studies to result in publications or guideline impact.
Individuals with type 2 diabetes are at increased risk for developing CVD. We assessed how dietary counselling on a high-quality, fibre-rich diet influenced cardiometabolic health of patients with type 2 diabetes. In this 6-month trial, 121 patients with type 2 diabetes (67 (sd 8·7) years, 68 % men, BMI 27·8 kg/m2) were assigned to dietary counselling (n 61) or standard care (n 60). Counselling included 4–7 individual sessions with a dietitian, aimed at increasing fibre intake to improve diet quality. The primary outcome was a composite risk score estimating 10-year CVD risk. Secondary outcomes included diet quality, assessed by the Dutch Healthy Eating Index-2015 (DHD15-index), HbA1c, LDL-cholesterol, blood pressure, body weight and medication use. Diet quality score at baseline was 115 (sd 26) and similar across groups. Over 6 months, DHD15-index scores improved by 4·5 points (95 % CI: −0·2, 9·1) in the intervention group v. control, but not significant. The change in 10-year CVD risk across the 6 months of the trial (primary outcome) did not differ between groups −0·1 %, 95 % CI: −0·2, 0·1. Changes over time in HbA1c (–1·1 mmol/mol, 95 % CI: −4·4, 2·3), LDL-cholesterol (0·0 mmol/l, 95 % CI: −0·2, 0·3), blood pressure (–1 mmHg, 95 % CI: −6, 4), body weight (–0·1 kg, 95 % CI: −1·2, 1·1) or medication use did not differ between groups. Dietary counselling for 6 months slightly improved adherence to a high-quality, fibre-rich diet in patients with type 2 diabetes but did not significantly impact cardiometabolic health or medication use.
The planetary health diet (PHD) is a mostly plant-based diet that aims to optimise human health while minimising the environmental impact of food production. Limited data exist on whether the PHD fulfils key nutritional requirements during pregnancy. This research aimed to examine the PHD in early pregnancy and how it aligns with daily nutrient intake and European Food Safety Authority (EFSA) dietary guidelines. Pregnant women (n 678) from two Irish cohorts (ROLO and MicrobeMom) were analysed, and PHD index (PHDI) scores were assigned based on data from 3-d food diaries. Women were dichotomised by the median score to create a ‘High PHDI’ (> 88·99) and a ‘Low PHDI’ group (≤ 88·99). Differences in nutrient intakes and adherence to dietary guidelines between ‘High’ and ‘Low’ PHDI groups were explored. Compared with those with a ‘Low’ score, those with a ‘High’ PHDI score reported higher intakes of dietary fibre (g/d) (17·32 (13·39, 21·08) v. 21·74 (18·28, 25·88), P < 0·001), Fe (mg/d) (10·48 (8·48, 12·82) v. 12·06 (9·48, 14·60), P < 0·001), folate (µg dietary folate equivalent per d) (250·73 (193·88, 312·45) v. 279·57 (219·43, 356·81), P < 0·001) and Ca (mg/d) (837·75 (695·36, 1056·72) v. 956·57 (751·84, 1155·03), P < 0·001). A greater proportion of women in the ‘High PHDI’ group met EFSA recommendations for dietary fibre intake (10·3 % v. 28·9 %, P < 0·001). The PHD may support maternal nutritional adequacy in pregnancy while promoting environmental sustainability. Our findings provide valuable insights that can inform future dietary recommendations for pregnancy, contributing to both maternal health and planetary well-being.
This paper summarises the UK Scientific Advisory Committee on Nutrition’s (SACN) 2023 and 2025 assessments of processed foods and health and its 2025 review of the WHO guideline on non-sugar sweeteners (NSS). On processed foods, SACN sought to identify available evidence on existing processed food classification systems, applying NOVA to UK National Diet and Nutrition Survey data and associations between food processing and health outcomes. For NSS, health outcomes of greatest policy relevance to the UK were considered. The assessments were undertaken in line with SACN’s Framework for the evaluation of evidence. SACN found that NOVA dominated the research literature and ultra-processed food (UPF) constitutes a significant proportion of UK dietary energy intake, especially among children. Higher UPF consumption was consistently associated with increased risks of adverse health outcomes, although not for all subgroups. Important limitations included most evidence being observational and inconsistent adjustment for covariables. For NSS, randomised controlled trials indicate a small reduction in body weight when NSS replace sugars, whereas prospective cohort studies indicate higher NSS intake is associated with higher measures of body fatness and may be associated with a range of adverse health outcomes. The findings were based on low- and/or very low-certainty evidence. SACN concluded that, on balance, most people are likely to benefit from reducing consumption of processed foods high in energy, saturated fat, salt and free sugars and low in fibre. SACN made a precautionary recommendation that intake of NSS be minimised. SACN made a range of recommendations to the government on processed foods and sweeteners.
Parenteral nutrition (PN) is used when sufficient oral or enteral nutrition is not possible or feasible. Current guidelines provide limited practical guidance in emergency surgical patients, and the evidence is sparse. The EATERS trial aims to investigate the effect of early supplemental PN on postoperative infections in major emergency abdominal surgery patients. The EATERS trial is an investigator-initiated, multicentre, randomised controlled trial. The trial will include 342 adults with reduced oral intake after emergency abdominal surgery, randomising them in a 1:1 ratio to early or postponed supplemental PN. The intervention group (early) will receive supplemental PN starting on postoperative day (POD) 2 for up to five days. The control group (postponed) will receive standard care and, if oral intake remains insufficient, will begin supplemental PN on POD5 for up to five days. The primary outcome is the incidence of postoperative nosocomial infections during admission. Outcome assessors and the statistician will be blinded to the treatment allocation. The secondary outcomes include non-infectious complications during admission, length of stay, mortality risk at 30 and 90 d, energy and protein intake, serious adverse events and readmission risk within 30 and 90 d of surgery. Analyses will follow the intention-to-treat principle and logistic regression used for primary outcome analysis. The EATERS trial will provide novel insights into the timing of PN in a high-risk patient population. This protocol and statistical analysis plan will reduce bias and increase transparency in the conduct and analysis of the trial.
Anorexia nervosa (AN) is an eating disorder that is mediated by psychological and metabolic factors, yet it is unclear how these factors interact. The NAMA trial objective is to clarify the metabo–psychiatric interaction and identify how it affects AN patients’ behaviour. This randomised trial will recruit thirty-six treatment-naïve female AN patients, 13–18 years of age, and thirty-six matched healthy controls. Participants will undergo psychiatric assessments followed by 12-h overnight fasting. The next morning, baseline assessments of outcomes will be performed. Patients will be randomly allocated 1:1 to receive a mixture with calories or receive a mixture without calories. Healthy controls will also be allocated to receive mixtures with/without calories. Mixtures will be standardised for taste and appearance, and allocation will be masked. The primary outcome measure is resting-state functional MRI 60 min post-consumption of the mixture. Secondary outcomes include (1) blood samples to study markers reflecting metabolic states, hunger/satiety and stress responses, (2) psychometric evaluations of subjective experiences and (3) assessment, in a second meal 3 h later, of the effects of previous calorie intake on subsequent food consumption. This article describes the study protocol, including the analysis plan, for a randomised controlled trial to comprehensively evaluate the effects of calorie intake in AN. The trial will distinguish psychological and metabolic neuronal networks associated with food intake and uncover how their integration affects food intake and other hallmark symptoms in AN. The aim is to accelerate treatment development by identifying brain mechanisms that drive AN.
Assessing depression symptoms in people with a chronic illness is challenging due to possible bias from overlapping somatic symptoms associated with both depression and chronic illnesses. Previous studies, however, have found that people with a chronic illness do not report more somatic symptoms on depression measures than people without a chronic illness with similar levels of mood and cognitive symptoms. The reason for this surprising finding is unknown. Our primary objective was to evaluate differences in mean sum scores of Patient Health Questionnaire-8 (PHQ-8) somatic symptom items (sleep disturbances, fatigue, appetite changes) in people with a chronic illness when the items were administered outside the context of a depression questionnaire versus as part of the PHQ-8. Secondary objectives were to evaluate individual somatic item scores. We hypothesised that people who completed somatic items outside of a depression assessment would have significantly higher scores than those who completed items as part of a depression assessment.
Methods
We conducted a randomised controlled experiment within the Scleroderma Patient-centred Intervention Network (SPIN) Cohort, a multinational cohort of people with systemic sclerosis. SPIN Cohort participants were randomly allocated to complete the PHQ-8 with somatic items (sleep disturbances, fatigue, appetite changes) presented separately from psychological items and without any indication that they were part of a depression questionnaire (Reordered Items arm) or in standard format (Standard PHQ-8 arm). Participants were automatically randomised when they logged into the SPIN Cohort platform to complete routine research assessments. The primary outcome was the mean sum score of PHQ-8 somatic items. Secondary outcomes were the mean scores of individual somatic items. Differences were assessed using between-groups t-tests.
Results
In total, 851 participants were included (N = 428 in Reordered Items arm, N = 423 in Standard PHQ-8 arm). Mean (SD) PHQ-8 score was 6.0 (5.3) for all participants. We found no statistically significant differences in PHQ-8 somatic item sum scores (0.05 points; 95% confidence interval [CI]: −0.29 to 0.38) or in mean scores for item 3 (sleep disturbances; 0.04 points; 95% CI: −0.09 to 0.19), item 4 (fatigue; 0.03 points; 95% CI: −0.11 to 0.16) and item 5 (appetite changes; −0.03 points; 95% CI: −0.15 to 0.10).
Conclusions
We did not find evidence that responses to PHQ-8 somatic items were influenced by whether participants were aware they were responding to items about depression. This finding supports the validity of self-reported questionnaires for depression symptom assessment in people with chronic medical conditions.
Major depressive disorder (MDD) is the leading cause of disability worldwide, affecting roughly 322 million people. Recently, doses of psilocybin have shown promise in treating mood disorders, sparking interest in other dosing practices. According to anecdotal reports and observational studies, microdosing psilocybin yields benefits to mental health; however, rigorously controlled trials have failed to produce compelling evidence for this.
Aims
To conduct a phase II, double-blind, placebo-controlled, randomised partial crossover trial to compare microdosing psilocybin to placebo for MDD, evaluating its safety, tolerability and preliminary antidepressant effects.
Method
Forty adults with MDD will be randomised to four doses of psilocybin (2 mg) or placebo (maltodextrin) once weekly over 4 weeks, then four doses of psilocybin (2 mg) once weekly for an additional 4 weeks. The primary efficacy end-point will be change in depression symptoms, as measured at baseline (0 weeks), after the experimental phase (4 weeks), and after the open-label phase (8 weeks). A battery of mood, well-being, attention, creativity, mindfulness and pro-sociality measures will be administered at each time point. Follow-ups will occur every 6 months for up to 2 years after the trial start date, as part of a long-term extension study.
Results
The results of the primary outcome of this trial will be published as a manuscript in a peer-reviewed science or medical journal regardless of the magnitude or direction of effect.
Conclusions
Findings will inform future research on microdosing psilocybin for MDD, regarding dose regimens, effect sizes and expectancy bias. Findings will also facilitate discussions on the comparable benefits of sub- versus threshold doses of psilocybin and the therapeutic value of radically altered perception.
This randomised controlled trial examined the effect of a 4-week, high-dose (Lf-High, 600 mg/d) or low-dose (Lf-Low, 200 mg/d) oral lactoferrin (Lf) intervention v. placebo on immune cell responses to respiratory virus, immune cell subsets and systemic inflammation. In healthy older adults (n 103, ≥50 years old), ex vivo cytokine release of interferon (IFN)-α2, IFN-γ, IL-6 and TNF-α from rhinovirus A-16 (RV-16) or influenza A virus (H1N1) stimulated peripheral blood mononuclear cells, circulating immune cell subsets, and plasma IL-6, C-reactive protein (CRP) and TNF-α were assessed. Ninety-seven participants completed the 4-week intervention (Lf-High n 32, Lf-Low n 31, placebo n 34, withdrawals n 6). There was no difference in RV-16 or H1N1-induced IFN-γ release between groups. RV-16-induced IL-6 was lower in Lf-High v. placebo (P = 0·001), and RV-16-induced IFN-α2 was higher in Lf-High v. Lf-Low (P = 0·04). Lf-High increased total T cells (P = 0·03) and CD4+ T cells (P = 0·03) v. placebo. Lf-Low reduced neutrophil (P = 0·04), natural killer cell (P = 0·045), activated CD8+ T cell (P = 0·03) and γδ T cell (P = 0·03) frequency v. placebo. Plasma IL-6 (P = 0·004) and CRP (P = 0·03) were lower following Lf-High v. Lf-Low, but not placebo. Both high- and low-dose Lf altered ex vivo immune cell responses after 4 weeks. High-dose increased T-cell subsets, promoting adaptive immunity, and reduced systemic inflammation, while low-dose reduced proinflammatory and cytotoxic immune cells. High- and low-dose Lf supplements may have immunoceutical benefits in older adults.
Forced displacement heightens mental health risks for children, including psychological, environmental and economic stressors, yet few interventions address whole-family needs within humanitarian contexts. Family-systemic approaches show promise, but evidence on interventions addressing social determinants of mental health remains limited. We will conduct a single-masked, two-arm randomised controlled trial with 550 families in East Amman, Jordan, to evaluate StrongerTogether, a modular whole-family intervention with a financial literacy component. Families experiencing multiple psychosocial challenges will be randomised 1:1 to receive the intervention or enhanced treatment as usual. The trial employs sequential dual outcomes testing, evaluating effectiveness through: (1) upstream improvements in at least one of three primary outcomes (family functioning, parenting practices and caregiver mental health) and (2) direct improvements in adolescent mental health among those with elevated baseline distress. We will also evaluate two implementation tools: ReachNow for family case detection and FamilyACT for facilitator competency assessment. A mixed-methods process evaluation will examine implementation, effectiveness and potential sustainability of core and optional modules. This will be the first rigorous evaluation of an integrated whole-family intervention addressing social and environmental determinants of mental health in humanitarian settings. Findings will inform evidence-based approaches to family mental health support and contribute validated tools for implementation at scale.
The new psychosocial goal-setting and manualised support intervention for independence in dementia (NIDUS-Family) is a manualised dementia care intervention.
Aims
To evaluate whether goal-setting plus NIDUS-Family is more effective than the control condition (goal-setting and routine care) in supporting dyads’ (family carers and care recipients with dementia) attainment of personalised goals; and to determine participant-perceived goal relevance over 24 months.
Method
We randomised dyads from community settings (2:1): to NIDUS-Family, a manualised psychological intervention tailored to goals that dyads set by selecting modules, delivered in 6–8 video call/telephone sessions over 6 months then 2–3 follow-ups monthly for 6 months; or to control. Outcomes were goal attainment scaling (GAS) (primary) at 18 and 24 months, functioning, quality of life, time until care home admission or death, carer anxiety and depression. Primary analysis, a mixed-effects model, accounted for randomisation group, study site, time, intervention arm facilitator and repeated measurements.
Results
In the period 2020–2021, 204 participants were randomised to intervention and 98 to control; 164 (54.3%) and 141 (46.7%) dyads completed 18- and 24-month outcomes, respectively.
In the primary analysis, including 277 participants contributing 6-, 12-, 18- or 24-month outcomes, adjusted GAS mean differences (intervention–control) at 18 and 24 months were 11.78 (95% CI 6.64, 16.93) and 8.67 (95% CI 3.31, 14.02), respectively. Secondary outcome comparisons were not significant. The hazard ratio for dying or care home admission was 0.80 (95% CI 0.45, 1.42; intervention versus control), and 0.87 (95% CI 0.41, 1.82) and 0.59 (95% CI 0.26, 1.33) for death and care home admission, respectively. Among baseline GAS goals, carers considered 436 (78.0%) relevant at 18 months and 383 (78.5%) at 24 months.
Conclusions
NIDUS-Family improved attainment of GAS goals over 2 years.
Obesity and depression are highly prevalent diseases that are strongly correlated. At the same time, there is a growing gap in care, and treatment options should be improved and extended. Positive effects of a Mediterranean diet on mental health have already been shown in various studies. In addition to the physiological effects of nutrients, the way food is eaten, such as mindful eating, seems to play a role. The present study investigates the effect of a Mediterranean diet and mindful eating on depression severity in people with clinically diagnosed major depressive disorder and obesity. Participants will be randomised to one of the four intervention groups (Mediterranean diet, mindful eating, their combination and a befriending control group). The factorial design allows investigating individual effects as well as potential synergistic effects of the interventions. The study consists of a 12-week intervention period, where five individual appointments will take place, followed by a 12-week follow-up. The primary outcome is depression severity. Secondary outcomes are remission of depression, assessor-rated depression severity, quality of life, self-efficacy, BMI, waist:hip ratio and body composition; adherence to the Mediterranean diet and mindful eating will also be assessed. Alongside mediator and moderator analysis, a microbiome analysis, a qualitative evaluation and an economic analysis will be conducted. The study investigates an important health issue in a vulnerable target group. It allows to draw valuable conclusions regarding the effectiveness of different interventions and therefore contributes to improving available care options for people suffering from depression and obesity.
Unhealthy eating patterns, physical inactivity and alcohol misuse are commonly reported by individuals with severe mental illness (SMI) and significantly contribute to premature mortality. People with SMI could benefit from psychoeducational interventions focused on lifestyle modification.
Aims
To evaluate the effectiveness of the LIFESTYLE programme to improve dietary habits and physical activity levels and reduce alcohol use in individuals with SMI versus controls receiving a less structured psychoeducational programme (Italian Ministry of University and Research, trial registration number: 2015C7374S).
Method
This multicentre randomised controlled trial (RCT) was conducted across six Italian universities and included 401 participants diagnosed with SMI, randomly allocated to either the test group or a comparison group.
Results
At 1-year follow-up, generalised estimating equations showed that the trial intervention boosted the likelihood of higher weekly metabolic equivalents of task (METs) expended on total activity (odds ratio 1.43, 95% CI 1.08–1.89; p < 0.01), on walking (odds ratio 1.50, 95% CI 1.18–1.90; p < 0.001) and on moderate activity (odds ratio 1.85, 95% CI 1.24–2.77; p < 0.01). Improvements in dietary habits included increased intake of fish (odds ratio 1.67, 95% CI 1.45–1.97; p < 0.05), fresh fruit (odds ratio 1.36, 95% CI 1.05–1.76; p < 0.05) and vegetables (odds ratio 1.91, 95% CI 1.56–1.96; p < 0.05), along with reduced junk food consumption (OR = 0.81, 95% CI 0.63–0.99; p < 0.05) and daily alcohol use (odds ratio 0.70, 95% CI 0.52–0.95; p < 0.05).
Conclusions
The LIFESTYLE intervention proved effective in promoting healthier lifestyles among individuals with SMI, with sustained benefits at 1 year. This structured programme could be a valuable addition to routine mental healthcare.
Social media offers many benefits but also carries risks, including exposure to distressing content. The UK’s Online Safety Act requires certain platforms to empower users to control the content they see. Content controls can reduce users’ exposure to sensitive content. However, there is little public data on how platform design shapes the use of these controls. In our online randomised controlled trial on a simulated social media platform, participants were given an initial choice between seeing ‘All content types’ or ‘Reduced sensitive content’. After browsing, they were given the opportunity to change their choice. In the Control arm, none of the options were pre-selected. 24% chose ‘Reduced sensitive content’. Pre-selecting ‘All content types’ reduced this proportion to 15%. Conversely, adding a description of ‘sensitive content’ on the choice page increased that figure to 29%. The initial choice proved to be ‘sticky’. When invited to review after browsing, those defaulted away from ‘Reduced sensitive content’ did not switch any more than those whose choice was not influenced by a default. Overall, user choice was susceptible to choice architecture, and users’ tendency to update their initial choice was weak. This highlights the importance of platform design to deliver genuine user empowerment.
Although metabolic syndrome (MetSyn) patients are frequently reported to experience alterations in ghrelin levels, appetite regulation and mood, these issues have been largely overlooked. Thus, the present randomised controlled trial (RCT) examined the effects of incorporating brown rice bran powder (BRBP) into a standard diet on ghrelin levels, appetite control, depression, insulin resistance and atherogenicity indices. This secondary analysis used data from our 8-week RCT involving forty-three MetSyn patients, with nineteen on a standard diet and twenty-four receiving an additional 15 g/d of BRBP. Serum ghrelin levels were measured using an ELISA kit, and seven atherosclerosis-related indicators were assessed before and after the intervention. Appetite rating and depression status were evaluated using a four-component visual analogue scale (VAS) and the Beck Depression Inventory (BDI) questionnaires. The ANCOVA model adjusted for baseline values (and BMI for ghrelin) indicated that patients receiving BRBP plus the standard diet experienced significant increases in ghrelin levels and feelings of satiety and fullness compared with those on the standard diet alone (P-value < 0·008; effect sizes (ES) of 0·95, 1·14, and 1·34, respectively). BRBP intake led to significant reductions in atherogenic coefficient, Castelli risk index-II, cholesterol index, metabolic score for insulin resistance, BDI scores, and hunger sensations (P-value ≤ 0·05; ES of −0·94, −0·96, −0·81, −1·74, −0·98 and −0·71, respectively) compared with the standard diet alone. Overall, this secondary analysis of the RCT supports the efficacy of BRBP administration in enhancing ghrelin levels while reducing appetite-related indices, depression scores, as well as markers of atherogenicity and insulin resistance. Nevertheless, given the study’s limitations, namely small sample size and lack of a placebo, further research is needed.
There is growing evidence that optimising dietary quality and engaging in physical activity (PA) can reduce dementia and cognitive decline risk and improve psychosocial health and quality of life (QoL). Multimodal interventions focusing on diet and PA are recognised as significant strategies to tackle these behavioural risk factors; however, the cost-effectiveness of such interventions is seldom reported. A limited cost consequence based on a 12-month cluster-randomised Mediterranean diet (MedDiet) and walking controlled trial (MedWalk) was undertaken. In addition, QoL data were analysed. Programme costs ($AUD2024) covered staff to deliver the MedWalk programme and foods to support dietary behaviour change. The primary outcome measure of this study was change in QoL utility score, measured using the Assessment of Quality of Life (AQoL-8D). Change scores were compared for the groups using general linear models while controlling for demographic factors associated with baseline group differences and attrition. Change in QoL (decreased, maintained or improved) was determined using a cross-tabulation test. MedWalk programme costs were estimated at $2695 AUD per participant and control group cost at $165 per person – a differential cost of $2530. Mean change in utility scores from baseline to 12 months was not statistically significant between groups. Nevertheless, the MedWalk group was significantly less likely to experience a reduction in their QoL (20·3 % MedWalk v. 42·6 % control group) (P = 0·020). A MedDiet and walking intervention may have a role in preventing decline in QoL of older Australians; however, longer-term follow-up would be beneficial to see if this is maintained.
Non-suicidal self-injury (NSSI) often emerges during adolescence and young adulthood. A prior open-label pilot study suggested that N-acetylcysteine (NAC) may reduce NSSI frequency in young individuals.
Aims
This study investigated potential NSSI-related biological markers for NAC in young adults with a history of NSSI using a placebo-controlled, randomised clinical trial of two NAC dosage regimens.
Method
Forty-three individuals (assigned female at birth) aged 16–24 years and with a history of NSSI were randomly assigned to either low-dose NAC (3600 mg/day), high-dose NAC (5400 mg/day) or placebo treatment for 4 weeks. Participants underwent blood draws, magnetic resonance imaging with spectroscopy and clinical assessments before and after treatment. Primary outcomes included brain glutathione (GSH), blood reduced to oxidised GSH ratio and brain glutamate. Secondary outcomes included antioxidant protein levels, brain gamma-aminobutyric acid concentrations, functional connectivity (between amygdala and insula) and clinical outcomes. Pharmacokinetics, tolerability and correlations among measures were also explored.
Results
For 39 participants who completed study assessments at follow-up, weekly NSSI and depression symptoms improved similarly across both treatment and placebo groups, with no significant group differences in primary or secondary outcomes at follow-up. Some significant correlations emerged.
Conclusions
The study did not support the proposed biological signatures of NAC in young adults with NSSI, although exploratory findings suggested potential biological correlates of clinical improvement. Further research is necessary to explore neurobiologically based treatments for young adults with NSSI.
Peer-supported Open Dialogue (POD) integrates peer practitioners within mental health teams, fostering a collaborative, person-centred and social network approach to care. Although peer practitioners are increasingly involved in Open Dialogue, the role of peer practitioners within such teams remains underexplored.
Aims
This study aimed to explore (a) the experiences of peer practitioners working within Open Dialogue teams in the Open Dialogue: Development and Evaluation of a Social Intervention for Severe Mental Illness trial, and (b) the perspectives of non-peer Open Dialogue practitioners regarding peer involvement. Our further objectives were to understand the nature, degree and perceived impact of peer practitioner involvement in Open Dialogue.
Method
A qualitative study was conducted using semi-structured interviews and joint interviews with peer practitioners (n = 9). Additionally, excerpts from 11 interviews and 4 focus groups (n = 18), in which non-peer practitioners discussed peer practitioners’ contributions in Open Dialogue, were analysed. Thematic analysis was employed to identify key themes.
Results
Three themes were developed. The first focuses on the perceived influence of peer practitioners on Open Dialogue network meetings; the second explores the opportunities and challenges of working as a peer practitioner in Open Dialogue, while the third details the perceived impact of peer practitioners on team and organisational culture.
Conclusions
Open Dialogue’s emphasis on a flattened hierarchy facilitates the integration of peer practitioners, enabling them to contribute meaningfully to network meetings and team culture. Despite the overall positive experiences, peers still faced common challenges faced by those in other services, such as low pay and occasional instances of a compromised, flattened hierarchy.
Nitrous oxide may possess antidepressant effects; however, limited data exist on repeated administrations and active placebo-controlled studies in treatment-resistant depression (TRD).
Aims
We aimed to test the feasibility of a randomised controlled trial examining a 4-week course of nitrous oxide or midazolam, an active placebo.
Method
In this randomised, active, placebo-controlled pilot trial, 40 participants with TRD were assigned either a 1-h inhalation of 50% nitrous oxide plus intravenous saline (n = 20) or a 1-h inhalation of 50% oxygen plus intravenous midazolam (0.02 mg/kg, up to 2 mg; n = 20) once weekly, for 4 weeks. Feasibility was assessed by examining rates of recruitment, withdrawal, adherence, missing data and adverse events. The main measure of clinical efficacy was the change in depression severity (Montgomery–Åsberg Depression Rating Scale (MADRS)) score from baseline to day 42.
Results
The recruitment rate was 22.3% (95% CI 16.9–29.0). Withdrawal rates were 10% (95% CI 2.8–30.1) in both groups and adherence rates were 100.0% (95% CI 82.4–100) in the nitrous oxide group and 94.4% (95% CI 74.2–99.0) in the placebo group. There were no missing primary clinical outcome data in either group (0.0%, 95% CI 0.0–17.6). MADRS score changed by −20.5% (95% CI −39.6 to −1.3) in the nitrous oxide group and −9.0% (95% CI −22.6 to 4.6) in the placebo group. Nearly all adverse events were mild to moderate and transient.
Conclusions
The findings support the feasibility and necessity of conducting a full-scale trial comparing nitrous oxide and midazolam in patients with TRD.