Who Benefited the Most? Effectiveness of a Lifestyle Intervention Against Cognitive Decline in Older Women and Men - Secondary Analysis of the AgeWell.de-trial.

INTRODUCTION: Differences between women and men matter in the prevalence and risk factors of dementia. We aimed to examine potential sex differences regarding the effectiveness by running a secondary analysis of the AgeWell.de trial, a cluster-randomized multicenter multi-domain lifestyle intervention to reduce cognitive decline. METHODS: Intention-to-treat analyses of women (n=433) and men (n=386) aged 60 to 77 years were used for models including interactions between intervention group allocation and sex followed by subgroup analysis stratified by sex on primary and secondary outcomes. Further, the same procedure was repeated for age groups (60-69 vs. 70-77) within sex-specific subgroups to assess the effectiveness in different age groups. TRIAL REGISTRATION: German Clinical Trials Register (ref. number: DRKS00013555). RESULTS: No differences were found between women and men in the effectiveness of the intervention on cognitive performance. However, women benefitted from the intervention regarding depressive symptoms while men did not. Health-related quality of life was enhanced for younger intervention participants (60-69 years) in both women and men. CONCLUSION: The AgeWell.de intervention was able to improve depressive symptoms in women and health-related quality of life in younger participants. Female participants between 60 and 69 years benefited the most. Results support the need of better individually targeted lifestyle interventions for older adults.

[Physician working hours and effects on health, satisfaction and healthcare]. / Arbeitszeit bei Ärzt:innen und Auswirkungen auf Gesundheit, Zufriedenheit und Gesundheitsversorgung.

Changes in the working environment with respect to innovative working time models are also increasingly affecting patient care. The number of physicians working part-time, for example, is continuously rising. At the same time, a general increase in chronic diseases and multimorbid conditions as well as the growing shortage of medical staff, leads to more workload and dissatisfaction among this profession. This short overview summarizes the current study situation and associated consequences regarding working hours of physicians and gives a first explorative overview of possible solutions.

Burnout, work engagement and work hours - how physicians' decision to work less is associated with work-related factors.

BACKGROUND: According to new estimates, the health care sector will suffer a shortage of physicians in primary and specialty care. In this context, work engagement and burnout are two constructs that have gained attention recently. The aim of this study was to investigate how these constructs are related to work hour preference. METHOD: The present study was based on the baseline survey of the long-term study of physicians with different specialties, in which 1,001 physicians took part (response rate: 33.4%). Burnout was measured using the Copenhagen Burnout Inventory adapted for health care professionals; work engagement was assessed using the Utrecht Work Engagement scale. Data analyses included regression and mediation models. RESULTS: Overall, 297 out of 725 physicians were planning to cut down work hours. Several reasons - such as burnout - are discussed. According to multiple regression analyses desire to work less hours was significantly linked to all three dimensions of burnout (p < 0.001), as well as work engagement (p = 0.001). In addition, work engagement significantly mediated the relationship between the burnout dimensions on work hour reduction (patient-related: b = - 0.135, p < 0.001; work-related: b = - 0.190, p < 0.001; personal: b = - 0.133, p < 0.001 ). DISCUSSION: Physicians tending to reduce work hours exhibited different levels of work engagement as well as burnout (personal, patient- and work-related). Moreover, work engagement influenced the relationship between burnout and work hour reduction. Therefore, interventions that increase work engagement may positively impact negative effects of burnout on work hour changes.

Gender-Specific Design and Effectiveness of Non-Pharmacological Interventions against Cognitive Decline - Systematic Review and Meta-Analysis of Randomized Controlled Trials.

BACKGROUND: The number of people living with dementia worldwide is increasing rapidly. Preventive approaches constitute a promising strategy to counter the dementia epidemic, and growing numbers of lifestyle interventions are conducted around the globe. Gender differences with respect to modifiable risk factors for dementia have been reported, however, little is known about gender-specific effectiveness of lifestyle trials against cognitive decline and dementia. A systematic review and meta-analysis was conducted to assess evidence on gender-specific design and effectiveness of randomized controlled trials against cognitive decline. METHODS: Systematic literature searches were conducted in MEDLINE, PsycINFO, Web of Science, Cochrane Central and ALOIS. Studies assessing global and/or domain-specific cognitive function in older adults free from dementia were eligible for the systematic review. We assessed between-group effect sizes using random-effects meta-analysis. Methodological quality of included studies was assessed using the Scottish Intercollegiate Guidelines Network (SIGN)-checklist. RESULTS: The systematic review and meta-analysis included 34 and 31 studies, respectively. Effects of lifestyle-interventions on global cognition were non-significant overall (g = .27; 95% CI: -.01; .56) and in male subsamples (g = -.05; 95% CI: -.55; .45), and small for female subsamples (g = .38; 95% CI: .05; .72). Small beneficial effects were found for memory (overall: g = .38; 95% CI = .17; .59). Stratified by gender, significant effects were observed only in women (g = .39; 95% CI = .13; .65; men: g = .37; 95% CI: .00; .73). Aspects of gender in study design and conduct were discussed in a small minority of studies. Comparable results were observed for executive function and verbal fluency. Methodological quality was deemed high in 17.6% of studies, acceptable and low quality in 52.9% and 29.4%, respectively. DISCUSSION: We found evidence for small differences in the effectiveness of lifestyle interventions on global cognition and memory in favor of women. However, small numbers of trials 1) targeting men and 2) reporting gender-specific results for older adults with mild cognitive impairment warrant further attention. Assessing differences in modifiable risk factors for dementia in men and women and systematically addressing aspects of gender in trial conduction and recruitment in future studies might increase knowledge on gender-specific effectiveness of lifestyle trials against cognitive decline.

Burnout and work-privacy conflict - are there differences between full-time and part-time physicians?

BACKGROUND: Changes in everyday work with regard to working time models have reached the medical profession. The number of physicians working part-time is steadily increasing. At the same time, however, the population's need for care is also rising. This can reinforce the impending shortage of doctors in the future. The aim was to investigate differences in work-privacy conflict and burnout among physicians working full-time or part-time. METHOD: The present study includes data from a baseline survey of the long-term study of physicians with different medical backgrounds. The analysis focused on a sub-sample of 598 physicians (not self-employed). The two main outcomes under investigation-burnout and work-privacy conflict-were measured using the Copenhagen Burnout Inventory adapted for health care professionals, as well as the associated subscale of the Copenhagen Psychosocial Questionnaire (COPSOQ). Data analyses included descriptive statistics followed by regression models. RESULTS: Descriptive analyses show, that 31.8% of physicians are working part-time, whereas 68.2% are working full-time. The part-time subsample is significantly older, and female physicians are more likely to work part-time. With regard to workload and work-privacy conflict, significant differences between part-time and full-time physicians were only observed in terms of work-privacy-conflict. However, regression analysis underline the importance of possible confounding variables (such as medical setting) within the relationship between job size and job-related well-being. DISCUSSION: Differences in working hour arrangements (full-time or part-time work) are only accompanied by less work-privacy conflict. No differences with regard to burnout (patient-related, work-related or personal) could be obtained. Rather, the data suggests that other job-related variables may play a role and should be further investigated.

Prosocial correlates of transformative experiences at secular multi-day mass gatherings.

Humans have long sought experiences that transcend or change their sense of self. By weakening boundaries between the self and others, such transformative experiences may lead to enduring changes in moral orientation. Here we investigated the psychological nature and prosocial correlates of transformative experiences by studying participants before (n = 600), during (n = 1217), 0-4 weeks after (n = 1866), and 6 months after (n = 710) they attended a variety of secular, multi-day mass gatherings in the US and UK. Observations at 6 field studies and 22 online followup studies spanning 5 years showed that self-reported transformative experiences at mass gatherings were common, increased over time, and were characterized by feelings of universal connectedness and new perceptions of others. Participants' circle of moral regard expanded with every passing day onsite-an effect partially mediated by transformative experience and feelings of universal connectedness. Generosity was remarkably high across sites but did not change over time. Immediately and 6 months following event attendance, self-reported transformative experience persisted and predicted both generosity (directly) and moral expansion (indirectly). These findings highlight the prosocial qualities of transformative experiences at secular mass gatherings and suggest such experiences may be associated with lasting changes in moral orientation.

Are self-managed online interventions for depression effective in improving behavioral activation? A secondary analysis of a cluster-randomized controlled trial.

BACKGROUND: Online interventions can effectively improve depressive symptoms. They often include behavioral activation (BA) techniques, but research on the effects on behavioral activation is scarce. This study aims to examine short- and long-term effects of online interventions on behavioral activation in routine care. METHODS: This study is a secondary analysis of a pragmatic cluster-randomized controlled trial (@ktiv) with a sample of N = 647 GP patients with mild to moderate depression. The intervention group (IG) received treatment-as-usual (TAU) and adjunct access to an online intervention; the control group (CG) received TAU. BA was assessed in terms of the frequency and enjoyment of pleasant activities at baseline, after six weeks and after six months. Intention-to-treat analyses were performed via multilevel mixed linear regression. RESULTS: The frequency of pleasant activities was significantly higher in the IG than in the CG six months after baseline (t(1406) = 2.25, p = .024). The enjoyment of pleasant activities was significantly higher in the IG than in the CG both six weeks (t(1405) = 2.11, p = .035) and six months after baseline (t(1405) = 3.44, p = .001). Initial depressive symptoms significantly moderated the treatment effect on the enjoyment but not the frequency of pleasant activities. LIMITATIONS: BA measures have not been validated in a clinical context. CONCLUSIONS: GP patients with mild to moderate depressive symptoms profited from access to an online adjunct intervention in terms of improved behavioral activation. The findings emphasize the usefulness of online interventions as supportive options in mental health care.

Life Events, Barriers to Care, and Outcomes Among Minority Women Experiencing Depression: A Longitudinal, Mixed-Method Examination.

ABSTRACT: The long-term course of depression is not well-understood among minority women. We assessed depression trajectory, barriers to depression care, and life difficulties among minority women accessing health and social service programs as part of the Community Partners in Care study. Data include surveys ( N = 339) and interviews ( n = 58) administered at 3-year follow-up with African American and Latina women with improved versus persistent depression. The majority of the sample reported persistent depression (224/339, 66.1%), ≥1 barrier to mental health care (226/339, 72.4%), and multiple life difficulties (mean, 2.7; SD, 2.3). Many barriers to care ( i.e. , related to stigma and care experience, finances, and logistics) and life difficulties ( i.e. , related to finances, trauma, and relationships) were more common among individuals reporting persistent depression. Results suggest the importance of past experiences with depression treatment, ongoing barriers to care, and negative life events as contributors to inequities in depression outcomes experienced by minority women.

Cardiac arrhythmias and electrophysiologic responses during spontaneous hyperglycaemia in adults with type 1 diabetes mellitus.

AIM: We examined the effect of spontaneous hyperglycaemia in adults with type 1 diabetes mellitus (T1DM) and without history of cardiovascular disease on heart rate variability (HRV), cardiac repolarisation and incidence of cardiac arrhythmias. METHODS: Thirty-seven individuals with T1DM (age 17-50 years, 19 males, mean duration of diabetes 19.3 SD(9.6) years) underwent 96 h of simultaneous ambulatory 12-lead Holter ECG and blinded continuous interstitial glucose (IG) monitoring (CGM). HRV, QT interval and cardiac repolarisation were assessed during hyperglycaemia (IG ≥ 15 mmol/l) and compared with matched euglycaemia (IG 5-10 mmol/l) on a different day, separately during the day and night. Rates of arrhythmias were assessed by calculating incidence rate differences. RESULTS: Simultaneous ECG and CGM data were recorded for 2395 hours. During daytime hyperglycaemia vs euglycaemia the mean QTc interval duration was 404 SD(21)ms vs 407 SD(20)ms, P = 0.263. T-peak to T-end interval duration corrected for heart rate (TpTendc) shortened: 74.8 SD(16.1)ms vs 79.0 SD(14.8)ms, P = 0.033 and T-wave symmetry increased: 1.62 SD(0.33) vs 1.50 SD(0.39), P = 0.02. During night-time hyperglycaemia vs euglycaemia, the mean QTc interval duration was 401 SD(26)ms vs 404 SD(27)ms, P = 0.13 and TpTend shortened: 62.4 SD(12.0)ms vs 67.1 SD(11.8)ms, P = 0.003. The number of cardiac arrhythmias was low and confined to bradycardia and isolated ectopic beats. A considerable inter-subject and diurnal variability was observed. CONCLUSIONS: Hyperglycaemia in individuals with T1DM without known cardiovascular disease was not associated with clinically important cardiac arrhythmias.

Grief and loss in old age: Exploration of the association between grief and depression.

BACKGROUND: The proportion of older adults is increasing due to demographic changes. Depression belongs to the most common mental disorders in late life. The loss of an emotionally significant person is a risk factor for the development of depression. The aim of this study is to analyze the association between depression and grief burden resulting from loss. Based on prior evidence, we examined loneliness as a possible mediator and social support as possible moderator of this association. METHODS: The cross-sectional analyses are based on a sample (N = 863) of study participants aged 75+ (M = 81.4 years, SD = 4.4, 62.2% female) with loss experience deriving from the multicenter prospective German cohort study AgeMooDe. Regression analyses (moderated mediation) were performed. RESULTS: With increasing age (ß = 0.10, p = .005) and grief burden (ß = 0.33, p <. 001) depression severity increased. There was an indirect mediating effect of loneliness on the correlation of grief burden and depression (b = 0.04, CI [0.03, 0.05]), but no moderating effect of social support on the correlation of grief burden and loneliness. People living alone had a significantly higher risk of depression, increased loneliness and lack of social support. LIMITATIONS: Assessments were based on self-reporting and recorded dimensionally. The cross-sectional design limits conclusions about directions and causality of associations. Sampling bias cannot be completely excluded. CONCLUSION: The study provides empirical evidence and a better understanding of the association between grief and depression among the very old and the mediating role of loneliness.

[Implementation of the principle of supported employment in Germany : Position paper of a task force of the DGPPN]. / Umsetzung der Prinzipien des Supported Employment in Deutschland : Positionspapier einer Task-Force der DGPPN.

The effects of mental diseases on the employment and working situation can be substantial. They are one of the main reasons for inability to work and reduced earning capacity. Against this background the question arises about suitable occupational reintegration measures for people with severe mental illnesses. In recent years, the principle of supported employment has been internationally shown to be increasingly more successful. In this context mentally ill people are primarily placed at a position of the first employment market and supported on-site by a job coach. This concept is inclusive, individual and evidence based. Despite proven effectiveness, it has so far been insufficiently implemented in German-speaking regions. In the future it will be a matter of considering the individual needs for assistance of mentally ill people more intensively than previously and to respond with functional and in a best-case scenario, multiprofessional and flexible offers.

Sustained type 1 diabetes self-management: Specifying the behaviours involved and their influences.

AIMS: Sustained engagement in type 1 diabetes self-management behaviours is a critical element in achieving improvements in glycated haemoglobin (HbA1c) and minimising risk of complications. Evaluations of self-management programmes, such as Dose Adjustment for Normal Eating (DAFNE), typically find that initial improvements are rarely sustained beyond 12 months. This study identified behaviours involved in sustained type 1 diabetes self-management, their influences and relationships to each other. METHODS: A mixed-methods study was conducted following the first two steps of the Behaviour Change Wheel framework. First, an expert stakeholder consultation identified behaviours involved in self-management of type 1 diabetes. Second, three evidence sources (systematic review, healthcare provider-generated 'red flags' and participant-generated 'frequently asked questions') were analysed to identify and synthesise modifiable barriers and enablers to sustained self-management. These were characterised according to the Capability-Opportunity-Motivation-Behaviour (COM-B) model. RESULTS: 150 distinct behaviours were identified and organised into three self-regulatory behavioural cycles, reflecting different temporal and situational aspects of diabetes self-management: Routine (e.g. checking blood glucose), Reactive (e.g. treating hypoglycaemia) and Reflective (e.g. reviewing blood glucose data to identify patterns). Thirty-four barriers and five enablers were identified: 10 relating to Capability, 20 to Opportunity and nine to Motivation. CONCLUSIONS: Multiple behaviours within three self-management cycles are involved in sustained type 1 diabetes self-management. There are a wide range of barriers and enablers that should be addressed to support self-management behaviours and improve clinical outcomes. The present study provides an evidence base for refining and developing type 1 diabetes self-management programmes.

Public stigma towards informal caregiving in Germany: a descriptive study.

OBJECTIVES: This study aims to investigate the public stigma towards informal caregivers of individuals aged 65 years and older in the German population. METHOD: In an Online-Survey 1038 participants (18 years and older and living in Germany) were sampled using a quota-system based on the German micro census data. To assess public stigma towards informal caregiving for individuals aged 65 years and older, three aspects of stigma were assessed: 1) emotional reactions (adapted Emotional Reaction to Mental Illness Scale), 2) behavioral reactions (adapted Social Distance Scale), and 3) cognitive reactions (newly developed List of Cognitions regarding informal caregiving). Exploratory and confirmatory factor analyses were conducted for the development and adaptation of the three instruments, and their composite reliability is provided. RESULTS: Emotional reactions in terms of devaluing feelings and feelings of misery were low, while appreciative feelings were neither low nor high. Reported social distance was low. Agreement with cognitions towards informal care in terms of devaluing and accusative cognitions was on average low, but high regarding appreciative cognitions. CONCLUSION: The results show that there is stigma towards informal caregiving for older individuals (65 years and older) in terms of emotional reactions, cognitions and social distance, although the magnitude of this stigma seems to be small. Knowledge regarding the occurrence and magnitude of stigma, as well as the processes that underlie this, is needed to prevent stigmatization and its negative outcomes, or at the very least, to enable the development of support for the affected individuals.

Parity and the risk of incident dementia: a COSMIC study.

AIMS: To investigate the association between parity and the risk of incident dementia in women. METHODS: We pooled baseline and follow-up data for community-dwelling women aged 60 or older from six population-based, prospective cohort studies from four European and two Asian countries. We investigated the association between parity and incident dementia using Cox proportional hazards regression models adjusted for age, educational level, hypertension, diabetes mellitus and cohort, with additional analysis by dementia subtype (Alzheimer dementia (AD) and non-Alzheimer dementia (NAD)). RESULTS: Of 9756 women dementia-free at baseline, 7010 completed one or more follow-up assessments. The mean follow-up duration was 5.4 ± 3.1 years and dementia developed in 550 participants. The number of parities was associated with the risk of incident dementia (hazard ratio (HR) = 1.07, 95% confidence interval (CI) = 1.02-1.13). Grand multiparity (five or more parities) increased the risk of dementia by 30% compared to 1-4 parities (HR = 1.30, 95% CI = 1.02-1.67). The risk of NAD increased by 12% for every parity (HR = 1.12, 95% CI = 1.02-1.23) and by 60% for grand multiparity (HR = 1.60, 95% CI = 1.00-2.55), but the risk of AD was not significantly associated with parity. CONCLUSIONS: Grand multiparity is a significant risk factor for dementia in women. This may have particularly important implications for women in low and middle-income countries where the fertility rate and prevalence of grand multiparity are high.

Serum BDNF levels correlate with regional cortical thickness in minor depression: a pilot study.

Serum brain-derived neurotrophic factor (BDNF) reflects state changes in mood disorders. But its relation to brain changes in depression has rarely been investigated in humans. We assessed the association between serum BDNF, cortical thickness, or gray matter volume in 20 subjects with a minor depressive episode and 40 matched healthy subjects. Serum BDNF positively correlated with cortical thickness and volume in multiple brain regions in the minor depression group: the bilateral medial orbitofrontal cortex and rostral anterior cingulate cortex, left insula, and cingulum, right superior frontal gyrus, and other regions-regions typically affected by major depression. Interestingly, these correlations were driven by subjects with first episode depression. There was no significant association between these imaging parameters and serum BDNF in the healthy control group. Interaction analyses supported this finding. Our findings point to a specific association between serum BDNF and magnetic resonance imaging parameters in first-episode minor depression in a region- and condition-dependent manner. A positive correlation between serum BDNF and structural gray matter estimates was most consistently observed for cortical thickness. We discuss why cortical thickness should be preferred to volumetric estimates for such analyses in future studies. Results of our pilot study have to be proven in future larger-scale studies yielding higher statistical power.

[Psychosocial therapy in psychiatry : Update of the DGPPN-S3 guidelines "Psychosocial therapies for severe mental illnesses"]. / Psychosoziale Therapien in der Psychiatrie : Update der DGPPN-S3-Leitlinie "Psychosoziale Therapien bei schweren psychischen Erkrankungen".

BACKGROUND: Severe mental illnesses are often associated with substantial impairments of psychosocial functioning and a high risk of social exclusion. Along with somatic and psychotherapeutic treatment approaches, psychosocial interventions are an integral component of treatment. Psychosocial therapies aim to improve participation and enable patients to live self-determined lives as far as possible. OBJECTIVE: This paper provides an overview of the structure and recommendations of the German S3 guidelines "Psychosocial therapies for severe mental illnesses" of the German Association for Psychiatry, Psychotherapy and Psychosomatics (DGPPN). MATERIAL AND METHODS: In the DGPPN S3 guidelines psychosocial therapies are systematically described for the first time and recommendations are formulated on the basis of a systematic processing of scientific evidence and a formalized consensus process. RESULTS: The evidence-based and consensus-based guidelines formulate a total of 33 recommendations and 12 statements. For many psychosocial interventions there is a broad evidence base. In the field of individual interventions psychoeducation, social skills training and health-promoting interventions have been given the highest recommendation strength (A). In the field of system level interventions, team-based, multiprofessional community psychiatric approaches, supported employment and self-determined housing with mobile support (supported housing) are given A level recommendations. For other interventions, the current evidence base is less robust. CONCLUSION: The successful implementation of guidelines depends not only on the quality but also on the dissemination. Therefore, in addition to the treatment guidelines a short version, a patient version and a waiting room version were developed.

Systematic review and meta-analysis of randomized controlled trials of psychological interventions to improve glycaemic control in children and adults with type 1 diabetes.

AIM: We conducted a systematic review aggregate and network meta-analysis of psychological interventions for people with type 1 diabetes to assess their effectiveness in improving glycaemic levels. METHODS: We searched the following databases from 1 January 2003 to 1 July 2018: MEDLINE, CINAHL, PsycINFO, Embase, Cochrane Controlled Trials, Web of Science, clinicaltrials.gov, Dissertation Abstract International. We included randomized controlled trials (RCT) of psychological interventions for children and adults with type 1 diabetes reported in any language. We extracted data on publications, participant characteristics at baseline, intervention and control group, and data for the primary outcome, change in glycaemic control [HbA1c (mmol/mol/%)]. Study authors were contacted for missing data. The review was registered with international prospective register of systematic reviews registration (PROSPERO) CRD42016033619. RESULTS: Twenty-four adult RCTs and 23 of children with type 1 diabetes were included in the systematic review. In aggregate meta-analysis there was no overall effect of psychological intervention compared with control on HbA1c [adults, nine RCTs, n = 1102, pooled mean difference -0.12, 95% confidence intervals (CI) -0.27 to 0.03, I2 = 29.0%, P = 0.19; children, 20 RCTs, n = 2567, -0.09, 95% CI -0.22 to 0.04, I2 =54.0% P=0.002]. Network meta-analysis suggested that probability and rank-ordering of effectiveness is highest for attention control groups (b = -0.47, 95% CI -0.80 to -0.12) followed by cognitive behavioural therapy (CBT) (-0.26, 95% CI -0.45 to -0.06) compared with usual care for adults. CONCLUSIONS: Overall psychological interventions for children and adults with type 1 diabetes do not improve glycaemic control. For adults, CBT-based interventions have the potential to be effective.

What are the characteristics of the best type 1 diabetes patient education programmes (from diagnosis to long-term care), do they improve outcomes and what is required to make them more effective?

The last 20 years have witnessed a marked change in approaches to the management of type 1 diabetes in the UK. This is exemplified by National Institute of Health and Care Excellence (NICE) guidance which acknowledges that reaching and maintaining target glucose depends on people with type 1 diabetes effectively implementing flexible intensive insulin therapy. The guidance emphasizes that successful self-management requires the acquisition of complex skills and is best achieved by participation in high-quality structured education. Controlled trials and other research have shown that programmes teaching self-management can lower glucose levels while reducing hypoglycaemia, improve psychological outcomes and are highly cost-effective. An important principle of successful programmes is therapeutic education in which learning becomes a partnership between the professional and the person with diabetes who learns to fit diabetes into his/her everyday life. Other recommended elements of programmes include a written curriculum, group teaching by a professional multidisciplinary team and quality assurance. Yet many participants struggle post-course to implement and maintain skills, and overall HbA1c levels, particularly in the UK, remain far from target. Recent studies have identified the barriers to sustained effective self-management and concluded that even high-quality programmes generally lack critical components. These include incorporating evidence from behaviour change research, exploiting the promise of new technologies in reducing the burden of self-management, and providing structured professional support once people have completed the training. Studies are currently underway to evaluate structured training courses which have added these elements and examine whether they can lower glucose to levels closer to target without impairing quality of life.

Reducing the burden of hypoglycaemia in people with diabetes through increased understanding: design of the Hypoglycaemia REdefining SOLutions for better liVEs (Hypo-RESOLVE) project.

BACKGROUND: Hypoglycaemia is the most frequent complication of treatment with insulin or insulin secretagogues in people with diabetes. Severe hypoglycaemia, i.e. an event requiring external help because of cognitive dysfunction, is associated with a higher risk of adverse cardiovascular outcomes and all-cause mortality, but underlying mechanism(s) are poorly understood. There is also a gap in the understanding of the clinical, psychological and health economic impact of 'non-severe' hypoglycaemia and the glucose level below which hypoglycaemia causes harm. AIM: To increase understanding of hypoglycaemia by addressing the above issues over a 4-year period. METHODS: Hypo-RESOLVE is structured across eight work packages, each with a distinct focus. We will construct a large, sustainable database including hypoglycaemia data from >100 clinical trials to examine predictors of hypoglycaemia and establish glucose threshold(s) below which hypoglycaemia constitutes a risk for adverse biomedical and psychological outcomes, and increases healthcare costs. We will also investigate the mechanism(s) underlying the antecedents and consequences of hypoglycaemia, the significance of glucose sensor-detected hypoglycaemia, the impact of hypoglycaemia in families, and the costs of hypoglycaemia for healthcare systems. RESULTS: The outcomes of Hypo-RESOLVE will inform evidence-based definitions regarding the classification of hypoglycaemia in diabetes for use in daily clinical practice, future clinical trials and as a benchmark for comparing glucose-lowering interventions and strategies across trials. Stakeholders will be engaged to achieve broadly adopted agreement. CONCLUSION: Hypo-RESOLVE will advance our understanding and refine the classification of hypoglycaemia, with the ultimate aim being to alleviate the burden and consequences of hypoglycaemia in people with diabetes.

Transformative experience and social connectedness mediate the mood-enhancing effects of psychedelic use in naturalistic settings.

Past research suggests that use of psychedelic substances such as LSD or psilocybin may have positive effects on mood and feelings of social connectedness. These psychological effects are thought to be highly sensitive to context, but robust and direct evidence for them in a naturalistic setting is scarce. In a series of field studies involving over 1,200 participants across six multiday mass gatherings in the United States and the United Kingdom, we investigated the effects of psychedelic substance use on transformative experience, social connectedness, and positive mood. This approach allowed us to test preregistered hypotheses with high ecological validity and statistical precision. Controlling for a host of demographic variables and the use of other psychoactive substances, we found that psychedelic substance use was significantly associated with positive mood-an effect sequentially mediated by self-reported transformative experience and increased social connectedness. These effects were particularly pronounced for those who had taken psychedelic substances within the last 24 h (compared to the last week). Overall, this research provides robust evidence for positive affective and social consequences of psychedelic substance use in naturalistic settings.