Psychiatry Research/Trial Protocols

Ataxia telangiectasia is a multisystem disorder with progressive neurodegeneration. Corticosteroids can improve neurological functioning in patients with the disorder but adrenal suppression and symptom recurrence on treatment discontinuation has limited their use, prompting the development of novel steroid delivery systems. The aim of the ATTeST study was to evaluate the efficacy and safety of intra-erythrocyte delivery of dexamethasone sodium phosphate compared with placebo in children with ataxia telangiectasia.

Existential distress is commonly experienced by patients diagnosed with a life-threatening illness. This condition has been shown to adversely impact quality of life and is correlated with increased suicidal ideation and requests for hastened death. While palliative care teams are experienced in treating depression and anxiety, existential distress is a distinct clinical condition for which traditional medications and psychotherapy approaches demonstrate limited efficacy or duration of effect. Psychedelic drugs, including psilocybin and lysergic acid diethylamide (LSD), in conjunction with psychotherapy have been shown to produce rapid and sustained reductions in existential and psychiatric distress and may be a promising treatment for patients facing existential distress in palliative care settings. In this narrative review article, we describe the history of psychedelic medicine including early studies and the modern wave of research over the past 20 years, which includes high quality clinical trial data. This review outlines specific considerations for therapeutic application of psilocybin including pharmacokinetics, patient selection, dosing, protocol designs, and safeguards to reduce potential adverse effects to help guide future psychedelic practitioners. With growing public interest and evolving state level policy reforms allowing access to psychedelic treatments, it is critical for palliative care providers to gain familiarity with the current state of science and the potential of psilocybin assisted psychotherapy in the treatment of existential distress.

This systematic review and meta-analysis aimed to systematically examine and summarize recent evidence on the effects of soccer-based training (SBT) on anthropometric measures in children and adolescents with overweight/obesity.

The development of alcohol use disorder (AUD) is a major concern in public health, and cognitive impairments caused by alcohol are involved in this process. Emerging neurobiological evidence suggests that donepezil, an anticholinesterase agent, may improve AUD treatment outcomes by enhancing neurocognitive functioning. Previous research has also suggested that cognitive remediation therapy (CRT) could potentially improve cognitive function and AUD treatment outcomes. We present the rationale and design of a trial to evaluate the combination of donepezil and cognitive remediation therapy (donepezil + CRT) as an intervention for AUD.

There is high comorbidity of opioid use disorder (OUD) and chronic pain (CP), which is often addressed by prescribing buprenorphine (BUP). While BUP is effective in preventing overdose, it does not address the psychological aspects of OUD and CP comorbidity and treatment retention rates are as low as 50%. The Virtual Opioid use disorder Integrated Chronic Pain Treatment (VOICE) study (NCT05039554) is a novel effectiveness-implementation trial to test a 12-week virtual group Acceptance and Commitment Therapy (ACT) protocol and a care management smartphone application (app; Valera Health) on pain and opioid use in patients with OUD and CP receiving BUP. Using a 2 × 2 factorial design, participants (expected N = 280) are randomized into: ACT, Valera app, ACT + Valera, or Treatment as Usual arm. This study is taking place in the Bronx, NY, a racially/ethnically diverse community that faces numerous socioeconomic stressors and is one of the nation's epicenters of the opioid epidemic. We created a culturally responsive ACT group protocol, and Valera psychoeducational material. Outcome measures include NIH HEAL Common Data Elements and ACT and Valera-specific measures. We are conducting a novel 2 × 2 trial investigating augmenting BUP treatment with ACT and Valera, with the goal that improved mental health and access to care will result in decreased and opioid use and pain interference.

Mechanical ventilation (MV) in intensive care units (ICUs) is a stressful experience for patients. However, these experiences have not been systematically explored in low- and lower-middle-income countries (LLMICs). This systematic review (SR) aims to explore the patients' experiences of MV in ICUs in LLMICs and the factors influencing their experiences.

In Vietnam and other global settings, men who have sex with men (MSM) have become the population at greatest risk of HIV infection. Although HIV pre-exposure prophylaxis (PrEP) has been implemented as a prevention strategy, PrEP outcomes may be affected by low persistence and adherence among MSM with unhealthy alcohol use. MSM have a high prevalence of unhealthy alcohol use in Vietnam, which may affect PrEP outcomes.

Social neuroscientists often use magnetic resonance imaging (MRI) to understand the relationship between social experiences and their neural substrates. Although MRI is a powerful method, it has several limitations in the study of social experiences, first and foremost its low ecological validity. To address this limitation, researchers have conducted multimethod studies combining MRI with Ecological Momentary Assessment (EMA). However, there are no existing recommendations for best practices for conducting and reporting such studies. To address the absence of standards in the field, we conducted a systematic review of papers that combined the methods. A systematic search of peer-reviewed papers resulted in a pool of 11,558 articles. Inclusion criteria were studies in which participants completed (a) Structural or functional MRI and (b) an EMA protocol that included self-report. Seventy-one papers met inclusion criteria. The following review compares these studies based on several key parameters (e.g., sample size) with the aim of determining feasibility and current standards for design and reporting in the field. The review concludes with recommendations for future research. A special focus is given to the ways in which the two methods were combined analytically and suggestions for novel computational methods that could further advance the field of social neuroscience.

Attention deficit hyperactivity disorder (ADHD) is a neuropsychiatric condition prevalent in both children and adults. With growing awareness of the importance of the preconception period in health, it is essential to understand whether preconception parental mental health and related factors are related to onset of offspring ADHD. This protocol presents the methodology for undertaking a systematic review to investigate associations between parental mental health and/or psychotropic use during the preconception years and offspring ADHD.

The quality of hospital care, especially surgery, is traditionally assessed using indicators derived from healthcare databases or safety indicators. Given the growing importance of placing the patient at the heart of care evaluation, the use of questionnaires such as the Patient-Reported Experience Measures and Patient-Reported Outcome Measures has become widespread in recent years. However, these tools-addressing factors such as satisfaction, pain management or wait times-only imperfectly reflect the patient's experience, and all such attempts at patient-centred care quality assessment rely on questions or indicators defined in advance by healthcare providers and health authorities. A biopsychosocial model may allow to better understand the patient experience and to improve care pathways. This study seeks to construct a narrative of the bariatric surgical care journey with instruments from narrative inquiry, propose a metanarrative that can serve as a basis for more sophisticated and reliable patient-focused care quality models and define indicators linked to patients' feelings and stories.

Poverty, HIV and perinatal depression represent a triple threat to public health in sub-Saharan Africa because of their combined negative effects on parenting and child development. In the resource-constrained context of low-income and middle-income countries, a lay-counsellor-delivered intervention that combines a psychological and parenting intervention could offer the potential to mitigate the consequences of perinatal depression while also optimising scarce resources for healthcare.Measuring the cost-effectiveness of such a novel intervention will help decision-makers to better understand the relative costs and effects associated with replicating the intervention, thereby supporting evidence-based decision-making. This protocol sets out the methodological framework for analysing the cost-effectiveness of a cluster randomised controlled trial (RCT) that compares a combined intervention to enhanced standard of care when treating depressed, HIV-positive pregnant women and their infants in rural South Africa.

Black women are sorely underrepresented in studies of Alzheimer's disease and related dementias (ADRD) despite higher rates of ADRD diagnoses than in non-Hispanic White women. There are many reasons for underrepresentation, including medical mistrust, limited access to clinical studies, and restrictive study inclusion criteria. These pervasive barriers to research participation are often not considered during study development and, if eventually thought of tend to be after the fact. Community-engaged research (CER) approaches are an effective method for reducing participation barriers. This article describes how CER approaches were used to develop the Black Women Inflammation and Tau Study (BWITS), a prospective study to identify biopsychosocial risk factors for ADRD in Black women. Guidelines discussed here for future ADRD research in diverse populations are informed by Community-Based Participatory Research (CBPR), the National Institute on Minority Health and Health Disparities (NIMHD), and the Patient-Centered Outcomes Research Institute (PCORI). HIGHLIGHTS: Understand the historical tragedies related to medical practices and research designs that may contribute to the underrepresentation of Black Americans in research studies today. Highlight community-engaged research approaches that effectively reduce participation barriers in minoritized groups. Review Community-Based Participatory Research, National Institute of Minority Health and Health Disparities, and the Patient-Centered Outcomes Research Institute guidelines for conducting research with minoritized communities. Describe using the three frameworks to inform the study development protocol for the Black Women Inflammation and Tau Study. Conclude by offering study design considerations that we hope can be a helpful starting point for others conducting research with minoritized communities.

Following the Hamas terror attack on Israeli towns on October 2023, 250 individuals were taken into captivity. On November-December 2023, during the cease-fire deal, 26 women and children were released. This study is the first to describe the physical and behavioural findings in children and their mothers in the immediate phase of returning home from captivity.

Emerging adult (EA) cannabis use is associated with increased risk for health consequences. Just-in-time adaptive interventions (JITAIs) provide potential for preventing the escalation and consequences of cannabis use. Powered by mobile devices, JITAIs use decision rules that take the person's state and context as input, and output a recommended intervention (e.g., alternative activities, coping strategies). The mHealth literature on JITAIs is nascent, with additional research needed to identify what intervention content to deliver when and to whom.

Promoting mental health, preventing and treating mental disorders are critically important in public health, and many randomised controlled trials (RCTs) evaluate intervention strategies for these objectives. However, distinguishing promotion from prevention and from treatment RCTs is challenging. A tool to place studies along the promotion-to-treatment continuum in mental health research does not exist, leaving it to researchers and policymakers to decide on how to classify individual RCTs, which hinders evidence synthesis.

Neuromelanin-sensitive MRI is a burgeoning non-invasive neuroimaging method with an increasing number of applications in psychiatric research. This MRI modality is sensitive to the concentration of neuromelanin, which is synthesized from intracellular catecholamines and accumulates in catecholaminergic nuclei including the dopaminergic substantia nigra and the noradrenergic locus coeruleus. Emerging data suggest the utility of neuromelanin-sensitive MRI as a proxy measure for variability in catecholamine metabolism and function, even in the absence of catecholaminergic cell loss. Given the importance of catecholamine function to several psychiatric disorders and their treatments, neuromelanin-sensitive MRI is ideally positioned as an informative and easy-to-acquire catecholaminergic index. In this review paper, we examine basic aspects of neuromelanin and neuromelanin-sensitive MRI and focus on its psychiatric applications in the contexts of mechanistic research and biomarker development. We discuss ongoing debates and state-of-the-art research into the mechanisms of the neuromelanin-sensitive MRI contrast, standardized protocols and optimized analytic approaches, and application of cutting-edge methods such as machine learning and artificial intelligence to enhance the feasibility and predictive power of neuromelanin-sensitive-MRI-based tools. We finally lay out important future directions to allow neuromelanin-sensitive-MRI to fulfill its potential as a key component of the research, and ultimately clinical, toolbox in psychiatry.

Continuous myelination of cerebral white matter (WM) during adolescence overlaps with the formation of higher cognitive skills and the onset of many neuropsychiatric disorders. We developed a miniature-pig model of adolescent brain development for neuroimaging and neurophysiological assessment during this critical period. Minipigs have gyroencephalic brains with a large cerebral WM compartment and a well-defined adolescence period.

Problem adaptation therapy (PATH) is a relatively new psychotherapy that recognises the importance of simultaneously targeting cognitive impairment and functional disability in the treatment of late-life depression. This is the first systematic review to examine the effectiveness of PATH.

Evaluate the cognitive, behavioural and affective processes involved in therapeutic change for young people with epilepsy and mental health difficulties receiving an integrated mental health intervention.

Despite considerable research examining the efficacy of psychedelic-assisted therapies (PATs) for treating psychiatric disorders, assessment of adverse events (AEs) in PAT research has lagged. Current AE reporting standards in PAT trials are poorly calibrated to features of PAT that distinguish it from other treatments, leaving many potential AEs unassessed.

Virtual reality (VR) interventions provide immersive, interactive computer-simulated virtual environments. There is interest in their use for people with dementia as they may provide stimulating experiences and improve dementia symptoms and quality of life. However, as more insight is needed about carers' and clinical professionals' perspectives to understand how VR may be implemented successfully, we elicited their views on the benefits of, and challenges to, using VR in dementia care.

Internal circadian phase assessment is increasingly acknowledged as a critical clinical tool for the diagnosis, monitoring, and treatment of circadian rhythm sleep-wake disorders and for investigating circadian timing in other medical disorders. The widespread use of in-laboratory circadian phase assessments in routine practice has been limited, most likely because circadian phase assessment is not required by formal diagnostic nosologies, and is not generally covered by insurance. At-home assessment of salivary dim light melatonin onset (DLMO, a validated circadian phase marker) is an increasingly accepted approach to assess circadian phase. This approach may help meet the increased demand for assessments and has the advantages of lower cost and greater patient convenience. We reviewed the literature describing at-home salivary DLMO assessment methods and identified factors deemed to be important to successful implementation. Here, we provide specific protocol recommendations for conducting at-home salivary DLMO assessments to facilitate a standardized approach for clinical and research purposes. Key factors include control of lighting, sampling rate, and timing, and measures of patient compliance. We include findings from implementation of an optimization algorithm to determine the most efficient number and timing of samples in patients with Delayed Sleep-Wake Phase Disorder. We also provide recommendations for assay methods and interpretation. Providing definitive criteria for each factor, along with detailed instructions for protocol implementation, will enable more widespread adoption of at-home circadian phase assessments as a standardized clinical diagnostic, monitoring, and treatment tool.

Pain and nicotine use are co-occurring conditions with a significant impact on health. Experimental evidence supports an acute analgesic effect of nicotine which may reinforce nicotine use among those with chronic pain. Evidence for nicotine analgesia have primarily been gathered in combustible cigarette users and have not been extended to electronic nicotine delivery systems (ENDS or vaping). Furthermore, the mechanisms of nicotine analgesia in humans are not well understood.

Bipolar disorder is highly prevalent and consists of biphasic recurrent mood episodes of mania and depression, which translate into altered mood, sleep and activity alongside their physiological expressions.

Structural and functional abnormalities in the cortical-striatal network (CSN) are hypothesised to play a key role in the pathogenesis of neurological disease-associated fatigue. Some small-scale functional MRI (fMRI) studies have suggested that poststroke fatigue (PSF) is related to focal functional connectivity (FC) changes. To date, there has been no published large-scale fMRI study on PSF. This planned study will examine the role of the CSN FC on PSF.

Postpartum anaemia is often caused by iron deficiency with onset during the antepartum period and can be exacerbated by excessive blood loss at birth. Its prevalence is estimated as 50-80% in low-income and middle-income countries. It poses adverse consequences on the mother and negatively impacts her ability to care for her newborn. Prompt treatment of postpartum anaemia is thus important. Adherence to oral iron is reportedly low in Nigeria due to its side effects and forgetfulness by the mothers. Intravenous iron such as ferric carboxymaltose, given as a single dose, might help overcome adherence issues, but investigation in a high-quality randomised control trial in Nigeria is first required while evaluation of challenges around its implementation is also warranted.

Drawing on our experiences conducting replications we describe the lessons we learned about replication studies and formulate recommendations for researchers, policy makers, and funders about the role of replication in science and how it should be supported and funded. We first identify a variety of benefits of doing replication studies. Next, we argue that it is often necessary to improve aspects of the original study, even if that means deviating from the original protocol. Thirdly, we argue that replication studies highlight the importance of and need for more transparency of the research process, but also make clear how difficult that is. Fourthly, we underline that it is worth trying out replication in the humanities. We finish by formulating recommendations regarding reproduction and replication research, aimed specifically at funders, editors and publishers, and universities and other research institutes.

The link between cannabis use and schizophrenia is well-established in epidemiological studies, especially among adolescents with early-onset use. However, this association in rodent models is less clear. This meta-analysis examined the effects of adolescent cannabinoid exposure on distinct schizophrenia-like behaviours in rodents and how experimental variations influence outcomes.

Current treatments for bipolar depression have limited effectiveness, tolerability and acceptability. Transcranial direct current stimulation (tDCS) is a novel non-invasive brain stimulation method that has demonstrated treatment efficacy for major depressive episodes. tDCS is portable, safe, and individuals like having sessions at home. We developed a home-based protocol with real-time remote supervision. In the present study, we have examined the clinical outcomes, acceptability and feasibility of home-based tDCS treatment in bipolar depression.

Gaming disorder (GD) is a new official diagnosis in the International Classification of Diseases, 11th Revision, and with its recognition, the need to offer treatment for the condition has become apparent. More knowledge is needed about the type of treatment needed for this group of patients.

To evaluate performance of synthetic and real FLAIR for identifying early stroke in a multicenter cohort.

The involvement of the right hemisphere, mainly the activation of the right cerebral regions, in recovery from post-stroke aphasia has been widely recognized. In contrast, the role of the right white matter pathways in the recovery from post-stroke aphasia is rarely understood. In this study, we aimed to provide a primary overview of the correlation between the structural integrity of the right hemispheric neural tracts based on the dual-stream model of language organization and recovery from post-stroke aphasia by systematically reviewing prior longitudinal interventional studies. By searching electronic databases for relevant studies according to a standard protocol, a total of 10 records (seven group studies and three case studies) including 79 participants were finally included. After comprehensively analyzing these studies and reviewing the literature, although no definite correlation was found between the right hemispheric neural tracts and recovery from post-stroke aphasia, our review provideds a new perspective for investigating the linguistic role of the right hemispheric neural tracts. This suggests that the involvement of the right hemispheric neural tracts in recovery from post-stroke aphasia may be mediated by multiple factors; thus, this topic should be comprehensively investigated in the future.

Prior research highlights that rural populations have been historically underrepresented/excluded from clinical research. The primary objective of this study was to describe the inclusion of rural populations within our research enterprise using Clinical Research Management System demographic information at a large academic medical center in the Southeast. This was a cross-sectional study using participant demographic information for all protocols entered into our Clinical Research Management System between May 2018 and March 2021. Descriptive statistics were used to analyze the representation of rural and non-rural participants and demographic breakdown by age, sex, race, and ethnicity for our entire enterprise and at the state level. We also compared Material Community Deprivation Index levels between urban and rural participants. Results indicated that 19% of the research population was classified as rural and 81% as non-rural for our entire sample, and 17.5% rural and 82.5% urban for our state-level sample. There were significant differences in race, sex, and age between rural and non-rural participants and Material Community Deprivation Indices between rural and non-rural participants. Lessons learned and recommendations for increasing the inclusion of rural populations in research are discussed.

The progression of Parkinson's disease (PD) is associated with microstructural alterations in neural pathways, contributing to both motor and cognitive decline. However, conflicting findings have emerged due to the use of heterogeneous methods in small studies. Here we performed a large diffusion MRI study in PD, integrating data from 17 cohorts worldwide, to identify stage-specific profiles of white matter differences. Diffusion-weighted MRI data from 1654 participants diagnosed with PD (age: 20-89 years; 33% female) and 885 controls (age: 19-84 years; 47% female) were analyzed using the ENIGMA-DTI protocol to evaluate white matter microstructure. Skeletonized maps of fractional anisotropy (FA) and mean diffusivity (MD) were compared across Hoehn and Yahr (HY) disease groups and controls to reveal the profile of white matter alterations at different stages. We found an enhanced, more widespread pattern of microstructural alterations with each stage of PD, with eventually lower FA and higher MD in almost all regions of interest: Cohen's d effect sizes reached d = -1.01 for FA differences in the fornix at PD HY Stage 4/5. The early PD signature in HY stage 1 included higher FA and lower MD across the entire white matter skeleton, in a direction opposite to that typical of other neurodegenerative diseases. FA and MD were associated with motor and non-motor clinical dysfunction. While overridden by degenerative changes in the later stages of PD, early PD is associated with paradoxically higher FA and lower MD in PD, consistent with early compensatory changes associated with the disorder.

The estimated lifetime prevalence of post-traumatic stress disorder (PTSD) in adults worldwide has been estimated at 3.9%. PTSD appears to contribute to alterations in neuronal network connectivity patterns. Current pharmacological and psychotherapeutic treatments for PTSD are associated with inadequate symptom improvement and high dropout rates. Repetitive transcranial magnetic stimulation (rTMS), a non-invasive therapy involving induction of electrical currents in cortical brain tissue, may be an important treatment option for PTSD to improve remission rates and for people who cannot tolerate existing treatments.

Prepubertal transgender, nonbinary, and gender-diverse (TGD) children (ie, those asserting gender identity, expressing gender-role behavior outside of culturally defined norms for their sex registered at birth, or both) are presenting in greater numbers to pediatric gender clinics across the United States and abroad. A large subset of TGD children experiences gender dysphoria, that is, distress that arises from the incongruence between gender identity and sex registered at birth. A lack of consensus exists regarding care for prepubertal TGD children due, in part, to a dearth of empirical research on longitudinal developmental trajectories of gender identity, role behavior, and gender dysphoria (when present).

Severe psychomotor agitation and aggression often require immediate pharmacological intervention, but clear evidence-based recommendations for choosing among the multiple options are lacking. To address this gap, we plan a systematic review and individual-participant-data network meta-analysis to investigate their comparative effectiveness in real-world emergency settings with increased precision.

Black or African American (hereinafter, Black) and Hispanic or Latino/a/x (hereinafter, Latinx) adults are disproportionally affected by Alzheimer disease, but most research studies do not enroll adequate numbers of both of these populations. The Alzheimer's Disease Neuroimaging Initiative-3 (ADNI3) launched a diversity taskforce to pilot a multipronged effort to increase the study inclusion of Black and Latinx older adults.

Research and public interest in psychedelic-assisted psychotherapy (PAP) are growing. This study investigated attitudes toward psychedelics among a diverse and multinational sample of psychiatrists currently working in Europe. We conducted an anonymous, web-based survey consisting of demographic information, a test of basic knowledge on psychedelics, and the previously validated 20-item Attitudes on Psychedelics Questionnaire (APQ), which was validated for the first time in English within this sample. We included N = 419 participants from 33 countries in the study. One-third of participants (34%) reported past use of psychedelics. The APQ sub-scale with the highest score was Openness to Psychedelics, while Risk Assessment of Psychedelics was rated lowest. Regression modelling, explaining 31.3% of variance in APQ scores, showed that younger male psychiatrists who identified as spiritual, were better at recognizing and classifying substances as psychedelics and had previously used psychedelics had more positive attitudes on psychedelics. No professional variables besides self-reported previous experience with PAP or psychedelic research predicted APQ scores. European psychiatrists, therefore, show a general openness to psychedelics and PAP, but are concerned by the potential risks associated with them. Our findings overall suggest that psychedelics are a subject where it is difficult to remain impartial. Protocol registration: The study was pre-registered at the Open Science Framework (available online at https://osf.io/upkv3 ).

Mild cognitive impairment (MCI) is an intermediate phase between normal cognitive ageing and dementia and poses a serious threat to public health worldwide; however, it might be reversible, representing the best opportunity for secondary prevention against serious cognitive impairment. As a non-pharmacological intervention for those patients, interventions that combine physical exercise and cognitive training, whether delivered simultaneously or sequentially, may have superior effects on various cognitive domains, including global cognition, memory, executive function and attention. The supportive evidence remains incomplete. This study aims to assess the effectiveness of a combined exercise and cognitive intervention in Chinese older adults with mild cognitive impairment (COGITO), empowered by digital therapy and guided by the Health Action Process Model and the Theory of Planned Behaviour (HAPA-TPB theory) in a home-based setting.

Cancer treatment-related cognitive impairment (CTRCI) can substantially reduce the quality of life of cancer survivors. Many treatments of CTRCI have been evaluated in randomized controlled trials (RCTs), including psychological interventions, pharmacologic interventions, and other therapies. There is a pressing need to establish the benefits and harms of previously studied CTRCI treatments. The proposed systematic review and network meta-analyses will assess the relative efficacy and safety of competing interventions for the management of CTRCI.

Chronic pain affects many people globally, requiring alternative management strategies. Psilocybin is gaining attention for its potential in chronic pain management despite being classified as Schedule I.

The COVID-19 pandemic required behavioral researchers to rapidly pivot to the implementation of remote study protocols to facilitate data collection. Remote implementation required robust and flexible research protocols including reliable audio/visual technology that met all the quality, security, and privacy hallmarks of lab-based equipment, while also being portable and usable by nontechnical staff and participants. The project's primary purpose was to develop a technology kit that could be deployed for data collection in homes with young children. The secondary objective was to determine the feasibility of the kit for use longitudinally across four disparate sites.

Racial inequities in severe maternal morbidity (SMM) and mortality constitute a public health crisis in the United States. Doula care, defined as care from birth workers who provide culturally appropriate, non-clinical support during pregnancy and postpartum, has been proposed as an intervention to help disrupt obstetric racism as a driver of adverse pregnancy outcomes in Black and other birthing persons of colour. Many state Medicaid programs are implementing doula programs to address the continued increase in SMM and mortality. Medicaid programs are poised to play a major role in addressing the needs of these populations with the goal of closing the racial gaps in SMM and mortality. This study will investigate the most effective ways that Medicaid programs can implement doula care to improve racial health equity.

The objective of this scoping review is to evaluate the effectiveness of mindfulness training in improving functioning in adolescents (aged 12-19 years) diagnosed with Attention Deficit Hyperactivity Disorder (ADHD). Previous research has demonstrated that psychological interventions improve functioning in a myriad of domains for individuals diagnosed with ADHD, such as attention training, interpersonal relationships, and social skills. Mindfulness-based interventions (MBI) are indicated as an intervention in attention training. It maybe argued that group based MBI programmes should begin early, for children and adolescents at a time that is critical in their development. Methods and reporting are in line with the PRISMA extension for scoping reviews, the protocol is preregistered in the (Open Science Framework register). The study outcomes included attention, impulsivity, and relationships of adolescents with ADHD. Findings demonstrated preliminary evidence for the use of group-based mindfulness interventions with adolescents continues to be nascent. Although studies reported positive results, the evidence of its effectiveness for adolescents with ADHD is inconclusive, due to limited studies available and the limitations of the study design. This scoping review provides a panorama of MBI for ADHD adolescents.

Chemotherapy-induced peripheral neuropathy (CIPN) is a troublesome side effect in patients exposed to taxanes in the treatment of cancer and may affect quality of life dramatically. Here we assessed whether serum levels of neurofilament light (NfL) and tau (two neuroaxonal injury biomarkers) and glial fibrillary acidic protein (GFAP, a biomarker for astrocytic activation) correlate with the development of CIPN in the adjuvant setting of early breast cancer.

The Health and Retirement Study International Partner Surveys (HRS IPS) have rich longitudinal data, but the brevity of cognitive batteries is a limitation.

Research on treatments for children with avoidant restrictive food intake disorder (ARFID) is needed. This pilot case series describes outcome data for 20 children ages 6-12 years old with a diagnosis of ARFID and who are low-weight.

Brain differences linked to autism spectrum disorder (ASD) can manifest before observable symptoms. Studying these early neural precursors in larger and more diverse cohorts is crucial for advancing our understanding of developmental pathways and potentially facilitating earlier identification. EEG is an ideal tool for investigating early neural differences in ASD, given its scalability and high tolerability in infant populations. In this context, we integrated EEG into an existing multi-site MRI study of infants with a higher familial likelihood of developing ASD. This paper describes the comprehensive protocol established to collect longitudinal, high-density EEG data from infants across five sites as part of the Infant Brain Imaging Study (IBIS) Network and reports interim feasibility and data quality results. We evaluated feasibility by measuring the percentage of infants from whom we successfully collected each EEG paradigm. The quality of task-free data was assessed based on the duration of EEG recordings remaining after artifact removal. Preliminary analyses revealed low data loss, with average in-session loss rates at 4.16 % and quality control loss rates at 11.66 %. Overall, the task-free data retention rate, accounting for both in-session issues and quality control, was 84.16 %, with high consistency across sites. The insights gained from this preliminary analysis highlight key sources of data attrition and provide practical considerations to guide similar research endeavors.

This study aims to assess the motivational factors influencing the participation of older adults in various exercise interventions during depressive episodes and to identify which types of exercise are most effective in alleviating depressive symptoms in this population. Therefore, randomized controlled trials (RCTs) focusing on exercise interventions and their impact on depression in older adult patients, identified by the terms "exercise" AND "depression" AND "elderly" OR "geriatric", were selected from primary electronic databases to conduct this network meta-analysis (NMA). The primary outcome was the effect on depressive symptoms, while the secondary outcome was the comparison of dropout rates between the intervention groups and the usual care control groups, as a measure of sustained motivation and engagement. Standardized mean difference (SMD) values and the corresponding 95% confidence intervals (CIs) were computed for effect evaluation. This study protocol has been registered in IPLASY (INPLASY 202460035). The results of 31 RCTs with 3238 participants indicated that qigong (SMD -1.17, -2.28 to -0.06), Otago Exercise (SMD -1.15, -2.29 to -0.01), and yoga (SMD -0.88, -1.55 to -0.21) significantly alleviate depressive symptoms in older adults. Walking (SMD -0.82, -1.34 to -0.31) and strength training (SMD -0.67, -1.05 to -0.30) also showed significant effects. Aerobic, physical training, and tai chi had moderate effects, while multisport showed a weaker impact with no significant improvement. In summary, our research findings demonstrate that exercise can effectively alleviate depressive symptoms in older adults, with low dropout rates likely due to interconnected physiological, psychological, and social mechanisms. This is crucial for enhancing treatment strategies for older adults' depression.

 Tuberculosis (TB) imposes a substantial physical and psychological burden on patients and their families. This study aimed to investigate the prevalence and predictors of depression and anxiety among pulmonary TB patients and their household contacts in Jamnagar, Gujarat, India.

To systematically review research testing nature-based interventions for people living with mild cognitive impairment or dementia, and to report how authors have defined their interventions by presenting a taxonomy of the nature-based interventions.

Many individuals receiving outpatient physical therapy have musculoskeletal pain and up to one-third use prescription opioids. The impact of physical therapist-led mindfulness-based interventions integrated with evidence-based physical therapy (I-EPT) to manage patients with chronic musculoskeletal pain and long-term opioid treatment has not been elucidated. This project evaluates the feasibility of conducting a cluster randomised trial to test the effectiveness of I-EPT.

Young people in care (i.e., in the child welfare system) are a group who have often experienced very high rates of potentially traumatic events, including maltreatment. It is well-documented that they have high rates of trauma-related mental health difficulties, such as posttraumatic stress. To address the needs of the large number of young people who may benefit from support, scalable interventions are crucial. But also important is that they are effective and deliverable - particularly given the complexity of this group and services. We assessed a five-session group CBT-based intervention for PTSD. The primary goal was to understand core procedural and protocol uncertainties to address prior to a definitive trial.

(1) : A significant proportion of cancer survivors report experiencing a cognitive 'fog' that affects their ability to think coherently and quickly, and reason with clarity. This has been referred to as cancer-related cognitive impairment (CRCI). CRCI has extensive impacts on the daily lives of people living with or beyond cancer, including occupational, social, and psychological functioning. Oncology health professionals report feeling under-resourced to effectively assess the needs of an individual with CRCI and then provide optimal care and referral. (2) : The objective of this project is to develop and provide an initial validation of the first purpose-built unmet needs assessment for CRCI: the Unmet Needs Assessment of Cancer-Related Cognitive Impairment Impact (COG-IMPACT). We will use a multiple-stage, co-design, mixed-methods approach to develop and provide an initial validation of the COG-IMPACT. (3) : The primary anticipated result of this research is the production of the COG-IMPACT, the first purpose-built unmet needs assessment for CRCI. The assessment could be used by health professionals to understand the unmet needs and facilitate optimal care and referral for cancer survivors, by survivors to elucidate their supportive needs and advocate for their care, and by researchers to examine the correlates of unmet needs relating to CRCI, as well as how best to support people with CRCI.

The aim of this pre-registered (NCT05051462), randomized controlled trial was to investigate the efficacy and safety of a pandemic-adjusted version of family/systemic constellation therapy in the general population. Altogether, 80 individuals were randomized (85% retained; 67.6% women, M = 41.9 ± 9.2 years) and followed up 1- and 6 months after participation in the single-day intervention. Numerous indicators of psychopathology and addiction as well as wellbeing were assessed. Members of the intervention group improved significantly in terms of the a priori primary outcome (overall psychopathology: d = 0.41, p = 0.003; d = 0.31, p = 0.028) as well as numerous secondary outcomes (obsession-compulsion, interpersonal sensitivity, anxiety, hostility, phobic anxiety, and paranoid ideation). However, the magnitude of improvements was small and mostly disappeared by 6-months. Further, no significant treatment benefit emerged considering time x group interactions regarding any of the outcomes (although statistical power was low). Due to the significant, pandemic-related deviations from the protocol of the intervention, these results may not be generalizable to systemic constellation interventions in general; instead - considering the previous, more favorable data regarding efficacy/effectiveness and tolerability - they rather call attention to the importance of process-related factors regarding this intervention specifically as well as the potential disadvantages of pandemic-related treatment modifications of in-person (non-virtual) group interventions in general.

Child-oriented psychotherapies, such as Attention Process Training (APT), target ADHD symptoms directly, whereas family-oriented interventions, like Parent Management Training (PMT), address its functional impairments. The aim of this study was to compare the effectiveness of APT and PMT in treating ADHD symptoms. This research was a randomized controlled trial in which 45 children (26 females and 19 males, with a mean age of 8.47 ± 1.66 years) with ADHD were selected conveniently and assigned randomly to one of three groups (PMT = 15, APT = 15, and CTRL = 15). The groups had no significant differences in ADHD severity. The PMT children were managed with parenting techniques. Children in the APT group practiced attention techniques, while children in the control group did not receive any intervention. Ritalin was prescribed to all the children in the three groups. The score on the Conners Parenting Rating Scale-Revised: Short form was the outcome variable. Both interventions decreased ADHD symptoms severity more than the control group. Howver, the reduction in the APT group was more than in the PMT group (P-value < 0.001). The scores of 40% of the APT group and 80% of the PMT group did not fall below the cut-off point. In the APT group after the intervention, the inattention subscale was significantly lower than the hyperactivity subscale, while in the PMT group, the hyperactivity subscale was lower. The effect sizes of APT and PMT were 2.18 and 2.09, respectively. For ADHD, psychological interventions are crucial in addition to medication. According to the results of this study, APT is more effective for inattention symptoms, while PMT is more effective for hyperactivity symptoms. When selecting psychotherapy, the subtype of ADHD should be taken into account. Treatment sessions must also be completed according to intervention protocols.

Immersive Virtual Reality (IVR) has shown promise in the assessment, understanding, and treatment of eating disorders (EDs), providing a dynamic platform for clinical innovation. This scoping review aims to synthesize the recent advancements and applications of IVR in addressing these complex psychological disorders.

Adolescents and young adults (AYAs) with cancer are at risk of poor psychosocial outcomes. AYAs grew up with the internet and digital technology, and mobile Health (mHealth) psychosocial interventions have the potential to overcome care access barriers.

Theta burst stimulation (TBS) is a non-invasive brain stimulation technique that can modulate neural activity. The effect of TBS on regions beyond the motor cortex remains unclear. With increased interest in applying TBS to non-motor regions for research and clinical purposes, these effects must be understood and characterised. We synthesised the electrophysiological effects of a single session of TBS, as indexed by electroencephalography (EEG) and concurrent transcranial magnetic stimulation and EEG (TMS-EEG), in non-clinical participants. We reviewed 79 studies that administered either continuous TBS (cTBS) or intermittent TBS (iTBS) protocols. Broadly, cTBS suppressed and iTBS facilitated evoked response component amplitudes. Response to TBS as measured by spectral power and connectivity was much more variable. Variability increased in the presence of task stimuli. There was a large degree of heterogeneity in the research methodology across studies. Additionally, the effect of individual differences on TBS response is insufficiently investigated. Future research investigating the effects of TBS as measured by EEG must consider methodological and individual factors that may affect TBS outcomes.

Wearable technology for objective, continuous, and reliable alcohol monitoring has been developed. These are known as transdermal alcohol sensors (TASs). They can be worn on the wrist or ankle with the sensor pressed against the skin and can measure sweat vapors being emitted from the skin, to record transdermal alcohol concentration (TAC). Previous studies have investigated the accuracy and acceptability of the available TAS brands, but there has been little research into their use in people with alcohol use disorders (AUD).

Network control theory (NCT) is a simple and powerful tool for studying how network topology informs and constrains the dynamics of a system. Compared to other structure-function coupling approaches, the strength of NCT lies in its capacity to predict the patterns of external control signals that may alter the dynamics of a system in a desired way. An interesting development for NCT in the neuroscience field is its application to study behavior and mental health symptoms. To date, NCT has been validated to study different aspects of the human structural connectome. NCT outputs can be monitored throughout developmental stages to study the effects of connectome topology on neural dynamics and, separately, to test the coherence of empirical datasets with brain function and stimulation. Here, we provide a comprehensive pipeline for applying NCT to structural connectomes by following two procedures. The main procedure focuses on computing the control energy associated with the transitions between specific neural activity states. The second procedure focuses on computing average controllability, which indexes nodes' general capacity to control the dynamics of the system. We provide recommendations for comparing NCT outputs against null network models, and we further support this approach with a Python-based software package called 'network control theory for python'. The procedures in this protocol are appropriate for users with a background in network neuroscience and experience in dynamical systems theory.

Premature Ventricular Complexes (PVCs) are very common in clinical practice, with frequent PVCs (more than 30 beats per hour) or polymorphic PVCs significantly increasing the risk of mortality. Previous studies have shown that vagus nerve stimulation improves ventricular arrhythmias. Stimulation of the auricular distribution of the vagus nerve has proven to be a simple, safe, and effective method to activate the vagus nerve. Transcutaneous au ricular vagus nerve stimulation (taVNS) has shown promise in both clinical and experimental setting for PVCs; however, high-quality clinical studies are lacking, resulting in insufficient evidence of efficacy.

IoT sensors offer a wide range of sensing capabilities, many of which have potential health applications. Existing solutions for IoT in healthcare have notable limitations, such as closed-source, limited I/O protocols, limited cloud platform support, and missing specific functionality for health use cases. Developing an open-source internet of things (IoT) gateway solution that addresses these limitations and provides reliability, broad applicability, and utility is highly desirable. Combining a wide range of sensor data streams from IoT devices with ambulatory mHealth data would open up the potential to provide a detailed 360-degree view of the relationship between patient physiology, behavior, and environment. We have developed RADAR-IoT as an open-source IoT gateway framework, to harness this potential. It aims to connect multiple IoT devices at the edge, perform limited on-device data processing and analysis, and integrate with cloud-based mobile health platforms, such as RADAR-base, enabling real-time data processing. We also present a proof-of-concept data collection from this framework, using prototype hardware in two locations. The RADAR-IoT framework, combined with the RADAR-base mHealth platform, provides a comprehensive view of a user's health and environment by integrating static IoT sensors and wearable devices. Despite its current limitations, it offers a promising open-source solution for health research, with potential applications in managing infection control, monitoring chronic pulmonary disorders, and assisting patients with impaired motor control or cognitive ability.

Patients who make 5 or more visits per year to hospital emergency departments (EDs) are usually considered ED frequent users (FUs). This study aims to better characterize the influence of alcohol and other drug use-related disorders in this phenomenon in a European Mediterranean country with public, universal, tax-financed healthcare system.

Despite continuing advancements in treatments for opioid use disorder (OUD), continued high rates of relapse indicate the need for more effective approaches, including novel pharmacological interventions. Glucagon-like peptide 1 receptor agonists (GLP-1RA) provide a promising avenue as a non-opioid medication for the treatment of OUD. Whereas GLP-1RAs have shown promise as a treatment for alcohol and nicotine use disorders, to date, no controlled clinical trials have been conducted to determine if a GLP-1RA can reduce craving in individuals with OUD. The purpose of the current protocol was to evaluate the potential for a GLP-1RA, liraglutide, to safely and effectively reduce craving in an OUD population in residential treatment.

The COVID-19 pandemic has introduced new challenges in managing neurological conditions, particularly among athletes. This paper explores the intersection of post-COVID-19 neurological syndrome (PCNS/PASC) and post-concussion syndrome (PCS), focusing on their implications in sports medicine. Our analysis covers the symptomatology, pathophysiology, and management strategies for PCNS/PASC and PPCS, with special attention paid to the unique challenges faced by athletes recovering from these conditions, including the risk of symptom exacerbation and prolonged recovery. Key findings reveal that both PCNS/PASC and PPCS present with overlapping symptoms such as cognitive difficulties, exercise intolerance, and mental health issues, but differ in specific manifestations like anosmia and ageusia, unique to COVID-19. Pathophysiological analysis reveals similarities in blood-brain barrier disruption (BBB) but differences in the extent of immune activation. Management strategies emphasize a gradual increase in physical activity, close symptom monitoring, and psychological support, with a tailored approach for athletes. Specific interventions include progressive aerobic exercises, resistance training, and cognitive rehabilitation. Furthermore, our study highlights the importance of integrating neurology, psychiatry, physical therapy, and sports medicine to develop comprehensive care strategies. Our findings underscore the dual challenge of COVID-19 and concussion in athletes, necessitating a nuanced, interdisciplinary approach to effective management. Future research should focus on the long-term neurological effects of both conditions and optimizing treatment protocols to improve patient outcomes. This comprehensive understanding is crucial for advancing the management of athletes affected by these overlapping conditions and ensuring their safe return to sports.

Despite clearly established guidelines, recent audits have found the conduct and reporting of systematic reviews and meta-analyses (SRMAs) within neurosurgery to be relatively lackluster in methodological rigor and compliance. Protocols of SRMAs allow for planning and documentation of review methods, guard against arbitrary decision-making during the review process, and enable readers to assess for the presence of selective reporting. To aid transparency, authors should provide sufficient detail in their protocol so that the readers could reproduce the study themselves. Development of our guideline drew heavily from the Preferred Reporting Items for Systematic Reviews and Meta-analyses Protocols (PRISMA-P) initiative. The objective of this article is not to enumerate every detail of this checklist, but to provide guidance to authors preparing their protocol, with examples, for a systematic review in neurosurgery. Particularly, we emphasize on the PICO framework - population (P), interventions (I), comparators (C), outcomes (O) - which is central to constructing a clinical question, defining the scope of the systematic review, defining and prioritizing the primary outcome, to specifying the eligibility criteria, designing the search strategy, and identifying potential sources of heterogeneity. We encourage our readers to make use of this guideline alongside the PRISMA-P 2015 statement, when drafting and appraising systematic review protocols.

Bipolar disorder (BP) is a recurring psychiatric condition characterized by alternating episodes of low energy (depressions) followed by manias (high energy). Cortical network activity produced by GABAergic interneurons may be critical in maintaining the balance in excitatory/inhibitory activity in the brain during development. Initially, GABAergic signaling is excitatory; with maturation, these cells undergo a functional switch that converts GABA channels from depolarizing (excitatory) to hyperpolarizing (inhibitory), which is controlled by the intracellular concentration of two chloride transporters. The earliest, NKCC1, promotes chloride entry into the cell and depolarization, while the second (KCC2) stimulates movement of chloride from the neuron, hyperpolarizing it. Perturbations in the timing or expression of NKCC1/KCC2 may affect essential morphogenetic events including cell proliferation, migration, synaptogenesis and plasticity, and thereby the structure and function of the cortex. We derived induced pluripotent stem cells (iPSC) from BP patients and undiagnosed control (C) individuals, then modified a differentiation protocol to form GABAergic interneurons, harvesting cells at sequential stages of differentiation. qRT-PCR and RNA sequencing indicated that after six weeks of differentiation, controls transiently expressed high levels of NKCC1. Using multi-electrode array (MEA) analysis, we observed that BP neurons exhibit increased firing, network bursting and decreased synchrony compared to C. Understanding GABA signaling in differentiation may identify novel approaches and new targets for treatment of neuropsychiatric disorders such as BP.

The phenomenon of chemsex has emerged as an essential public health issue in recent years. This systematic review aimed to investigate currently available harm reduction strategies and to evaluate the efficacy of the corresponding interventions.

Despite most episodes of low back pain (LBP) being short-lasting, some transition into persistent long-lasting problems. Hence, the need for a deeper understanding of the physiological mechanisms of this is pertinent. Therefore, the aims of the present study are (1) to map pain-induced changes in brain activity and blood gene expression associated with persistent LBP, and (2) to explore whether these brain and gene expression signatures show promise as predictive biomarkers for the development of persistent LBP. The participants will be allocated into three different pain groups (no pain, mild short-lasting, or moderate long-term). One in-person visit, where two blood samples will be collected and sent for RNA sequencing, along with resting 64-channel electro-encephalography measurements before, during, and after a cold pressor test, will be conducted. Thereafter, follow-up questionnaires will be distributed at 2 weeks, 3 months, and 6 months. Recruitment will start during the second quarter of 2024, with expected completion by the last quarter of 2024. The results are expected to provide insight into the relationship between central nervous system activity, gene expression profiles, and LBP. If successful, this study has the potential to provide physiological indicators that are sensitive to the transition from mild, short-term LBP to more problematic, long-term LBP.

Remethylation disorders such as 5,10-methylenetetrahydrofolate reductase () deficiency reduce the remethylation of homocysteine to methionine. The resulting hyperhomocysteinemia can lead to serious neurological consequences and multisystem toxicity. The role of genotypes has not been investigated in patients with Rett Syndrome (RTT). In this study, we sought to assess the impact of co-occurring genotypes on symptom profiles in RTT.

Contingency management (CM) for substance use disorders (SUD) is effective in strengthening recovery behaviors, however can be quite burdensome. When health facilities experience staff shortages, adapting current CM protocols to be less staff and time intensive may be one way to address this challenge.

The Accelerating Medicines Partnership Schizophrenia (AMP SCZ) funds a longitudinal study of 43 research sites across 5 continents to develop tools to stratify developmental trajectories of youth at clinical high risk for psychosis (CHR) and identify homogenous targets for future clinical trials. However, there are no sites in Africa, leaving a critical gap in our knowledge of clinical and biological outcomes among CHR individuals.

AI technologies have the potential to transform patient care. AI has been used to aid in differential diagnosis and treatment planning for psychiatric disorders, administer therapeutic protocols, assist with interpretation of cognitive testing, and patient treatment planning. Despite advancements, AI has notable limitations and remains understudied and further research on its strengths and limitations in patient care is required. This study explored the responses of AI (Chat-GPT 3.5) and trained clinicians to commonly asked patient questions.

There is a growing recognition of the key role of the therapeutic relationship in the outcomes of psychotherapy. However, current understanding of its specific components, their interplay and related patient-therapist dynamics is limited.

Spinal Cord Stimulation (SCS) may provide pain relief in patients with therapy-refractory Persistent Spinal Pain Syndrome Type II (PSPS-T2). Despite the evidence that SCS can reduce disability and reduce pain medication usage, only 25% of the patients is able to completely omit pain medication usage after 12 months of SCS. To tackle the high burden of patients who consume a lot of pain medication, tapering programs could be initiated before starting a trajectory with SCS. The current objective is to examine whether a pain medication tapering program before SCS alters disability in PSPS-T2 patients compared to no tapering program.

Apathy is a frequent and debilitating condition among subarachnoid hemorrhage (SAH) survivors. Few studies have evaluated apathy in SAH, and none have examined the course of the condition, predictors of persistent apathy, or its impact on functional outcomes. The proposed study will examine, for the first time, the 12-month course of apathy and its impact on functional outcomes in the largest cohort of SAH survivors to date.

Schizophrenia (SCZ) is characterized by cognitive deficits that are linked to prefrontal cortex dysfunction. While transcranial direct current stimulation (tDCS) shows promise for improving cognition, the effects of intensified 3mA tDCS protocols on brain physiology are unknown. This project aims to elucidate the neurophysiological and cognitive effects of an intensified prefrontal tDCS protocol in SCZ.

Nurses, who care for patients with various traumas, may also experience post-traumatic stress disorder due to indirect or direct exposure to traumatic situations. This study examined the effectiveness of an Internet-based trauma recovery intervention for Korean nurses.

Impairments in social cognition are known to be a key factor in several psychiatric and neurodevelopmental disorders. Interest in psychedelic drugs has increased in recent years, with significant research identifying psychedelic and hallucinogenic drugs as modulators of social cognition. However, more research is necessary before psychedelics are implemented in clinical settings as treatments for social cognition defects. Therefore, this study describes a scoping review protocol which will be used to analyze the body of literature on psychedelic drugs as modulators of social cognition in patients with psychiatric and neurodevelopmental disorders.

Perinatal depression and anxiety (PDA) is prevalent in new and expectant mothers, affecting millions of women worldwide. Those with a history of mood and anxiety disorders are at the greatest risk of experiencing PDA in a subsequent pregnancy. Current safety concerns with pharmacological treatments have led to a greater need for adjunctive treatment options for PDA. Changes in the composition of the microbiome have been associated with various diseases during pregnancy, and these changes are thought to play some role in perinatal mood disorders. While the relationship between PDA and the microbiome has not been explored, evidence suggests that nutritional interventions with fiber, fish oils, and probiotics may play a favorable role in neuropsychiatric outcomes during and after pregnancy. The primary objective of the present study is to assess the feasibility and acceptability of a combination of nonpharmacological interventions to maintain stability in pregnant women who have a history of depression and/or anxiety. This study will also aim to understand ease of recruitment and protocol adherence in this cohort.

Neurodevelopmental disorders affect the lifespan of diagnosed individuals and their families. COVID-19 challenged these families with daily routine unpredictability requiring rapid adaptations. Moreover, associations and schools were closed, leaving these families without regular social support. Here, we investigate which individual and family factors can predict the caregiver's depressive state and overall burden. An online study took place between 2021 and 2022. A total of 32 caregivers (30 women; 48 ± 8.22 years old; range 26 to 63 years old) reported having a family member with a neurodevelopmental disorder, the majority diagnosed with autism spectrum disorder. Caregivers responded to a protocol to assess the burden, resilience, depressive, anxious, and stress symptomatology, as well as the behavior of the diagnosed individual. Hierarchical multiple regressions were performed to identify protective and risk factors for the caregivers' well-being. Caregivers' depressive state was explained by 29.3% of the variance of the family cohesion factor, indicating that high levels of balanced family cohesion represent a crucial protective factor for reducing the caregiver's depressive state. Additionally, overall caregiver burden was explained by 17.8% of the variance due to self-perception and 26.4% due to family cohesion, with the caregiver's self-perception playing an important protective role in the overall perception of burden. The proportion of male and female respondents seems to corroborate the significant role of women in caregiving. These results emphasize the importance of considering both individual and family factors of caregivers during interventions, which have implications for family therapy with families of members diagnosed with neurodevelopmental disorders, specifically with autism.

Treatment-Resistant Depression (TRD) poses a substantial health and economic challenge, persisting as a major concern despite decades of extensive research into novel treatment modalities. The considerable heterogeneity in TRD's clinical manifestations and neurobiological bases has complicated efforts toward effective interventions. Recognizing the need for precise biomarkers to guide treatment choices in TRD, herein we introduce the SelecTool Project. This initiative focuses on developing (WorkPlane 1/WP1) and conducting preliminary validation (WorkPlane 2/WP2) of a computational tool (SelecTool) that integrates clinical data, neurophysiological (EEG) and peripheral (blood sample) biomarkers through a machine-learning framework designed to optimize TRD treatment protocols. The SelecTool project aims to enhance clinical decision-making by enabling the selection of personalized interventions. It leverages multi-modal data analysis to navigate treatment choices towards two validated therapeutic options for TRD: esketamine nasal spray (ESK-NS) and accelerated repetitive Transcranial Magnetic Stimulation (arTMS). In WP1, 100 subjects with TRD will be randomized to receive either ESK-NS or arTMS, with comprehensive evaluations encompassing neurophysiological (EEG), clinical (psychometric scales), and peripheral (blood samples) assessments both at baseline (T0) and one month post-treatment initiation (T1). WP2 will utilize the data collected in WP1 to train the SelecTool algorithm, followed by its application in a second, out-of-sample cohort of 20 TRD subjects, assigning treatments based on the tool's recommendations. Ultimately, this research seeks to revolutionize the treatment of TRD by employing advanced machine learning strategies and thorough data analysis, aimed at unraveling the complex neurobiological landscape of depression. This effort is expected to provide pivotal insights that will promote the development of more effective and individually tailored treatment strategies, thus addressing a significant void in current TRD management and potentially reducing its profound societal and economic burdens.

The present study aims to present a novel cognitive-behavioral intervention protocol focused on treating social isolation through telematic interaction, thus overcoming common barriers characteristic of face-to-face interventions.

The objective of the study is to evaluate how electroconvulsive therapy (ECT) affects treatment-resistant depression, bipolar and schizophrenic patient groups, and suicide attempt histories and to evaluate the relationship between treatment variables and patient outcomes.

This review aimed to assess the current evidence on the relationship between resilience and mental health employed in response to the impacts of mental health.

Evidence suggests inflammation plays a role in the pathophysiology of psychosis even in early illness, indicating a potential avenue for anti-inflammatory interventions that simultaneously address high rates of metabolic disease in this population. The aim of this study is to design a novel anti-inflammatory diet intervention (DI) that is feasible to implement in a first-episode psychosis (FEP) population.

Behavioral and Psychological Symptoms of Dementia (BPSD) are a heterogeneous set of psychological and behavioral abnormalities seen in persons with dementia (PwD), significantly impacting their quality of life and that of their caregivers. Current assessment tools, such as the Neuropsychiatric Inventory (NPI), are limited by recall bias and lack of direct observation. This study aims to overcome this limitation by making caregiver reports more objective through the use of a novel instrument, referred to as the BPSDiary. This randomized controlled trial will involve 300 caregiver-PwD dyads. The objective is to evaluate whether the use of the BPSDiary could significantly reduce caregiver burden, assessed using the Zarit Burden Interview (ZBI), compared to usual care. The study will include adult PwD, caregivers living with or close to the patient, and BPSD related to the HIDA (hyperactivity, impulsivity, irritability, disinhibition, aggression, agitation) domain. Caregivers randomized to the intervention arm will use the BPSDiary to record specific BPSD, including insomnia, agitation/anxiety, aggression, purposeless motor behavior, and delusions/hallucinations, registering time of onset, severity, and potential triggers. The primary outcome will be the change in ZBI scores at 3 months, with secondary outcomes including changes in NPI scores, olanzapine equivalents, NPI-distress scores related to specific BPSD domains, and caregiver and physician satisfaction. The study will be conducted in 9 Italian centers, representing diverse geographic and sociocultural contexts. While potential limitations include the relatively short observation period and the focus on specific BPSD disturbances, the BPSDiary could provide physicians with objective data to tailor appropriate non-pharmacological and pharmacological interventions. Additionally, it may empower caregivers by encouraging reflection on BPSD triggers, with the potential to improve the quality of life for both PwD and their caregivers.

Mental disorders are increasingly understood as involving complex alterations of self that emerge from dynamical interactions of constituent elements, including cognitive, bodily, affective, social, narrative, cultural and normative aspects and processes. An account of self that supports this view is the pattern theory of self (). The is a non-reductive account of the self, consistent with both embodied-enactive cognition and phenomenological psychopathology; it foregrounds the multi-dimensionality of subjects, stressing situated embodiment and intersubjective processes in the formation of the self-pattern. Indications in the literature already demonstrate the viability of the for formulating an alternative methodology to better understand the lived experience of those suffering mental disorders and to guide mental health research more generally. This article develops a flexible methodological framework that front-loads the self-pattern into a minimally structured phenomenological interview. We call this framework 'Examination of Self Patterns' (). The is unconstrained by internalist or externalist assumptions about mind and is flexibly guided by person-specific interpretations rather than pre-determined diagnostic categories. We suggest this approach is advantageous for tackling the inherent complexity of mental health, the clinical protocols and the requirements of research.

Post-stroke depression (PSD) is a prevalent psychiatric disorder affecting about one-third of stroke survivors, significantly hindering recovery and quality of life. PSD also imposes a substantial burden on caregivers and healthcare systems. Aromatherapy has shown promise in alleviating depression, anxiety, and sleep disorders. This pilot randomized controlled trial aims to assess the feasibility and preliminary efficacy of mixed herb aromatherapy in treating PSD. Feasibility outcomes encompass recruitment, intervention adherence, assessment completion and safety assessment. Secondary outcomes include evaluations of depression, anxiety, cognitive function, sleep quality, quality of life, and brain function using EEG and fNIRS.

The performance of everyday technology-based tasks, such as online banking or shopping, can be challenging for older adults, especially those with a cognitive impairment. Technology-based tasks are cognitively demanding and require learning new skills. This study explored the efficacy of a technology-based functional skills assessment and training program (FUNSAT) among aging adults with and without mild cognitive impairment (MCI) in home settings.

Ketamine has recently attracted considerable attention for its rapid effects on patients with major depressive disorder, including treatment-resistant depression (TRD). Despite ketamine's promising results in treating depression, a significant number of patients do not respond to the treatment, and predicting who will benefit remains a challenge. Although its antidepressant effects are known to be linked to its action as an antagonist of the N-methyl-D-aspartate (NMDA) receptor, the precise mechanisms that determine why some patients respond and others do not are still unclear.

Individuals with posttraumatic stress disorder (PTSD) are at heightened risk for cardiovascular disease (CVD) compared to the general population. Inflammation and autonomic dysfunction are candidate mechanisms of CVD risk in PTSD; however, these mechanisms have not been well-characterised in the PTSD-CVD link. Further, these mechanisms may operate through altered stress-related neural activity (SNA). Yet, it remains unknown if changes in PTSD are associated with changes in CVD risk mechanisms. This manuscript describes the design and procedures of a pilot randomised controlled trial to assess the impact of a first-line treatment for PTSD (Cognitive Processing Therapy; CPT) versus waitlist control on mechanisms of CVD risk. Further, this study will test the hypothesis that CPT reduces CVD risk through its effects on inflammation and autonomic function and that these changes are driven by changes in SNA. Adults with PTSD and CVD risk ( = 30) will be randomised to CPT or waitlist control. Participants complete two laboratory visits (baseline and post-treatment) that include surveys, brain and peripheral imaging via 18F-fluorodeoxyglucose positron emission tomography (FDG-PET), and resting measures of autonomic function. Primary outcomes include arterial inflammation and heart rate variability. Secondary outcomes include leukopoiesis (bone marrow uptake), heart rate, and blood pressure. The indirect effects of PTSD treatment on changes in inflammation and autonomic function through SNA will also be examined. This study seeks to characterise candidate neuroimmune mechanisms of the PTSD-CVD link to identify treatment targets and develop personalised interventions to reduce CVD events in PTSD populations. ClinicalTrials.gov identifier: NCT06429293..

Electrolytes (sodium, potassium, calcium, magnesium, chloride, phosphate) are required in specific amounts for proper functioning of the human body. Although the body has different organ systems, such as the kidneys, that regulate electrolyte levels in the blood, electrolyte abnormalities occur frequently in people with eating disorders. The objective of this review will be to examine the association between electrolyte imbalances and adverse outcomes in people with eating disorders.

Adults with mental health symptoms stemming from childhood interpersonal trauma require specialized trauma-focused psychological interventions. Limitations in accessing treatment interventions for this population necessitate innovative solutions. This study explored the feasibility of a protocol for a blended e-health psychoeducational treatment intervention for this population called the Trauma PORTAL (Providing Online tRauma Therapy using an Asynchronous Learning platform), combining asynchronous online modules and weekly live virtual group sessions.

Increasing evidence has shown that gut microbiota (GM) was involved in the pathophysiology of musculoskeletal disorders through multiple pathways such as protein anabolism, chronic inflammation and immunity, and imbalanced metabolism. We performed a systematic review and meta-analysis of human studies to evaluate GM diversity differences between individuals with and without sarcopenia, and explore bacteria with potential to become biomarkers. PubMed, Embase and Cochrane library were systematically searched from inception to February 16, 2024. Studies were included if they (1) sampled adults with sarcopenia, and (2) performed GM analysis and reported α-diversity, β-diversity or relative abundance. The methodological quality of included studies and the certainty of evidence were assessed through the Joanna Briggs Institute critical appraisal checklist for analytical cross-sectional studies and the Grades of Recommendation, Assessment, Development and Evaluation (GRADE) Working Group system, respectively. Weighted standardized mean differences (SMDs) and corresponding 95% confidence intervals (CIs) were estimated for α-diversity indices using a fixed-effects and a random-effects model. Beta diversity and the relative abundance of GM were summarized qualitatively. A total of 19 studies involving 6,565 participants were included in this study. Compared with controls, significantly moderate decrease in microbial richness in participants with sarcopenia were found (Chao1: SMD = -0.44; 95%CI, -0.64 to -0.23, I2 = 57.23%, 13 studies; observed species: SMD = -0.68; 95%CI, -1.00 to -0.37, I2 = 66.07%, 5 studies; ACE index: SMD = -0.30; 95%CI, -0.56 to -0.04, I2 = 8.12%, 4 studies), with very low certainty of evidence. Differences in β-diversity were consistently observed in 84.6% of studies and 97.3% of participants. The detailed analysis of the gut microbial differential abundance identified a loss of Prevotellaceae, Prevotella, and Megamonas in sarcopenia compared with non-sarcopenia. In conclusion, sarcopenia was found to be associated with reduced richness of GM, and supplementing intestinal bacteria described above may contribute to preventing and treating this muscle disease. The research protocol was registered and approved in PROSPERO (CRD42023412849).

One of the most common concerns of patients undergoing surgery is preoperative anxiety, with a prevalence of up to 48%. The effects of preoperative anxiety continue beyond the preoperative period and are associated with more severe postoperative pain and poorer treatment outcomes. Treatment options for preoperative anxiety are often limited as sedatives cause side effects and their efficacy remains controversial. Placebo research has shown that optimization of positive treatment expectations, as can be achieved through placebo administration and education, has clinically relevant effects on preoperative anxiety, pain and treatment outcomes. As the administration of masked placebos raises ethical questions, clinical studies have increasingly focused on the use of open, non-deceptive placebo administration (open-label placebo, OLP). The use of OLPs to reduce preoperative anxiety and modify clinically relevant postoperative outcomes has not yet been investigated. This bicentric, prospective, randomized-controlled clinical trial (PATE Trial; German Registry for Clinical Studies DRKS00033221), an associated project of the Collaborative Research Center (CRC) 289 "Treatment Expectation", aims to alleviate preoperative anxiety by optimizing positive treatment expectations facilitated by OLP. Furthermore, this study examines a potential enhancement of these effects through aspects of observational learning, operationalized by a positive expectation-enhancing video. In addition, patient's perspective on the self-efficacy and appropriateness of OLPs prior to surgery will be assessed. To achieve these objectives, female patients will be randomized into three groups before undergoing gynecological laparoscopic surgery. One group receives the OLP with a positive rationale conveyed by a study physician. A second group receives the same intervention, OLP administration and rationale provided by a physician, and additionally watches a video on OLP presenting a satisfied patient. A third group receives standard treatment as usual (TAU). Outcome measures will be effects on preoperative anxiety and postoperative experience, particularly visceral and somatic postoperative pain. As the non-deceptive administration of placebos; when indicated; may yield positive outcomes without side effects, and as current treatment of preoperative anxiety is limited, evidence from clinical placebo research has the potential to improve outcomes and patient experience in the surgical setting.

Compared to civilians and non-medical personnel, military medical doctors are at increased risk for sleep disturbances and impaired psychological well-being. Despite their responsibility and workload, no research has examined sleep disturbances and psychological well-being among the medical doctors (MDs) of the Swiss Armed Forces (SAF). Thus, the aims of the proposed study are (1) to conduct a cross-sectional study (labeled 'Survey-Study 1') of sleep disturbances and psychological well-being among MDs of the SAF; (2) to identify MDs who report sleep disturbances (insomnia severity index >8), along with low psychological well-being such as symptoms of depression, anxiety and stress, but also emotion regulation, concentration, social life, strengths and difficulties, and mental toughness both in the private/professional and military context and (3) to offer those MDs with sleep disturbances an evidence-based and standardized online interventional group program of cognitive behavioral therapy for insomnia (eCBTi) over a time lapse of 6 weeks (labeled 'Intervention-Study 2').