Psychiatry Research/Trial Protocols

Body dysmorphic disorder (BDD) is severe and undertreated. Digital mental health could be key to expanding access to evidence-based treatments, such as cognitive behavioral therapy for BDD (CBT-BDD). Coach guidance is posited to be essential for effective uptake of digital interventions. However, little is known about how different patients may use coaching, what patterns correspond to meaningful outcomes, and how to match coaching to patient needs.

Understanding the impacts of environmental exposures on health outcomes during development is an important area of research for plenty of reasons. Collecting retrospective and prospective residential history can enrich observational studies through eventual linkages to external sources. Augmenting participant health outcome data with environmental data can better inform on the role of the environment, thereby enhancing prevention and intervention efforts. However, collecting the geospatial information needed for this type of research can be difficult, especially when data are collected directly from participants. Participants' residential histories are unique and often complex. Collecting residential history data often involves capturing precise spatial locations along specific timeframes as well as contending with recall bias and unique, complex living arrangements. When trying to assess lifetime environmental exposures, researchers must consider the many changes in location a person goes through and the timeframes in which these changes occur, ultimately creating a multidimensional and dynamic dataset. Creating data collection protocols that are feasible to administer, result in accurate data, and minimize data missingness is a major challenge to undertake. Here, we provide an overview of the protocol developed to collect the lifetime residential address information of participants in the Adolescent Brain Cognitive Development (ABCD) Study.

Pre-menstrual disorders, including pre-menstrual syndrome and pre-menstrual dysphoric disorder, are highly prevalent disorders in women of reproductive age. Pre-menstrual disorders are associated with debilitating symptoms that onset in the days prior to menses. A complex interplay between hormonal fluctuations, cellular sensitivity, and psychosocial stressors likely underly the pathophysiology of pre-menstrual disorders. Current treatment options include selective serotonin reuptake inhibitors, hormonal therapies, and psychosocial support. There is growing evidence for oestrogen, progesterone, gonadotropin Releasing Hormone analogues and Complementary and Alternative Medicines in treating Pre-menstrual disorders. (S)-S-adenosylmethionine is a complementary and alternative medicine with postulated roles in the treatment of depression, with a rather rapid onset of action and minimal side effect profile. We propose a protocol for investigating the efficacy of (S)-S-adenosylmethionine in the treatment of pre-menstrual disorders. The proposed study is an open label pilot study, that will recruit thirty women between the ages of 18-45 who experience a pre-menstrual disorder. Daily and interval questionnaires will provide a quantification of symptoms across four menstrual cycles (16 weeks). During two consecutive menstrual cycles it is proposed that participants receive oral (S)-S-adenosylmethionine Complex 400 mg three times a day (total daily dose 1200 mg), during the pre-menstrual time-period (14 days prior to menses). Changes in pre-menstrual disorder symptoms between control and treatment cycles will assist in elucidating the clinical efficacy of (S)-S-adenosylmethionine. This study has the potential to support a larger double blinded, placebo controlled randomised control trial and aims to enrich the knowledge surrounding pre-menstrual disorders.

Neurocognitive deficits in bipolar disorder (BD) have a negative impact on the quality of life, even during the euthymic phase. And many studies conducted to improve cognitive deficits in bipolar disorder. This systematic review aims to summarize studies on cognitive rehabilitation (CR) conducted in bipolar patients and evaluate its impact on neurocognitive deficits. The primary objective is to explore how CR interventions can enhance cognitive functioning, treatment outcomes, and overall quality of life in this population.

This is a protocol for a Campbell systematic review of intervention effectiveness. The goal of this systematic review is to answer the following questions based on the available empirical evidence: Are there nutritional interventions (dietary manipulation, fortification or supplementation) that can reduce excessive aggression towards others in children/youth? If yes, how strong is their effect and is there a difference among the three intervention types? Are there nutritional interventions that can reduce antisocial behaviors in children/youth? If yes, how strong is their effect and is there a difference among the intervention types? Are there nutritional interventions that can reduce violent offending in children/youth? If yes, how strong is their effect and is there a difference among the intervention types? Are there nutritional interventions that can reduce non-violent offending in children/youth? If yes, how strong is their effect and is there a difference among the intervention types? What implementation barriers and solutions to these exist in relation to the above nutritional interventions in children/youth?

The COVID-19 pandemic has been extensively discussed in the context of its effect on mental health. Although global suicide rates have remained stable during the pandemic, the specific effect on non-fatal suicide behaviours during and after the pandemic remains underexplored. This study aims to investigate patterns of non-fatal suicide behaviours before, during, and after the pandemic.

Expert consensus operationalized treatment response and remission in obsessive-compulsive disorder (OCD) as a Yale-Brown Obsessive-Compulsive Scale (Y-BOCS) reduction ≥35% and score ≤12 with ≤2 on Clinical Global Impressions Improvement (CGI-I) and Severity (CGI-S) scales, respectively. However, there has been scant empirical evidence supporting these definitions.

Higher pre-diagnosis physical activity (PA) is associated with lower all-cause mortality in breast cancer (BCa) patients. However, the association with pathological complete response (pCR) is unclear. We investigated the association between pre-diagnosis PA level and chemotherapy completion, dose delay, and pCR in BCa patients receiving neoadjuvant chemotherapy (NACT).

US military veterans who have experienced homelessness often have high rates of housing transition. Disruptions caused by these transitions likely exacerbate this population's health problems and interfere with access to care and treatment engagement. Individuals experiencing homelessness increasingly use smartphones, contributing to improved access to medical and social services. Few studies have used smartphones as a data collection tool to systematically collect information about the daily life events that precede and contribute to housing transitions, in-the-moment emotions, behaviors, geographic movements, and perceived social support.

Deuterium metabolic imaging (DMI) is an emerging magnetic resonance technique, for non-invasive mapping of human brain glucose metabolism following oral or intravenous administration of deuterium-labeled glucose. Regional differences in glucose metabolism can be observed in various brain pathologies, such as Alzheimer's disease, cancer, epilepsy or schizophrenia, but the achievable spatial resolution of conventional phase-encoded DMI methods is limited due to prolonged acquisition times rendering submilliliter isotropic spatial resolution for dynamic whole brain DMI not feasible. The purpose of this study was to implement non-Cartesian spatial-spectral sampling schemes for whole-brain H FID-MR Spectroscopic Imaging to assess time-resolved metabolic maps with sufficient spatial resolution to reliably detect metabolic differences between healthy gray and white matter regions. Results were compared with lower-resolution DMI maps, conventionally acquired within the same session. Six healthy volunteers (4 m/2 f) were scanned for ~90 min after administration of 0.8 g/kg oral [6,6']-H glucose. Time-resolved whole brain H FID-DMI maps of glucose (Glc) and glutamate + glutamine (Glx) were acquired with 0.75 and 2 mL isotropic spatial resolution using density-weighted concentric ring trajectory (CRT) and conventional phase encoding (PE) readout, respectively, at 7 T. To minimize the effect of decreased signal-to-noise ratios associated with smaller voxels, low-rank denoising of the spatiotemporal data was performed during reconstruction. Sixty-three minutes after oral tracer uptake three-dimensional (3D) CRT-DMI maps featured 19% higher (p = .006) deuterium-labeled Glc concentrations in GM (1.98 ± 0.43 mM) compared with WM (1.66 ± 0.36 mM) dominated regions, across all volunteers. Similarly, 48% higher (p = .01) H-Glx concentrations were observed in GM (2.21 ± 0.44 mM) compared with WM (1.49 ± 0.20 mM). Low-resolution PE-DMI maps acquired 70 min after tracer uptake featured smaller regional differences between GM- and WM-dominated areas for H-Glc concentrations with 2.00 ± 0.35 mM and 1.71 ± 0.31 mM, respectively (+16%; p = .045), while no regional differences were observed for H-Glx concentrations. In this study, we successfully implemented 3D FID-MRSI with fast CRT encoding for dynamic whole-brain DMI at 7 T with 2.5-fold increased spatial resolution compared with conventional whole-brain phase encoded (PE) DMI to visualize regional metabolic differences. The faster metabolic activity represented by 48% higher Glx concentrations was observed in GM- compared with WM-dominated regions, which could not be reproduced using whole-brain DMI with the low spatial resolution protocol. Improved assessment of regional pathologic alterations using a fully non-invasive imaging method is of high clinical relevance and could push DMI one step toward clinical applications.

Following years of pandemic severe acute respiratory syndrome coronavirus 2 infections labelled Covid-19, long lasting impairment summarized as post-Covid syndrome (PCS) challenges worldwide healthcare. Patients benefit from rehabilitation programs, but sex specific aspects of improvement remain little understood. The aim of the study was to assess whether women and men differ in response to outpatient pulmonary rehabilitation for PCS.

Individuals with severe and treatment-resistant obsessive-compulsive disorder (trOCD) represent a small but severely disabled group of patients. Since trOCD cases eligible for deep brain stimulation (DBS) probably comprise the most severe end of the OCD spectrum, we hypothesize that they may be more likely to have a strong genetic contribution to their disorder. Therefore, while the worldwide population of DBS-treated cases may be small (~300), screening these individuals with modern genomic methods may accelerate gene discovery in OCD. As such, we have begun to collect DNA from trOCD cases who qualify for DBS, and here we report results from whole exome sequencing and microarray genotyping of our first five cases. All participants had previously received DBS in the bed nucleus of stria terminalis (BNST), with two patients responding to the surgery and one showing a partial response. Our analyses focused on gene-disruptive rare variants (GDRVs; rare, predicted-deleterious single-nucleotide variants or copy number variants overlapping protein-coding genes). Three of the five cases carried a GDRV, including a missense variant in the ion transporter domain of KCNB1, a deletion at 15q11.2, and a duplication at 15q26.1. The KCNB1 variant (hg19 chr20-47991077-C-T, NM_004975.3:c.1020G>A, p.Met340Ile) causes substitution of methionine for isoleucine in the trans-membrane region of neuronal potassium voltage-gated ion channel KV2.1. This KCNB1 substitution (Met340Ile) is located in a highly constrained region of the protein where other rare missense variants have previously been associated with neurodevelopmental disorders. The patient carrying the Met340Ile variant responded to DBS, which suggests that genetic factors could potentially be predictors of treatment response in DBS for OCD. In sum, we have established a protocol for recruiting and genomically characterizing trOCD cases. Preliminary results suggest that this will be an informative strategy for finding risk genes in OCD.

One-third of people with depression do not respond to antidepressants, and, after two adequate courses of antidepressants, are classified as having treatment-resistant depression (TRD). Some case reports suggest that ketogenic diets (KDs) may improve some mental illnesses, and preclinical data indicate that KDs can influence brain reward signalling, anhedonia, cortisol, and gut microbiome which are associated with depression. To date, no trials have examined the clinical effect of a KD on TRD.

Anxiety and depression pose a significant global health challenge, especially affecting adults in low-income and middle-income countries. In many low-income and middle-income countries, including those in sub-Saharan Africa, social determinants such as access to affordable health services, conflict, food insecurity, and poverty may be associated with the prevalence of anxiety and depression, further contributing to health disparities. To mitigate the burden of anxiety and depression in sub-Saharan Africa, it is essential to develop country-level tailored mental health policies and strategies. For example, Ghana is working towards improving mental health via its 12 year Mental Health policy launched in 2021. However, the prevalence of anxiety and depression among adults in Ghana, along with associated social determinants remains largely unknown, posing challenges for mental health planning, resource allocation and developing targeted interventions. This systematic review seeks to (1) examine the prevalence of anxiety and depression among adults in Ghana and (2) explore social determinants potentially associated with anxiety and depression.

Research suggests that problems with emotion regulation, that is, how a person manages and responds to an emotional experience, are related to a range of psychological disorders (eg, bipolar disorder, anxiety and depression). Interventions targeting emotion regulation have been shown to improve mental health in adults, but evidence on related interventions for adolescents is still emerging. Increasingly, self-directed digital interventions (eg, mobile apps) are being developed to target emotion regulation in this population, but questions remain about their effectiveness. This systematic review aimed to synthesise evidence on current self-directed digital interventions available to adolescents (aged 11-18 years) and their effectiveness in addressing emotion regulation, psychopathology and functioning (eg, academic achievement).

The underlying neurobiology of the complex autism phenotype remains obscure, although accumulating evidence implicates the serotonin system and especially the 5HT receptor. However, previous research has largely relied upon association or correlation studies to link differences in serotonin targets to autism. To directly establish that serotonergic signalling is involved in a candidate brain function our approach is to change it and observe a shift in that function. We will use psilocybin as a pharmacological probe of the serotonin system in vivo. We will directly test the hypothesis that serotonergic targets of psilocybin - principally, but not exclusively, 5HT receptor pathways-function differently in autistic and non-autistic adults.

Mental disorders are common among people with HIV (PWH) and are associated with poor HIV outcomes. Despite high unmet mental health needs among PWH, use of evidence-based mental health screening and treatment protocols remains limited at HIV treatment facilities across low-resource settings. Integrating mental health services into HIV care can reduce this gap. This study's objective was to explore factors that influence integration of mental health screening and treatment into HIV clinics in Cameroon.

Urinary incontinence is highly prevalent in women while pelvic floor muscle training is recommended as the first-line therapy. However, the exact treatment regimen is poorly understood. Also, patients with pelvic floor muscle damage may have decreased muscle proprioception and cannot contract their muscles properly. Other conservative treatments including electromagnetic stimulation are suggested by several guidelines. Thus, the present study aims to compare the effectiveness of electromagnetic stimulation combined with pelvic floor muscle training as a conjunct treatment for urinary incontinence and different treatment frequencies will be investigated.

This study employs a descriptive phenomenological approach to investigate the challenges anesthesia nurses face in managing emergence delirium (ED), a common and complex postoperative complication in the post-anesthesia care unit. The role of nurses in managing ED is critical, yet research on their understanding and management strategies for ED is lacking.

The increasing burden of non-communicable diseases, such as hypertension, diabetes and dyslipidaemia, presents key challenges to achieving optimal HIV care outcomes among ageing people living with HIV. These diseases are often comorbid and are exacerbated by psychosocial and structural inequities. This interaction among multiple health conditions and social factors is referred to as a syndemic. In the USA, there are substantial disparities by social position (ie, racial, ethnic and socioeconomic status) in the prevalence and/or control of non-communicable diseases and HIV. Intersecting stigmas, such as racism, classism and homophobia, may drive these health disparities by contributing to healthcare avoidance and by contributing to a psychosocial syndemic (stress, depression, violence victimisation and substance use), reducing success along the HIV and non-communicable disease continua of care. Our hypothesis is that marginalised populations experience disparities in non-communicable disease incidence, prevalence and control, mediated by intersectional stigma and the psychosocial syndemic.

Problematic pornography use (PPU) can be a manifestation of compulsive sexual behavior disorder (CSBD). Studies investigating PPU confirm approach-avoidance tendencies in response to pornographic stimuli in this population. This study show indications of the significance of the efficacy of imaginal retraining, a variant of approach bias modification, as an intervention for PPU.

Functional PET (fPET) is a novel technique for studying dynamic changes in brain metabolism and neurotransmitter signaling. Accurate quantification of fPET relies on measuring the arterial input function (AIF), traditionally achieved through invasive arterial blood sampling. While non-invasive image-derived input functions (IDIF) offer an alternative, they suffer from limited spatial resolution and field of view. To overcome these issues, we developed and validated a scan protocol for brain fPET utilizing cardiac IDIF, aiming to mitigate known IDIF limitations.

Motor and cognitive alterations in schizophrenia-spectrum disorders (SSD) share common neural underpinnings, highlighting the necessity for a thorough exploration of the connections between these areas. This relationship is crucial, as it holds potential significance in unraveling the underlying mechanisms of SSD pathophysiology, ultimately leading to advancements in clinical staging and treatment strategies. The purpose of this review was to characterize the relationship between different hyper and hypokinetic domains of motor alterations and cognition in SSD. We systematically searched the literature (PROSPERO protocol CRD42019145964) and selected 66 original scientific contributions for review, published between 1987 and 2022. A narrative synthesis of the results was conducted. Hyper and hypokinetic motor alterations showed weak to moderate negative correlations with cognitive function across different SSD stages, including before antipsychotic treatment. The literature to date shows a diverse set of methodologies and composite cognitive scores hampering a strong conclusion about which specific cognitive domains were more linked to each group of motor alterations. However, executive functions seemed the domain more consistently associated with parkinsonism with the results regarding dyskinesia being less clear. Akathisia and catatonia were scarcely discussed in the reviewed literature. The present review reinforces the intimate relationship between specific motor alterations and cognition. Identified gaps in the literature challenge the formulation of definitive conclusions. Nevertheless, a discussion of putative underlying mechanisms is included, prompting guidance for future research endeavors.

Culturally safe service provision is essential to improving social and emotional wellbeing among Aboriginal and Torres Strait Islander communities, and to eliminating health inequities. Cultural safety is about ensuring that all people have a safe and healing journey through services, regardless of their cultural background. In this project, we aim to (1) understand how Aboriginal and Torres Strait Islander peoples conceptualise cultural safety, and (2) co-design a qualitative interview for the next phase of this project, where we plan to learn about experiences of cultural safety within mental health services.

The difficulty is remained to accurately distinguish bipolar disorder (BD) from major depressive disorder (MDD) in early stage, with a delayed diagnosis for 5-10 years. BD patients are often treated with antidepressants systematically due to being diagnosed with MDD, affecting the disease course and clinical outcomes. The current study aims to explore the role of plasma exosomes as biomarker to distinguish BD from MDD in early stage.

The objective of this study is to determine demographic and diagnostic distributions of physical pain recorded in clinical notes of a mental health electronic health records database by using natural language processing and examine the overlap in recorded physical pain between primary and secondary care.

There is widespread use of emergency preparedness drills in public K-12 schools across the US, but considerable variability exists in the types of protocols used and how these practices are conducted. This review examines research into both "lockdown drills" and "active shooter drills" as it relates to their impact on participants across different outcomes and evaluations of their procedural integrity.

Severe mental illnesses (SMIs), including schizophrenia, bipolar affective disorder, and major depressive disorder, are associated with an increased risk of physical health comorbidities and premature mortality from conditions including cardiovascular disease and diabetes. Digital technologies such as electronic clinical decision support systems (eCDSSs) could play a crucial role in improving the clinician-led management of conditions such as dysglycemia (deranged blood sugar levels) and associated conditions such as diabetes in people with a diagnosis of SMI in mental health settings.

Clinical pharmacy services often involve multifaceted pharmacist-led interventions. However, current pharmacy practice models vary across different countries. Despite the documented benefits of clinical pharmacy services, the characteristics of pharmacist-led interventions in different countries have not yet been adequately explored and described. Therefore, this protocol outlines the methodology for a proposed scoping review aiming to investigate various types of multifaceted pharmacist-led interventions and the outcomes used to evaluate their effectiveness within secondary care settings. Additionally, the scoping review will map the current evidence surrounding the characteristics of interventions and outcomes reported across various countries of socioeconomic status.

Electroencephalographic neurofeedback (NFB), as a non-invasive form of brainwave training, has been shown to be effective in the treatment of various mental health disorders. However, only few results regarding manualised and standardised NFB trainings exist. This makes comparison as well as replication of studies difficult. Therefore, we developed a standard manual for NFB training in patients with mental health disorders attending a psychosomatic outpatient clinic. The current study aims at investigating the conduction of a standardised manual for NFB training in patients with mental health disorders. If successful, the study provides new opportunities to investigate NFB in a more controlled and comparable manner in clinical practice.

As the availability and performance of artificial intelligence (AI)-based clinical decision support (CDS) systems improve, physicians and other care providers poised to be on the front lines will be increasingly tasked with using these tools in patient care and incorporating their outputs into clinical decision-making processes. Vignette studies provide a means to explore emerging hypotheses regarding how context-specific factors, such as clinical risk, the amount of information provided about the AI, and the AI result, may impact physician acceptance and use of AI-based CDS tools. To best anticipate how such factors influence the decision-making of frontline physicians in clinical scenarios involving AI decision-support tools, hypothesis-driven research is needed that enables scenario testing before the implementation and deployment of these tools.

Major depressive disorder (MDD) is prevalent, yet sub-optimally treated among persons with multiple sclerosis (MS). We propose that exercise training may be a promising approach for treating depression in persons with MS who have MDD. Our primary hypothesis predicts a reduction in depression severity immediately after an exercise training intervention compared with minimal change in an attention control condition, and the reduction will be maintained during a follow-up period.

Monogenic disorders account for a large proportion of population-attributable risk for neurodevelopmental disabilities. However, the data necessary to infer a causal relationship between a given genetic variant and a particular neurodevelopmental disorder is often lacking. Recognizing this scientific roadblock, 13 Intellectual and Developmental Disabilities Research Centers (IDDRCs) formed a consortium to create the Brain Gene Registry (BGR), a repository pairing clinical genetic data with phenotypic data from participants with variants in putative brain genes. Phenotypic profiles are assembled from the electronic health record (EHR) and a battery of remotely administered standardized assessments collectively referred to as the Rapid Neurobehavioral Assessment Protocol (RNAP), which include cognitive, neurologic, and neuropsychiatric assessments, as well as assessments for attention deficit hyperactivity disorder (ADHD) and autism spectrum disorder (ASD). Co-enrollment of BGR participants in the Clinical Genome Resource's (ClinGen's) GenomeConnect enables display of variant information in ClinVar. The BGR currently contains data on 479 participants who are 55% male, 6% Asian, 6% Black or African American, 76% white, and 12% Hispanic/Latine. Over 200 genes are represented in the BGR, with 12 or more participants harboring variants in each of these genes: CACNA1A, DNMT3A, SLC6A1, SETD5, and MYT1L. More than 30% of variants are de novo and 43% are classified as variants of uncertain significance (VUSs). Mean standard scores on cognitive or developmental screens are below average for the BGR cohort. EHR data reveal developmental delay as the earliest and most common diagnosis in this sample, followed by speech and language disorders, ASD, and ADHD. BGR data has already been used to accelerate gene-disease validity curation of 36 genes evaluated by ClinGen's BGR Intellectual Disability (ID)-Autism (ASD) Gene Curation Expert Panel. In summary, the BGR is a resource for use by stakeholders interested in advancing translational research for brain genes and continues to recruit participants with clinically reported variants to establish a rich and well-characterized national resource to promote research on neurodevelopmental disorders.

Obstetrician-Gynaecologists (ObGyns) frequently face work-related adverse events such as severe obstetric complications and maternal or neonatal deaths. In 2014, the WATER-1 study showed that ObGyns are at risk of developing work-related posttraumatic stress disorder (PTSD), while many hospitals lacked a professional support system. The aim of the present study is to evaluate the current prevalence of work-related traumatic events and mental health problems among Dutch ObGyns, as well as to examine the current and desired support.

Neurofilament proteins have been implicated to be altered in amyotrophic lateral sclerosis (ALS). The objectives of this study were to assess the diagnostic and prognostic utility of neurofilaments in ALS.

In the global strategy to eliminate leprosy, there remains a need for early case detection to successfully interrupt transmissions. Poor knowledge about leprosy and leprosy-related stigma are key drivers of delayed diagnosis and treatment. Sensitization campaigns to inform and increase awareness among the general population are an integral part of many national neglected tropical disease programs. Despite their importance, the effectiveness of such campaigns has not been rigorously studied in the West African context. A multilingual rural setting with low health literacy in this region presents challenges to the potential impact of sensitization campaigns.

There is a high prevalence of mental illness in nursing home residents compared to older adults living in the community. This was highlighted in the most recent comprehensive systematic review on the topic, published in 2010. In the context of a rapidly aging population and increased numbers of older adults requiring residential care, this study aims to provide a contemporary account of the prevalence of mental illness among nursing home residents.

For over 30 years, combined research and treatment settings in the US have been critical to conceptualizing care for first-episode psychosis (FEP). Here we describe an early example of such a context, the Services for the Treatment of Early Psychosis (STEP) clinic, which is affiliated with the University of Pittsburgh.

Equity, diversity and inclusion (EDI) in the healthcare field are crucial in meeting the healthcare needs of a progressively diverse society. In fact, a diverse healthcare workforce enables culturally sensitive care, promotes health equity and enhances the understanding of various needs and patients' viewpoints, potentially resulting in more effective patient treatment and improved patient outcomes. Despite this, information on the effectiveness of policies or programmes promoting EDI in health institutions is scarce. The objective of this systematic review is to assess the effects and outcomes of EDI programmes in healthcare institutions.

Decision-making in healthcare is increasingly complex; notably in hospital environments where the information density is high, e.g., emergency departments, oncology departments, and psychiatry departments. This study aims to discover decisions from logged data to improve the decision-making process.

CNS injuries are associated with profound changes in cell organization. This protocol presents a stepwise approach to quantitatively describe the spatiotemporal changes in glial cell rearrangement in the injured murine brain, which is applicable to other biological contexts. Herein, we apply common immunolabeling of neurons and glial cells and wide-field microscopy imaging. Then, we employ computational tools for alignment to the Allen Brain Atlas, unbiased/automatic detection of cells, generation of point patterns, and data analysis. For complete details on the use and execution of this protocol, please refer to Manrique-Castano et al..

Two million people in the UK are living with or beyond cancer and a third of them report poor quality of life (QoL) due to problems such as fatigue, fear of cancer recurrence, and concerns about returning to work. We aimed to develop and evaluate an intervention based on acceptance and commitment therapy (ACT), suited to address the concerns of cancer survivors and in improving their QoL. We also recognise the importance of exercise and vocational activity on QoL and therefore will integrate options for physical activity and return to work/vocational support, thus ACT Plus (+).

This study aims to investigate the specific effects of the EMDR Flash Technique on adolescents with depression. This follow-up study consists of 32 adolescents, 12-17 years of age ( = 14.34, = 1.56), including 7 males and 25 females. They were evaluated with Kiddie Schedule for Affective Disorders and Schizophrenia for School-Age Children Present, the Beck Depression Inventory (BDI), and Children Revised Impact of Event Scale-8 (Crıes-8). These were administered at baseline, at the end of the 4th and 12th weeks of treatment. The EMDR Flash Technique which can be utilized in the preparation phase of Eye Movement Desensitization and Reprocessing (EMDR) to reduce the intensity of highly distressing memories rapidly and relatively painlessly was applied for 12 weeks, one session per week as a free-standing intervention. Also, the EMDR Flash Technique can be effective in decreasing the rate of noncompliance and drop-outs of adolescents. The baseline means of total BDI scores decreased from 48.19 to 2.16 at the end of the 12th week of treatment. Also, the CRIES scores decreased from 31.78 to 0.44 at the end of the 12th week of treatment. In addition, the baseline means of SUD scores decreased from 9.53 to zero at the end of the 12th week of treatment. Overall, our results underscore the effectiveness of the EMDR-Flash Technique in adolescents with depression.

The ERBBprofiler assay measures compound effects on ERBB family receptors and key downstream signaling pathways that are implicated in cancer or other complex diseases. Here, we present a protocol for identifying properties of ERBB receptor antagonists using the barcoded ERBBprofiler assay. We describe steps for in-solution transfection, cell treatment, combined processing of samples, amplification and indexing of PCRs, sequencing, and data analysis. This approach allows for the simultaneous assessment of drug effects and cell-type-dependent effects. For complete details on the use and execution of this protocol, please refer to Popović et al..

About one third of patients with depression are in a condition that can be termed as "difficult-to-treat". Some evidence suggests that difficult-to-treat depression is associated with a higher frequency of childhood trauma and comorbid personality disorders or accentuated features. However, the condition is understudied, and the effects of psychotherapy for difficult-to-treat depression are currently uncertain. The aim of this trial is to investigate the beneficial and harmful effects of 30 sessions of individual schema therapy versus treatment as usual for difficult-to-treat depression in the Danish secondary, public mental health sector.

Preoperative anxiety and depression symptoms among older surgical patients are associated with poor postoperative outcomes, yet evidence-based interventions for anxiety and depression have not been applied within this setting. We present a protocol for randomised controlled trials (RCTs) in three surgical cohorts: cardiac, oncological and orthopaedic, investigating whether a perioperative mental health intervention, with psychological and pharmacological components, reduces perioperative symptoms of depression and anxiety in older surgical patients.

Liver disease is within the top five causes of premature death in adults. Deaths caused by complications of cirrhosis continue to rise, whilst deaths related to other non-liver disease areas are declining. Portal hypertension is the primary sequelae of cirrhosis and is associated with the development of variceal haemorrhage, ascites, hepatic encephalopathy and infection, collectively termed hepatic decompensation, which leads to hospitalisation and mortality. It remains uncertain whether administering a non-selective beta-blocker (NSBB), specifically carvedilol, at an earlier stage, i.e. when oesophageal varices are small, can prevent VH and reduce all-cause decompensation (ACD).

Treatment effects of conventional approaches with antipsychotics or psychosocial interventions are limited when it comes to reducing negative and cognitive symptoms in schizophrenia. While there is emerging clinical evidence that new, augmented protocols based on theta-burst stimulation can increase rTMS efficacy dramatically in depression, data on similar augmented therapies are limited in schizophrenia. The different patterns of network impairments in subjects may underlie that some but not all patients responded to given stimulation locations.

Rapamycin is an inhibitor of the mechanistic target of rapamycin (mTOR) protein kinase, and preclinical data demonstrate that it is a promising candidate for a general gero- and neuroprotective treatment in humans. Results from mouse models of Alzheimer's disease have shown beneficial effects of rapamycin, including preventing or reversing cognitive deficits, reducing amyloid oligomers and tauopathies and normalizing synaptic plasticity and cerebral glucose uptake. The "Evaluating Rapamycin Treatment in Alzheimer's Disease using Positron Emission Tomography" (ERAP) trial aims to test if these results translate to humans through evaluating the change in cerebral glucose uptake following six months of rapamycin treatment in participants with early-stage Alzheimer's disease.

The COVID-19 Vaccine Safety Research Committee (CoVaSC) was established in November 2021 to address the growing need for independent, in-depth scientific evidence on adverse events (AEs) following coronavirus disease 2019 (COVID-19) vaccination. This initiative was requested by the Korea Disease Control and Prevention Agency and led by the National Academy of Medicine of Korea. In September 2022, the COVID-19 Vaccine Safety Research Center was established, strengthening CoVaSC's initiatives. The center has conducted various studies on the safety of COVID-19 vaccines. During CoVaSC's second research year, from September 29, 2022 to July 19, 2023, the center was restructured into 4 departments: Epidemiological Research, Clinical Research, Communication & Education, and International Cooperation & Policy Research. Its main activities include (1) managing CoVaSC and the COVID-19 Vaccine Safety Research Center, (2) surveying domestic and international trends in AE causality investigation, (3) assessing AEs following COVID-19 vaccination, (4) fostering international collaboration and policy research, and (5) organizing regular fora and training sessions for the public and clinicians. Causality assessments have been conducted for 27 diseases, and independent research has been conducted after organizing ad hoc committees comprising both epidemiologists and clinical experts on each AE of interest. The research process included protocol development, data analysis, interpretation of results, and causality assessment. These research outcomes have been shared transparently with the public and healthcare experts through various fora. The COVID-19 Vaccine Safety Research Center plans to continue strengthening and expanding its research activities to provide reliable, high-quality safety information to the public.

Mental disorders are common in childhood, but many young people do not receive adequate professional support. Help-seeking interventions may bridge this treatment gap, however, there is limited research on interventions for primary-school children. This study aims to evaluate the effectiveness of an emotion literacy program at increasing literacy, reducing stigma, and promoting help-seeking in children aged 8-10 years.

The high prevalence of cannabis use and the potential for negative effects indicate the need for effective prevention strategies and treatment of people who use cannabis. Studies show that harm reduction (HR) in cannabis use is effective in minimising the harmful consequences of the substance. However, health professionals often misunderstand it and resist its adoption due to various obstacles. To our knowledge, there has been no review of the scientific literature on the factors that facilitate or hinder practitioners' adoption of HR in cannabis use. To fill this gap, we aim to identify, through a scoping review, facilitators and barriers to healthcare providers' adoption of HR in cannabis use in Organisation for Economic Cooperation and Development (OECD) countries.

Insomnia and eveningness are common and often comorbid conditions in youths. While cognitive behavioural therapy for insomnia (CBT-I) has been suggested as a promising intervention, it remains unclear whether it is sufficient to also address circadian issues in youths. In addition, despite that light has been shown to be effective in phase-shifting one's circadian rhythm, there has been limited data on the effects of bright light therapy and its combination with CBT-I on sleep and circadian outcomes in youths. The current protocol outlines a randomised controlled trial that examines the efficacy of CBT-I and CBT-I plus bright light therapy (BLT) in reducing insomnia severity, improving mood symptoms and daytime functioning (e.g. sleepiness, fatigue, cognitive function), and improving subjective and objective sleep and circadian measures compared to a waitlist control group.

Deep brain stimulation (DBS) modulates local and widespread connectivity in dysfunctional networks. Positive results are observed in several patient populations; however, the precise mechanisms underlying treatment remain unknown. Translational DBS studies aim to answer these questions and provide knowledge for advancing the field. Here, we systematically review the literature on DBS studies involving models of neurological, developmental and neuropsychiatric disorders to provide a synthesis of the current scientific landscape surrounding this topic. A systematic analysis of the literature was performed following PRISMA guidelines. 407 original articles were included. Data extraction focused on study characteristics, including stimulation protocol, behavioural outcomes, and mechanisms of action. The number of articles published increased over the years, including 16 rat models and 13 mouse models of transgenic or healthy animals exposed to external factors to induce symptoms. Most studies targeted telencephalic structures with varying stimulation settings. Positive behavioural outcomes were reported in 85.8% of the included studies. In models of psychiatric and neurodevelopmental disorders, DBS-induced effects were associated with changes in monoamines and neuronal activity along the mesocorticolimbic circuit. For movement disorders, DBS improves symptoms via modulation of the striatal dopaminergic system. In dementia and epilepsy models, changes to cellular and molecular aspects of the hippocampus were shown to underlie symptom improvement. Despite limitations in translating findings from preclinical to clinical settings, rodent studies have contributed substantially to our current knowledge of the pathophysiology of disease and DBS mechanisms. Direct inhibition/excitation of neural activity, whereby DBS modulates pathological oscillatory activity within brain networks, is among the major theories of its mechanism. However, there remain fundamental questions on mechanisms, optimal targets and parameters that need to be better understood to improve this therapy and provide more individualized treatment according to the patient's predominant symptoms.

It is important to promote resilience in preadolescence; however, there is limited research on children's understandings and experiences of resilience. Quantitative approaches may not capture dynamic and context-specific aspects of resilience. Resilience research has historically focused on white, middle-class Western adults and adolescents, creating an evidence gap regarding diverse experiences of resilience in middle childhood which could inform interventions. East London's Muslim community represents a diverse, growing population. Despite being disproportionately affected by deprivation and racial and cultural discrimination, this population is under-represented in resilience research. Using participatory and arts-based methods, this study aims to explore lived experiences and perceptions of resilience in black and South Asian Muslim children living in East London.

Brain-derived neurotrophic factor (BDNF) is essential for antidepressant treatment of major depressive disorder (MDD). Our repeated studies suggest that DNA methylation of a specific CpG site in the promoter region of exon IV of the BDNF gene (CpG -87) might be predictive of the efficacy of monoaminergic antidepressants such as selective serotonin reuptake inhibitors (SSRIs), serotonin-norepinephrine reuptake inhibitors (SNRIs), and others. This trial aims to evaluate whether knowing the biomarker is non-inferior to treatment-as-usual (TAU) regarding remission rates while exhibiting significantly fewer adverse events (AE).

There has been a prevailing but erroneous belief in the medical community that there is a biological vulnerability in the American Indian/Alaskan Native (AI/AN) community to substance use disorders (SUDs), with alcohol use disorder (AUD) being the most prevalent. This scoping review aimed to examine what possible psychosocial issues could lead to the development of the perpetuation of SUDs in the AI/AN population.

Patients with hematologic cancer experience severe symptoms (i.e. insomnia, fatigue, pain, distress). Few interventions addressing insomnia and other symptoms exist for this population. Mindfulness-Based Therapy for Insomnia (MBTI) may be appropriate but has only been tested in healthy outpatients. This study aimed to develop and test an adapted MBTI protocol for hematologic cancer patients.

In schizophrenia spectrum disorders (SSD) personal recovery and subjective quality of life (S-QOL) are crucial and show conceptual overlap. There is limited knowledge about how these outcomes change over time. Therefore, we investigated changes in personal recovery or S-QOL for patients with SSD. We specifically focused on the influence of the patients' durations of illness (DOI) on changes in personal recovery and S-QOL.

The quality of the therapeutic relationship is pivotal in determining psychotherapy outcomes. However, facilitating patients' self-awareness, reflection on, and sharing of their affective responses toward their therapist remains underexplored as a potential tool for enhancing this relationship and subsequent treatment outcomes.

Despite its high lifetime prevalence rate and the elevated disability caused by posttraumatic stress disorder (PTSD), treatments exhibit modest efficacy. In consideration of the abnormal connectivity between the dorsolateral prefrontal cortex (DLPFC) and amygdala in PTSD, several randomized controlled trials (RCTs) addressing the efficacy of different noninvasive brain stimulation (NIBS) modalities for PTSD management have been undertaken. However, previous RCTs have reported inconsistent results. The current network meta-analysis (NMA) aimed to compare the efficacy and acceptability of various NIBS protocols in PTSD management.

Physiological synchrony is the phenomenon of linked physiological processes among two or more individuals. Evidence of linkage between dyads has been found among a broad range of physiological indices, including the endocrine systems. During the transition to parenthood, both men and women undergo hormonal changes that facilitate parenting behavior. The present review sought to address the question as to whether hormonal synchronization occurs among expecting or new parents. A systematic literature search yielded 13 eligible records. The evidence of cortisol synchrony during the prenatal period, with additional testosterone, prolactin, and progesterone covariations in the time leading up to childbirth, was found to be most significant. During the postpartum period, parental synchrony was reported for oxytocin, testosterone, and cortisol levels. The implications of these covariations were found to translate into adaptive parenting behaviors and the facilitation of romantic bond. Associations with infant development were also reported, suggesting far-reaching effects of hormonal synchrony outside the parental dyad. The results highlight the importance of physiological interrelatedness during this sensitive period, underscoring the need for further research in this field. In view of the limited data available in this research domain, we have put forward a framework for future studies, recommending the adoption of standardized research protocols and repeated collections of specimens.

Practicing newly acquired skills in different contexts is considered a crucial aspect of Cognitive Behavioral Therapy (CBT) for anxiety disorders (Peris et al. J Am Acad Child Adolesc Psychiatry 56:1043-1052, 2017; Stewart et al. Prof Psychol Res Pract 47:303-311, 2016). Learning to cope with feared stimuli in different situations allows for generalization of learned skills, and experiencing non-occurrence of the feared outcome helps in developing non-catastrophic associations that may enhance treatment outcomes (Bandarian-Balooch et al. J Behav Ther Exp Psychiatry 47:138-144, 2015; Cammin-Nowak et al. J Clin Psychol 69:616-629, 2013; Kendall et al. Cogn Behav Pract 12:136-148, 2005; Tiwari et al. J Clin Child Adolesc Psychol 42:34-43, 2013). To optimize treatment outcome, homework is often integrated into CBT protocols for childhood anxiety disorders during and following treatment. Nevertheless, practicing at home can be challenging, with low motivation, lack of time, and insufficient self-guidance often listed as reasons for low adherence (Tang and Kreindler, JMIR Mental Health 4:e20, 2017). This conceptual review provides an overview of (1) how existing CBT childhood programs incorporate homework, and empirical evidence for the importance of homework practice, (2) evidence-based key elements of practice, and (3) how mHealth apps could potentially enhance practice at home, including an example of the development and application of such an app. This review therefore sets the stage for new directions in developing more effective and engaging CBT-based homework programs for childhood anxiety disorders.

While ecological momentary assessment (EMA) is commonly used to study social contexts and social influence in the real world, EMA almost exclusively relies on participant self-report of present circumstances, including the proximity to influential peers. There is the potential for developing a proximity sensing approach that uses small Bluetooth beacons and smartphone-based detection and data collection to collect information about interactions between individuals passively in real time.

Midlife hypertension is associated with cognitive decline and Alzheimer's disease and related dementia (ADRD), suggesting that blood pressure control may be a therapeutic target for dementia prevention. Given excess hypertension in non-Hispanic Black (NHB) adults, blood pressure control may also reduce ADRD disparities. We describe a pilot randomized controlled trial (RCT) to evaluate the feasibility and preliminary efficacy of a multicomponent lifestyle-based intervention versus enhanced usual care on cognition among middle-aged NHB adults.

Individuals with a history of moderate-severe traumatic brain injury (TBI) experience a significantly higher prevalence of insomnia compared to the general population. While individuals living with TBI have been shown to benefit from traditional insomnia interventions (e.g., face-to-face [F2F]), such as Cognitive Behavioral Therapy for Insomnia (CBTI), many barriers exist that limit access to F2F evidence-based treatments. Although computerized CBT-I (CCBT-I) is efficacious in terms of reducing insomnia symptoms, individuals with moderate-severe TBI may require support to engage in such treatment. Here we describe the rationale, design, and methods of a randomized controlled trial (RCT) assessing the efficacy of a guided CCBT-I program for reducing insomnia symptoms for participants with a history of moderate-severe TBI.

The University of California, San Francisco (UCSF) Core Center for Patient-centric, Mechanistic Phenotyping in Chronic Low Back Pain (REACH) is one of the three NIH Back Pain Consortium (BACPAC) Research Programs Mechanistic Research Centers (MRCs). The goal of UCSF REACH is to define cLBP phenotypes and pain mechanisms that can lead to effective, personalized treatments for patients across the population. The primary objective of this research project is to address the critical need for new diagnostic and prognostic markers, and associated patient classification protocols for chronic low back pain (cLBP) treatment.

Concussion in children and adolescents is a significant public health concern, with 30% to 35% of patients at risk for prolonged emotional, cognitive, sleep, or physical symptoms. These symptoms negatively impact a child's quality of life while interfering with their participation in important neurodevelopmental activities such as schoolwork, socializing, and sports. Early psychological intervention following a concussion may improve the ability to regulate emotions and adapt to postinjury symptoms, resulting in the greater acceptance of change; reduced stress; and recovery of somatic, emotional, and cognitive symptoms.

Major Depressive Disorder (MDD) is one of the common depressive disorder. MDD has high comorbidity and has greater implications on quality of life. Whole system Ayurveda management protocol (WSAP) is explored for it's possible role in management of MDD.

Previous research has shown that cognitive bias modification of interpretations (CBM-I) may be a promising intervention for anxiety in youth; however, results are mixed. Given the high comorbidity between anxiety and depression in youth, it is surprising that no child studies have targeted biases associated with both. This study aims to evaluate the effectiveness and acceptability of an online CBM-I intervention (Mindmaster) for children with symptom scores of anxiety or depression above a borderline or clinical threshold. The intervention has been codesigned with children, parents and mental health professionals to promote user engagement.

Many of the challenges in advanced care planning (ACP) conversations are linked to the waxing and waning progress of serious illnesses. Conversations with patients about future medical care decisions by a surrogate decision maker have historically been left until late in the patient's disease trajectory. These conversations often happen at a time when the patient is already very ill. The challenge in effective early ACP and serious illness conversations is to create a situation where patients appreciate the link between current and future medical care. Setting the stage to make these conversations more accessible includes using telehealth to have conversations at the patient's place of choice. The personalization used includes addressing the current medical and social needs of the patient and ensuring that expressed needs are addressed as much as possible. Engaging patients in these conversations allows the documentation of patient preferences in the electronic health record (EHR), providing guidelines for future medical care.

Popular "pod-style" e-cigarettes commonly use nicotine salt-based e-liquids that cause less irritation when inhaled and can deliver higher nicotine concentrations than free-base nicotine. We aimed to investigate the pharmacokinetic and pharmacodynamic effects of different nicotine formulations (salt vs. free-base) and concentrations that might influence systemic nicotine absorption and appeal of e-cigarettes.

Drivers for remission, relapse and violence-related behaviour among patients with schizophrenia are the most complicated issue.

Accurate assessment of cerebral perfusion is vital for understanding the hemodynamic processes involved in various neurological disorders and guiding clinical decision-making. This guidelines article provides a comprehensive overview of quantitative perfusion imaging of the brain using multi-timepoint arterial spin labeling (ASL), along with recommendations for its acquisition and quantification. A major benefit of acquiring ASL data with multiple label durations and/or post-labeling delays (PLDs) is being able to account for the effect of variable arterial transit time (ATT) on quantitative perfusion values and additionally visualize the spatial pattern of ATT itself, providing valuable clinical insights. Although multi-timepoint data can be acquired in the same scan time as single-PLD data with comparable perfusion measurement precision, its acquisition and postprocessing presents challenges beyond single-PLD ASL, impeding widespread adoption. Building upon the 2015 ASL consensus article, this work highlights the protocol distinctions specific to multi-timepoint ASL and provides robust recommendations for acquiring high-quality data. Additionally, we propose an extended quantification model based on the 2015 consensus model and discuss relevant postprocessing options to enhance the analysis of multi-timepoint ASL data. Furthermore, we review the potential clinical applications where multi-timepoint ASL is expected to offer significant benefits. This article is part of a series published by the International Society for Magnetic Resonance in Medicine (ISMRM) Perfusion Study Group, aiming to guide and inspire the advancement and utilization of ASL beyond the scope of the 2015 consensus article.

People with opioid use disorder have substantially higher standardised mortality rates compared to the general population; however, lack of clear individual prognostic information presents challenges to prioritise or target interventions within drug treatment services. Previous prognostic models have been developed to estimate the risk of developing opioid use disorder and opioid-related overdose in people routinely prescribed opioids but, to our knowledge, none have been developed to estimate mortality risk in people accessing drug services with opioid use disorder. Initial presentation to drug services is a pragmatic time to evaluate mortality risk given the contemporaneous routine collection of prognostic indicators and as a decision point for appropriate service prioritisation and targeted intervention delivery. This study aims to develop and internally validate a model to estimate 6-month mortality risk for people with opioid use disorder from prognostic indicators recorded at initial assessment in drug services in England.

This systematic review evaluated psychiatric adverse events (AEs) following vaccination against coronavirus disease 2019 (COVID-19). We included studies that reported or investigated psychiatric AEs in individuals who had received an approved COVID-19 vaccine in the Republic of Korea. Systematic electronic searches of Ovid-Medline, Embase, CENTRAL, and KoreaMed databases were conducted on March 22, 2023. Risk of bias was assessed using the Risk of Bias Assessment Tool for Non-randomized Studies 2.0. The study protocol was registered in the International Prospective Register of Systematic Reviews (CRD42023449422). Of the 301 articles initially selected, 7 were included in the final analysis. All studies reported on sleep disturbances, and 2 highlighted anxiety-related AEs. Sleep disorders like insomnia and narcolepsy were the most prevalent AEs, while depression was not reported. Our review suggests that these AEs may have been influenced by biological mechanisms as well as the broader psychosocial context of the COVID-19 pandemic. Although this study had limitations, such as a primary focus on the BNT162b2 vaccine and an observational study design, it offered a systematic, multi-vaccine analysis that fills a critical gap in the existing literature. This review underscores the need for continued surveillance of psychiatric AEs and guides future research to investigate underlying mechanisms, identify risk factors, and inform clinical management.

While there is extensive research on alcohol dependence, the factors that make an individual vulnerable to developing alcoholism haven't been explored much. In this study, we aim to investigate how neonatal exposure to sex hormones affects alcohol intake and the regulation of the mesolimbic pathway in adulthood. The study aimed to investigate the impact of neonatal exposure to a single dose of testosterone propionate (TP) or estradiol valerate (EV) on ethanol consumption in adult rats. The rats were subjected to a two-bottle free-choice paradigm, and the content of dopamine (DA) and 3,4-dihydroxyphenylacetic acid (DOPAC) in the nucleus accumbens (NAcc) was measured using HPLC-ED. The expression of critical DA-related proteins in the mesolimbic pathway was evaluated through RT-qPCR and western blot analysis. Supraphysiological neonatal exposure to EV or TP resulted in increased ethanol intake over four weeks in adulthood. In addition, the DA and DOPAC content was reduced and increased in the NAcc of EV and TP-treated rats, and β-endorphin content in the hypothalamus decreased in EV-treated rats. The VTA μ receptor and DA type 2 form short receptor (D) expression were significantly reduced in EV and TP male rats. Finally, in an extended 6-week protocol, the increase in ethanol consumption induced by EV was mitigated during the initial two hours post-naloxone injection. Neonatal exposure to sex hormones is a detrimental stimulus for the brain, which can facilitate the development of addictive behaviors, including alcohol use disorder.

Altered intestinal permeability and low-grade chronic inflammation disrupt the integrity of the blood-brain barrier (microbiota-gut-brain axis), probably playing a role in the pathophysiology of schizophrenia-spectrum disorders. However, studies assessing the microbiota-gut-brain axis are inconsistent. This article describes the rationale, objectives, protocol, and presents descriptive results for a new project.

The use of standard protocols in studies supports consistent data collection, improves data quality, and facilitates cross-study analyses. Funded by the National Institutes of Health, the PhenX (consensus measures for otypes and eposures) Toolkit is a catalog of recommended measurement protocols that address a wide range of research topics and are suitable for inclusion in a variety of study designs. In 2020, a PhenX Working Group of smoking cessation experts followed a well-established consensus process to identify and recommend measurement protocols suitable for inclusion in smoking cessation and smoking harm reduction studies. The broader scientific community was invited to review and provide feedback on the preliminary recommendation of the Working Group. Fourteen selected protocols for measuring smoking cessation, harm reduction, and biomarkers research associated with smoking cessation were released in the PhenX Toolkit ( https://www.phenxtoolkit.org) in February 2021. These protocols complement existing PhenX Toolkit content related to tobacco regulatory research, substance use and addiction research, and other measures of smoking-related health outcomes. Adopting well-established protocols enables consistent data collection and facilitates comparing and combining data across studies, potentially increasing the scientific impact of individual studies.

Suicide is one of the most largely preventable causes of death worldwide. The aim of the STRONG study is to assess the effectiveness of a specific intervention (an extended Safety Planning Intervention) called iFightDepression-SURVIVE (iFD-S) in suicidal attempters by changes in psychosocial functioning. As secondary outcomes, quality of life, cognitive performance, clinical state and neuroimaging correlates will be considered.

Repetitive transcranial magnetic stimulation (rTMS) is a widely used therapeutic tool in neurology and psychiatry, but its cellular and molecular mechanisms are not fully understood. Standardizing stimulus parameters, specifically electric field strength, is crucial in experimental and clinical settings. It enables meaningful comparisons across studies and facilitates the translation of findings into clinical practice. However, the impact of biophysical properties inherent to the stimulated neurons and networks on the outcome of rTMS protocols remains not well understood. Consequently, achieving standardization of biological effects across different brain regions and subjects poses a significant challenge.

Pregnancy exerts a detrimental effect on women's mental health. Maternal mental health is considered as one of the public health concerns as it impacts the health of both mother and the child. One in five people in developing countries experience serious mental health issues during pregnancy and after giving birth. In India, postpartum depression (PPD) affects 22% of women, according to a research by WHO. The available data on mental health literacy among women, showed that only 50.7% of the postpartum mothers who were attending paediatric tertiary care centres had adequate knowledge about PPD. It is crucial to diagnose early and adequately manage postpartum depression to avoid long-term consequences. It is also essential to seek help and utilise the available resources and services to avoid worsening of the condition and to aid in the recovery. This demonstrates the need to promote awareness, improve help seeking, reduce stigma and treatment gap associated with PPD through educational video intervention specific to cultural context and beliefs.

There is an urgent need to develop more effective and safer antipsychotics beyond dopamine 2 receptor antagonists. An emerging and promising approach is TAAR1 agonism. Therefore, we will conduct a living systematic review and meta-analysis to synthesize and triangulate the evidence from preclinical animal experiments and clinical studies on the efficacy, safety, and underlying mechanism of action of TAAR1 agonism for psychosis.

The period after psychiatric hospitalization is an extraordinarily high-risk period for suicidal thoughts and behaviours (STBs). Affective-cognitive constructs (ACCs) are salient risk factors for STBs, and intensive longitudinal metrics of these constructs may improve personalized risk detection and intervention. However, limited research has examined how within-person daily levels and between-person dynamic metrics of ACCs relate to STBs after hospital discharge. Adult psychiatric inpatients (N = 95) completed a 65-day ecological momentary assessment protocol after discharge as part of a 6-month follow-up period. Using dynamic structural equation models, we examined both within-person daily levels and between-person dynamic metrics (intensity, variability and inertia) of positive and negative affect, rumination, distress intolerance and emotion dysregulation as risk factors for STBs. Within-person lower daily levels of positive affect and higher daily levels of negative affect, rumination, distress intolerance and emotion dysregulation were risk factors for next-day suicidal ideation (SI). Same-day within-person higher rumination and negative affect were also risk factors for same-day SI. At the between-person level, higher overall positive affect was protective against active SI and suicidal behaviour over the 6-month follow-up, while greater variability of rumination and distress intolerance increased risk for active SI, suicidal behaviour and suicide attempt. The present study provides the most comprehensive examination to date of intensive longitudinal metrics of ACCs as risk factors for STBs. Results support the continued use of intensive longitudinal methods to improve STB risk detection. Interventions focusing on rumination and distress intolerance may specifically help to prevent suicidal crises during critical transitions in care.

The NIMH-funded Multilevel Community-Based Mental Health Intervention to Address Structural Inequities and Adverse Disparate Consequences of COVID-19 Pandemic on Latinx Immigrants and African Refugees study aims to advance the science of multilevel interventions to reduce the disparate, adverse mental health, behavioral, and socioeconomic consequences of the COVID-19 pandemic that are a result of complex interactions between underlying structural inequities and barriers to health care. The study tests three nested levels of intervention: 1) an efficacious 4-month advocacy and mutual learning model (Refugee and Immigrant Well-being Project, RIWP); 2) engagement with community-based organizations (CBOs); and 3) structural policy changes enacted in response to the pandemic. This community-based participatory research (CBPR) study builds on long-standing collaboration with five CBOs. By including 240 Latinx immigrants and 60 African refugees recruited from CBO partners who are randomly assigned to treatment-as-usual CBO involvement or the RIWP intervention and a comparison group comprised of a random sample of 300 Latinx immigrants, this mixed methods longitudinal waitlist control group design study with seven time points over 36 months tests the effectiveness of the RIWP intervention and engagement with CBOs to reduce psychological distress, daily stressors, and economic precarity and increase protective factors (social support, access to resources, English proficiency, cultural connectedness). The study also tests the ability of the RIWP intervention and engagement with CBOs to increase access to the direct benefits of structural interventions. This paper reports on the theoretical basis, design, qualitative and quantitative analysis plan, and power for the study.

The response to antipsychotic therapy is highly variable. Pharmacogenomic (PGx) factors play a major role in deciding the effectiveness and safety of antipsychotic drugs. A hybrid type 2 effectiveness-implementation research will be conducted to evaluate the clinical utility (safety and efficacy), cost-effectiveness, and facilitators and barriers in implementing PGx-assisted management compared to standard of care in patients with schizophrenia attending a tertiary care hospital in eastern India.

Aggressive conduct among delinquents presents a pervasive issue, bearing substantial implications for not only society at large but also for the victims and the individuals displaying the aggression. Traditional approaches to treating aggression regulation deficiencies generally employ Cognitive Behavioral Therapy (CBT) in conjunction with analog role-playing exercises. A body of research supports the efficacy of various therapeutic models for aggression regulation, including Responsive Aggression Regulation Therapy (Re-ART). Role-playing within a therapeutic context has been shown to contribute significantly to reductions in violent reoffending. However, the practical application of these skills in real-world settings remains challenging due to the inherent risk of aggressive outbreaks. Additionally, the conventional role-playing scenarios, often conducted in a therapy room, lack contextual realism and may induce role confusion between the patient and the therapist. Virtual Reality (VR) technology could offer a viable solution to these limitations by allowing for skill training in both behavioral and cognitive domains within a realistic yet safe and controlled setting. The technology also facilitates real-time awareness of emotional states and tension levels in the patient. This paper describes the study protocol of a randomized controlled trial in which Re-ART offered in a virtual environment (Re-ART VR) is compared to Re-ART offered as treatment as usual.

Post-traumatic stress disorder (PTSD) is an impairing mental health condition with high prevalence among military and general populations alike. PTSD service dogs are a complementary and alternative intervention needing scientific validation. We investigated whether dogs can detect putative stress-related volatile organic compounds (VOCs) in the breath of people with trauma histories (54% with PTSD) exposed to personalized trauma cues.

Internet-based psychological interventions have increased the accessibility of evidence-based treatments in clinical psychology but are still an unexplored delivery format in sport psychology research. This study describes the development and evaluates the experiences of an internet-based acceptance and commitment therapy/training (I-ACT) intervention in ice hockey players focusing on performance enhancement and a sustainable sport participation. I-ACT consisted of seven weekly modules and the feasibility of the intervention was investigated using a qualitative research design. Four national level ice hockey players took part of I-ACT and were interviewed about their experiences using a semi-structured protocol. Interview transcripts were analyzed using qualitative content analysis. Findings suggest that the content of I-ACT was comprehensible, relevant, and that it was possible to put the psychological skills into practice. I-ACT was described as helpful to the ice hockey players either in their sport performance or in their life outside of sport. The internet-format was generally perceived as positive, flexible, and a feasible option for delivering psychological interventions in an elite sport context. Some concerns were raised regarding the timing of the intervention at the end of the season, and some players also wished for more time to complete I-ACT. It was also expressed that some of the exercises could have been better adapted for goaltenders. Further trials are needed to evaluate the effects of I-ACT on performance and mental health outcomes in various sport populations using robust quantitative research methodology. Internet-based psychological interventions are a potential future opportunity to make evidence-based practices more accessible for athletes.

More than half of women with psychosis take care of their children despite the difficulties caused by the disease. Additionally, these kids have a higher risk of developing a mental health disorder. However, no interventions have been developed to meet these needs. Metacognitive Training (MCT) is a psychological intervention that has demonstrated its efficacy in improving cognitive insight, symptom management and social cognition in people with first-episode psychosis (FEP). Additionally, MCT has shown better results in women than men with FEP. This study aims to adapt and evaluate the efficacy of MCT-F in mothers and adolescent children in an online group context with the main purpose of improving family relationships, cognitive awareness and symptoms in women with psychosis and increase their children's knowledge of the disease and their functioning. As secondary objectives, it also aims to evaluate improvements in metacognition, social cognition, symptoms, protective factors and self-perception of stigma.

Remote monitoring technologies (RMTs) can measure cognitive and functional decline objectively at-home, and offer opportunities to measure passively and continuously, possibly improving sensitivity and reducing participant burden in clinical trials. However, there is skepticism that age and cognitive or functional impairment may render participants unable or unwilling to comply with complex RMT protocols. We therefore assessed the feasibility and usability of a complex RMT protocol in all syndromic stages of Alzheimer's disease and in healthy control participants.

Transcranial direct current stimulation (tDCS) may effectively preserve and improve cognitive function in patients with mild cognitive impairment (MCI). Research has shown that Individual brain characteristics can influence the effects of tDCS. Computer three-dimensional brain modeling based on magnetic resonance imaging (MRI) has been suggested as an alternative for determining the most accurate tDCS electrode position based on the patients' individual brain characteristics to enhance tDCS effects. Therefore, this study aims to determine the feasibility and safety of applying tDCS treatment using optimized and personalized tDCS electrode positions in patients with Alzheimer's disease (AD)-induced MCI using computer modeling and compare the results with those of a sham group to improve cognitive function.

Anorexia Nervosa (AN) has one of the highest mortality rates of all mental health disorders, low recovery rate and is associated with widespread endocrine dysfunction. Resistance training (RT) has been consistently shown to provide beneficial effects on health outcomes that are often negatively affected by AN, however participation in exercise is controversial for individuals with AN. The objective of this study was to assess the effects of maximal RT as an add-on to standard of care in patients with AN.

Clinical trials of innovative neural implants are rapidly increasing and diversifying, but little is known about participants' post-trial access to the device and ongoing clinical care. This exploratory study examines common practices in the planning and coordination of post-trial access to neurosurgical devices. We also explore the perspectives of trial investigators on the barriers to post-trial access and ongoing care, as well as ethical questions related to the responsibilities of key stakeholder groups.

The Pathway for Eating disorders and Autism developed from Clinical Experience (PEACE pathway) is a clinical pathway of adapted treatment for individuals with eating disorders and autism in the UK. This study aims to investigate multidisciplinary clinicians' views of the strengths and challenges of PEACE pathway adaptations, while identifying areas where further improvement is needed.

Informed by the UN Convention on the Rights of Persons with Disabilities, the Indian government replaced the 1987 Mental Health Act with the transformative "Indian Mental Healthcare Act, 2017" (IMHCA 2017), which gained presidential approval on April 7, 2017. While the new act aligns with CRPD guidelines, emphasizing the promotion, protection and realization of complete and equitable human rights, legal capacity, equality and dignity for persons with mental illness, it has faced diverse criticism from various stakeholders, particularly psychiatrists. This study systematically explores the critiques and apprehensions expressed by psychiatrists regarding the IMHCA 2017 using available published resources and assesses these criticisms within the context of CRPD guidelines.

Prompt access to evidence-based treatment for children and young people with eating disorders is important for outcomes, yet the gap in service provision remains pervasive. Record levels of young people are waiting for eating disorder treatment and access to care is limited. Guided self-help interventions that are brief and require minimal clinician support have the potential to meet the unprecedented demand for treatment quickly and effectively.

Brain banks provide small tissue samples to researchers, while gross anatomy laboratories could provide larger samples, including complete brains to neuroscientists. However, they are preserved with solutions appropriate for gross-dissection, different from the classic neutral-buffered formalin (NBF) used in brain banks. Our previous work in mice showed that two gross-anatomy laboratory solutions, a saturated-salt-solution (SSS) and an alcohol-formaldehyde-solution (AFS), preserve antigenicity of the main cellular markers (neurons, astrocytes, microglia, and myelin). Our goal is now to compare the quality of histology and antigenicity preservation of human brains fixed with NBF by immersion (practice of brain banks) vs. those fixed with a SSS and an AFS by whole body perfusion, practice of gross-anatomy laboratories.