Active clinical trials for "Mental Disorders"

Psychosis is a disabling condition that typically has its onset in adolescence and early adulthood. Many young people with psychosis have difficulty navigating services or are reluctant to engage in treatment until their illness becomes an emergency. Consequently, nearly half of all new psychotic disorders are diagnosed in the emergency department (ED). Despite the rationale and evidence for early psychosis intervention (EPI), around half of youth do not access these services. The investigators will use short message service (SMS)/text messaging, a low-cost, low-complexity, youth-friendly approach, to improve transitions in care from the ED and related acute services to EPI services, investigating the intervention's effect on attendance at the first consultation appointment, longer term service engagement, and system-level outcomes. The investigators will also evaluate cost-effectiveness and user perspectives of the intervention.

A growing number of trials have demonstrated treatment effectiveness for mental illness by non-specialist providers, such as primary care providers, in low-resource settings. A barrier to scaling up these evidence-based practices is the limited uptake from trainings into service provision and lack of fidelity to evidence-based practices among non-specialists. This arises, in part, from stigma among non-specialists against people with mental illness. Therefore, interventions are needed to address attitudes among non- specialists. To address this gap, REducing Stigma among HeAlthcare Providers to improvE Mental Health services (RESHAPE), is an intervention for non-specialists in which social contact with persons with mental illness is added to training and supervision programs. A cluster randomized control trial will address primary objectives including changes in stigma (Social Distance Scale) and improved quality of mental health services, operationalized as accuracy of identifying patients with mental illness in primary care. The control condition is existing mental health training and supervision for non-specialists delivered through the Nepal Ministry of Health's adaptation of the World Health Organization mental health Gap Action Programme. The intervention condition will incorporate social contact with people with mental illness into existing training and supervision. Participants in the cluster randomized control trial will be the direct beneficiaries of training and supervision (primary care providers) and indirect beneficiaries (their patients). Primary care workers' outcomes include stigma (Social Distance Scale), knowledge (mental health Gap Action Programme knowledge scale), implicit attitudes (Implicit Association Test), clinical self-efficacy (mental health Gap Action Programme knowledge scale), and clinical competence (Enhancing Assessment of Common Therapeutic factors) to be assessed pre-training, post-training, and at 3- and 6-month follow-up. Accuracy of diagnoses will be determined through the Structured Clinical Interview for the Diagnostic and Statistical Manual version 5, which will be assessed at 3 months after patient enrollment. Patient outcomes include functioning, quality of life, psychiatric symptoms, medication side effects, barriers to care, and cost of care assessed at enrollment and 3 and 6 months. This study will inform decisions regarding inclusion of persons living with mental illness in training primary care providers.

Disorders in the recognition of emotional facial expressions are part of the social cognition disorders described in several diseases. They are notably present in a quasi-systematic way in diseases associated with socio-emotional behavior disorders, such as schizophrenia and autism. They are also found in some genetic syndromes with atypical neurodevelopment. In previous studies, the investigators adopted the FPVS-EEG approach to investigate facial emotion discrimination abilities in typical and atypical developing populations. the investigatorshave shown that, in typical adults, the neural response to facial expressions emerges as emotional intensity parametrically increases. A time-domain analysis revealed three components, with the first two increasing linearly with expressive intensity, and the third (beyond 300 ms) showing categorical sensitivity to increasing expressive intensity. The investigators have already successfully extended this approach to the investigation of patients, such as those with 22q11.2 syndrome. The brain response to facial expression was reduced by approximately 36% in these patients, revealing impaired visual coding of emotional facial signals. In this study, response amplitude was associated with positive symptom severity, indicating a potential endophenotype for psychosis risk. Here, the investigators study the implementation of high-level processes and the top-down effect it should have on the response of occipitotemporal regions to identify altered brain markers in schizophrenic patients, but also in other populations with expression recognition deficits (autistic, 22q11.2, in particular). The implementation of compensatory strategies that should result in an increased exploration of the lower part of the face at the oculometric level will also be studied.

Cognitive deficits (CD) are considered one of the essential characteristics in psychotic disorders and occur throughout the course of the disease, being a key characteristic in the evolution of the disease and in the functionality and prognosis of patients. Intervening in the early stages of the disease and specifically in adolescence, a period of high brain plasticity can reduce disabilities in adulthood associated with early-onset psychosis. The objective of this study is to assess the efficacy of cognitive rehabilitation therapy in adolescents with a first psychotic episode, comparing two groups of these patients: a first group (CCRT) will carry out 40 sessions of a computerized cognitive remediation therapy with the usual treatment too, and a second group will perform only the usual treatment (TAU). The main hypothesis is that the CCRT group will present a significant improvement in verbal memory, visual attention, executive function, and social cognition and will present better global functioning compared to the TAU group.

Purpose: The primary aim of this research is to evaluate the effectiveness of teacher-delivered transdiagnostic mental healthcare for school-aged children in resource-limited primary schools. Participants: Within 60 rural, low-cost private primary schools of the Darjeeling Himalayas, all teachers meeting eligibility criteria will be invited to participate in training and the intervention. The number of teachers consented and enrolled into the study will be determined by the size of the school. The number of students nominated by a teacher is at their discretion (including an option to not nominate any student in a given year if they do not perceive any of the student's to be appropriate for the intervention) However, based on the research team's pilot data and prior experience, teachers will be provided with the suggestion that they nominate two children to receive targeted intervention. For each child receiving intervention, a paired parent or guardian will be recruited and enrolled to the study. Procedures (methods): Effectiveness will be evaluated through a stepped-wedge cluster randomized controlled trial (SW-CRCT) with an embedded mixed methods evaluation of implementation and qualitative study of context (guided by the RE-AIM framework). Year 1 will include 60 schools in the control arm, year 2 will include 40 schools in the control arm and 20 in the intervention arm, year 3 will include 20 schools in the control arm and 40 in the intervention arm, and year 4 will include 60 schools in the intervention arm.

KANOPEE is a free smartphone application providing screening, follow-up tools and autonomous digital interventions to lower psycho-social stress and its repercussions on sleep and behaviors in the general population. Additionally, KANOPEE permits an adaptation of the intervention to the subject (i.e., an adapted waiting period, frequency, and content), enabling to perform innovative trial conditions. The objective of this long-term study is to evaluate the efficacy of KANOPEE on users among the French general population exposed to psycho-social stress.

The investigators will determine, in an 8-site, hybrid Type 1 cluster randomized effectiveness implementation trial, if an acute mental health care bundle, compared to standard care, improves wellbeing at 30 days in children and youth seeking emergency department care for mental health and substance use concerns.

Global mental health (MH) and substance use disorders prevention, treatment and research gaps require that efficacious treatments be scaled-up, leveraging existing platforms. In tandem, participation of Ministries ready to apply evidence-inform policies must sustain them over time. PRIDE SSA may generate templates for other low- and middle-income countries (LMICs) by conducting a state of the art scale up study in Mozambique and by establishing a collaborative research network of nascent research "Seed Teams." Such "Seed Teams," trained by the capacity building component, may work across the region to build capacity and conduct implementation research to sustainably scale-up MH services. Scale Up Research (Mozambique) in MH and substance use disorders will evaluate strategies and costs of scaling up an innovative, integrated, sustainable, stepped-care community approach. The scale up study will leverage: (1) Mozambique's task-shifting strategy of training psychiatric technicians (PsyTs) to provide MH care, (2) the WHO-funded epilepsy community care program successfully implemented in 5 Provinces, now primed for scale-up by the Health Ministry. The cost-effective approach redefines work roles without requiring new human resources. Importantly, it comports with the Health Ministry's plan to implement prevention and treatment for all MH conditions, rather than single disorders. The model employs evidence-based practices (EBPs; e.g. Psychopharmacology; Interpersonal Therapy), already in use by PsyTs to: a) establish a sustainable program delivered and supervised by non-MH professionals, overseen by MH specialists; b) provide community screening, care and/or referrals for all MH disorders; and c) use implementation tools to monitor sustainability. This collaborative network will scale-up a cost-effective, sustainable program and inform policy.

The Veterans Health Administration (VHA) is advocating that Veterans with serious mental illness (SMI) receive recovery-oriented, rehabilitation approaches that target real-world functioning. One such approach is Cognitive-Behavioral Social Skills Training (CBSST). Unlike traditional cognitive-behavioral therapy, CBSST is a more recovery-oriented psychosocial rehabilitation intervention that teaches Veterans with SMI to correct errors in thinking and build social skills. While effective, CBSST has only been tested when facilitated by masters- or doctoral-level therapists, which limits its use in VHA. However, the investigators' pilot data shows that Peer Specialists-individuals with SMI who are hired and trained to use their own recovery experience to assist others with SMI-can also provide CBSST (called CBSST-Peer). Stand-alone social skills training (SST) is also a recovery-oriented program that VHA is attempting to rollout nationwide for Veterans with SMI. A few Peer Specialists have been trained to co-lead SST with professionals. However, SST is not widely implemented because professionals are busy and Peer Specialist delivered SST has not been tested. This study will evaluate the effectiveness of Peer Specialist-delivered CBSST and SST, which would increase access Veterans with SMI have to effective treatment. The investigators' aims are: Aim 1 (Effectiveness): To compare the impact of CBSST-Peer on outcomes in Veterans with SMI to Veterans receiving Peer Specialist-delivered SST groups of equal duration and to treatment as usual. The investigators will also assess fidelity of SST and CBSST. Aim 2: (Helpfulness of CBSST/SST--Peer and implementation barriers and facilitators): To use focus groups with patients and interviews with Peer Specialists and other staff to assess perceptions of SST- and CBSS Peer and identify potential barriers and facilitators to future implementation. Methods: This is a randomized, Hybrid 1 trial involving 252 Veterans with SMI (n=126 each from Pittsburgh, San Diego) comparing 3 treatment arms: CBSST-Peer vs. SST-Peer vs. treatment as usual. Hybrid 1 trials test the effectiveness of an intervention and collect implementation data that could inform its future adoption. At each site, across 6 waves (a wave = 1 CBSST-Peer and 1 SST-Peer group), 2 Peer Specialists will co-lead 12 groups, each lasting 20 weeks. Peer Specialists will be trained and receive an hour of supervision weekly by the CBSST developers. Master trainers from the SST rollout will train and supervise Peer Specialists in each site. All three arms' sessions will be taped and 25% rated for fidelity on standardized measures. A survey battery that assesses functioning, quality of life, recovery, and symptoms will be administered to the Veterans in each wave at: baseline, mid-intervention (10 weeks), end-of-intervention (20 weeks), and follow-up (32 weeks, 3 months post intervention). The investigators will examine all outcomes using Hierarchical Linear Models (HLM), with treatment condition included as a time-invariant covariate, and random intercepts for person and random slopes for time. Relevant covariates will include site, treatment attendance, symptom severity, service use, and demographic variables. The investigators will evaluate the effect for treatment conditions (CBSST-Peer vs. SST-Peer vs. treatment as usual group) in the expected direction and the time X group effect. Qualitative data on SST- and CBSST-Peer helpfulness and implementation factors will be collected from 8 focus groups, audio-recorded from a random sample of Veterans who participated in SST- and CBSST-Peer. Interviews will be conducted with participating Peer Specialists (n=approximately 8 per site), and key mental health staff (n=3-4 per site). The qualitative interviews and focus groups will be analyzed using rapid assessment, a team-based, iterative data collection and analysis approach providing data on the barriers and facilitators to future implementation of SST- and CBSST-Peer. Innovation: No study has tested peer-delivered SST or CBSST, or compared the two, in a rigorous trial. Significance/Expected Results: CBSST and SST are not widely available. If SST- or CBSST-Peer is effective, it could greatly increase the delivery of evidence-based services Veterans receive and enhance the services by VHA Peer Specialists.

This clinical trial is a single center, single dose study of the acute effects of intranasal insulin on energy metabolism and cognitive function in patients with schizophrenia, schizoaffective and bipolar disorders, compared and healthy controls.