View clinical trials related to Severe Mental Disorder.
Filter by:Despite being originated in Wuhan, in the China mainland region of the Hubei, Italy has been the hardest-hit country in the world by the COVID-19 pandemic during the month of March. Due to the uncontrollable spread of the contagion, the Italian Government has been forced to impose a series of restrictions and social distancing measures, culminating in the extension of lockdown to the entire Italian territory on March 8th. During this period, the general population has been overwhelmed by feelings of worry, anxiety, and discomfort. The discomfort is reinforced by the lengthening of the lockdown, to the point that it may be considered as a mass model of chronic or subchronic mild stress. The predictable effects of this stress on mental health have already been claimed, Post-traumatic symptoms were found in 7% among 285 Wuhan and surrounding cities' residents during the COVID-19 outbreak. A recent survey in the Italian general population reported similar outcomes. In this context, the psychic conditions of the most fragile ones, i.e. those already affected by a severe mental disorder, represent a major concern. Having a history of psychiatric illness is regarded as one of the most relevant predictors of a negative psychological impact of quarantine. Patients with severe mental disorders may be among the hardest hit subjects, as they may be more vulnerable by the COVID-19 outbreak for a series of clinical and psychological factors. In the Italian context, the vulnerability of these patients may be increased by the lockdown of mental health services as a consequence of mass quarantine and optimization of health resources toward action to contrast COVID-19-related sanitary emergencies. Despite several reports investigated the psychological effects of COVID-19 pandemic on health-care workers, COVID-19 affected people, or the general population, at the moment, no study has investigated the effects of the distress caused by fear of contagion and mass quarantine on severe mental disorder patients. The present study aimed at providing a first evaluation of anxiety, depressive, stress-related symptoms in these patients.
The investigators aim to test the effectiveness of Individual Placement and Support (IPS) on 1. employment, 2. welfare dependency, and 3. public-sector health care utilization. This is a naturalistic controlled trial, where one municipality (Bodø in Norway) with about 50000 inhabitants get access to IPS services in public sector mental health services during the period 2013-2016. The target group for the intervention is patients with severe mental illness (SMI) in the age group 18-40 at time of treatment. Patients already receiving lifelong disability benefits will be excluded. The control group will be an average of 10 municipalities in Norway without IPS services. Data for outcomes will be based on public registries available for research.
Using a design-for-dissemination approach, this application proposes to use combined methods to adapt and pilot test an interactive obesity treatment approach (iOTA) for obesity prevention in early serious mental illness (eSMI) that uses text messaging to provide between-visit support. Derived from the lifestyle intervention used in the Diabetes Prevention Program, the parent iOTA targets diet, activity and adherence using web-based and health coach support.
A single-blinded hybrid effectiveness-implementation trial (Type II), that both evaluates the intervention outcomes (clinical and service use outcomes) through patient-randomization in the implementation sites, as well as evaluates the implementation strategy chosen for the intervention and its impact on implementation outcomes (e.g. adoption, fidelity, acceptability and maintenance (continued implementation) of the intervention).
To contribute to improving the level of functioning and quality of life and mental health outcomes for people with severe and enduring mental ill health (SMI) (schizophrenia, bipolar disorder, depression) by adapting and up scaling the implementation of a community‐based service delivery model in Croatia.
Background: Adequate and stable housing conditions are fundamental for the psychiatric rehabilitation of individuals with severe mental illness (SMI). A common approach in psychiatric rehabilitation relies on a continuum of residential services that aims at enabling the person with SMI to live eventually independently. Current state of research, however, shows clearly that most persons in question remain in residential care settings or other treatment as usual conditions (RCS/TAU). The Independent Housing and Support (IHS) scheme is a new model that aims at direct placement in an independent accommodation in the community. Support is provided according to individual needs in a permanent housing situation without time limit. Up to now, randomized controlled trials (RCTs) to evaluate the effectiveness of IHS have only been conducted with homeless populations in North America. The purpose of the present study is to evaluate IHS compared to traditional RCS/TAU for non-homeless persons with severe mental illness. With this study, the investigators aim at demonstrating that IHS is not inferior to RCS/TAU. The rationale for utilizing a non-inferiority approach is based on the current state of research and on research that has shown strong preferences for IHS against RCS/TAU by people with SMI. Methods: As the preference issue makes RCTs in housing research difficult the investigators will use a specific time window in Zurich that allows conducting a RCT due to a scarcity of IHS settings and will combine the RCT with a comparative observational study in Berne where IHS is already well-established. At the Zurich site, a RCT compares the effects of living with IHS against living in residential care. At the Berne site, an observational study design (OSD) will be applied in connection with the same types of housing as in Zurich. Propensity scoring will be utilized to minimize the risk of bias in the OSD. A number of N=56 eligible subjects in Zurich and N=112 subjects (due to specific requirements for propensity scoring) in Berne complying with the inclusion criteria will be recruited and allocated to intervention and control groups according to the site-specific study designs. Recruitment period will last 21 months.
The study of psychological trauma has become increasingly important in the field of mental health research due to the strong negative impact it has on the course and prognosis of psychiatric pathologies. However, from a clinical point of view it is still an overlooked and even ignored component. There is scientific evidence that treating traumatic events at outpatient hospital services in patients with severe mental disorder improves both trauma-related symptoms and clinical symptoms. A first-line treatment for psychological trauma is Eye Movement Desensitization and Reprocessing (EMDR) therapy. This therapy is recommended by the World Health Organization for treating Post-Traumatic Stress Disorder and which has obtained promising first results in patients with severe mental disorder. This project proposes to test whether EMDR therapy in addition to standard treatment is more effective than standard treatment alone in psychiatric in-patients with severe mental disorder, in terms of reducing symptoms related to psychopathology and trauma, and in terms of improving functioning. Our first hypothesis is that EMDR will be more effective than standard treatment alone in reducing the severity of psychiatric symptoms. Our second hypothesis is that EMDR will be more effective than standard treatment alone in reducing the severity of trauma-related symptoms. Our third hypothesis is that EMDR will be more effective than standard treatment alone in improving functioning.
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.
Randomized, open label, prospective study with a 12-month follow-up period. The primary objective evaluates the effectiveness of an intensive anti-smoking programme that informs patients of their individual risk of lung damages and the possibilities of prevention. The main measurement will be having given up smoking in month 12, measurement of self-reported abstinence on the 7 previous days and confirmed by a CO-oximeter test< 10 ppm, between the intervention and control group. A total of 9 urban and rural mental health centres will participate in the study. The intervention group will undergo spirometry and presence and the degree of respiratory obstruction will be assessed. Participants will be given individual information to generate a motivational message about the possibilities of prevention and the information will be maintained for three months by sending text messages (SMS) to their mobile phones. The efficacy of the method and the pulmonary damage variables will be evaluated: smoking cessation at the end of follow-up will be confirmed by cooximetry, and the COPD diagnosis and the severity of the staging for disease will be assessed
This study aims to identify the determinants of diabetes and to explore variation in diabetes outcomes for people with severe mental illness (schizophrenia, schizoaffective disorder and bipolar disorder) in order to develop potential healthcare interventions that can be tested further. The study utilises a mixed methods design comprising analysis of patient primary care records and interviews with patients living with comorbid SMI and diabetes, family carers and healthcare professionals involved in commissioning or delivering healthcare for this population. This entry on the Protocol Registration and Results System describes only the quantitative Work Package of the study in detail i.e. analysis of patient primary care records.