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Severe Mental Disorder clinical trials

View clinical trials related to Severe Mental Disorder.

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NCT ID: NCT06315049 Completed - Schizophrenia Clinical Trials

Music Therapy to Reduce Anxiety in Community-Dwelling Individuals With Severe Mental Illness

Start date: June 26, 2023
Phase: N/A
Study type: Interventional

This study aims to measure the effectiveness of the Music Therapy nursing intervention in reducing anxiety in outpatients diagnosed with severe mental illness (SMI) (bipolar disorder and schizophrenia). The intervention was structured over five weeks (ten 1-hour sessions, twice weekly). Objective measures (blood pressure, heart rate, and respiratory rate) and subjective measures (anxiety response and the subjective perception of relaxation) were taken before and after every session.

NCT ID: NCT06069739 Completed - Obesity Clinical Trials

Health Education Programme Through Physical Exercise for People With Severe Mental Disorders

HEPPE-PSMI
Start date: March 1, 2016
Phase: N/A
Study type: Interventional

The goal of this clinical trial is to [learn about, test, compare etc.] in individuals with severe mental disorders and obesity comorbid. The main question[s] it aims to answer are: - Are inflammatory activity, oxidative and vascular damage and metabolic mechanisms, as well as neurocognitive and functional performance, related to different physical exercise interventions? - Do inflammatory, oxidative stress and cardiometabolic biomarkers predict neurocognitive improvement after physical activity training? Participants will guided-exercise of moderate intensity and frecuency, and incentive of autonomous physical activity proposals by the specialist; guided physical activity group (GPAG), or (b) 12 weeks of an exercise program standard physical activity without guided and incentives; standard physical activity group (SPAG). If there is a comparison group: Researchers will compare GPAG and SPAG to see if inflammatory, oxidative stress, and cardio-metabolic biomarkers improve neurocognitive performance after physical activity training

NCT ID: NCT05456984 Completed - Type2Diabetes Clinical Trials

The PsychOsis and Diabetes Service Model (PODS) Population Profile Study.

Start date: May 3, 2022
Phase:
Study type: Observational [Patient Registry]

People with severe mental illness (SMI), defined as psychotic and bipolar disorders, die 17-20 years earlier than the general population, the most common cause of death being cardiovascular diseases (CVD). The major contributor to CVD mortality in SMI is the increased prevalence of type 2 diabetes (T2D) compared to the general population. T2D is a paradigm of a single condition that progresses to multiple conditions. T2D requires annual reviews of 9 diabetes care processes and for patients to adopt multiple self-care tasks to prevent diabetes complications. The 9 diabetes care processes include: 3-6 monthly blood glucose measurement (HbA1c) with appropriate targets; blood pressure measurements and targets depending on diabetes complication status; annual blood cholesterol measurement; kidney function testing with urinary albumin; kidney function testing with serum creatinine; weight check; smoking status; diabetes annual eye screening; and annual foot examination. In the National Diabetes Audit 2016-17, people with SMI and T2D were 10% less likely to take up all 9 diabetes care processes and have worse glycaemic control as a result. Therefore the aim of this study is to determine who is receiving these care processes and to develop new care pathways/interventions that support this population. This project is a cross-sectional study and will take place in Lambeth south London, an area with high prevalence of SMI, and therefore T2D, and deprivation. W aim to profile the entire population of people with SMI and T2D within the Hills Brook and Dales and StockWELL Primary Care Networks. The investigators will access the participants medical records and record details of their latest physical health assessment and ask them to complete 7 validated questionnaires and brief informal interview either face to face in their GP surgery or over the phone. This project has been funded by the Burdett Trust for Nursing.

NCT ID: NCT04792268 Completed - Diabetes Mellitus Clinical Trials

Electronic Clinical Decision Support for Diabetes and Dysglycaemia in Secondary Mental Healthcare

Start date: May 1, 2022
Phase: N/A
Study type: Interventional

People with serious mental illness (SMI) such as schizophrenia, schizoaffective disorder and bipolar affective disorder have a significantly reduced life expectancy, caused in part by increased incidences of mortality from physical health conditions such as cardiovascular disease (CVD) and diabetes. Electronic clinical decision support systems (eCDSS) offer clinicians patient-specific advice and recommendations based on clinical guidelines, theoretically overcoming obstacles in the use of existing paper-based guidelines. Adoption of eCDSS to address CVD risk in people with SMI presents a unique opportunity for research, but requires evidence of acceptability and feasibility before scaling up of research. The key objective of this study is to establish the feasibility and acceptability of an eCDSS (CogStack @ Maudsley) compromising a real-time electronic health record powered alerting and clinical decision support system for diabetes management in secondary inpatient mental healthcare settings. End-users of the eCDSS will be clinicians only. Firstly we will conduct initial surveys and interviews with clinicians on inpatient wards to scope experiences of managing diabetes in secondary mental healthcare settings and attitudes towards use of digital technologies to aid in clinical decision making. A feasibility study will then be run to evaluate the acceptability and feasibility of implementing eCDSS on inpatient wards. This will involve a cluster RCT on inpatient general adult psychiatry wards, where 4 months of eCDSS use by clinicians on intervention wards will be compared to 4 months of treatment as usual on control wards. All clinicians on recruited wards will be eligible to participate. At the end of the study, participating clinicians on intervention wards will be invited to take part in a survey and interview which will explore their experiences and attitudes towards using the eCDSS, and an implementation science framework will be applied to inform future implementation of eCDSS. Group level pseudonymised outcome data will be gathered through a separate study.

NCT ID: NCT04357769 Completed - COVID Clinical Trials

COVID-19 Pandemic Burden in Severe Mental Disease Patients

PsyCOVID
Start date: April 10, 2020
Phase:
Study type: Observational

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.

NCT ID: NCT03815604 Completed - Clinical trials for Severe Mental Disorder

Independent Housing and Support for People With Severe Mental Illness

Start date: April 1, 2019
Phase: N/A
Study type: Interventional

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.

NCT ID: NCT03664713 Completed - Clinical trials for Psychological Trauma

EMDR in Psychiatric Inpatients With Severe Mental Disorder

Start date: February 1, 2019
Phase: N/A
Study type: Interventional

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.

NCT ID: NCT03583203 Completed - COPD Clinical Trials

Tobacco Intensive Motivational and Estimate Risk

Start date: July 12, 2018
Phase: N/A
Study type: Interventional

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

NCT ID: NCT03534921 Completed - Clinical trials for Diabetes Mellitus, Type 2

Improving Diabetes Outcomes for People With Severe Mental Illness (SMI)

EMERALD
Start date: April 1, 2018
Phase:
Study type: Observational

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.