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Serious Mental Illness clinical trials

View clinical trials related to Serious Mental Illness.

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NCT ID: NCT02188121 Completed - Schizophrenia Clinical Trials

Fixed Dose Intervention Trial of New England Enhancing Survival in SMI Patients

FITNESS
Start date: February 2015
Phase: Phase 4
Study type: Interventional

Patients with severe mental illness (SMI) die younger than persons in the general population. Much of the excess mortality for SMI patients is attributable to cardiovascular disease, and is exacerbated by treatment with second-generation antipsychotics (2GAs). Although the cardiovascular risks are well-known, and safe, efficacious therapy exists, few SMI patients receive cardiovascular prevention drugs. Care delivery fragmentation and poor patient adherence are central problems to reducing cardiovascular risks for patients with SMI. To address these problems, we propose to conduct a multi-site, open-label, randomized controlled trial comparing an initial treatment strategy of free, fixed-doses of two generic, cardiovascular prevention drugs (statins and angiotensin drugs) delivered within mental health clinics versus usual treatment. The study will include adult patients (18+ years old) with schizophrenia, schizoaffective disorder, bipolar disorder, major depressive disorder, or psychosis not otherwise specified (NOS) who have received 2GAs treatment within the past six months from within four mental health clinics in the Boston area. We have three aims: 1) to compare the proportions of subjects in each arm who are receiving cardiovascular drug treatment and are adherent to therapy during 12-months of follow-up; 2) to compare changes in composite (e.g., Framingham scores) and individual (e.g., lipid levels) cardiovascular risk factor levels using an intent-to-treat (ITT) approach; and 3) to compare risk factor levels, accounting for variation in adherence over time, using causal inference techniques to estimate the per-protocol effect of the intervention. Our three aims examine whether this low cost, streamlined treatment strategy increases the numbers of subjects receiving cardiovascular prevention therapy and improves cardiovascular risk levels. We will follow subjects for 12 months, and collect interview and biometric data at baseline and over the following 12 months. Subjects will have the option to continue for another 12 months, during which we will continue to collect interview and biometric data, but will not prescribe cardiovascular medications. This population-based initial treatment strategy could be an effective and efficient approach for overcoming traditional barriers to cardiovascular disease prevention within the SMI population. Findings from this study will inform efforts to improve care and outcomes, and to enhance survival for patients with severe mental illness.

NCT ID: NCT02127671 Completed - Clinical trials for Cardiovascular Risk Factors

Intervention Trial to Decrease Cardiovascular Risk in Persons With Serious Mental Illness

IDEAL
Start date: December 12, 2013
Phase: N/A
Study type: Interventional

This study will determine whether a program where a health coach works with participants on heart healthy behaviors and treatment of risk factors is coordinated with primary care can reduce overall heart disease risk in people with serious mental illness.

NCT ID: NCT02022462 Completed - Depression Clinical Trials

Project Bridge: Peer Health Navigator Intervention

Bridge
Start date: April 2014
Phase: N/A
Study type: Interventional

The mortality rate among people with Serious Mental Illness (SMI) is 2 to 3 times that of the general population, meaning that those with a serious mental illness die, on average, 25 years earlier than those without an SMI. These deaths are largely attributed to preventable medical conditions, many of which are more common in the SMI population. The "Bridge" intervention is a peer navigator model that was developed to target factors that negatively impact healthcare access, utilization, and outcomes among individuals with serious mental illness (e.g., severe mood disorders and psychotic disorders). This intervention targets male and female, adult consumers across races/ethnicities and has been utilized by Pacific Clinics (Southern California's largest behavioral healthcare agency) and the Department of Mental Health of Los Angeles County to improve the health and quality of life for their consumers. Investigators will test the comparative effectiveness of a peer navigator intervention (the Bridge) to treatment as usual. The Bridge navigator intervention is designed to teach SMI consumers the skills to engage health care providers and to overcome motivational deficits in order to improve their health and healthcare use. The specific aims of this application are: 1. To use randomized methods to examine the effectiveness of the Bridge intervention on the health care utilization, satisfaction with care, health status, and health care self-management for a sample of individuals with severe mental illness receiving public mental health services in the community; 2. To use randomized methods to examine the effectiveness of the Bridge intervention on psychological and social well-being for a sample of individuals with severe mental illness receiving public mental health services in the community. 151 participants in an Full Service Partnership (FSP) clinic operated by Pacific Clinics were recruited to participate in an approximately 24-month long study of Bridge navigation. Participants will be randomly assigned to either treatment as usual (waitlist) or immediate intervention with the Bridge. Participants in both groups will complete three assessments (baseline, 6 months, 12 months) and statistically compared over time. Staff stakeholders (n = 20) will also be interviewed at baseline and every three months of the study in order to ensure that the intervention is being implemented appropriately.

NCT ID: NCT01686815 Completed - Schizophrenia Clinical Trials

Cross-Sectional Iloperidone IVGTT

Start date: October 2012
Phase:
Study type: Observational

This study aims to utilize state of the art procedures such as the frequently sampled intravenous glucose tolerance test (FSIVGTT), Bergman's Minimal Model Analysis, lipoprotein analysis, and DEXA scans to demonstrate that a newer agent, iloperidone, is devoid of the metabolic abnormalities associated with other atypical antipsychotic treatments, namely olanzapine and risperidone, and offers an advantage over these other agents.

NCT ID: NCT01566513 Completed - Clinical trials for Serious Mental Illness

Effectiveness and Cost Effectiveness of Peer Mentors in Reducing Hospital Use

Project PEP
Start date: August 2011
Phase: N/A
Study type: Interventional

The current study, through a randomized controlled design, will evaluate the effectiveness of peer support, as compared to usual care and to an equivalent amount of support offered by peer case managers and non-peer recovery mentors, in reducing hospital days and readmissions and in promoting recovery and community inclusion among adults with mental illnesses with histories of multiple hospitalizations. The current study evaluates the cost-effectiveness of adding peer support to the array of services available to persons with serious mental illnesses who have histories of multiple hospitalizations and will test a theoretical model of the active ingredients of peer support, focusing specifically on the roles of 1) instillation of hope through positive self-disclosure; 2) role modeling of self-care and exploring new ways of using experiential knowledge; and 3) a trusting relationship characterized by acceptance, understanding, and empathy with conditional regard.

NCT ID: NCT01115114 Completed - Clinical trials for Serious Mental Illness

Treatment of Metabolic Syndrome in a Community Mental Health Center

Start date: January 2009
Phase: N/A
Study type: Interventional

The purpose of this study is to learn if patients being treated with second generation antipsychotics and with clinically meaningful elevations/levels in any metabolic syndrome elements will have better access to medical treatment more quickly if they are randomized to one of the following conditions: 1) a primary care provider located in the community mental health center where mental health treatment is provided (IMBED), 2) a medical care manager to help coordinate treatment with an outside primary care provider (Liaison) or 3) the standard practice of advising the patient to see a primary care doctor (Treatment as Usual).

NCT ID: NCT01043653 Completed - Clinical trials for Serious Mental Illness

Assessing Recovery

MARS
Start date: January 2010
Phase: N/A
Study type: Observational

In 2003 the VA Undersecretary's Action Agenda mandated that mental health services throughout the system be transformed to a recovery model. That mandate and many of the Workgroup recommendations have since been formalized in the Uniform Mental Health Services Package, which specifies a range of recovery-oriented services that must be available to veterans. A key aspect of these policy mandates is the need to assess recovery status of veterans and to monitor their progress over time as a way to evaluate the effectiveness of recovery services. However, there is no established instrument that is suitable for system-wide application. The purpose of this project is to develop a reliable, valid and practical measure of recovery, and use the measure in a study to better understand recovery in veterans with serious mental illness.

NCT ID: NCT00520728 Completed - Clinical trials for Serious Mental Illness

Efficacy of an Occupational Time Use Intervention for People With Serious Mental Illness

Start date: August 2007
Phase: Phase 1
Study type: Interventional

The purpose of this study is to test the efficacy of a new Occupational Time Use Intervention designed to increase activity participation and improve meaning in the lives of people with serious mental illness living in the community.