13 Clinical Trials for Various Conditions
Background: Addressing behavioral and neuropsychiatric symptoms of Veterans with dementia and serious mental illness (SMI) such as schizophrenia can be challenging for staff in VA long-term care settings, called Community Living Centers or CLCs. These behaviors of distress (agitation, aggression, and mood disturbance) are not just associated with staff stress and burnout; they also hasten residents' functional decline, decrease quality of life, and increase mortality. Staff training in non-pharmacological interventions can be effective. Yet systems barriers, task-based care models, and time constraints often result in staff employing "quicker," less effective strategies. Montessori Approaches to Person-Centered Care for VA (MAP-VA)- a staff training, intervention, and delivery toolkit- developed in collaboration with VA operational partners, Veterans, and frontline CLC staff is positioned to respond to this challenge. The investigators' prior work shows probable impacts on CLC quality indicators at the individual and unit level (e.g., psychotropic medications, depressive symptoms, weight loss, falls, pain). The goal of this study is to evaluate the MAP-VA program and necessary supports for a successful implementation at 8 VA CLCs. Significance/ Innovation: VHA's Modernization Plan focuses on empowering front-line staff to lead quality improvement efforts like the ones taught through MAP-VA. MAP-VA is distinct from existing interventions in its: 1) application to Veterans with a range of diagnoses and cognitive abilities; 2) emphasis on pairing practical skill-building for staff with overcoming system-level barriers that inhibit person-centered care; and 3) engagement of all staff rather than a reliance on provider-level champions. Yet, MAP-VA is a complex intervention that requires participation of multiple stakeholder groups, making implementation facilitation necessary. To date, no studies have evaluated MAP implementation success in operational settings (community or VA) and sustainability is rarely examined. Aims: This 4-year study will examine both the effectiveness of the MAP-VA program on resident outcomes, person-centered care practices, and organizational culture as well as an evaluation of the implementation barriers to adopting MAP-VA in a sustainable way over a 12 month period. Staff and residents at 8 CLCs will participate in the study.
Use of polypharmacy has significantly increased over the past two decades, which has unproven clinical benefit and is associate with an increased the risk of adverse side effects. Pharmacogenetic assays, such as the Genecept® Assay, have the purported benefit of being able to predict response(s) to specific medication based on genetic markers. Thus, this study is a 12-week open-label, naturalistic study of the provision of pharmacogenetic testing and a computerized decision tool for providers to determine the potential efficacy of the assay to reduce polypharmacy and improve patient outcomes.
Drama Therapy involves of the use of theatrical techniques (such as script development, acting exercises, improvisation, etc.) to help treat patients' mental illness and improve their functioning and overall sense of wellbeing. This study will evaluate the effectiveness of a specific version of drama therapy for the treatment of patients suffering from both mental illness (such as depression, bipolar disorder, schizophrenia, etc.) and one or more substance use disorders. The study will also assess participants feelings and thoughts about the drama therapy intervention (such as whether or not they enjoyed it and if/how they found it helpful). The drama therapy intervention will consist of one group drama therapy session per week, for a total of twelve weeks (i.e., total twelve sessions) followed by a single performance (with composition of the audience determined by unanimous agreement of the participants) of the dramatic work (script) produced by the participants during the course of the drama therapy intervention.
Babies with single ventricle congenital heart disease (SVCHD) are often diagnosed during pregnancy. While prenatal diagnosis has important clinical benefits, it is often stressful and overwhelming for parents, and many express a need for psychological support. HeartGPS is a psychological intervention for parents who receive their baby's diagnosis of SVCHD during pregnancy. It includes 8 sessions with a psychologist, coupled with tailored educational resources, and a personalized care plan. The intervention focuses on fostering parent psychological adjustment and wellbeing, and supporting parents to bond with their baby in ways that feel right for them. Through this study, the investigators will learn if HeartGPS is useful and effective for parents and their babies when it is offered in addition to usual fetal cardiac care. The investigators will examine the effects of the HeartGPS intervention on parental anxiety, depression, and traumatic stress; fetal and infant brain development; parent-infant bonding; and infant neurobehavioral and neurodevelopmental outcomes. The investigators will also explore mechanisms associated with stress biology during pregnancy, infant brain development and neurodevelopmental outcomes, and parent and infant intervention effects.
The purpose of this study is to test and evaluate the Preparing Heart and Mind™ (PHM™) patient engagement pathway as a nurse-guided intervention to lower psychological distress and enhance caregiving competencies among mothers/birthing persons and their caregiving partners after a major fetal anomaly diagnosis.
This study is investigating the self-report adherence and assessment completion rates when presented with a transdiagnostic, partial assessment multiple times a day when compared with a monotopic, complete assessment once a day. Specifically, the investigators are testing the hypothesis that the personalization of diagnostic assessment topics and timing will lead to improved self-report regiment adherence rates, assessment completion rates, and total assessments completed during the study period. The study does not test the efficacy of the personalized assessments as a diagnostic instrument, there is no clinical decision support provided to clinicians during this study, and there is no treatment provided during this study.
This research is being done to: * identify any emotional, behavioral or other troubling psychological problems that some people have who are seeking and receiving treatment for heroin or other drug use problems, * learn if providing additional psychiatric treatment services in the ATS drug abuse treatment program is as beneficial for and acceptable to patients as referring them to the Bayview Community Psychiatry Program to get help for their emotional, behavioral and other psychological problems.
The purpose of this pilot project is to test the effectiveness of three 20 minute health education modules on patient empowerment, patient activation and retention in care.
This project aims to study health outcomes of individuals with mental illness attending a co-located primary health care center in a mental health center. This study uses mixed methods to collect a range of information about who chooses to use what Wellness Center services and in what combinations, with what short and longer-term effects and with what outcomes. Based on participant interviews, identify barriers to and facilitators of access, service, and improvements in person-centered outcomes and elicit suggestions for enhancing health care outcomes and choice. Collaborate with persons in recovery in using the data collected through Aims 1 and 2 to develop and pilot the effectiveness of a new peer-led community based intervention in enhancing access and choice and improving person-centered health outcomes.
The purpose of this research is to study new ways of classifying mental disorders in children based on observable behavior and genetics to ultimately diagnose these disorders better.
This is a pilot comparative effectiveness study designed to determine whether trazodone is as effective as quetiapine for treatment of insomnia in veterans with a history of addiction and mental health issues. The study will have two concurrent phases (parts); first an acceptability determination phase, to determine whether and why (or why not) veterans already taking quetiapine are willing to try an alternative to quetiapine for sleep; and second, a randomized trial phase which will test whether staying on quetiapine has any advantage over switching to trazodone. The purpose of the first phase will be a) to document the proportions of patients and physicians who are willing to agree to such a switch, b) to characterize sociodemographic and clinical characteristics of potentially eligible subjects associated with a willingness to switch from quetiapine to trazodone and c) to record the reasons given why patients and their prescribers are (or are not) willing to accept a switch from quetiapine to trazodone. It will also function to provide some educational background to patients and a reminder to providers about the potential severe side-effects of quetiapine, and will thus facilitate clinical informed consent for the clinical trial phase of the study. Completion of the first part of the study will also serve as the screening component for part II. Part II includes, first, obtaining written informed consent from eligible subjects, and then randomly assigning them to continue quetiapine or to be switched to trazodone in open-label "real world" fashion for the duration of 4 weeks, followed by another four weeks of open, non-randomized follow- up. The purpose of the second part of the study is to determine if trazodone is an adequate substitute for quetiapine, primarily in terms of treating insomnia. The investigators hypothesize that trazodone will not be inferior to quetiapine in maintaining good quality of sleep measured by sleep scales (i.e., scores will not significantly worsen once switched). This study is open to Veterans in the VA system only. Eligible subjects must have a history of "dual diagnosis" (i.e., a history of addiction and mental illness).
Through a grant funded by the National Institute on Drug Abuse (NIDA) the Center for Multicultural Mental Health Research at Cambridge Health Alliance is testing a screening and intervention project designed to improve the quality of care for Latino patients with comorbid mental health and substance use problems. We will first test a screening of comorbid problems with patients identified in mental health as well as primary health care. Building on that work, we will test the feasibility, acceptability and efficacy of the "Integrated Intervention for Dual Problems and Early Action" (IIDEA) intervention addressing mental health, substance use, and prevention of HIV, as well as a smoking cessation supplement. The project is being conducted in Massachusetts as well as at two sites in Spain. As such, the proposed ILRP multi-site international project is a critical step towards developing models of integrated care for the large and diverse Latino migrant population and more broadly towards understanding how best to integrate evidence-based assessment and treatments for co-occurring substance and mental health problems and HIV risks.
Homelessness severely affects health and well-being and is particularly negative for youth. Between 70-95% of youth experiencing homelessness (YEH) report problem substance use and 66-89% have a mental health disorder. Youth appear to be at greater risk for living on the streets or being homeless than adults and are more vulnerable to long term consequences of homelessness. Multiple social determinants of health (SDOH) are uniquely associated with homelessness, driving substance use and adverse mental health consequences. However, limited research has identified pragmatic interventions that have a long-term ameliorating impact on the complex, multi-symptomatic issues among these youth. This study overcomes prior gaps in research through testing a multi-component comprehensive prevention intervention targeting SDOH that may affect biopsychosocial health indicators and longer-term health outcomes. In partnership with a drop-in center for YEH, youth between the ages of 14 to 24 years, will be engaged and randomly assigned to conditions using a dismantling design so that essential intervention components can be efficiently identified. In particular, youth (N = 300) will be randomly assigned to a) Motivational Interviewing/Community Reinforcement Approach + Services as Usual (MI/CRA + SAU, n = 80), b) Strengths-Based Outreach and Advocacy + Services As Usual (SBOA + SAU, n = 80), c) MI/CRA + SBOA + SAU (n = 80) or d) SAU (n=60) through the drop-in center. In order to assess the longer-term prevention effects on substance use, mental health and other outcomes, all youth will be assessed at baseline and at 3, 6, 12, 18 and 24-months post-baseline. The primary goal of this study is to establish the impact of a comprehensive intervention embedded within a system that serves YEH, a community drop-in center, on youth's opioid misuse and disorder, other substance misuse and disorders, mental health diagnoses, and other targeted outcomes. This study will offer unique information on the physiological and psychological stress pathways underlying change for specific subgroups of youth along with cost estimates to inform future implementation efforts in drop-in centers around the country.