11 Clinical Trials for Various Conditions
Cardiovascular disease is the leading cause of death worldwide, with ischemic heart disease (IHD) the leading cause of cardiovascular mortality. Persons with IHD suffering from psychological distress, including hopelessness, are more likely to die from IHD. Following a stressful event, the vagus nerve enables activation of either a sympathetic (fight/flight) or parasympathetic (rest/digest) response. Heart rate variability (HRV), the beat-to-beat variability between normal successive heart beats, is a biomarker of both adaptive and maladaptive reactions to stress. Decreased HRV predicts greater risk for morbidity and mortality and is associated with poor mental health outcomes in persons with IHD. As stated by polyvagal theory, HRV may be influenced by social support. Decreased perceived social support (PSS), a social determinant of cardiovascular risk, is predictive of increased morbidity and mortality in persons with IHD. Decreased PSS has been associated with hopelessness in patients with cancer, but this relationship has not been studied in IHD beyond the applicant's small pilot study of patients with hopelessness. Hopelessness, a negative outlook and sense of helplessness about the future, is present in 27-52% of patients with IHD. This is of grave concern, because hopelessness is associated with a 3.4 times increased risk of mortality and nonfatal myocardial infarction in patients with IHD, independent of depression. This research focuses on understanding the biological (HRV) and social (PSS) aspects of hopelessness, with the long-term goal of developing and testing novel interventions to reduce the adverse effects of hopelessness and improve health outcomes in patients with IHD. Participants for this cross-sectional study will be recruited while hospitalized for an IHD event. Participants will include patients who report moderate to severe hopelessness from the sponsor's NIH-funded study (n = 225); additional patients with minimal to no hopelessness will be recruited and enrolled by the applicant (n = 45). Data collection will take place remotely two weeks after hospital discharge. Specific aims include: Aim 1) Evaluate the relationship between HRV and hopelessness in patients with IHD; Aim 2) Determine the relationship between PSS and hopelessness in patients with IHD; and Aim 3) Explore the possible mediating effect of HRV on the relationship between PSS and hopelessness in patients with IHD.
After a 30-year decline, heart disease is projected to increase up to 18% by 2030. Participation rates in cardiac rehabilitation remain extremely low and hopeless individuals are less likely to participate. This innovative study has the potential to advance science, improve patient care, and improve patient outcomes by demonstrating the effectiveness of the Heart Up! program to increase physical activity and reduce hopelessness in patients with heart disease. Hopelessness is associated with a 3.4 times increased risk of mortality or nonfatal myocardial infarction in patients with ischemic heart disease (IHD), independent of depression. Hopelessness has been identified in 27-52% of patients with IHD and can persist for up to 12 months after hospital discharge. Hopelessness, a negative outlook and sense of helplessness toward the future, can be a temporary response to an event (state) or a habitual outlook (trait). Hopelessness is associated with decreased physical functioning and lower physical activity (PA) levels in individuals with IHD. While research has investigated strategies to increase PA among IHD patients in general, the study team is the only group to design an intervention to promote PA specifically in hopeless IHD patients. The purpose of this randomized controlled trial is to establish the effectiveness of our 6-week mHealth intervention (Heart Up!) to promote increased PA in hopeless patients with IHD. A total of 225 hopeless IHD patients will be enrolled from a large community teaching hospital in the Midwest. Patients will be randomized (75 per group) to one of three groups: 1) motivational social support (MSS) from a nurse, 2) MSS from a nurse with additional significant other support (SOS), or 3) attention control (AC). It is hypothesized that 1) The MSS with SOS group will have the greatest increase in average minutes of moderate to vigorous PA per day at 8 and 24 weeks as compared to the MSS only or AC groups; 2) Greater increase in minutes of moderate to vigorous PA per day will be associated with decreased state hopelessness levels from baseline to weeks 8 and 24; and 3) Increased social support and increased motivation will mediate the effects of Heart Up! on a greater increase in moderate to vigorous PA at 8 and 24 weeks. The findings from this study could transform care for IHD patients who are hopeless by promoting self-management of important PA goals that can contribute to better health outcomes.
The purpose of this project is to provide further evidence regarding a groundbreaking psychological treatment for suicide prevention in individuals with moderate to severe traumatic brain injury (TBI), Window to Hope (WtoH). The study will be one of the first five randomized clinical trials (RCTs) internationally to evaluate a psychological treatment for affective distress after TBI and the first conducted in the United States (U.S.) to specifically address suicide risk as an outcome. The current project aims to adapt WtoH for U.S. military personnel/Veterans (expert Consensus Conference, participant total up to 15), implement the intervention in a Veterans Affairs Medical Center (VAMC) (Pilot Groups 1-4, participant total up to 12), and replicate the results from the original trial in this novel context with a larger sample size (n=70 completed protocols \[up to 90 recruited\]. Deliverables are expected to include an intervention suitable for both dissemination and larger Phase III trials.
Specific aim #1: To assess the study team's ability to recruit subjects in this cohort and to successfully complete follow-up assessments by phone or mail. Hypothesis: Over 50% of eligible subjects will enroll in the observational study, and 70% of follow-up assessments will be successfully completed. Specific aim #2: To determine the natural history of hopelessness, ongoing suicidal thoughts, and optimism in subjects at 2, 4 and 8 weeks after discharge. Hypothesis: Subjects will continue to have moderate levels of hopelessness, suicidal thoughts, and optimism at follow-up assessments.
Hopelessness is associated with 3.4 times increased risk of mortality or nonfatal myocardial infarction in patients with ischemic heart disease (IHD), independent of depression. Hopelessness has been identified in 27-52% of patients with IHD and can persist for up to 12 months after hospital discharge. Hopelessness, a negative outlook and sense of helplessness toward the future, can be a temporary response to an event (state) or a habitual outlook (trait). Hopelessness is associated with decreased physical functioning and lower physical activity (PA) levels in individuals with IHD. Low levels of PA independently contribute to increased death and adverse events in patients with IHD. Rates of PA in IHD patients continue to be unacceptably low in both hospital-based cardiac rehabilitation and home settings. Compounding this issue is often the symptom of hopelessness. The links among hopelessness, PA and mortality and morbidity for patients with IHD remain largely unknown, especially in rural and minority IHD patients. The purpose of this study is to delineate differences in hopelessness between urban and rural patients with IHD, as well as between racial minority, including Hispanic and Native American, and White patients with IHD. Potential mediation of urbanicity and race/ethnicity by social connectedness, a key variable in rural settings, will also be examined. A 6-month longitudinal study will be conducted at Sanford Heart Hospital and Avera Health in Sioux Falls, South Dakota. Hopelessness will be measured using the State-Trait Hopelessness Scale. The results of this study have potential to transform nursing practice by providing a better understanding of hopelessness in IHD patients and informing future exercise rehabilitation studies and interventions in rural and minority populations.
The purpose of this study is to develop an accurate and useful way of measuring patients' thoughts and feelings about hope and hopelessness as they relate to their illness. Doctors and psychologists from Memorial Sloan-Kettering Cancer Center, Calvary Hospital, the Peter MacCallum Cancer Centre, and Fordham University are working together to design a new measure. Findings from this research will help us study the nature of illness and develop improved methods of diagnosis and treatment. We hope what we learn from you will help us learn more about how to care better for patients with cancer and other severe illnesses.
Across multiple models of suicide risk, hopelessness and perceptions of social relatedness (i.e., lack of social connection/thwarted belongingness, perceived burdensomeness) have emerged as candidate mechanisms that maintain STBs. Although these mechanisms have garnered strong empirical support in predicting STBs, there has been virtually no integration with interventions aimed for individuals at acute risk for suicide. Thus, the overarching goal of the present proposal is to evaluate a mechanism-focused intervention that explicitly targets two core mechanisms implicated in the maintenance of STBs: hopelessness and negative perceptions of social relatedness. Given that the period immediately following hospital discharge presents the highest risk for suicide attempts and up to 70% of patients admitted for a suicide attempt do not attend their first outpatient appointment, the intervention will be evaluated on an inpatient unit. Additionally, most of the extant interventions for STBs are administered across multiple sessions (i.e., 4 sessions and up to one year); however treatments of this length are unlikely to be feasible in acute care settings. Fortunately, very brief suicide prevention interventions, are effective in reducing future suicide attempts and increasing the likelihood of attending follow-up treatments. Additionally, single-session interventions (not suicide specific) have been shown to reduce hopelessness immediately and at a one-month follow-up. The present study is an RCT comparing a novel Single Session Mechanism Focused Intervention (SSMFI) for STBs to treatment-as-usual (TAU) on a psychiatric inpatient unit for patients admitted for suicidal ideation or attempt. The engagement of the putative processes (hopelessness and negative perceptions of social relatedness) that maintain STBs will be assessed, along with the feasibility and acceptability of SSMFI for STBs on an inpatient psychiatric unit.
The overarching aim of the Success Over Stress Prevention Project is to reduce African American youth suicide. This study examines the impact of a 15-session, group-delivered, culturally-grounded, cognitive-behavioral intervention (i.e., PI Robinson's Adapted-Coping with Stress Course \[A-CWS\]), on the outcomes of interest, when it is delivered by social workers who are indigenous to the school system. The main objectives of this project are to (a) determine whether the intervention is effective when facilitated by social workers who are indigenous to the school system and (b) enhance resilience, increase adaptive coping strategies, and reduce both intrapersonal and interpersonal violence among youth receiving the prevention intervention. It is expected that increases in adaptive coping will lead to an increased ability for youth to manage stressors, thereby decreasing the incidence of suicide and violence among the youth. In addition, it is expected that evidence of the intervention's effectiveness, when facilitated by social workers who are indigenous to the school system, will lead to greater dissemination and sustainability of the intervention, thus, providing access to effective intervention resources to greater numbers of African American youth.
The investigators hypothesize that patients receiving citalopram in combination with lithium will have a greater reduction in depressive symptoms than patients receiving citalopram in combination with placebo.
The purposes of this study are to determine: The safety of duloxetine and any side effects that might be associated with it. Whether duloxetine can help patients with major depression. The safety associated with switching from a medication you may be taking for depression to taking duloxetine. It is possible that information collected during this study will be analyzed by the sponsor in the future to evaluate duloxetine for other possible uses or for other medical or scientific purposes other than those currently proposed.
The Purposes of this Study are to determine: The safety of duloxetine and any side effects that might be associated with it. Whether duloxetine can help patients with major depression. It is possible that information collected during this study will be analyzed by the sponsor in the future to evaluate duloxetine for other possible uses or for other medical or scientific purposes other than those currently proposed. Duloxetine might not have any good effects for you.