337 Clinical Trials for Various Conditions
Investigators are conducting this study to test if temporarily and non-invasively stimulating the brain will affect the emotional response to stress in healthy participants. Participants will perform a series of tasks while completing an MRI scan. After this, participants will be randomized to undergo transcranial magnetic stimulation (TMS) at two visits, undergoing active stimulation at one visit and undergoing 'sham' stimulation at another visit. Immediately following both stimulation sessions, participants will repeat the tasks during MRI scanning.
The present study will examine the relationship between metabolically excessive cardiovascular and neural responses to acute psychological stress using a cross-sectional approach.
The objective of this proposal is to demonstrate a viable, functionally integrated multivariable artificial pancreas (mvAP) that will address meal, physical activity (PA) and acute psychological stress (APS) challenges without any manual inputs to better regulate glucose levels of people with diabetes. Acute psychological stress and many other forms of PA besides planned exercise can affect blood glucose levels and cause challenges to maintaining euglycemia for people with type 1 diabetes mellitus (T1DM). Various PA and APS affect the metabolism and sensitivity to insulin in different ways. Hence, their types, intensities and durations, and their individual and concurrent presence must be detected in order to determine the optimal insulin administration. The mvAP approach provides a well-integrated and user-friendly technology with minimal burden on the user and mitigates the effects of unexpected PA and APS inducements. Twenty subjects with type 1 diabetes (ages 18-60) who use insulin pumps enrolled in this study. The study will take place at the UIC-College of Nursing Diabetes and Exercise Laboratory. The protocol will include 1 screening visit and 5 sessions at the laboratory. The primary activities at each meeting will include: (1) screening; (2) measurement of peak exercise capacity; (3) estimation of maximal strength from submaximal strength tests; (4) Trier Social Stress Test; (5) submaximal bouts of aerobic and resistance exercise, and activities of daily living with and without stress (e.g., mental calculations, video games). These activities will be included visit 3, 4 and 5 as appropriate. In addition, subjects will perform activities at home include: housekeeping chores, stationary bike (if available); treadmill (if available); walking; and light weights (if available). Periodically, the research assistant will call the subject during these times and ask them to perform stress-inducing activities while performing the activity. The stress inducing activities will include mental challenges such as a mathematical computation while performing the activity. The subjects will be called at home 3-5 times during the study. The fully automated algorithm will be tested in a home setting, however, the methodology will be developed and approved for testing later in the study.
The aim of the Everyday Moments of Mindfulness (EMMI) study is to test whether brief mindfulness-based practices will improve daily psychological stress responses in women (age 30-60) who report a history of early life adversity. Following a baseline visit (remotely or in person), participants complete daily surveys and audio-guided mindfulness-based practices in everyday life via the study app. Specifically, participants receive app-notifications three times/day (morning, afternoon, evening) to complete daily surveys of current stressors and psychological states. At each notification, each participant is then randomly assigned to either receive a mindfulness-based intervention or not (max of 3 interventions/day). Thus, participants are randomized many times over the course of this 30-day study. At the end of the study, participants complete a follow-up visit (remotely or in person).
The investigators have developed a mobile app called Resolving Psychological Stress (REPS) to help alleviate symptoms of PTSD. The app will administer threat-related attention bias modification to individuals who have both a Diagnostic and Statistical Manual of Mental Disorders V (DSM-V) diagnosis of PTSD (and meet at least one DSM-V criteria for threat sensitivity) and a DSM-V diagnosis of Alcohol Use Disorder. The aims of the study are to explore both the feasibility and acceptability of the app with it's users, and to explore the efficacy of the app at alleviating PTSD severity.
The investigators have developed a mobile app called Resolving Psychological Stress (REPS) for people with posttraumatic stress disorder (PTSD). The app will administer threat-related attention bias modification to individuals who score high on a PTSD checklist. This study will be administered remotely to individuals in the United States. The aims of the study are to explore feasibility, acceptability and usability of the app in an entirely remote study, as well as to explore the efficacy of the app at reducing attention bias and PTSD symptom severity.
This randomized, double-blind, placebo-controlled study of propranolol will shed important light on how sympathetic nervous system (SNS) activation influences psychological and inflammatory responses to acute stress. Results from this study will inform both the basic science literature that is attempting to map the physiological mechanisms by which psychological stress may lead to poor mental and physical health, and may also ultimately have therapeutic relevance for individuals who are experiencing high levels of stress that is putting their health at risk. Utilizing a psychopharmacological approach allows for the circumvention of many of the challenges of conducting this research in human populations, and will allow for conclusions regarding causality, given that SNS activation will be experimentally manipulated, rather than relying on correlational measures of SNS activity that are difficult to assess and are not appropriate for asking if SNS activity causes changes in psychology and biology.
To evaluate 1) the extent of patient overestimation of breast cancer development risk in subjects referred to a physician-based high-risk breast clinic; 2) the ability of physician counseling to improve patient risk perception and reduce psychological distress; 3) to identify factors relevant in clinical practice associated with increased distress and risk perception.
This is an open-label psilocybin-assisted therapy study that will examine the safety and tolerability of psilocybin-assisted therapy in the offspring of genocide survivors with mood and anxiety disorders. The study will also investigate the efficacy of psilocybin-assisted therapy in reducing symptoms such as depression, anxiety and stress, as well as changes to the psychological effects of parental exposure to genocide, and changes to psychological resilience.
Volunteers for the study are asked to participate in two laboratory sessions. In the first laboratory session, volunteers are asked to provide a blood sample which will be used to measure factors related to health. Participants also complete questionnaires related to demographic and health-related information and undergo evaluations of their body composition. In the second laboratory visit, participants are asked to have cardiovascular, neuroendocrine, and inflammatory activity measured during a brief period of rest and during a short challenging psychological task. Participants will also complete questionnaires. The study is designed to examine the associations between experiences such as trauma and resiliency with changes in bodily systems during a challenge and current health.
Stress, when left unmanaged, can have detrimental effects on both physical and mental health, contributing to conditions such as high blood pressure, anxiety, and even cardiovascular disease. Effective stress management therapies may help maintain overall well-being and reduce the risk of long-term health complications. The Primal Reflex Release Technique (PRRT) is a novel manual therapy that may reduce markers related to stress such as heart rate variability (HRV) and patient-reported outcomes (PROs). Therefore, the purpose of this study is to elucidate the potential for PRRT to improve HRV and PROs.
The goal of this experimental study is to improve our understanding of the effects of stress on the decision to consume (more) alcohol in regular drinkers. The main question\[s\] it aims to answer are: * Does psychological stress affect the decision to consume (more) alcohol? * How does psychological stress affect the decision to consume (more) alcohol? Participants will be randomly assigned to one of four conditions (stress alcohol, stress no alcohol, no stress alcohol, no stress no alcohol) and complete a value-based decision-making task twice (once before and once after the manipulations).
This study examines cardiovascular responses to a brief psychological challenge under laboratory conditions among adult volunteers. The study volunteers are asked to complete two study sessions. In one session, the volunteers are asked to provide demographic and health-related information via questionnaires and an interview. In that session, volunteers would then be asked to undergo evaluations of their body composition, blood pressure, heart rate, and other signs of cardiovascular function and health. Lastly, volunteers would be asked to take part in a brief and challenging psychological task after a period of rest while cardiovascular activity is measured. In the other session, volunteers are asked to undergo magnetic resonance imaging and to complete neuropsychological tests of memory, attention, and processing speed. In addition to these two sessions, volunteers are asked to complete online questionnaires. The study is designed to examine associations between transient changes in cardiovascular activity induced by the psychological task, measures of overall cardiovascular health, and measures of cerebrovascular health measured by magnetic resonance imaging. Study results are expected to provide new information about the relationships between cardiovascular activity changes to psychological challenges and cardiovascular and cerebrovascular health in adults.
This study tests the impact of mindfulness vs. relaxation training on psychological threat and challenge, emotions/emotion regulation, motivation/engagement, and performance among undergraduates enrolled in introductory physics courses. Data used to compare groups will be collected from a variety of sources, including self-report surveys, experience sampling and daily diary assessments, physics learning activities, and academic records.
The current study is the second phase of a two-part study to examine the feasibility and utility of using an mHealth mindfulness intervention to help parents mitigate the stress associated with the impact of sustained community crisis situations, such as COVID-19 and its consequences, on low-income families living in under-resourced settings.
Older adults have been disproportionately impacted and distressed by the COVID-19 pandemic. Social distancing and stay-at-home orders have increased older adults' risk of social isolation and loneliness that will has led to a pandemic-induced fear of being in close proximity to other people. These fears and avoidant behaviors will have lasting effects if not treated with effective, safe, and convenient psychological interventions. This study will evaluate the acceptability and feasibility of delivering a small group intervention, called Acceptance and Commitment Therapy (ACT), through a telehealth modality to Veterans ages 65 and older who are experiencing pandemic-related emotional and physical distress. ACT helps decrease emotional suffering, improve well-being and promote positive behavior change by increasing one's psychological flexibility through the practice of mindfulness, acceptance, and values-based behaviors. The knowledge gained from this study will be used to better tailor the invention to meet the needs of older Veterans in an era of post-pandemic recovery.
The unjust social, economic, and environmental conditions that African Americans face throughout their lives lead to pervasive health disparities. These disparities are driven by healthcare differences. They are driven by economic differences. Those with less financial wealth have poorer health as compared to those with higher socioeconomic status. And yet, even when controlling for these two important social determinants of health, race still predicts morbidity and mortality. What can account for this? Stress. African Americans experience more stress than their White peers. The story is even more dire for African American women who simultaneously face both racial discrimination and sexism. Indeed, gendered racial discrimination is nearly ubiquitous for Black women at all socioeconomic levels. It is also a distinct form of stress, with unique outcomes compared to other non-race-or-gender-related stressors. Finally, stress has clear downstream negative effects on health. At present, there is no mobile cognitive-behavioral stress management intervention (m-CBSMi) designed to help African American women manage racial and nonracial daily stress. The investigators intend to fill this void. Using proven CBSMi techniques, participants will learn how to manage their stress through text messages and integrated mobile web content. Supportive texts will inspire, motivate, and affirm the life experiences of participants. Educational texts will increase knowledge, develop skills, and reduce barriers to adaptive coping. A library of individually tailored videos will be delivered to each participant. All mobile web content will be accessible only through touch-based links embedded within text messages, making it easy and effortless to view this material. During Phase II the investigators will complete development of the m-CBSMi. Then, the investigators will examine the effectiveness of the m-CBSMi to reduce stress among African American female participants. Participants will be randomly assigned to either the intervention condition or to a matched control condition. Secondary measures will assess coping, well-being, subjective health, gendered racial identity, and knowledge.
During the current COVID-19 Pandemic, all communities are relying heavily on medical personnel and first-responders to maintain high levels of psychological and occupational functioning. However, during times of persistent high levels of stress, many individuals experience depletion in psychological resources, suffering intense distress that can make daily occupational and interpersonal functioning difficult. In order to assist with this immense challenge, this research team has developed a brief daily intervention based on decades of stress and trauma research that may help to support psychological health in individuals on the frontlines who are most essential to society. Considerable evidence supports the role of attention to and conceptualization of emotional experience in psychological resilience. This project tests a highly innovative combination of interventions targeting these processes in a brief, daily activity. The primary project aim is to investigate the Daily Coping Toolkit for medical personnel and first responders to determine efficacy over time, to test relative dosing, and to explicate the underlying therapeutic processes. The toolkit consists of 3 activities, administered one time each day, taking minutes to complete and will be administered to n=1000 personnel. Data analysis will test the impact of the toolkit on momentary affective processes and on symptoms and wellbeing over 9 months. The impact of this research will be evidence to support the further use of this novel tool to assist essential front-line personnel during this ongoing crisis helping to mitigate the psychological toll and also support occupational functioning now and in the future.
The investigators plan to conduct a crossover experimental trial examining physiological responses to a socio-evaluative speech task under laboratory conditions. Participants will attend two laboratory sessions. At one session participants will take part in a brief laboratory stress task and at the other participants will rest for the same period. Measures of cardiovascular response will be assessed at both sessions. In addition, blood will be drawn at multiple time points across a 125 minute period to assess changes in circulating levels of cortisol, catecholamines, markers of inflammation and cell free mitochondrial DNA in response to the task. The investigators expect that the stress task will induce a specific increase in ccf-mtDNA, which will statistically mediate subsequent peak circulating Interleukin-6 and Tumor Necrosis Factor-α levels. In secondary analyses, the investigators will examine whether stress-induced increases in circulating cortisol, epinephrine, and norepinephrine levels correlate with increases in ccf-mtDNA. These studies will establish the kinetics and magnitude of psychological stress-induced ccf-mtDNA release, the association with early stress mediators, and whether ccf-mtDNA mediates the inflammatory response to acute stress in humans.
The purpose of this study is to evaluate the Personalized Support for Progress (PSP) intervention in a Veterans Health Administration (VHA) Women's Wellness Clinic. PSP uses a peer support provider to help women identify their primary concern, develop a personalized plan to help address that concern, and provide practical and emotional support to implement the plan. The primary aim is to evaluate the feasibility, acceptability, and utility of PSP and the research protocol.
Cancer patients will be randomly shown one of 18 emotional support messages created by the research team that differ based on how much of the message consists of positive statements and how much consists of negative statements. The messages with negative statements also differ based on whether the negative statements occur at the start or end of the message. After viewing the message, participants have the opportunity to rate the effectiveness of the message, to what extent the message made them feel better, and to what extent the message affects how they view the message provider as a useful source of emotional support.
Burnout and stress at work can make individuals less productive, which can carry over into their personal and at-home lives and negatively impact health. Customer service representatives are under especially high strain as they are exposed to significant interpersonal conflict at work, both with frustrated customers and with pressure from coworkers and supervisors. However, recent research has found that different stress management interventions (e.g., mindfulness meditation training) can increase job satisfaction and work productivity. However, individuals with significant stress might find these training program classes difficult to attend with their busy schedules. Newer interventions have focused on smartphone mobile applications as an effective delivery system for these training programs. Thus, the purpose of this project is to conduct a randomized controlled trial (RCT) comparing two different stress management smartphone app programs to evaluate effects on job-related outcomes, functional and structural brain outcomes, and biology.
The impact of well-known risk factors for such disorders (stress, biological sex, anxiety-related dispositions) on fear generalization will be examined. Findings from this study may provide insight into how these risk factors influence the development and/or maintenance of psychological disorders that involve overgeneralization of fear and could facilitate future approaches to their treatment.
This project aims to contextualize delivery of mindfulness training to U.S. Army personnel, evaluate its effectiveness on measures of executive functions and psychological well-being, and determine best practices for its delivery.
This project aims to contextualize the delivery of mindfulness training for military spouses and evaluate its effectiveness on measures of executive functions and psychological well-being.
The aims of this study are to determine if: 1. during pregnancy, a progressive muscle relaxation and abdominal touch ritual involving a pleasing scent (i.e. a "relaxation ritual") can, acutely, reduce maternal stress and affect the fetus (in terms of movement, changes in heart rate and heart rate variability); 2. a progressive muscle relaxation and abdominal touch ritual involving a pleasing scent (i.e. a "relaxation ritual") during pregnancy can have an effect on mitochondria functioning in the placenta through reducing maternal stress during pregnancy (based on our recent findings (Monk et al, 2016)); 3. the scent will come to function as a conditioned stimulus such that exposure to the scent postpartum will induce greater maternal relaxation, which will have an effect on the mother-infant interaction and infant physiology; 4. prenatal maternal exposure to scent combined with abdominal touch will lead to mothers' increased likelihood of utilizing infant massage with a lotion of the same scent postpartum; 5. the prenatal ritual and the increased likelihood of engaging in infant massage will lead to a maternal perception of greater mother-infant bonding, attachment and parenting efficacy, and improved maternal mood; 6. the prenatal ritual and the increased likelihood of engaging in infant massage will lead to improved performance on the conjugate reinforcement paradigm conditioning task administered to infants at 4 months of age
This study is a two-arm randomized controlled trial comparing two 8-week stress management programs for reducing inflammation and improving well-being among older adults.
Health professional students experience high levels of psychological stress. Individuals with higher levels of resilience are better equipped to handle stress. The purpose of this study is to evaluate the effects of an 8-hour resilience curriculum on stress levels, resilience, coping, protective factors, and symptomatology on students enrolled in a doctor of physical therapy (DPT) program. Hypothesis: The curriculum will decrease stress levels, increase resilience, coping flexibility, protective factors (optimism, positive affect, and social support), and reduce symptomatology (negative affect, illness). Research on stress and its consequences experienced by physical therapy students in particular is limited. If the results of this study support this hypothesis, it may establish the benefit of adding a resilience component to the curriculum for students of physical therapy.
This study is a three-arm randomized controlled trial of a mindfulness stress reduction intervention, with the aim of dismantling the experience-monitoring and nonjudgmental-acceptance elements of mindfulness programs to determine the active treatment component. In addition to enhancing understanding of mechanisms underlying the effects of mindfulness interventions, identifying the therapeutic constituent(s) could inform development of targeted interventions as well as provide strategies to optimize adherence.
The investigators propose to evaluate the potential utility of stress-related biomarkers obtained via dried blood spots (DBS) and retinal scans by collecting new data from mothers and children within the New Haven MOMS Partnership, a well-established community-partnered research setting. The proposed research could greatly advance the application of stress-related biomarkers within community-based research by increasing our understanding of how stress, trauma, and depression influence biology in childhood and adulthood, as measured using minimally-invasive approaches.