38 Clinical Trials for Various Conditions
Determine the feasibility, practicality, and early efficacy of a TeleRehab program (ICARE) to improve outcomes for persons with traumatic brain injury (TBI) in recognizing and responding to others' emotions alongside their care partner (CP).
Randomized controlled trial of the effectiveness in managing diabetes and improving mental health through a telephonic layperson-delivered empathy and relationship-focused program for patients at a Federally Qualified Health Center (FQHC) against usual care.
The Embodied Empathy pilot study proposes to use VR technology to create original narratives of real life patients from their own perspectives for medical students to embody. Instead of using an animated avatar, researchers will use live-action first-person 220 degree video to capture these vignettes. In "Virtual Body Swap: A New Feasible Tool to Be Explored in Health and Education," Oliveria discusses the impact of using an actual person as an avatar as opposed to animation. "Many possibilities stem from the concept of body swapping. The relationship between individuals and their own bodies has implications on their ego and own personality. Feeling to be in another person's skin and controlling another body's movement, can facilitate the development of empathy, playing with one's ego and emotions. Such experiments could, for example, be used as a theme for discussion and behavioral changes related to issues such as racism, altruism, inclusion and anorexia, among others" (Oliveria, Bertrand, Lesur, Palomo, Demarzo, and Cebolla, 2016). Although the study will not focus on a true one-to-one body swap, as in BeAnotherLab's The Machine To Be Another, the assertion of a real person as an avatar is essential to our project.
The purpose of this study is to observe whether people would report being less likely to sue a physician who shows more empathy when giving a patient potentially bad news regarding their medical condition.
Our research hypothesis is that residents who participate in the empathy and relational skills training modules will significantly improve in these skills as compared to a control group of residents who receive residency training as usual that includes the current standard training in the doctor-patient relationship. To evaluate this hypothesis, we will use a two-pronged approach to assessment. The first prong is the residents' self assessment of empathy and the second is from the patients' perspective.
Background: Empathy is critical to clinician-patient communication and patient outcomes. Perspective-taking, an intervention demonstrated in other contexts to induce empathy, has never been studied in a medical context. As a first step in evaluating its potential clinical value, the studies described below assess perspective taking in a series of clinical skills examinations. These examinations are simulated clinical encounters: students encounter and are evaluated by standardized patients (SPs)--actors trained to take on patient roles. Though not real clinical encounters, clinical skills examinations have been demonstrated to test clinical competency well enough to be incorporated into the licensure examination of the National Board of Medical Examiners. Objective: To assess if perspective-taking improves the satisfaction of standardized patients in three clinical skills examinations. Hypothesis: Students receiving a perspective taking intervention will receive better standardized patient satisfaction scores than control students. Design and Setting: Three randomized, controlled studies. Studies 1 and 3: Junior medical students(N = 503), 6-station clinical skills examination. Study 2: physician assistant students (N = 105), 3-station clinical skills examination. Intervention: The intervention students received a perspective-taking instruction prior to their examination asking them to put themselves in their "patients" shoes and to imagine what they were thinking and feeling. The control students received standard pre-examination instructions. Simulated patients were blind to study condition. Main Outcome Measure: Simulated patient satisfaction scores.
The purpose of the research is to: 1) to test whether psychotherapy including immediate feedback of empathy data is more efficacious than therapy without such an exchange of data, 2) to measure the degree of accuracy of therapist's empathy and its relationship to the patient's estimate of the therapist's empathy.
Atrial Fibrillation is a chronic disease with significant health consequences like increased risk of stroke, heart failure, heart attack and death. Educating patients about the disease is important for them to be able to understand the condition better, feel empowered and take an active part in their care plan. AI technology can potentially be used to impart such education. However, doing so with care and empathy is equally important. Therefore, it is necessary to ensure when AI technology is used to impart education about atrial fibrillation to patients, the humane aspects of the interaction are rigorously tested. This study examines a way to impart atrial fibrillation education through interaction with an AI chatbot, that uses text and links to educational videos. To participate in this study, people need to be age 18 or older and have a history of newly diagnosed atrial fibrillation. Approximately 40 individuals will be asked to take part in this study. The first step to the study will be reading through, understanding, and signing an informed consent. People who then agree to join the study will have a one-time interaction with the AI chatbot and structured educational material by using an iPad provided to them for the approximately 1 hour duration of the study. People in the study will obtain atrial fibrillation education by typing one by one on the iPad, up to 10 questions about the disease. Answers will include text and links to videos. Before and after atrial fibrillation education, people who join this study will be asked to fill out a survey. The study team will teach patients how to use the iPad and type in questions.
The goal of this project is to investigate the effect of cognitive empathy training on mental health, inflammation, and immune function in caregivers of people living with dementia (PLWD), and to examine the underlying psychological and neurobiological mechanisms. The primary aim is to establish the effectiveness of cognitive empathy training in improving caregiver mental health and immune function, and in decreasing caregiver inflammation The secondary aim is to investigate the psychological and neurobiological mechanism by which cognitive empathy training improves caregiver well-being
This is a quantifiable study evaluating the ability of a mixed reality (MR), immersive simulation experience to evoke empathy in anesthesiology trainees. Quantitative methodologies will be employed using standardized questionnaires including the The Jefferson Scale of Physician Empathy for Health Professions Students, (HP-version). Trainees will assess their preliminary, baseline empathy using the Jefferson Scale and after the simulation and debrief, will reassess empathy scores, once again using the Jefferson Scale. A satisfaction survey to assess simulated patient embodiment as a valuable exercise and contributor to empathy education curriculum.
This study investigates patients' perceptions of their doctor's or nurse's empathy during an in-person interaction with the doctor or nurse wearing personal protective equipment (PPE) compared to during a video interaction with the doctor or nurse without PPE. The goal of this research study is to learn whether patients who visit the Acute Cancer Care Center at MD Anderson believe they get better (more empathetic) care from doctors who visit them in person wearing PPE or from doctors who visit them by video call and do not wear PPE.
The aim of the ENHANCE study was to determine if an intervention focused on empowering medical inpatients to discuss their values and interests with their Cleveland Clinic Caregivers leads to greater caregiver empathy, improved patient experience, and improved Caregiver experience. The intervention patient participants received a poster where they were able to share things about themselves that they wanted their Caregivers to know. These posters were hung on the wall behind their bed. A few days later, they were given a survey to assess their experiences in the hospital. On the control floors, medicine patients were recruited a few days into their admission and administered a survey. CCF Caregivers completed surveys before the intervention period and afterward. Data collection is complete, data analysis is largely finished and a manuscript is in progress. 320 patients and 219 CCF Caregivers participated in the study.
The proposed study, may significantly contribute to improve healthcare delivery in patients with Chronic Myeloid Leukemia (CML) treated with modern tyrosine kinase inhibitors (TKIs) in two ways. First, it may provide novel empirical data on the positive effects of systematically monitoring of patient-reported adverse events (AEs) in routine practice for improving symptom management and adherence to therapy. Second, it will inform the development of a large international randomized controlled trial (RCT) to test whether systematic collection of patient-reported AEs, could improve clinical response to TKI therapy.
The proposed study is a pilot study to gather data on the effectiveness and feasibility of a software tool (EMPATHy) to help patients communicate effectively with doctors about problems they face with their medication regimens. EMPATHy will be incorporated into an existing clinic-based intervention called Coached Care, in which community health workers (CHWs, non-professional community members) work as a "Coach" to patients to help them improve engagement and communication during the medical visit.
The effect of medical humanities on medical student bias and clinical management is unclear. This study characterized medical student attitudes toward obese individuals and whether reading a play employing empathic characters can modulate negative reactions.
Empathy is defined as sensitivity to the needs of others.Maternal empathy, or a mother's sensitivity to the needs of her child, is critical for healthy child development ,Small Moments, Big Impact: Supporting Maternal Empathy by Adding Media to Child Health Services (SMBI) will develop and pilot a media-based pediatric primary care intervention that aims to answer two Big Questions: 1) Can media sent by pediatricians to mothers from low-income backgrounds promote empathy? 2) Is there a feasible and scalable approach? If successful, SMBI will result in: 1) increased maternal empathy; 2) new evidence and knowledge about an effective approach for supporting empathy in mothers from low-income backgrounds; 3) acceptability, feasibility of administering, and therefore potential for scalability through standard pediatric care; 4) increased support of maternal empathy as a core component of pediatric care; and 5) increased support by other stakeholders (including medical professionals, child health care facilities, and funders) to further explore, expand, and ultimately rollout the intervention
This study aims to assess changes in empathy levels before and after residential treatment among individuals with substance use disorders.
Researcher from UNC Greensboro have partnered with Prevention Strategies and key stakeholders from the Kingdom of Bahrain to conduct a study using the innovative, engineering-inspired methodological approach, the Multiphase Optimization Strategy (MOST), to optimize and evaluate the Peaceful Coexistence and Anti-Extremism middle and high school curricula. No other curriculum targeting tolerance and/or extremism has been optimized using the state-of-the-art MOST methodology. The overall goal of the project is that the optimized versions of Peaceful Coexistence and Anti-Extremism curricula will be used across the Kingdom of Bahrain and translated for use in other countries to combat the spread of extremism and intolerance. Additionally, the D.A.R.E. keepin' it REAL (kiR) and D.A.R.E. myPlaybook high school programs will be evaluated as part of the Peaceful Coexistence and Anti-Extremism evaluation.
Patients diagnosed with cancer commonly have a high degree of anxiety during an initial oncology consultation, which may interfere with a patient's ability to retain information required to make informed treatment decisions. A previous study randomized breast cancer survivors (volunteers) to view either (a) a brief video depicting a standard initial consultation from an oncologist or (b) an identical consultation with the addition of compassionate statements from the oncologist, and found the compassionate statements reduced anxiety among the volunteers. However, it is currently unknown if watching a video containing compassionate statements from an oncologist prior to an actual initial oncology consultation will reduce anxiety among patients referred to a cancer center. The aim of this randomized control trial is to test if watching a brief video containing compassionate statements from an oncologist, compared to watching a standard introduction video, prior to an initial oncology consultation will reduce the degree of anxiety among patients referred to a cancer center. This is a prospective, randomized controlled clinical trial at an academic cancer center. The investigators will enroll adult patients scheduled for an initial oncology consultation. Subjects will be randomly assigned to receive a "standard introduction video" or "enhanced compassion video" for viewing prior to the initial oncology consultation. On arrival to the cancer center anxiety severity will be measured using the Hospital Anxiety and Depression scale (HADS). The HADS has two 7-item subscales (HADS Anxiety and HADS Depression) and is well-validated among oncology patients. Wilcoxon rank-sum test will be used to test for a difference in the HADS subscales between the two video groups.
The goal of this study is to test a novel intervention for children ages 6-11 with elevated callous-unemotional (CU) traits. Conduct problems are among the most prevalent and costly mental health conditions of childhood, and a common antecedent to adult psychiatric disorders. An established risk factor for early, persistent, and severe youth misconduct is the presence of CU traits. CU traits (e.g., lack of empathy or guilt, shallow affect) are analogous to the core affective features of adult psychopathy, interfere with child socialization, and predict poorer outcomes, even with well-established treatments for disruptive behavior disorders. Thus, novel intervention approaches are needed to target CU traits. Youth with elevated CU traits show deficits in facial emotion recognition (FER) for distress-related expressions, particularly fear or sadness. The central hypothesis is that impaired sensitivity for emotional distress cues (fear and/or sadness) is mechanistically linked to CU traits in children, and that, by targeting affect sensitivity directly, intervention can exert downstream effects on CU traits. A gap in the field regards how to remediate these neurocognitive deficits. This project will directly target affect sensitivity in high-CU youth. The investigators propose an experimental therapeutics approach to develop a novel neurocognitive intervention for CU traits, in which a clearly identified target, facial affect sensitivity (FAS), will be engaged and assessed via primary (distress FER accuracy and/or heightened eye gaze) and secondary (electroencephalograph event-related potential) neurocognitive and behavioral processes. If investigators can demonstrate engagement of the target (FAS) in the initial R61 phase, then in the R33 phase, this finding will be replicated with a new, larger sample, and feasibility and preliminary efficacy of FAST on CU traits will be examined. The long-term goal is to examine FAST impact on behavioral outcomes and to potentially apply this targeted intervention to the wider range of problems associated with CU traits.
The purpose of this randomized controlled trial is to evaluate an intervention, Supporting Survivors and Self: An Intervention for Social Supports of Survivors of Partner Abuse and Sexual Aggression (SSS). SSS trains potential recipients of IPV or SA disclosure on the best methods of responding to a victim's disclosure. Consenting college students will be randomized into the SSS intervention or a wait-list control condition. Evaluation data will be multi-informant (i.e., data from both informal supports and victims) and multi-method (i.e., qualitative and quantitative). The investigators hypothesize that individuals receiving the SSS intervention, compared to individuals in the wait-list control condition, will provide less negative and more positive social reactions to victims' disclosure.
The purpose of this study is to evaluate feasibility of modularized delivery of the Impact of Crime (IOC) group intervention with jail inmates, and obtain preliminary data on its effectiveness in reducing post-release recidivism, substance abuse, and HIV risk behavior.
The purpose of this study is to evaluate whether the Impact of Crime (IOC) group intervention with jail inmates reduces post-release recidivism, substance abuse, and HIV risk behavior.
The goal of this study is to evaluate the effectiveness of a mind-body medicine training program on parole services staff. The main questions it aims to answer are: * Will participation in the training increase resilience; empathy; the belief that one can cope with difficult situations; and decrease symptoms of depression, stress, anxiety, and burnout? * What is the personal and professional impact of the training program? Sixty staff members of the Indiana Department of Correction Parole Services Division will do the following: * Attend an initial 4-day mind-body medicine training. Mind-body techniques taught in the training include: meditation; a breathing exercise; biofeedback; guided imagery; expressing oneself through drawings and writing; movement to reduce stress; and family trees to explore family dynamics. * Attend a 2-day practicum. The 2-day practicum will teach staff the ways in which they can share the skills they have learned one-on-one with parolees and families of parolees. * Attend 4 biweekly sessions of 2-hour group consultation sessions. The consultations will support the use of the mind-body skills with the parolees. Participants will also do the following: * Fill out standardized questionnaires online before and after the training program in order to measure changes in resilience; empathy; the belief that one can cope with difficult situations; and symptoms of depression, stress, anxiety, and burnout. * Fill out an additional online questionnaire three months after the consultation sessions to determine how trainees are using the mind-body skills in their work. * Participate in an online group interview to determine how trainees are using the skills and how the training has affected them personally and professionally.
The goal of this clinical trial is to learn more about the interaction between a patient in the hospital and their treating doctor. A good relationship between patients and their doctors can help improve patient care. Doctors will be asked to use strategies to improve their interactions with patients in the hospital. The main questions it aims to answer are: * Will using the intervention strategies improve doctors' empathy towards their patients? * Will using the intervention strategies lead to improved scores in patient views of doctors' empathy? There will be 2 study arms. One group of doctors will be asked to use the intervention strategies. The other group of doctors will provide care as they would normally. Researchers will compare the doctors in the intervention arm to those in the control arm. Doctors are the primary subjects for this study. The doctors in both study arms will be asked to do the following: 1. Allow study staff to observe the interaction between them and their patients. 2. Complete a brief survey at the end of their 2-week work rotation. Doctors who are in the intervention arm will be asked to use suggested strategies when visiting with patients in the hospital. Patients are secondary subjects for this study. Patients of participating doctors may be asked to do the following: 1. Allow study staff to observe the interaction between them and their doctors. 2. Complete a brief survey after meeting with their doctor.
The purpose of this study is to establish the antiviral efficacy of ensovibep against severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in humans, identify the optimal dose, and demonstrate its clinical value for treating COVID-19 in adult ambulatory patients.
The objective of this study is to determine whether a mindfulness coaching program was efficacious at reducing work stress, improving psychological and physical health outcomes, and improving work outcomes. The target population is employed adults (18 years and older) working in the industries of media, consulting, and healthcare.
Working with patients at risk for suicide is highly stressful for clinicians and often elicits powerful negative emotional responses that may adversely affect suicidal outcomes. A proposed explanation has been that negative emotional responses may result in less empathic communication and unwitting rejection of the patient, which is liable to damage therapeutic alliance. Thus, there is a need for clinician training in effective management of negative emotions towards suicidal patients, which can result in tangible improvement in suicidal outcomes. The training must be web-based, scalable and easy to disseminate, making it available to clinicians everywhere. In this project, the study team will address this critical need by using Virtual Human Interaction (VHI) to train outpatient clinicians in emotional self-awareness (ESA), which includes both recognition of one's own negative emotional responses, and ability to engage in verbal empathic communication with acutely suicidal patients. The study team will conduct a prospective multisite, blinded, randomized trial comparing VHI ESA training with a Control condition, which will assess both clinician-level and patient-level outcomes in 80 outpatient clinician participants (CPs) and 400 of their participating patients (PPs). Using the same VHI scenarios, the ESA group will receive clinician-focused, comprehensive feedback in ESA, while the Control group will assess the VH's suicide risk without receiving the ESA feedback. The study team will measure efficacy of the VHI ESA training on clinicians by comparing ESA feedback and Control CPs' post-training (T2) ESA towards virtual humans, adjusting for pre-training (T1) ESA. The study team will measure the impact of the VHI ESA training on patients' suicidal outcomes by assessing the primary and secondary outcome variables in both CPs and PPs three times: at baseline (T0), after the first post-training treatment session (T3) and one-month post-training (T4). The study team will examine the role of therapeutic alliance as a possible mediator of the relationship between clinicians' ESA and their patients' Suicidal Ideation (SI) and Suicide Crisis Syndrome (SCS). To accomplish this goal, the study team will use the novel validated suicide risk assessment instruments developed in preliminary studies: the Therapist Response Questionnaire - Suicide Form (TRQ-SF), which assesses negative emotional responses to suicidal patients, and the Suicide Crisis inventory (SCI), which assesses the SCS severity and predicts near-term suicidal behavior. For web-based VHI training the study team will use the already tested and disseminated web-based empathy-teaching platform, coupled with an assessment of verbal empathy measured by the Empathic Communication Coding System (ECCS).
The purpose of this study is to assess the impact of a brief, emotion regulation intervention on the ability to perceive other people's emotions.
This study will evaluate a Mind-Body Medicine curriculum for high school peer counselors in order to answer the following research questions: 1. Will peer counselor participation in the Mind-Body Medicine curriculum increase their sense of self-regulation, responsibility, social competence, and empathy; decrease anxiety; and increase hope? 2. What are the experiences of peer support counselors participating in the Mind-Body Medicine curriculum?