Clinical Research Directory

Caring for Providers to Improve Patient Experience (CPIPE) Trial

The activities described in this proposal are aimed at addressing health care provider stress and unconscious bias to improve quality of maternal health care, particularly related to the person-centered dimensions of care-i.e. care that is respectful and responsive to women's needs, preferences, and values. The investigators focus on health provider stress and unconscious bias because they are key drivers of poor-quality care that are often not addressed in interventions designed to improve quality of maternal health care. The investigators plan to (1) test the effectiveness of an intervention that targets provider stress and bias to improve PCMC; (2) assess the cost-effectiveness of CPIPE; (3) examine the mechanisms of impact of CPIPE on PCMC; and (3) assess impact of the CPIPE intervention on distal outcomes including maternal health seeking behavior and maternal and neonatal health.

Work-Related Health Factors in General and Special Education Teachers

This cross-sectional study aims to compare work-related health outcomes between general education teachers and special education teachers. The study will assess burnout, occupational balance, perceived stress, musculoskeletal symptoms, pain characteristics, and general job satisfaction. Participants will complete an online questionnaire including sociodemographic and occupational characteristics, such as age, sex, teaching experience, working hours, and type of teaching assignment. Standardized self-report measures will be used to evaluate burnout, occupational balance, perceived stress, musculoskeletal symptoms, and pain-related characteristics. The study will examine whether teachers working in special education differ from general education teachers in terms of burnout, stress, occupational balance, musculoskeletal problems, and pain. The findings may help identify occupational health needs among teachers and support the development of preventive strategies for improving their well-being and working conditions.

Vital Coach: A Study of Resiliency in Medical Students

Medical students often begin training with psychological and physiological health metrics superior to their age-matched peers. By graduation, however, rates of depression, anxiety, and physiologic dysregulation are markedly higher, reflecting the cumulative strain of long study hours, high-stakes examinations, and the emotional burden of early patient care. Despite this, few medical schools provide structured, evidence-based tools for students to develop resiliency and recovery skills before clinical rotations begin.

Psilocybin-Assisted Therapy for Physician Well-Being and Burnout

Through an open-label study involving a small group of UCSD physicians experiencing burnout, the investigators will evaluate the feasibility, safety, and preliminary effectiveness of PAT to reduce burnout symptoms.

Non-Invasive Sleep Monitoring for Burnout and Retention Risk in Postgraduate Nurses

Newly graduated nurses often experience high levels of psychological stress, sleep disturbance, fatigue, and burnout during the early transition into clinical practice. Early identification of burnout and retention risk may help improve mental well-being, workforce stability, and quality of patient care. This longitudinal observational study aims to develop a non-invasive sleep-based prediction platform for assessing burnout and retention risk among postgraduate nurses. Participants will undergo repeated psychological assessments and non-contact sleep monitoring during the study period. Sleep-related physiological parameters, including sleep efficiency, sleep structure, heart rate variability, and respiratory variability, will be collected together with validated psychological questionnaires. The study will further apply machine learning and artificial intelligence approaches to integrate longitudinal physiological and psychological data for risk prediction and early identification of burnout-related conditions. The findings may support future development of precision mental health monitoring and supportive management strategies for high-stress healthcare workers.

Virtual Reality for Enhancing Self Compassion and Reducing Burnout Among Healthcare Providers

Healthcare providers in high-demand clinical settings are at high risk for burnout and secondary traumatic stress due to repeated exposure to patient trauma, which can compromise well-being and quality of care. Compassion-focused cognitive behavioral therapy (CF-CBT) can reduce stress and enhance self-compassion, but traditional delivery is time- and resource-intensive. This project evaluates the feasibility, acceptability, and potential effectiveness of virtual reality (VR)-enhanced CF-CBT specifically adapted for healthcare providers experiencing vicarious trauma. Grounded in Neff's self-compassion framework (emphasizing self-kindness, common humanity, and mindfulness) the VR intervention provides 8 immersive environments where participants can practice compassion-focused skills, engage in procedural learning, and regulate emotional responses in real time. The study will be conducted at UC San Diego Health using a two-arm randomized design comparing VR-enhanced CF-CBT with self-guided compassion-focused CBT/mindfulness exercises delivered without VR. Participants will complete 8 brief VR interventional sessions (approximately 6-10 minutes each) over 4-6 weeks. Outcomes include self-compassion, burnout, and secondary traumatic stress, measured using validated instruments. Feasibility and acceptability will be evaluated through recruitment, retention, session completion, engagement, and participant feedback. Findings will provide preliminary evidence for VR-enhanced compassion-focused interventions as a scalable and accessible approach to supporting healthcare providers' emotional well-being in demanding clinical environments, and will inform future cultural adaptation and implementation in low-resource and conflict-affected healthcare settings such as those in post-war zones.

A Study of a Mental Fitness Intervention for Anesthesiology Resident Wellbeing and Self-Compassion

The goal of this clinical trial is to learn if app-based wellness programs can help improve wellbeing and self-compassion for medical residents. This is a pilot study, which is done on a small group of people to learn if a larger study would be useful. The main questions it aims to answer are: 1. Are app-based wellness interventions feasible and acceptable in a high-stress population like medical residents? 2. Can app-based wellness programs improve wellbeing and self-compassion in medical residents? Researchers will compare the app-based wellness program to a time- and attention-matched control program. Participants will: * Complete online questionnaires at the start of the study and again after completion of the wellness program * Be assigned by chance (like a coin toss) to one of two different app-based programs, and will participate in the assigned program for 6 weeks. Both programs will involve weekly lessons and brief, daily exercises. Engagement with these exercises will not be mandatory but highly encouraged.

Effectiveness of an Interventional Intervention in Improving the Work Environment of Nurses and Nursing Assistants in the Hospital

The goal of this interventional study is to evaluate the effectiveness of a training course on a healthy work environment for nurses and nursing assistants in a hospital. The main questions it aims to answer are: * To evaluate the effectiveness of a training course on a healthy work environment * To know the perception of nursing and nursing assistants on what is needed to have a healthy work environment, what elements it should contain and whether it has changed after the course has been completed Participants in the intervention group will receive the training course and the control group will not. Researchers will compare intervention group with control group to see if the training course on healthy work environment is effective.

Work-related Challenges in Psychiatric-psychosomatic Clinics

The aim of this project is to evaluate the work-related challenges faced by healthcare professionals (nurses, psychologists, and doctors) in German psychiatric-psychosomatic clinics. By applying the Job Demands-Resources (JD-R) model, this study investigates how job demands and resources influence job satisfaction, turnover intention, and subjective service quality. Special focus is given to the roles of burnout, engagement, and psychological safety as mediators and moderators in these relationships. The project consists of two phases. In Phase 1, a cross-sectional online survey targeting healthcare professionals in psychiatric-psychosomatic clinics across Germany is conducted to identify key factors affecting well-being and performance in mental health settings. In Phase 2, a participatory co-design workshop with multiprofessional healthcare professionals is conducted to further explore work-related challenges, supportive factors, interprofessional collaboration, and possible practical support approaches for the clinical work environment. The findings will contribute to a better understanding of work-related experiences in psychiatric-psychosomatic care and support the development of feasible and practice-oriented approaches to improve working conditions and service quality.

XR2ESILIENCE - XR-Based Resilience Training for Stress and Mental Health in Healthcare Workers

This study investigates the effectiveness of an extended reality (XR) based resilience training program designed to support the mental health and well-being of nurses working in hospital settings. Nurses are exposed to high emotional, cognitive, and organizational demands and show elevated levels of work-related stress and stress-associated mental health problems. Strengthening resilience and coping capacities is therefore an important preventive approach to support nurses' well-being and sustain quality of care. The study is conducted as a pragmatic randomized controlled trial with a waitlist control group and includes approximately 232 nurses from hospitals in several European countries. Participants are randomly assigned either to an XR-based resilience training group or to a waitlist control group that continues with care as usual during the waiting period. The XR-based intervention consists of eight immersive training sessions delivered over approximately ten weeks using a head-mounted display. The training focuses on behavioral, cognitive, and emotional coping strategies and aims to enhance key resilience factors such as problem-solving, cognitive reappraisal, emotion regulation, and positive self-care. The primary outcome is perceived stress, assessed using the Perceived Stress Scale. Secondary outcomes include resilience, occupational self-efficacy, quality of life, psychological distress, burnout symptoms, coping strategies, work-related rumination, and turnover intentions. Assessments are conducted at baseline, post-intervention, and at a 20-week follow-up. In addition, a subgroup of participants will optionally provide physiological data during selected XR sessions to explore digital biomarkers related to stress and recovery. The findings of this study will provide evidence on the effectiveness, feasibility, and acceptance of XR-based resilience training for nurses and inform future implementation of digital mental health interventions in healthcare workplaces.

Mindfulness Training for First Responders

The present study evaluates the efficacy of Mindfulness-Based Attention Training on measures targeting cognitive abilities and emotional well-being in first responders.

The Effect of Student-Midwife Support Circle Intervention on Burnout, Resilience, and Professional Belonging Levels of Midwifery Students

Midwifery students are exposed to multifaceted stressors such as traumatic and unsupportive clinical experiences and psychosocial burdens; this can negatively impact emotional well-being, leading to secondary traumatic stress, burnout, compassion fatigue, and decreased sense of belonging. In this context, there is a growing need for structured and supportive interventions aimed at strengthening students' self-efficacy, resilience, and perceptions of social support. The aim of this research is to determine the effect of the Student Midwife Support Circle Intervention on midwifery students' levels of burnout, resilience, and professional belonging.

A Tool of the Future for Strengthening Compassion in a Danish Hospital Setting.

This study is a multi-phase, mixed-methods clinical investigation designed to examine the feasibility, validity, and organizational applicability of a structured measurement framework for assessing compassion in a Danish hospital setting. The study is conducted at Herlev and Gentofte Hospital and involves both patients and healthcare professionals across multiple clinical departments. The study is structured in three sequential phases, each addressing distinct methodological and implementation components. Phase 1 (Translation and Cultural Adaptation): The initial phase involves the linguistic translation and cultural adaptation of three versions of the Sinclair Compassion Questionnaire (SCQ) and associated healthcare professional measures. This process follows established international guidelines for cross-cultural validation, including forward translation, back-translation, expert panel review, and pilot testing. Cognitive interviewing techniques are used to evaluate comprehension, relevance, and cultural appropriateness among both patients and healthcare professionals. Particular attention is given to semantic equivalence and the contextual meaning of key constructs across languages and professional groups. Phase 1b (Psychometric Validation): Following adaptation, the instruments are administered to a patient sample recruited from departments of anesthesia, surgery, and intensive care. Data collected in this phase are used to assess the psychometric properties of the translated instruments, including internal consistency, construct validity, factor structure, and measurement invariance. Statistical analyses include confirmatory factor analysis and reliability testing. The aim of this phase is to ensure that the instruments demonstrate robust measurement properties within the Danish healthcare context. Phase 2 (Observational Implementation Study): In the second phase, the validated instruments are implemented across four hospital departments, including medical, nephrology, orthopedic surgery, and emergency care. Data are collected from both patients and healthcare professionals to allow for multi-perspective analysis. In addition to questionnaire data, contextual variables such as demographic characteristics, professional background, and organizational factors are recorded. Administrative data, including sick leave and workforce indicators, are incorporated where available. This phase employs a cross-sectional observational design with embedded comparative analyses across departments and professional groups. Multilevel modeling approaches are used to account for clustering within departments and to explore variation at individual and organizational levels. The design enables identification of patterns and differences across settings without introducing experimental manipulation. Phase 3 (Contextualized Implementation and Development): The third phase involves the application of findings from earlier phases to inform targeted implementation strategies. Rather than introducing a predefined intervention, this phase adopts an adaptive approach in which context-specific initiatives are selected or developed based on identified needs. This may include integration of existing training programs, workflow adjustments, or development of new tools. The implementation process is supported by interdisciplinary collaboration, including expertise in clinical practice, education, and organizational development. Data Collection and Management: Data are collected using secure electronic platforms compliant with Danish data protection regulations. All participant data are handled in accordance with GDPR requirements. Identifiable data are stored separately from research data, and access is restricted to authorized personnel. Data quality assurance procedures include validation checks and standardized data entry protocols. Participant Involvement: Patients are recruited during their contact with hospital departments and provide self-reported data through questionnaires. Healthcare professionals participate by completing self-assessment measures. Participation is voluntary, and no experimental interventions are administered. Statistical Considerations: The study uses both descriptive and inferential statistical methods. Psychometric analyses are conducted in Phase 1b, while Phase 2 includes regression analyses and multilevel modeling to examine associations between variables. Missing data are handled using appropriate statistical techniques, such as multiple imputation where relevant. Ethical Considerations: The study adheres to ethical guidelines for clinical research involving human participants. Informed consent is obtained from all participants. Participation does not influence clinical care or employment conditions. The study design minimizes participant burden by integrating data collection into existing clinical workflows where possible.

Burnout, Secondary Traumatic Stress and Inflammatory Biomarkers in ICU Healthcare Workers

Healthcare professionals working in intensive care units (ICUs) are frequently exposed to high levels of psychological stress due to critically ill patients, frequent encounters with death, complex clinical decision-making, and prolonged working hours. This environment increases the risk of burnout and secondary traumatic stress, which may not only affect mental well-being but also have measurable physiological consequences. Emerging evidence suggests that chronic psychological stress and burnout may influence immune function through activation of proinflammatory pathways. Elevated levels of inflammatory biomarkers such as C-reactive protein (CRP), interleukin-6 (IL-6), tumor necrosis factor-alpha (TNF-α), and neutrophil-to-lymphocyte ratio (NLR) have been associated with stress-related conditions. However, data examining the relationship between burnout, secondary traumatic stress, and inflammatory biomarkers in intensive care healthcare workers remain limited. This cross-sectional observational study aims to investigate the association between burnout and secondary traumatic stress levels, assessed using validated psychometric instruments (Maslach Burnout Inventory and Professional Quality of Life Scale), and inflammatory biomarkers (CRP, IL-6, TNF-α, and NLR) in ICU healthcare workers. Blood samples will be obtained in conjunction with routine annual health screening, and additional serum samples will be collected for biomarker analysis. The study seeks to clarify the psychoneuroimmunological mechanisms underlying occupational stress in critical care settings.

The WISER Study: Web Based Methods for Enhancing Resilience

This is a research study to find out if web-based resilience tools can increase well-being. Enrolled participants will try out one or more brief positive psychology tools. The tools ask participants to reflect on positive experiences or to do an activity (e.g., write a letter of gratitude). The study is entirely online and participants will be prompted to participate via email or text messages. The study team is interested in the effects of the tools on stress, depression, and burnout in adults. A set of brief surveys are administered before and after using the tool, and again at follow-up periods (e.g., 1, 3, 6 and 12 months). Surveys are collected electronically using the secure, HIPAA-compliant survey software. There is no direct benefit to participants for participating in this research study aside from the potential to experience improvements in well-being. Risks are minimal and include the potential to feel emotional or psychological distress when asked questions related to burnout.

Empowerment Training for Personal Agency Development of Primary Health Care Workers

This study evaluates an Empowerment Agency Training (EAT) intervention within the SPHERES programme that aims to strengthen personal agency among workers in primary healthcare centers (Puskesmas) in Indonesia. The intervention focuses on building self-efficacy, behavioural control, leadership, and intentional decision-making through structured training, follow-up action planning, observational support, and sustainability-oriented incentives. Strengthening personal agency is expected to improve the use of data for decision-making and the delivery of priority primary health services at the Puskesmas level.

PATH (Peer Advanced Training in Harm Reduction) to Reducing Burnout Among Peers Who Deliver Harm Reduction Services (R61 Phase Pilot)

The investigators propose to develop and test the effectiveness of PATH (Peer Advanced Training in Harm reduction) as an educational workforce intervention for improving peer recovery support specialists' (PRSS) harm reduction (HR) service delivery ability and quality and as a PRSS workforce and service system support. The PATH intervention combines (a) virtual education and (b) case-based consultation. The investigators hypothesize that PATH will improve organizational-level PRSS burnout, additional workforce outcomes, and HR service quality.

Professional Readiness Through Emotional Preparedness (PREP)

The purpose of this study is to examine the impact of the PREP program on participants' psychological and occupational well-being, and work readiness

On-Demand AI Support Via LINE-Based GPT Assistant to Improve Emotional Resilience and Reduce Burnout Among Clinical Nurses

Clinical nurses are frequently exposed to high emotional demands due to heavy workloads, time pressure, patient suffering, and the interpersonal complexity of clinical care. These stressors may contribute to compassion fatigue, burnout, reduced resilience, and decreased occupational well-being. However, timely and accessible psychological support is often limited in busy clinical environments, and many nurses may hesitate to seek help due to stigma, time constraints, or limited resources. This study is a prospective, randomized, controlled, parallel-group interventional trial designed to evaluate the feasibility and effectiveness of an on-demand, human-centered emotional support intervention delivered through a LINE-based GPT assistant. The AI assistant provides real-time supportive conversations, reflective prompts, stress-coping guidance, and resilience-enhancing strategies tailored specifically for clinical nurses, offering a private and easily accessible support resource. Eligible clinical nurses (target sample size: 100-120) are randomly assigned to either an Intervention Group, which interacts with the AI assistant, or a Control Group, which receives non-interactive static messages, over a four-week intervention period. Primary outcomes include changes in compassion fatigue, burnout, and compassion satisfaction, as measured by the Professional Quality of Life Scale (ProQOL). Secondary outcomes include changes in resilience (Brief Resilience Scale), general self-efficacy (General Self-Efficacy Scale), and perceived stress (Perceived Stress Scale-10). The results of this study are expected to provide evidence on the feasibility and potential effectiveness of AI-based emotional support as a scalable and accessible tool to promote psychological well-being among clinical nurses, thereby informing future digital mental health interventions in healthcare settings.

Leadership ThriveCircles

This study aims to strengthen leadership competencies among CU SOM faculty who have at least five direct reports by promoting meaningful behavior change in leadership practices and fostering a culture of peer support, to advance employee well-being and help reduce burnout among healthcare professionals. 125 leaders will take part in a six-month leadership development program consisting of 6 self-paced learning focus areas and 6 in-person sessions with peers to discuss. The investigators will evaluate the program's implementation process and its effectiveness in achieving desired outcomes.

tDCS for Stress and Burnout in Higher Education

The goal of this clinical trial is to evaluate if transcranial direct current stimulation (tDCS) works to reduce occupational stress and burnout in university professors. The main questions it aims to answer are: Does tDCS reduce levels of occupational stress in university professors? Does tDCS reduce burnout levels in university professors? Researchers will compare active tDCS to a sham stimulation (a look-alike procedure that contains no active stimulation) and a control group to see if tDCS effectively reduces stress and burnout. Participants will: * Complete questionnaires assessing stress and burnout levels before the intervention * Complete follow-up assessments immediately after the intervention and 5 weeks later During intervention, participans of active tDCS and Sham gruops will: * Receive 10 sessions of tDCS over 4 weeks (excluding weekends), 20 minutes each

A Pilot Study of RISE for Nurse Managers Retreat

The purpose of this study is to determine the feasibility and acceptability of the RISE for Nurse Managers retreat and its impact on occupational and psychological well-being indicators

Heart Rate Variability Biofeedback in Security Forces

This exploratory study evaluates the effectiveness of a 12-session Heart Rate Variability Biofeedback (HRV-BFB) protocol in reducing distress and burnout while promoting psychological well-being among Portuguese National Republican Guard (GNR) professionals. Exposed to high occupational stress from unpredictable risks, shift work, and limited resources, these individuals face elevated vulnerability to chronic stress outcomes. The intervention leverages real-time HRV feedback to enhance autonomic regulation, breathing techniques, and emotional self-regulation.

Online Parenting Support With VIPP-SD in Chile

The goal of this randomized controlled trial is to test whether the online Video-feedback Intervention to Promote Positive Parenting and Sensitive Discipline (VIPP-SD) can reduce parental burnout and improve parenting practices, in mothers of young children in Chile. The main questions it aims to answer are: * Does the online VIPP-SD increase maternal sensitivity and the use of consistent but gentle limit setting? * Does it reduce parental burnout? * Does it improve parental stress and child attachment security and reduce child conduct problems? Researchers will compare families who receive the online VIPP-SD to families in a waitlist control group with dummy treatment to see if VIPP-SD has benefits for parents and children. Participants will be mothers of children aged 11-16 months at the start of the study who report elevated levels of parental burnout. Mothers in the intervention group will: * Take part in 12 weekly online sessions with a trained intervener * Receive video-feedback on their own interactions with their child * Learn strategies to respond sensitively to their child's needs and to use positive discipline The study will also measure potential moderators such as maternal mental health, child temperament, and family sociodemographic factors.