Clinical Research Directory

Burnout and Well-Being in Healthcare Workers Participating in Workplace Yoga

This study aims to evaluate changes in burnout, perceived stress, coping strategies, anxiety, depression, and psychological well-being among healthcare workers participating in a workplace yoga program. Healthcare professionals are frequently exposed to high emotional demands, workload pressure, irregular shifts, and substantial clinical responsibilities, which may increase the risk of work-related stress and burnout. Workplace-based mind-body activities, including yoga, may support emotional regulation, physical recovery, stress management, and professional well-being. Using a prospective pre-post observational design, participants will undergo a multidimensional psychological assessment before starting the workplace yoga program and after completing the 10-week program. The evaluation will include measures of burnout, coping strategies, depressive symptoms, anxiety, and satisfaction with the program. The findings are expected to improve understanding of the potential association between participation in workplace yoga activities and changes in psychological and occupational well-being among healthcare workers. The results may also provide useful information for the development of organizational initiatives aimed at promoting employee well-being and preventing burnout in healthcare settings.

AI Ambient Scribe in Psychiatry

The goal of this clinical trial is to learn if an artificial intelligence (AI) tool that listens to appointments and drafts clinical notes can help clinicians in psychiatric care. Researchers also want to know if the tool changes how patients experience their care. The study includes mental health care providers (physicians, psychologists/psychotherapists, nurses, and social workers) at Psychiatrie St. Gallen and the adult patients they see in their appointments. The main questions it aims to answer are: * Does the AI tool lower the time clinicians spend writing notes? * Are notes written with the AI tool as good as or better than notes written without it? * Do patients notice a difference in their relationship with their clinician when the tool is used? Researchers will compare clinicians who use the AI tool to clinicians who keep writing notes their usual way, before and during the intervention period, to see if writing time, note quality, and the patient-rated therapeutic relationship differ between the two groups. Clinicians will: Join one of two groups. One group starts using the AI tool on August 14, 2026. The other group keeps writing notes the usual way. Both groups will be observed until the end of November 2026, with note quality evaluation completed in December 2026. Clinicians who cannot contribute to all measurements may, with their consent, remain in the study for automated measurement of documentation time only. Patients will: * Be invited to fill out a short, anonymous survey about their experience with their clinician. * Be asked to agree, in writing, that researchers may review the report from their initial assessment appointment.

Evidence-Based Quality Improvement to Reduce VA Primary Care Burnout

Burnout is highly prevalent among VA primary care providers and staff, impairing productivity and retention, as well as safety, quality, and patient experience. In this pilot trial, the investigators will facilitate the development of burnout reduction interventions using an evidence-based quality improvement (EBQI) approach, and then evaluate the feasibility, acceptability and effectiveness of a pilot EBQI-facilitated burnout reduction intervention in a modified stepped wedge design in one VA region.

Khanya Ekhaya: A Home-Based Intervention

Mental health conditions, such as depression, anxiety, and harmful alcohol use are prevalent among people with chronic diseases, including HIV, and contribute to poor engagement in care. There is a need to address untreated mental health problems. Community health workers (CHWs) are frontline workers who play a central role in supporting vulnerable individuals to stay in care, including seeking people living with HIV who are newly initiating antiretroviral therapy (ART) or re-initiating after a period of care disengagement. CHW-delivered interventions are promising for improving engagement and retention in care. Yet, these programs rarely address mental health -a significant barrier to chronic disease care engagement and treatment. An approach that moves beyond providing care in the clinic setting is needed. Community-delivered mental health care shows promise for integration into broader community health care services for people with chronic conditions, such as HIV. However, as CHWs are taking on more mental health care roles and community-based work, our team's preliminary research has demonstrated that high levels of stress and burnout are important considerations for successful implementation of these models.

Mindfulness-based Relapse Prevention for Peer Workers

Adapt and test the effectiveness of MBRP for substance use peer workers compared to a standard of care (referral to 12-step) control condition on substance use, relapse risk, and burnout among peers in a pilot hybrid type 1 trial. The goal of this clinical trial is to learn if Mindfulness-Based Relapse Prevention can reduce substance use, relapse risk, and burnout among substance use peer workers. The objectives are to: 1. Identify the causes, consequences, and risk and protective factors for relapse among peer workers; 2. Identify peers' preferences related to MBRP content, structure, and delivery; 3. Adapt the MBRP intervention for peer workers; and 4. Assess the preliminary effectiveness and implementation outcomes of the adapted MBRP intervention. Researchers will compare MBRP to referral to 12-step (standard of care) to see if MRBP works to reduce substance use, relapse risk, and burnout. Participants will asked to: * Participate in MBRP (8 weekly 2-hour virtual sessions) * Complete 4 surveys assessing well-being outcomes * Participate in 1 virtual interview about your experience

Coping Psychoeducation for Family Caregivers of Palliative Care Patients

This quasi-experimental study aims to evaluate the effectiveness of a six-week, nurse-led structured coping psychoeducation program for family caregivers of patients receiving palliative care. The study will examine the effects of the intervention on caregiver burden, coping strategies, and burnout using pre- and post-intervention assessments.

Emergency Medicine Practitioners Overall Well-being Enhancement With Ambient AI Scribes

The primary objective of the study is to investigate the impact of an ambient AI scribe on clinicians' wellness and well-being outcomes; additionally, the investigators will also explore how the use of the ambient AI scribe will lead to changes in documentation burden, clinical note characteristics and financial productivity.

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.

Buckeye Pause Bundle

Mind-body resilience is particularly important in workplaces where there are frequent exposures to primary or secondary emotional and/or physical trauma. A 2020 report from the U.S. Bureau of Labor Statistics highlighted health workers as among the largest service industries in the state of Ohio with the most amount of missed work days due to injury or illness. The purpose of this study is to develop and establish proof-of-concept of the "Buckeye Pause Bundle," a proactive workplace facilitation of mind-body resilience protective and recovery activities that includes an evidence-based mindfulness-based intervention, a wearable health device that offers user prompts and reminders based on physiological data, and worksite respite pods to support brief mindfulness practices during the workday. The target market segment for this proof-of-concept testing is healthcare providers working in acute care hospital settings. It is anticipated that end prototypes and deliverables will be very transferable to other high-stress work environments.

Implementation of the ASCEND Training for Supervisors in Dutch Small and Medium-sized Enterprises (SMEs)

This cluster randomized controlled trial (cRCT) aims to evaluate the effectiveness of the Dutch adaptation of an in-person group intervention for workplace supervisors - Advancing Supervisors' Capacity for Mental Health at Work (ASCEND) - in Dutch Small and Medium-sized Enterprises (SMEs). The ASCEND intervention is designed to equip supervisors with the skills to: i) know when to support their workers; ii) how to direct workers to support, and iii) advocate for action on mental health at work. The primary objectives of this project are to: * Assess to what extent the Dutch adaptation of the WHO-developed ASCEND intervention is effective in enhancing supervisors' confidence, responsiveness, mental health literacy, and self-care practices, and in reducing supervisor stigma towards mental health conditions within Dutch SMEs. * Evaluate the impact of the ASCEND intervention on employee outcomes, including mental health and work-related outcomes among supervisees (i.e., subordinates), as well as overall organizational absenteeism rates. * Identify barriers, facilitators, and key implementation and adoption indicators to support future opportunities for scaling up the ASCEND intervention. Researchers will compare two groups to evaluate the effectiveness of the ASCEND intervention. One group will receive the training (the intervention group), while the other group will receive the training after the final follow-up period (the control group). Data will be collected from both supervisors and their supervisees (i.e., subordinates) via online questionnaires at various time points. In addition, general organizational information, including absenteeism rates, will be gathered through a representative from each participating organization. To further explore the feasibility of scaling up the ASCEND intervention within the Netherlands, qualitative data will be collected through interviews and/or focus group discussions.

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.

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.

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.