Clinical Research Directory

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.

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.

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.

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.

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.

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.

Commensality Groups: A Professional Fulfillment Intervention for Medical Students in Their Clinical Years

Medical students are at high risk for burnout, depression, anxiety, suicidal ideation and substance use disorder with burnout seen as a mitigating factor for suicidal ideation. Help-seeking among medical students suffering from burnout is only 30%. The highest rates of burnout among medical students is at the end of their clinical rotations, with estimates of up to 60%. "Commensality groups" have been found to significantly reduce burnout and improve meaning in work by creating opportunity for connection and collegiality among physicians. These groups consist of providing a reimbursed monthly meal with structured questions that generate conversation for the first 15 minutes with 6-8 participants meeting monthly, for six months. Physician participants in Commensality groups maintain these gains one year later. The investigators propose to apply the model of Commensality groups to medical students who are launching into their experience clinical practice, and have been on clinical rotations for at least 4 months. The investigators will form randomly assigned groups of 6-8 medical students with 1 resident leader. The resident leader role has been added to encourage compliance with the standardized discussion questions and to avoid the potential negative impact of a "venting" session. The overall intention of this study is to explore whether Commensality groups can increase well-being for medical students in their clerkship years, as it has previously been shown to do for residents and physicians.

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.

Strengthening Health Literacy in Healthcare Workers Through Mind Body Medicine and Nutrition

This is a randomized controlled trial aiming to develop and evaluate a workplace health program to improve stress resilience and mental well-being among healthcare workers at University Medicine Essen using a participatory research design (including a steering committee composed of hospital staff, needs assessment through focus groups, and pilot testing). The intervention combines mind-body medicine techniques, complementary medicine self-care strategies, and psycho-biotic nutrition. If successful, the program will be integrated into routine workplace health management and serve as a model for other healthcare institutions.

Prevalence of Psychiatric Problems Among Patients and Healthcare Providers in a Cardiology Department: A Cross-Sectional Study

The goal of this observational cross-sectional study is to determine the prevalence of psychiatric problems (depression, anxiety, stress, and burnout) among patients with cardiovascular diseases and healthcare providers working in the Department of Cardiovascular Medicine at Assiut University Heart Hospital. The main questions it aims to answer are: * What is the prevalence of depression, anxiety, and stress among cardiovascular patients? * What is the prevalence of burnout, depression, and anxiety among healthcare providers in the same department? The study will also explore potential sociodemographic, occupational, and clinical factors associated with these psychological outcomes.

Comparing ACT, Recuperation, and ACT Plus Vocational Support for Clinical Burnout

This study compares three different online psychological treatments for people with clinical burnout (stress-related exhaustion) who are on sick leave or have major difficulties coping at work or in daily life. Many patients with burnout receive broad, recuperation-focused interventions (rest, stress reduction, lifestyle changes), but there is still no clearly evidence-based treatment or agreed clinical model. It is also known that returning to work can be difficult, and there is a need for more structured support. In this trial, 210 adults in Sweden with clinical burnout will be randomly assigned to one of three 10-week, internet-based treatments: Online Acceptance and Commitment Therapy (ACT) A structured, values-based CBT approach that focuses on helping participants clarify what matters to them, relate differently to difficult thoughts and feelings, and gradually re-engage in meaningful activities despite exhaustion. Online Recuperation-focused treatment An active comparison condition that emphasizes rest, recuperation, and healthy daily routines. It provides psychoeducation and practical tools for sleep, relaxation, physical activity, pacing, and balance in everyday life, but does not include ACT-specific methods such as exposure or values work. Online ACT plus Vocational Support The same ACT program as in group 1, together with three additional sessions with a licensed psychologist focused on work. These sessions help the participant identify work-related barriers, plan a gradual return-to-work (RTW), and formulate a written RTW plan that can be shared with the employer and treating physician. All three treatments are delivered via a secure digital platform. Participants work through weekly online modules, receive written feedback from a therapist, and have three video sessions during the 10-week period. Clinical psychology students in their final semester deliver the ACT and recuperation treatments, and licensed psychologists deliver the ACT + vocational support condition. The study has two primary aims: 1. to test whether online ACT reduces self-rated burnout symptoms more than the recuperation-focused treatment at the end of treatment, and 2. to test whether adding structured vocational support to ACT reduces the total number of registered sick-leave days in the year after treatment, compared with ACT alone. Key secondary outcomes include perceived stress, depression, anxiety, insomnia, everyday memory problems, quality of life, functional impairment, treatment response and remission, treatment credibility and satisfaction, and cost-effectiveness. Outcomes are measured before treatment, weekly during treatment (for selected measures), immediately after treatment, and at 6- and 12-month follow-ups. Sick-leave data are obtained from the Swedish Social Insurance Agency. To be eligible, participants must be 18 years or older, have symptoms consistent with clinical burnout (including pronounced fatigue and reduced stress tolerance after prolonged psychosocial stress), be on at least 25% sick leave or have marked functional impairment due to these symptoms, have a stable occupation or study situation, and be able to read and write Swedish. People with very long sick leave (more than two years), severe psychiatric conditions (such as severe depression, bipolar disorder, untreated PTSD, or psychosis), current substance abuse, or active suicidal ideation will not be included. Potential risks include temporary increases in distress, fatigue, or symptom awareness when working with emotions, behavior change, or work-related issues. Participants are monitored closely through weekly questionnaires and therapist contact. If risk for self-harm or serious deterioration is detected, a licensed psychologist will perform a risk assessment and, if needed, refer the participant to appropriate health care. The hope is that this study will identify effective, scalable, and theory-based online treatments for clinical burnout and clarify whether adding structured vocational support improves long-term work outcomes.

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 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 novel, WHO-developed ASCEND intervention is effective in enhancing supervisors' confidence, responsiveness, mental health literacy, and SelfCare 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 in the context of Dutch SMEs. 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.

Investigating the Effects of a Dyad Intervention on Teacher Resilience, Mental Health, and Social Emotions and Behavior

The COVID-19 pandemic increased psychological burdens in Germany, especially among teachers who have reported higher levels of emotional exhaustion and burnout compared to the general population. Even before the pandemic, teachers found their work highly stressful. Mindfulness- and compassion-based interventions, as well as socio-emotional learning interventions, show promise in combating burnout among educators. Despite increased research, partner-based Dyads have not been explored in schools. Recent studies suggest these social practice formats are more effective than solo mindfulness techniques in reducing loneliness, and social stress, and enhancing social connections and resilience. Additionally, the impact of these interventions on student, classroom, collegium, and system levels remains under-researched. This study extends the CovSocial project and the ReSource project, which showed the effectiveness of partner-based dyadic mental training on stress reduction, resilience, and social cohesion. The first goal is to test a 10-week online empathy-compassion (EmCo) Dyad training program, inspired by the Affect Dyad from the ReSource project and the online coaching Dyad from the CovSocial project, incorporating empathic and compassionate listening. The second goal is to evaluate the Dyad intervention's effects in an educational context, focusing on teachers' mental health, social capacities, social networks, and classroom climate, measured across: 1) mental health and resilience, 2) social emotions, 3) social interaction, 4) communication and listening skills, and 5) classroom climate. The third aim is to develop and validate the Teacher Autonomic Voice Assessment (TAVA) and the Egocentric Social Network Analysis Paradigm (e-SNAP), using autonomic measures and voice recordings to assess teachers' emotional states. The final aim is to investigate the cognitive and affective mechanisms driving changes in teachers' mental health, resilience, and social-emotional competencies.

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.