Clinical Research Directory

Prevention of Burnout in Spanish Healthcare Professionals Through Attachment-Based Compassion Therapy (ABCT)

Burnout is a common problem among healthcare professionals and may affect their psychological well-being, quality of life, and professional functioning. This study will examine whether an intensive compassion-based intervention can help reduce burnout and improve well-being in healthcare professionals. Participants will be randomly assigned to either an Attachment-Based Compassion Therapy intervention or a relaxation intervention. Outcomes will be measured before the intervention, immediately after the intervention, and three months later. Attachment-Based Compassion groups will be composed of 80 participants each, and TAU group will be composed of 80 participants (total sample n = 160). Burnout Inventory-Human Services Survey - MBI-HSS. Burnout will be assessed using the Maslach Burnout Inventory-Human Services Survey. This questionnaire evaluates the three main dimensions of burnout: emotional exhaustion, depersonalization, and personal accomplishment. Items are rated on a Likert-type scale according to the frequency with which the participant experiences each symptom. Scores are calculated separately for each burnout dimension. In this study, emotional exhaustion and depersonalization will be considered the primary outcome variables, while reduced personal accomplishment will be considered a secondary outcome variable

NeuroFinance Human Stress Trial During Financial and Informational Volatility

The NeuroFinance Human Stress Trial (NFHST-2026-001) is a decentralized observational clinical study designed to evaluate how financial market volatility, economic uncertainty, digital media exposure, and information-driven stress environments affect human physiologic and behavioral health. Participants will undergo remote monitoring using wearable biosensors, cardiovascular telemetry devices, sleep tracking systems, heart rate variability monitoring, and behavioral analytics platforms. The study will use artificial intelligence and machine learning systems to analyze relationships between external financial and informational events and biologic stress responses, including autonomic nervous system activity, sleep disruption, cardiovascular strain, emotional resilience, and inflammatory signaling. The goal of the study is to develop predictive digital biomarkers and AI-assisted forecasting systems capable of identifying stress-related physiologic deterioration before clinical manifestation.

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.

Health and Work Ability Following Inpatient Treatment for Stress-related Disorders - Follow-up Study of the HARMODI Cohort

When treating stress-related conditions, it is important to understand how health and work ability develop over the long term. In our research project, we aim, firstly, to investigate how health and work ability develop over the three years following inpatient treatment, and, secondly, to identify the factors that influence a return to work and work ability. Former inpatients undergoing treatment for stress-related disorders who took part in the HARMODI-study will be invited to complete online questionnaires up to three years after their discharge from the clinic. The online questionnaires contain questions regarding current work ability, mental and physical health as well as the process of return to work after discharge.

The COMET Study: a Prospective COhort of MEdical residenTs to Assess Professional, Personal and Psychological Trajectories of Residents in General Internal Medicine

Introduction. Switzerland, like most Western countries, faces a paradox: an ageing, multimorbid population needs general internal medicine (GIM) physicians more than ever, yet fewer young doctors choose - and stay in - the specialty. Career decisions during residency are intertwined with well-being, mental and physical health, and work-life balance, and distress in training has been associated with depression, burnout, attrition and poorer patient care. Longitudinal data following GIM residents across these domains, and linking them to actual career trajectories, are lacking. The COMET study establishes a multicentre prospective cohort of GIM residents to fill this gap. Methods and analysis. COMET is a prospective, open, multicentre cohort conducted in the departments of (general) internal medicine of Fribourg Hospital (HFR, four sites), Bern University Hospital (Inselspital) and Lausanne University Hospital (CHUV). All GIM residents providing direct patient care are eligible (≈334 residents; expected enrolment ≥267, assuming 80% participation). Participants complete an annual online survey (REDCap; French or German) at baseline and for at least four years, covering sociodemographics; job characteristics; career intentions and 24 factors for or against a GIM career; well-being (Physician Well-Being Index, Professional Fulfillment Index, quality of life, work-life balance); mental health (CES-D, Perceived Stress Scale, Maslach Burnout Inventory, Questionnaire of Cognitive and Affective Empathy); and physical health (step counts, physical activity, fatigue, sleep, healthcare utilisation). Primary endpoints are the longitudinal course of well-being and distress (PWBI, PFI, CES-D) and residents' career trajectory. Analyses combine descriptive statistics, mixed-effects and regression models, and comparisons with the population-based CoLaus\|PsyCoLaus cohort.

Efficacy of a Gamified Blended Mindfulness Program to Reduce Burnout, Stress, and Anxiety in Nursing Students: A Randomized Controlled Trial

The primary purpose of this randomized controlled trial is to evaluate the efficacy of a 12-week gamified blended mindfulness intervention in reducing academic burnout, perceived stress, and anxiety among first-year nursing students. Nursing students frequently face high academic and clinical demands that deplete their psychological resources, leading to high levels of stress and emotional exhaustion during their training. While mindfulness interventions can mitigate these negative effects, adherence to standard digital programs often remains a challenge. To address this, the study investigates the impact of incorporating gamification elements into a mindfulness program. Participants are randomly assigned to one of three groups: a minimal-treatment control group, a standard blended mindfulness group, or a gamified blended mindfulness group. The intervention spans 12 weeks and consists of 24 guided meditation sessions (16 online and 8 in-person). The central hypothesis is that the gamified architecture will act as a behavioral reinforcement mechanism, improving student adherence to the program. Consequently, researchers hypothesize that participants in the gamified group will exhibit significantly lower post-intervention levels of emotional exhaustion, perceived stress, and anxiety compared to those in both the standard mindfulness intervention and the control group.

Evaluating the Impact of Mindfulness Based Physical Therapy on Burnout Syndrome Among University Students.

The goal of this clinical trial is to evaluate whether a mindfulness-based physical therapy intervention can reduce burnout syndrome and improve musculoskeletal pain and quality of life among undergraduate Allied Health Sciences students aged 18-30 years who are experiencing burnout symptoms, musculoskeletal pain, and reduced quality of life. The main questions it aims to answer are: * Does a structured Mindfulness-Based Physical Therapy (MBPT) program reduce burnout symptoms compared to standard physical therapy alone? * Does MBPT improve musculoskeletal pain and quality of life compared to standard physical therapy alone? Researchers will compare a Mindfulness-Based Physical Therapy intervention group to a control group receiving a standardized physical therapy program to determine whether the addition of mindfulness techniques results in greater improvements in burnout, pain, and quality of life. Participants will: * Be randomly assigned to either the intervention or control group. * Attend supervised 60-minute sessions three times per week for six weeks (total of 18 sessions). * Receive a standardized baseline physical therapy program consisting of full-body active range of motion and general mobility exercises within pain-free limits. * If assigned to the intervention group, receive structured mindfulness meditation, breathing exercises, posture correction, stretching, progressive muscle relaxation, and group reflection during each session. * Complete 10-15 minutes of daily home mindfulness practice (intervention group only). * Complete validated questionnaires at baseline and immediately after the 6-week intervention.

Self-Care Program and Burnout Prevention in First-Year Medical Oncology Residents (Mixed-Methods Quasi-Experimental Study)

Burnout is highly prevalent among oncology clinicians, including residents in training. This prospective, mixed-methods, quasi-experimental study will evaluate how burnout changes over 12 months during the first year of medical oncology residency and explore which work-related, professional identity, and program support factors influence this variation. Residents will participate in a structured self-care and burnout prevention program with multiple modules (e.g., yoga, mindfulness, art therapy, music therapy, Balint groups, workshops, mentorship). Quantitative burnout outcomes will be measured using the Maslach Burnout Inventory (MBI-HSS), and qualitative insights will be collected through individual semi-structured interviews. The study will also describe sociodemographic characteristics, baseline burnout prevalence, participation/adherence, satisfaction, and implementation barriers/facilitators.

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

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.

Burnout Syndrome in the Intensive Care Unit Before and During a Palliative Care Trial

One hundred ICU doctors, nurses and psychologists from the 28 units participating in the EPIC stepped-wedge trial (ClinicalTrials.gov NCT06605079) will each complete the same four-part survey twice-once during their unit's usual-care phase and again during the EPIC tele-palliative-care intervention. The questionnaire begins with Part A, gathering demographic and professional details such as age, gender, family status, education, role, years of ICU service, shift patterns, leave days and any prior palliative-care or ethics training. Part B then probes 22 workplace stressors and ethical dilemmas-resource constraints, family pressures, moral conflicts, emotional distancing from colleagues, perceived control over decisions and work-life balance-using a five-point frequency scale. Part C merges a 19-item Maslach Burnout Inventory subset (emotional exhaustion, depersonalization, personal accomplishment) on a seven-point frequency scale with a 16-item Oldenburg Burnout Inventory subset (exhaustion, disengagement) on a four-point agreement scale. Finally, Part D employs Neff's 16-item Self-Compassion Scale-rated from almost never to almost always-to assess self-kindness, common humanity, mindfulness, self-judgment, isolation and over-identification. Within-subject, repeated-measures analyses of total and subscale scores will quantify how EPIC's blended-learning curriculum and standardized teleconsultations shift clinician burnout profiles and self-compassion over time.

Continuous Heart Rate Variability Monitoring in Doctors; Understanding Patterns of Stress and Recovery and Their Relationship With Self-reported Resilience, Burnout and Wellbeing.

Burnout is an increasing concern in the medical professions. This study aims to utilise established, validated self-report measures combined with continuous heart rate variability measurements to better understand the stress and recovery patterns experienced by doctors that may contribute to burnout. This mixed methods study design will consist of an ecological momentary assessment phase where participants will complete commonly used and validated real-time subjective measures while concurrently wearing a heart rate variability monitor to provide an objective measure of stress. Following on from this, participants of interest will be invited to participate in semi structured interviews to further explore their experiences of stress and recovery.

Effects of Cannabidiol on Burnout Syndrome and Empathy of Caregivers of Older Adults

Burnout syndrome is an occupational disease that has affected health care providers, for example, caregivers of older adults. This syndrome negatively affects physical and psychological health, which may reflect on the mental health of the caregiver and the care provided to the older adults. Interventions have been developed to minimize the impacts of burnout. Thus, this study has two main objectives: 1) to identify the effect of cannabidiol on indicators of burnout and empathy of caregivers of older people with functional dependence for activities of daily living; 2) identify possible associations between burnout indicators, empathy levels and their domains, and quality of care. This is a two-phase study (i.e., Phase 1: cross-sectional; Phase 2: clinical trial). In Phase 1, caregivers will answer questionnaires developed by researchers for sociodemographic characterization, care and satisfaction of care. In addition, they will complete instruments to assess the functional dependence of the older people - EIAVD, depressive symptoms - PHQ-9, social support - EAS, Burnout syndrome - MBI and Empathy - EMRI and MET. In Phase 2, caregivers will be randomized to cannabidiol or placebo intervention. Caregivers with number 0 will be allocated to the intervention using cannabidiol (300mg - divided into two times a day) and those drawn with number 1 will be allocated to the placebo group. Both interventions will be performed for four weeks. Caregivers will fill in the MBI, EMRI, MET, NPI and QAO instruments before and after the intervention. UKU-SERS will also be applied to evaluate side effects, IECC to assess the impact of intervention on care and CGI to assess severity and response to treatment.