Clinical Research Directory

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.

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 17, 2026 (7 clinicians whose devices were delivered late start on November 9, 2026). The other group keeps writing notes the usual way. Both groups will be observed until the end of November 2026 (the 7 late-starting clinicians and additional control data collection until February 22, 2027), with note quality evaluation in February and March 2027. 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.

PATH to Reducing Burnout Among Peers Who Deliver Overdose Prevention Services (R33 Phase Clinical Trial)

The investigators propose to test the effectiveness of PATH (Peer Advanced Training for total Health) as an educational workforce intervention for improving peer recovery support specialists' (PRSS) overdose prevention (OP) 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 OP service quality.

The Effect of Exercise and Ergonomics Training Program on Musculoskeletal Disorders in Teachers

This randomized controlled trial tested whether adding a 12-week structured exercise program to ergonomics training improves low back and neck disability, burnout, musculoskeletal symptoms, and pain intensity in schoolteachers with musculoskeletal pain, compared with ergonomics training alone. Eighty teachers from preschool, primary, middle, and high schools in Tatvan (Bitlis, Türkiye) were stratified by school level and randomized 1:1. Outcomes were assessed at baseline and at week 12.

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, ca 400 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.

PATH to Reducing Burnout Among Peers Who Deliver Overdose Prevention Services (R61 Phase Pilot)

The investigators propose to develop and test the effectiveness of PATH (Peer Advanced Training for total Health) as an educational workforce intervention for improving peer recovery support specialists' (PRSS) overdose prevention (OP) 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 OP service quality.

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.

Study of Psychosocial and Contextual Determinants of General Practitioners' Management of Burnout

Burnout is a major public and occupational health issue. Despite accumulated knowledge to date on the determinants of burnout and its treatment, shortcomings when providing support against this complex phenomenon have been found. Although many professionals are involved in the management of burnout, general practitioners (GPs), as primary care providers, are on the front line, and face a range of difficulties that are reflected in the wide variability of medical support brought to the patients. As a result, the diversity of these practices can affect the recovery process of burnout sufferers and their ability to return to work. Deviations from recommended practices can lead to shortcomings in the treatment of burnout. Using an exploratory et descriptive study design, the main objective of BOPEC-MG is to describe the psychosocial mechanisms involved in the management of burnout in general practice that could explain the variation in medical practices.

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

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

Transcendental Meditation Intervention to Reduce Burnout and Enhance Resilience Among NewYork-Presbyterian Hospital and Weill Cornell Medicine Employees and Residents

The goal of this study is to learn if a meditation intervention called Transcendental Meditation or TM can be used in a small department at Weill Cornell Medicine to help reduce employees' levels of burnout, anxiety, insomnia, and depression as well as to determine the feasibility and acceptability of the meditation practice by Weill Cornell employees. The main question the study aims to answer is whether: • Levels of burnout, anxiety, insomnia, and depression will be decreased, and overall mental well-being will improve over a 3.5-month period before and after TM intervention. Participants will attend 9 sessions total (8 group sessions and 1 individual session) with a certified TM instructor from The David Lynch Foundation Institute for Mental Health and Resilience where they will gain experience in proper TM techniques. Also, participants will conduct 2 of their own TM sessions at home daily during the course of this study.

Floatation Experience in Nurses and Physicians

The goal of this observational study is to monitor the floatation experience and continue the program as long as deemed important. The main question it aims to answer is: will inventory wellbeing scores increase according to the number of floatation sessions accrued? Nurses (registered, practitioner, and anesthetist) and physicians, employed at St. Elizabeth Youngstown Trauma Center, Mercy Health, will be welcomed to participate in the floatation experience. Participants will be given an option to complete the Wellbeing Inventory survey prior to each floatation session.

From Burnout to Balance: Implementing a Theory-Driven Resiliency Program in Occupational Therapy Doctoral Education

The purpose of this study is to learn about burnout among first-year Occupational Therapy Doctoral (OTD) students and how it may affect their mental health, daily activities, and overall well-being. Students will be asked questions about their stress levels, daily habits, and experiences in school. The study will also evaluate a resilience program that is built into a hybrid OTD curriculum to see whether it helps students manage stress, improve their well-being, perform well academically, and support their long-term success. Researchers will look for patterns in the responses to better understand student experiences. The findings may help occupational therapy programs and other healthcare schools provide better support for students.

Hand in Hand: Feasibility of a Compassion-Focused App to Support Parents of Children With Mental Health Problems

Parents of children and adolescents with mental health problems may experience substantial caregiving burden and emotional distress, including persistent stress, self-criticism, shame, and parental burnout. Hand in Hand is a four-week, self-guided, compassion-focused app developed to support parents of children and adolescents referred to Child and Adolescent Mental Health Services (CAMHS). Drawing on principles from Compassion Focused Therapy (CFT) and inspired by work by Kirby et al., the app was developed through a participatory co-design process involving parents and clinical and research experts. The project comprises two interrelated sub-studies. Sub-study 1 is an open feasibility study evaluating the feasibility and preliminary outcomes of Hand in Hand among parents of children and adolescents referred to CAMHS in the Central Denmark Region. Feasibility outcomes include recruitment, retention, adherence, engagement, acceptability, and data completeness. Preliminary changes in parental outcomes, including parental burnout, emotion regulation, family empowerment, self-compassion, self-criticism, shame, and emotional distress, as well as parent-reported child outcomes, will also be explored. Sub-study 2 is an embedded qualitative study exploring parents' experiences of using Hand in Hand and their perceptions of whether and how the intervention influences parental well-being and family interactions.

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.

The Surgical Education Culture Optimization Through Targeted Interventions Based on National Comparative Data - "The SECOND Trial"

Due to a number of factors, residents are susceptible to mistreatment (i.e., discrimination, harassment, and abuse) and toxic outcomes (i.e., burnout, attrition, and suicidality). Our work following the FIRST Trial identified considerable variation in program-level rates of resident-reported burnout, gender discrimination, racial discrimination, sexual harassment, and verbal abuse. To investigate these issues, the SECOND Trial will include a national mixed-methods analysis of and a pragmatic cluster-randomized controlled trial to improve the resident learning environment and trainee wellness.

Fostering Optimal Regulation of Emotion for Prevention of Secondary Trauma (FOREST)

FOREST is a positive emotion skills program designed to target mental health and coping needs for frontline violence prevention workers at UCAN. Ten skills are taught over a period of nine months during existing meetings and wellness activities, as well as in online modules in UCAN's Learning Management System (LMS). Through infusing the FOREST skills throughout UCAN, we hope to inspire organizational culture change that will emphasize the importance of wellbeing and enhance resilience, therefore reducing burnout and turnover.

Effects of a Connection-Enhancement Program for Newly Employed Generation Z Nurses.

The purpose of this randomized controlled trial is to evaluate the effects of a connection-enhancement program on resilience, perceived stress, burnout, and intention to stay among newly employed Generation Z nurses in a military hospital. Approximately 80 eligible nurses will be randomly assigned to either an intervention group or a control group. The control group will receive conventional orientation education for newly employed nurses, whereas the intervention group will receive the connection-enhancement program in addition to conventional orientation education. The intervention will be delivered over four weeks, with one 50-60-minute session per week. Outcomes will be assessed before and after the intervention using self-reported questionnaires and salivary cortisol measurements.

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.

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.

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.

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.

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.

Evaluation of Speech and Voice Biomarkers in Association With Burnout

This project aims to explore how speech patterns and voice characteristics can be used to detect signs of burnout and stress in physicians.