Clinical Research Directory

The Coma Family Program (COMA-F): A Resilience Program for Caregivers of Patients With Severe Acute Brain Injury

The purpose of this research study is to determine whether COMA-F is more efficacious at reducing emotional distress in caregivers of patients with severe acute brain injuries, compared to health education control.

Effects of Pastel Nagomi Art on Psychological Well-Being in Nursing Students

The purpose of this quasi-experimental study is to evaluate the effects of a Pastel Nagomi Art intervention on the psychological well-being of nursing students. Nursing students often experience high levels of stress and academic anxiety during their professional training. Pastel Nagomi Art, a therapeutic and accessible form of art making using soft pastels and fingers, has gained attention for its potential to foster relaxation, mindfulness, and emotional expression. This study employs a non-randomized, quasi-experimental design. Participants will be assigned to either the Pastel Nagomi Art intervention group or the control group based on their personal preference and availability. The intervention group will receive structured Pastel Nagomi Art workshops, while the control group will maintain their usual routine. Psychological well-being will be assessed at baseline and post-intervention. The results aim to provide evidence on the feasibility and effectiveness of integrating soft art interventions into nursing education to support student mental health.

Music Breathing in Enhancing Resilience Among Elders at Risk of Mental Health Problems

The goal of this pilot randomised controlled trial is to examine the effects of a mindfulness-based music breathing intervention in enhancing resilience (primary outcome), and in reducing anxiety, depressive symptoms, loneliness, and improving health-related quality of life (secondary outcomes) among community-dwelling older adults at risk of mental health problems. It is hypothesised that compared with the control group, participants in the intervention group will report enhanced resilience, reduced anxiety, depressive symptoms, and loneliness, and improved health-related quality of life immediately post-intervention.

The Effect of MIND-BE Program on Mental Health Parameters (Mindfulness Based Empowerment)

This study will be carried out in a prospective (pre-test, post-test, and 3-month and 6-month follow-up), randomized controlled (parallel), experimental order in order to examine the effect of the MIND-BE program applied to intensive care nurses on mental health parameters. The hypothesis of this study is that MIND-BE program increases resilience, posttraumatic growth, mindfulness, self-compassion levels, and reduces mental symptoms.

RISE for Nurse Preceptors

The purpose of this study is to determine whether RISE for Nurse Preceptors has a significant impact on nurse preceptors' burnout, resilience, insight, self-compassion, and empowerment, as well as mental well-being, in their personal lives and their working environment.

The Effects of a Nurse-led Community-based Sailing Programme on Resilience of School-aged Children With Autism: An RCT

The goal of this randomised controlled trial is to evaluate the effect of a nurse-led community-based sailing programme on resilience of school-aged children with autism in inclusive education. Does intervention improve the resilience of participants? Does intervention improve the quality of life, self-esteem, depressive symptoms, and social functioning outcomes of participants? Researchers will compare the effect of intervention (community-based sailing programme) to the attention control group (Crafting activities) at baseline, post-intervention, and at 3-month and 9-month follow-ups. Participants will: Participants in the intervention group will participate in a nurse-led community-based sailing programme over six days, with each day consisting of 4 sessions, each lasting an hour, for a total of 24 hours. Participants in the attention control group will engage in crafting activities with minimal difficulty, focusing on maintaining attention without any emotional or reflective discussions.

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.

Mind-body Resilience Program for Cardiac Arrest Survivors and Their Caregivers: Recovering Together After Cardiac Arrest

The purpose of this study is to pilot two resilience interventions for cardiac arrest survivors and their informal caregivers, Recovering Together after Cardiac Arrest 1 and Recovering Together after Cardiac Arrest 2 . The data the investigators gather in this study will be used to further refine the interventions.

Partial Digitalization of Mission ReST

The goal of this non-randomized trial is to partially digitalize and develop a web-based resilience-building intervention and pilot-test its feasibility, acceptability, and appropriateness in an undergraduate sample over a 6-month implementation period. The main questions it aims to answer are: * What are the rates of recruitment, adoption, and full program completion? * What is the intervention's overall effectiveness in enhancing resilience and mental health outcomes? Researchers will compare the partially digitalized intervention with a structurally equivalent in-person mode of delivery.

SAFEGUARD Level Up Study

This project will evaluate the effectiveness of Level Up: Boost Your Life Skills ("Level Up"), a strengths based, military-specific life skills training program. The goal is to determine whether Level Up can decrease suicidal-related behaviors (SRBs) and other harmful behaviors, improve mental health, enhance job performance, and reduce early military separation. The Level Up program components will be made available to participants through an online platform or mobile app that can be downloaded onto their personal mobile devices. These training materials will help Soldiers learn and practice skills. The Level Up program will also involve personalized messages from a Level Up trainer and virtual booster sessions. Active duty Soldiers who are currently stationed at Fort Hood, Texas and are members of a participating platoon will be randomized to receive either Level Up or Training as Usual (TAU). Participants will complete baseline and follow up surveys 1, 3, and 6 months post-baseline.

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.

Comparing a Workplace Resilience and a Physical Activity Intervention on Early Childhood Educators Well-being

The goal of this 15-month cluster clinical trial is to compare a resilience and stress management program to a physical activity program for early childhood education (ECE) staff on change in well-being. It will also look to see if changes in well-being continue over time. The study sample will include 80 child care centers. Including 80 ECE center directors and approximately 560 ECE center staff. Some ECE centers will receive only the remotely delivered Resilience program. This program works with ECE staff and helps them recognize and strengthen their resilience assets and resources. Other ECE centers will receive only the remotely delivered Physical Activity program that will focus on staff physical activity habits and strength training. There will be 3 months of active program participation and 12 months of a maintenance period where participants will only have access to program materials.

Testing the Efficacy and Mechanisms of an Adapted Resilience Building Intervention in People Aging With HIV

This study will examine the mechanisms and efficacy of a resilience building intervention in older people living with HIV.

Older Adults' Recovery Dynamics After Cardiac Surgery

Population aging has increased the number of older adults exposed to interventions with high physiological demand, which are associated with frequent adverse outcomes such as delirium, organ dysfunction, and delayed functional recovery. Current clinical tools, such as frailty assessments, help identify higher-risk populations but do not adequately explain the marked individual variability in recovery or accurately predict who will develop complications. This variability may be partly explained by individual resilience, defined as the ability to recover toward, return to, or even surpass a prior functional state after an acute stressor. Evidence suggests that biological mechanisms related to aging influence resilience; however, biomarkers and integrated clinical models capable of characterizing and potentially modulating resilience in humans remain limited. Therefore, a standardized clinical platform is needed to characterize physiological resilience and its determinants, generating actionable knowledge to improve risk stratification, guide interventions, and optimize recovery in older adults. To this end, a single-center prospective cohort study will be conducted at Clinica Bicentenario Santiago, including individuals aged ≥65 years who are independent or have mild dependency and are undergoing elective cardiac surgery requiring sternotomy for valvular and/or coronary artery disease, recruited between 2026 and 2027. Participants will undergo a baseline assessment 2-3 weeks before surgery; an early postoperative assessment focused on the systematic recording of clinical outcomes, including delirium and organ dysfunction; and longitudinal follow-up to characterize recovery after discharge. Follow-up assessments will include frailty, intrinsic capacity (the composite of an individual's physical and mental capacities across the cognitive, locomotor, psychological, vitality, and sensory domains), functional status, health-related quality of life, and perceived fatigability, according to the prespecified assessment schedule. In addition, blood samples will be collected at three time points (baseline, 24 hours postoperatively, and one month after surgery) to measure plasma levels of growth differentiation factor 15 (GDF-15), a biomarker associated with aging-related biological stress and systemic responses to tissue injury. It is projected that at least 75 participants will be recruited over a 12-month period, allowing characterization of baseline clinical and functional profiles, the frequency of postoperative complications and organ dysfunction, trajectories of recovery, and associations between baseline characteristics, biological markers, and subsequent recovery outcomes.

Effectiveness of Integrated Network for Student Psychosocial Intervention, Resilience, and Education (INSPIRE) on Mental Health Outcomes Among Indonesian Adolescents in Bandung

The INSPIRE (Integrated Network for Student Psychosocial Intervention, Resilience, and Education) intervention is an 8-week, school-based mental health program designed to enhance adolescents' mental health literacy and resilience while addressing symptoms of depression and anxiety. Implementation is conducted by school counselors who undergo an intensive two-day training program. The intervention is supported by comprehensive curriculum materials including detailed lesson plans, activities, discussion prompts, and instructional slides featuring key concepts, visuals, and explanatory content. Supplementary materials are developed for both participating adolescents and their parents. The study aims to: 1. Evaluate the usability and feasibility of the INSPIRE intervention within the school environment. 2. Assess the intervention's effectiveness in improving: * Primary outcome: Mental health knowledge among adolescents * Secondary outcomes: Attitudes toward mental health, help-seeking behaviors, mental health literacy, resilience, and symptoms of depression and anxiety among adolescents * Secondary outcomes: mental health knowledge, attitudes, help-seeking behaviors, and mental health literacy among parents 3. Explore the experiences of intervention participants (both adolescents and parents) against the control group to develop comprehensive insights into the psychosocial intervention's impact. The research hypothesis proposes that the INSPIRE intervention group will demonstrate significantly higher scores in mental health knowledge, more positive attitudes toward mental health, increased help-seeking behaviors, enhanced mental health literacy, and greater resilience, while simultaneously showing reduced symptoms of depression and anxiety compared to the control group receiving standard care. These outcomes will be measured immediately following the intervention (post-test 1) and at one-month follow-up (post-test 2).

Aging Resilience Through Microbiota Optimization and Regulation

Sarcopenia, characterized by the progressive loss of muscle mass and strength in older adults, is a key factor in health deterioration. It affects 15% of people between 65 and 80 years old and over 50% of those over 80, compromising autonomy and increasing the risk of diseases. Sarcopenia not only impacts muscle function but also bone health, mobility, and is associated with cardiometabolic diseases and cognitive decline. It has been proposed that changes in the gut microbiota in aging individuals, known as gut dysbiosis, contribute to sarcopenia. Species diversity decreases, and bacterial representation is altered, which could impair muscle function through various pathways, such as mitochondrial dysfunction, chronic inflammation, and disruption of protein synthesis. Muscle function loss is strongly associated with cognitive and metabolic impairment in older adults. Recently, it has been demonstrated that fecal microbiota transplantation (FMT) is an effective procedure for modulating gut microbiota and has proven highly effective in managing cases of Clostridium difficile-associated chronic diarrhea. The main objective of this project is to carry out FMT from young, physically active donors to a cohort of older adults to evaluate its effect on muscle, cognitive, and metabolic function. Why donors who exercise? There is growing evidence that gut microbiota diversity is increased in young, physically active individuals. The FMT is planned to be administered through lyophilized microbiota capsules. By restoring microbial diversity, it is expected to improve the quality and function of skeletal muscles, leading to greater cognitive and metabolic resilience. This project has great potential to develop an innovative approach for treating highly debilitating diseases that affect older adults, based on the lyophilization and encapsulation of gut microbiota from young, trained donors, which can be easily stored in a conventional freezer. Due to the high percentage of older adults worldwide and the high prevalence of sarcopenia within this age group, the aim of the project is to address a significant public health issue with a large target population eager for options to promote muscle health, functional autonomy, as well as cognitive and metabolic well-being.

Operating Room Black Box Supported Debriefings and Their Effect on Healthcare Professionals Effectiveness and Psychological Safety.

This study is enrolled in the European KEEPCARING Project. KEEPCARING aims to (re-)build wellbeing and resilience of healthcare workforce in EU hospitals by co-creating a multi-faceted non-digital, digital, and AI-supported solution package to prevent burnout among (aspirant) healthcare professionals on the individual, team, and organizational level. This study specifically investigate the operating room staff wellbeing and resilience. The healthcare system is currently struggling to retain and attract operating room personnel. A factor of importance to consider here is occupational stress. If not recognized or mitigated well, occupational stress and personal efficacy can eventually evolve into a syndrome labelled as 'burnout'. In addition, communication and resilience patterns between operating room staff members are of influence, poor and/or inadequate communication among staff may be a factor of stress, compromising their work and wellbeing. In contrast, communication patterns that have a high standard and clarity may support resilience. The ability to speak up and being able to advocate concerns of all team members is of the highest importance here. Indeed, psychological safety and effective teamwork patterns are key for the working environment, performance, patient safety, and job satisfaction. To prevent mistakes during surgery, a safe space where team members can freely speak up is vital. To improve psychological safety, and teamwork among OR staff, team debriefing after surgery is known to be effective. What is not known; is whether team debriefing with the additional support derived from audio- and video recordings of the surgery is equally effective as debriefing without. The objective of this study is to evaluate the impact of structured postoperative debriefings with and without procedural, structured audio- and video recordings, on team performance, psychological safety, and non-technical skills in the operating room. Specifically, this study aims to compare augmented debriefings with non-augmented debriefings, to assess differences in perceived usefulness, psychological safety, and observed improvements in teams' non-technical skills. This is an international quasi-experimental comparative study. The intervention consists of postoperative team debriefing using audio and video recordings ('augmented debriefing') from Operating Room Black Box system provided by Surgical Safety Technologies. The control group will have a postoperative team debriefing that is not augmented with Operating Room Black Box derived data. An identical debriefing template will be designed for both groups.

NAVO:J School-Based Group Intervention for Adolescent Mental Health

The purpose of this study is to determine and verify whether a school-based group intervention using the digital mental health platform NAVO:J can effectively improve the mental health of adolescents-particularly reducing depression, anxiety, and stress while enhancing resilience.

Role Model-Based Ethics Education and Moral Injury Prevention in Second-Year Medical Students

This study examines whether role model-based ethics education can reduce moral injury and perceived stress, and improve resilience, among second-year medical students in Taiwan. Students participated in a general education ethics course and self-selected into one of two groups: a standard-intensity group receiving role model narratives and guided handouts, or an enhanced-intensity group receiving the same content plus reflective writing assignments and live guest appearances by featured practitioners. Validated questionnaires measuring moral injury (MIDS), perceived stress (PSS-14), and resilience (CD-RISC-10) were administered before and after the course. Open-ended written responses were also collected and analyzed. The study aims to inform early curricular integration of ethics education in medical training and to identify instructional designs that support moral agency without inadvertently promoting emotional disengagement.

Evaluation of a Group-based, Skills Training for Increasing Mental Toughness

The goal of the Life Force study is to (1) evaluate the efficacy of targeted, skills-based training for enhancing mental toughness and mitigating harmful and high-risk behaviors in active-duty Soldiers, and (2) to determine who benefits the most from this type of training. Researchers will compare the training group to a control group. All participants will complete a baseline survey and two follow up surveys at 6 and 12 months post-baseline. The group assigned to the Life Force training condition will also complete a 5-session, group-based, skills training program.

Mind-Body Conditioning Course for University Dance Students

Mindfulness in Motion (MIM) is an eight-week evidenced based program designed specifically to help participants learn practical stress reduction, burnout and resiliency building techniques. Content includes didactic instruction, community-building group discussion, mindfulness practices, and gentle yoga. Weekly themes include Willingness to Daily Practice, Mindful Sleep, Vision of Self, Supported by the Breath, Mindful Eating and Yoga, Movement Through Balance, Awareness of Sensation, Clarity and Release, and Staying Grounded and Moving Forward. An Ohio State University endorsed, ADA compliant companion smartphone app reinforces weekly content and offers a variety of individual mind-body and mediations practices. The evidence-based MIM content has been tailored to meet the physical, mental, and emotional needs of student Dance majors at The Ohio State University and integrated into the Dance 2802 course content as Mind-Body Conditioning for second year students. Over the course of the second year student's fall semester, this study will evaluate the effectiveness of this integrated course content on students' perceived stress, burnout, resilience, musculoskeletal injury and discomfort, and weekly respiratory rates. After the semester long course is completed, the students will also assess how well the Mind-Body Conditioning course content was integrated into the required first year seminar for University Dance majors.

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.

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.

Cluster RCT of Cognitive Behavioral Therapy to Support Caregivers of Older Adults in Hong Kong

The goal of this cluster randomized controlled trial study is to compare the effectiveness of a novel psychosocial intervention based on Cognitive Behavioral Therapy, lifestyle intervention and effective communication skills in caregivers of older adults in Hong Kong. The main question\[s\] it aims to answer are: What is the impact of the 6-week psychosocial intervention on distress and burden among participants? Participants will participate in a 6-week psychosocial intervention. Researchers will compare the results between the intervention group and the active control group to see if participants in the intervention group have lower distress and burden.