Clinical Research Directory

The Effect of Online Solution- Focused Group Counseling On Adjustment, Psychological Well- Being and Resilience

In this study, the effect of online solution- focused group counseling on adjustment, psychological well- being and resilience in individuals will be examined. The research will be carried out as a randomized controlled experimental study with a pre-test, post- test and follow- up design.

Using Integrated Care and Wearable Technology to Evaluate Outcomes of the Shields & Stripes Program for Veterans and First Responders

This study aims to evaluate outcomes from the Shields \& Stripes (S\&S) program - a 12-week, multidisciplinary wellness intervention designed for veterans and first responders. The S\&S program integrates occupational therapy (OT), mental health (MH), physical therapy (PT), and registered dietitian (RD) services to promote recovery, resilience, and performance in individuals who have experienced cumulative stress, trauma exposure, or occupational burnout. This research will use a retrospective mixed-methods observational design to analyze data collected from previous S\&S participants who consent to research use of their de-identified information. No intervention or treatment changes will occur as part of this study. Quantitative data will include biometric information (e.g., sleep, activity, and heart rate variability via Oura Ring), standardized self-report measures (GAD-7, PHQ-9, PCL-5, RAND-36, PSQI, ISI), satisfaction surveys, and laboratory nutrition panels. Qualitative data will include semi-structured interviews with consenting participants and S\&S providers following program completion. The purpose of the study is to identify patterns of improvement in physical, psychological, and occupational functioning and to explore how integrated, team-based care supports holistic recovery. Findings may inform the development of future evidence-based wellness programs for military and first-responder populations. Participation involves minimal risk, and all data will be de-identified before analysis.

Assessing the Effects of Cool Roofs on Mental Health in Ahmedabad, India

Ambient air temperatures in India have broken record highs. Solutions are needed to build heat resilience in communities and adapt to increasing heat from climate change. Sunlight-reflecting cool roof coatings may passively reduce indoor temperatures and energy use to protect home occupants from extreme heat. Occupants living in poor housing conditions are susceptible to increased heat exposure. Heat exposure can instigate and worsen mental health. The worst adverse health effects are experienced in communities that are least able to adapt to heat exposure. By reducing indoor temperatures, cool roof use can promote mental wellbeing in household occupants. The long-term research goal of the investigators is to identify viable passive housing adaptation technologies with proven health benefits to reduce the burden of heat stress in communities affected by heat. To meet this goal, the investigators will conduct a cluster-randomized controlled trial to establish the effects of cool roof use on mental health in Ahmedabad, India.

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.

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.

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.

Evaluating The Impact of A Mental Health App on Depression and Resilience Among Medical Students

This randomized controlled trial aims to determine whether access to a mental health app improves resilience and reduces depressive symptoms among medical students over a three-month period. Compared to the control group, researchers hypothesized that medical students in the intervention group are expected to show: * Significant reductions in depressive symptoms and greater improvements in resilience after three months of usage. * Significant reduction in thoughts of self-harm and anxiety, and improvement in self-esteem after three months of usage. Researchers will compare two groups to evaluate the app's impact on wellbeing: * Intervention group: Receives immediate full access to the mental health app. * Control group: Receives basic, without full access to the mental health app. Participants will explore and experience the various features offered in the mental health app over a three-month period.

Jockey Club Support Project

Guided by the process model of emotion regulation, integrative affect-regulation framework for resilience, and the reciprocal dynamics of emotion, affect, and resilience in the family system, researchers will develop a parallel intervention to incorporate two key members in Mainland-Hong Kong cross-boundary families: a parent and a child by improving their affect/emotion regulation skills, de-escalate family conflicts, and flourish under hardships. Specifically, researchers predict that participants in the intervention group will report greater improvement in resilience, emotion regulation, psychological well-being, family harmony, and social connectedness than those in the control group.

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.

Life Skills Training for Soldiers Arriving at Their First Duty Location

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. Soldiers arriving at their first duty location will be randomized to receive either Level Up or a single session Army bystander intervention program. Participants will complete baseline and follow up surveys 1, 3, and 6 months post-baseline.

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.

Musical Training to Enhance Resilience of Underprivileged School-aged Children

This is a multi-centre randomised controlled trial aims to examine the effects of a group-based gamified instrumental musical training in enhancing resilience (primary outcome), reducing psychological distress (depressive symptoms and anxiety), enhancing self-esteem, and improving HRQoL (secondary outcomes) among underprivileged school-aged children at risk of mental health problems (depression and anxiety) during a 12-month follow-up.

Culturally Adapted i-CBT for Farsi/Dari Speaking Migrants

The aim of this randomized controlled trial (RCT) is to investigate the effectiveness of a culturally adapted internet-based cognitive behavioral therapy (i-CBT) intervention in reducing symptoms of common mental health issues among Farsi/Dari-speaking youth migrants and refugees. Investigator hypothesizes that there will be a significant decrease in psychological symptoms after participants receive the intervention compared to a control group.

This Study Explores the Mental Health Impact of Two Akashic Records Sessions.

The goal of this clinical study is to learn the impact of two Akashic Records sessions on mental health symptoms in adults. We want to see how sessions are linked to stress, anxiety, and depression, and to resilience (ability to bounce back) and feelings of connectedness (to self, community, and humanity). Main questions this study will answer are: After two sessions, what is the impact on stress, anxiety, and depression? After two sessions, what is the impact on resilience and connectedness? How do participants describe their experience of the sessions? After two sessions, what are participants' views of their problems (insight), emotional experiences (impact) and observable behaviors in their daily life? What participants will do: Complete online surveys about their mood at four points: before the first session, before the second session, after the second session, and again 2 months later. Surveys include: DASS-21 (Depression, Anxiety, and Stress Scale) CD-RISC-10 (Connor-Davidson Resilience Scale) WATTS (Connectedness Scale) A short demographic form and satisfaction survey Attend two individual Akashic Records sessions (50-90 minutes each) over private video platform with a licensed clinical social worker (principal investigator) The first 50 participants will also join a one-hour interview with open ended questions with a licensed clinical social worker (co-investigator) about one week after the second session to share their experience in their own words. Who can take part: Adults ages 18 and older who can read and consent in English and who have experienced stress, anxiety, or low mood in the past year. How the research will happen: Sessions are held by secure video call. Participants will also complete private online surveys before, during, and after the sessions. Some participants may be invited to share their experiences in a one-on-one interview. All information is kept private and names are removed before analysis. Risks and benefits: Talking about personal topics may bring up strong emotions. Licensed clinicians conduct sessions, offer support, and provide referrals if needed. Possible benefits include new insights, greater peace or meaning, and improved coping; benefits are not guaranteed. Why this matters: Many people seek spiritual or transpersonal support for emotional concerns. This pilot study will provide early evidence on whether Akashic Records sessions may be a helpful, low-risk option and will guide future research.

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.

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.

Healthspan Connect Programme of Research

Healthspan Connect is a new research programme designed to understand what helps people stay healthy as they age. The programme will explore how lifestyle, environment, genetics, and social factors influence healthy ageing and overall wellbeing. The programme will recruit participants aged 12 years and older across the UK. By including adolescents, the programme aims to understand how early life behaviours and experiences shape long-term health. There is no upper age limit, and people from all backgrounds are encouraged to participate. Special pathways ensure that young participants provide consent in an age-appropriate way. Healthspan Connect is a digital and home-based study, meaning participants can take part from home using smartphones, computers, and online surveys. Participants may also be asked to collect samples such as blood, saliva, stool, urine, or other biological specimens at home using easy-to-use kits. In some sub-studies, participants may be invited to attend research visits for additional tests, scans, or clinical assessments. Family members and close contacts may also be invited to participate in some studies. Through Healthspan Connect, researchers aim to: * Identify the biological, environmental, and social factors that help people live longer, healthier lives. * Understand how different groups, including those historically underrepresented in research, experience ageing. * Explore ways to support behaviour changes that improve health over the lifespan. * Provide near real-time information to inform health policies and interventions. Participants may also be asked for permission to link their information with health records, education records, and environmental data to better understand health outcomes over time. This programme will serve as a flexible platform for multiple sub-studies, allowing participants to contribute to a wide range of research questions related to healthy ageing, resilience, and long-term health. All data and biological samples will be stored securely and used to advance scientific knowledge, with participant privacy carefully protected.

SAFIR Family Talk - Investigating the Effect of The Family Talk Intervention

The goal of this clinical trial is to test the effect of the Family Talk Preventive Intervention compared to service as usual for families where a parent has mental illness. Participants are the parent with a mental illness receiving treatment from a secondary mental health service within the last two years from inclusion, their youngest child aged 7-17 years and the other parent of this child. The main questions it aims to answer are: Is Family Talk superior to service as usual regarding improving? * The child's level of functioning * The parent's sense of competence * Family functioning Participants will undergo interviews and fill out questionnaires. Half will be randomized to Family Talk and receive a manualized, family-based intervention of approximately 8 conversations with a trained, Family Talk interventionist. The other half will be randomized to service as usual which is normally two conversations with a professional in the mental health sector. The researchers will compare the two groups on child's level of functioning, parental sense of competence and family functioning.

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.

RCT: the Effectiveness of LifeHack in Improving Mental Wellbeing in University Students.

Psychological issues are common among university students and affect mental wellbeing. The Caring Universities (CU) project, involving nine Dutch universities, aims to enhance students' mental health through an annual online questionnaire and a platform offering guided eHealth interventions. One intervention, LifeHack, utilizes cognitive behavioral therapy-based modules to improve mental wellbeing by enhancing resilience and life skills. The effects of LifeHack with pre-post measurements (total n = 216 at post-test) found found that LifeHack led to improvements in mental wellbeing, but dropout rates were influenced by lack of motivation and module relevance. A personalized version of LifeHack is being developed to address these issues and will be evaluated in an RCT to assess its effectiveness in improving mental wellbeing and related outcomes among university students.

An Online Ecoaching RCT Intervention for Carers: Enhancing Wellbeing and Resilience Through Self-Help Strategies

The goal of this three-armed, double-blind randomized controlled trial (RCT) is to compare the effectiveness of an online self-help eCoaching intervention designed for caregivers. The main questions it aims to answer are: What is the impact of the online self-help eCoaching intervention on the well-being, depressive symptoms, and self-efficacy of participants? Researchers will compare the results between the intervention groups and the control group to see if participants in the intervention groups have lower distress, burden and higher accuracy.

Survey of Psychological Well-being of Health Care Workers in the Hospital Setting

The psychological well-being of healthcare workers in hospital settings is a topic of growing interest in the scientific literature, given the crucial importance of their role in ensuring high-quality care. In addition, the Covid-19 pandemic health emergency has further accentuated the relevance of this issue, increasing anxiety and stress levels, testing the resilience and resistance of those working in care settings, revealing and highlighting how the accumulation of work-related stress can result in disabling pathologies for the caregiver, with an inevitable impact on the facility and care in general. Recent studies show that health care workers are particularly vulnerable to work-related stress, which can result from various factors such as high work demands, emotional pressure, irregular shifts, and interactions with critically ill patients. Burnout syndrome, characterized by emotional exhaustion, depersonalization and reduced personal accomplishment, is widely documented among hospital staff. Research indicates that burnout not only compromises the psychological health of healthcare workers, but also negatively affects the quality of care provided by increasing the risk of medical errors. In light of these factors, it is crucial to deepen our understanding of the dynamics that influence psychological well-being and work-related stress in health care workers in order to develop effective interventions that can improve their quality of life and consequently the quality of care provided to patients. Preliminary assessment of the emotional burden and motivational aspects of health care workers (showing what very often eludes a first glance, making visible something that is often invisible), along with effective stress management, would allow for greater ability to remain calm under pressure, reduced frustration, increased ability to make informed decisions, and to communicate effectively with patients and colleagues. These aspects translate into an image of a safer and more caring health care system in promoting better quality of care. The aim of this project is to highlight the importance of psychological wellbeing for those working in health care settings and to promote attention to this area, also with a view to identifying possible interventions aimed at identifying preventive and protective factors in relation to health care workers. The aim, therefore, is to show what is very often invisible at first sight, to make visible what is invisible: to explore, accommodate and contain areas of criticality and fragility in the context of work in health care settings, working on interventions aimed at the psychological well-being of workers.