Clinical Research Directory

A Mentalization Based Prevention Program to Foster Well-Being and Mental Health in Pre-Adolescent Children and Their Families

The FLOW project involves the implementation and rigorous evaluation of an evidence-based, multi-level mentalization prevention program targeting social and psychological determinants of well-being in four European countries (Germany, Lithuania, Spain, and Switzerland). Prevention programs will be tailored to the needs of 8-10 year old children in elementary schools and their parents. All children will participate in a project day focused on mental health. Parents will either attend one of two parent trainings of varying lengths or receive a parenting guidebook. A total of 5,000 children, along with their teachers and parents, are included in the survey. To measure long-term effects, surveys are conducted over the course of a whole year. The project examines the following hypotheses: Primary hypotheses: A multilevel mentalization based prevention program will lead to significantly greater improvements in well-being and mental health among children and parents compared to control groups, as measured at the post-intervention assessment. Secondary hypotheses: 1. A universal prevention program on mental health enhances help-seeking behavior and reduces mental health stigma among children, parents and teachers at post and follow-up measurement. 2. A universal prevention program on mental health improves classroom climate and increases teaching efficacy at post and follow-up measurement. 3. A multi-level mentalization based prevention program leads to greater improvements in well-being and mental health among children and parents than control groups, as measured at follow-up. 4. A multi-level mentalization based prevention program leads to greater improvements in parental efficacy and family adjustment in parents and reduces parental stress compared to control groups at post and follow-up measurement. 5. The longer intervention group will yield greater improvements in outcome measures compared to the shorter intervention group.

Technology-assisted Methods to Advance Suicide Prevention Among Youth in Colombia

This study will investigate a multi-level approach that applies technology-assisted methods to reduce suicidal thoughts and behaviors (SIB) and promote mental health among Colombian youth: (a) digital platform for youth; (b) digital platform for teachers; and (c) hybrid mental health training diploma program for teachers. This approach will evaluate an open-access digital platform for suicide prevention among Colombian youth. Key features of the digital platform include mental health self-help tools, a customizable safety plan, links to online counseling services, and gamification elements. The digital platform's teacher interface will incorporate psychoeducation, brief suicide-risk screening and decision support tools to enhance teacher capacity to assess risk for suicide and refer youth to the appropriate level of services. Study investigators will conduct a hybrid-type 1 implementation-effectiveness stepped wedge pilot trial design to evaluate the digital platform and hybrid mental health teacher training program implemented within secondary schools in Bogota, Colombia. Study aims are to: Aim 1. An initial needs assessment will be conducted with key stakeholders (youth, teachers, caregivers, school administrators) to identify barriers and facilitators to successful implementation of the multi-level approach. User-centered design methods will be used to refine the digital platform and incorporate end-user feedback into the final prototype. Aim 2. Investigators will evaluate: (a) feasibility, acceptability, and usability of the digital platform across three schools in Colombia; and (b) the preliminary effects of the digital platform in reducing SIB and improving mood (e.g., anxiety/depression) among Colombian youth aged 14-19 attending the three schools. Safety planning skills acquisition (youth-level) and linkages to mental health services (service-level) will be assessed as potential mechanisms of change. Aim 3. The study will apply a multi-disciplinary capacity building model to strengthen behavioral health and implementation science research, healthcare delivery capacity, and mental health policy. In partnership with Pontificia Javeriana University, experts in suicide prevention, data science, and implementation science will be engaged to build in-country research capacity at the individual and institutional level.

Telephone-Based Care Coordination for Services Addressing Childhood Adversity

The goal of this study is to learn how telephone-based screening and care coordination impacts children experiencing adverse childhood events (ACEs). The main questions are: 1. Does telephone-based screening and care coordination for children experiencing ACEs increase child receipt of ACEs-related services? 2. Does telephone-based screening and care coordination for children experiencing ACEs improve parent health and wellbeing? 3. Does telephone-based screening and care coordination for children experiencing ACEs improve child social and emotional health? Researchers will compare families who have been randomly selected to receive telephone-based screening and care coordination with those who will receive usual care at their clinic. Participants will: * Be randomly assigned to receive usual care or usual care plus telephone-based screening and care coordination (the intervention) * If selected for the intervention, be connected to 211 Los Angeles to receive screening and care coordination for up to 6 months * Complete four surveys via interview; surveys will be done at enrollment and 1 month, 6 months, and 12 months following enrollment * Agree to allow researchers to review their child's medical records to collect information about their child's health, screenings, diagnoses, and referrals.

Leading Well-being and the Psychosocial Working Environment - A Cluster-randomized Waitlist Controlled Trial

The design comprises a cluster, randomized waitlist controlled design. The goal of the study is to prevent stress and burnout in middle managers and employees in a hospital setting. The study population is middle managers in a hospital setting. The intervention comprises five training modules with practice in small groups in between. Training will take place over 5 months. The training will be received in groups of 20 middle managers and the training will be facilitated by 2 facilitators. Themes of training are inspired by the concept of Health Oriented Leadership which takes into account that the well-being of managers is important for the well-being of employees. Central themes of the training are: 1) Self-care and well-being of the manager and how to cope with stress as a manager. 2) Employee well-being and reducing risk-factors in the psychosocial working environment of employee mental health problems. 3) Enhancing protective factors social social support and a healthy team climate. 4) Responding to employees at risk and how to handle difficult conversations and procedures on return to work. 5) Managing well-being in employees during changes and pressure. In order to establish commitment for the waitlist control group, the control group will receive an offer of a webinar and some written information. Middle managers in both intervention arms will receive a questionnaire at baseline, after the intervention and at 6 months follow-up. The intervention group will also receive a short questionnaire after each training. The following expectations are hypothesized: The training will improve self-care and perceived staff-care in middle managers and employees in the intervention group when compared to the control group The training will improve psychological outcomes of stress, well-being, exhaustion and psychological symptoms among middle managers and employees in the intervention group when compared to the control group The training will improve the perceived psychosocial working environment (PSWE) among middle managers and employees in the intervention group when compared to the control group The training will reduce sickness absence and retention among middle managers and employees in the intervention group when compared to the control group Middle managers who adhere more to the training will experience larger improvements in self-care, staff-care and mental outcomes

Sensory Mindfulness for NICU Mothers: Effects on Breast Milk, Well-Being, and Stress

Abstract Background: Breast milk is the optimal source of nutrition for infant growth and development and provides important physical and psychological benefits for mothers. Because many infants in the Neonatal Intensive Care Units (NICU) cannot be breastfed directly, mothers are required to express milk regularly; however, stress, anxiety, and depression may negatively affect milk production and the milk ejection reflex. This study aims to evaluate the effect of the sensory mindfulness intervention on breast milk volume, pumping duration, maternal well-being, stress levels, and cognitive and emotional mindfulness.

Light Therapy for University Students

The effects of light therapy on well-being among university students was investigated. A three-week intervention study examined whether the use of light glasses improved sleep quality and concentration and reduced symptoms of depression and anxiety among university students. First, a questionnaire was administered to about 130 students to screen for sleep problems. Based on the responses, those with the most sleep problems were invited to participate in the intervention study, which resulted in 39 participants in total. Although studies of light therapy for sleep problems and depression among patients have yielded positive results, the use of light has not been studied much among healthy individuals. The intervention study used glasses that project light in two intensities and participants were randomized into two groups with different intensities of light. The aim of the study was to: a) compare the effects of different light intensities on sleep and concentration and b) investigate whether light therapy influences symptoms of depression and anxiety among university students. The study is expected to increase knowledge of light therapy among healthy individuals, and if the treatment proves successful, it is an easy and inexpensive way to increase well-being among university students.

WELL-being Improvement Following Sophrology Practice

Stress and psychosocial risks are a major public health problem.Sophrology is a psycho-corporal method exclusively verbal and non-tactile used as a therapeutic technique. It combines a set of techniques that will act both on the body and on the mind through breathing exercises, muscle relaxation and mental imagery (or visualization). It allows to find a state of well-being and to activate all physical and psychological potential in order to acquire a better knowledge of oneself. Sophrology demonstrated some benefits on symptoms of patients. However, these approaches have never been evaluated with a prolonged follow-up of several months, with biological measures or with adjustments according to the levels of mastery of sophrology. This project proposes to evaluate the effects of sophrology practice. The investigators aim to evaluate both subjective and objective measures of stress.

Exploring and Evaluating the Impact of 'Refresh and Reconnect!'

Dementia and mild cognitive impairment are a rising concern for the ageing population in Singapore, leading to diminished quality of life and health outcomes. Arts-based interventions in a museum setting have been shown to improve cognitive health and well-being for Persons with Cognitive Impairment (PWCIs), however little is known about the relationship of heritage-based interventions on the health and well-being of PWCIs. This mixed-methods study evaluates the 6-week "Refresh and Reconnect!" programme (R\&R!), a museum-based heritage programme including guided artist-led activities and tours of the National Museum of Singapore. (i) In the quantitative study (n = 64-120 PWCIs, comprising with mild cognitive impairment (MCI) or mild dementia), assessments will be conducted at 2 time points (pre-programme, post-programme) to evaluate change in cognitive, social, and mental well-being. ii) In the qualitative study, ethnographic observations of the R\&R! programme; ethnographic interviews with staff (n= max 3), \& artists (n= max 6); and in-depth interviews with PWCIs (n=16) will be used to elicit the underlying context-mechanisms-outcomes which enable R\&R! success. Programme volunteers will also be engaged through casual or informal conversations as part of the ethnographic observations. The study will provide valuable insights for the development of effective, non-pharmacological interventions for PWCIs. The primary objectives of the study are to (a) compare the change (before and after programme participation) in the health and well-being of PWCIs participating in the programme, and (b) assess the change (before and after programme participation) in the perception of the museum, 'heritage' and learning among PWCIs participating in the programme. The secondary aims are to understand the factors, contexts, and mechanisms that influence the implementation of the museum-based intervention and its effects, including the place-based effects of the curated museum Reunion space for PWCIs. Achieving the objectives will help answer the following research questions: 1. To what extent, and how does participation in the "Refresh and Reconnect!" programme impact health and well-being of PWCIs? 2. To what extent, and how does participation in the programme affect the study participants' understanding and perception of the museum as a potential place to enhance one's health and well-being? \[Note: Study Participants include all who are participating in the study such as PWCIs and those who are implementing (e.g. museum staff), facilitating (e.g. artists) and assisting (e.g. volunteers) with the R\&R! Programme\] 3. What are the contexts and mechanisms that influence the implementation of the programme? These findings are of significant public health importance for Singapore, potentially informing policy decisions, resource allocation, and healthcare strategies to better support PWCIs, ultimately improving their quality of life. Findings of the study may also contribute to similar heritage-based programmes in future, contributing to the understanding of key elements of programme success, and for whom these programmes are effective for.

A Tailored and Digital Approach to Address Equity and Support Well-being for Healthcare Workers in the Era of COVID

For this project the broad research objective is to evaluate the effectiveness of an enhanced digital wellbeing program in improving well-being, depression, anxiety, stress, resilience, and job satisfaction of physicians. The intent of the investigators is that this will enable a proactive culture of well-being and mental health support for the broader healthcare workforce during the multiple phases of the pandemic. The investigator's approach evaluates existing digital models which can be executed in a timely fashion and rapidly scaled for use across other health systems. Aim 1: Conduct interviews of URM and women physicians to identify barriers and facilitators to accessing and receiving digital well-being, mental health, and culturally sensitive support resources. Aim 2: Through a randomized controlled trial (RCT) investigate the immediate and long-term effect of a comprehensive well-being focused intervention (push text messaging, resource support, semi-facilitated peer groups hosted by Cobalt) vs. usual care on well-being, depression, anxiety, stress, resilience, and job satisfaction of physicians practicing in the era of COVID.

Evaluation of a Personalised Digital Intervention (EviBody) for Healthy and Sustained Lifestyle Behaviors and Well-being Among Adults: a Real-world Quasi-experimental Study

The goal of this quasi-experimental observational study is to evaluate the impact of a personally tailored digital intervention aimed to support a healthy lifestyle on well-being, lifestyle behaviors, and mental health among the adult population. The main questions it aims to answer are: I) Is a digital intervention developed to offer personalised digital support for healthy habits effective in improving well-being compared to a control group from the general population after 6 months? II) Is the effectiveness dose-dependent (better effect with higher membership level)? III) Does the digital intervention assist in maintaining healthy eating and physical activity habits, mental health, and well-being across 24 months? IV) Are sociodemographic factors associated with achieving the self-identified goals and improvements in eating and physical activity habits, mental health, and well-being? VI) Do engagement, motivation, self-efficacy, and perceived barriers mediate the associations between sociodemographic characteristics and changes in self-identified goals, eating and physical activity habits, mental health, and well-being over a 24-month period? V) How is the pattern of user engagement across 24 months? Participants are users of the mobile phone application EviBody. The group will be compared with individuals from the general population to evaluate if the digital intervention is effective in improving well-being, eating and physical activity habits, and mental health.

"11 for Health" in Pakistan - Effects on Physical Fitness, Health Knowledge and Well-being of 8-14-year-old Schoolchildren

This study examined the effects of a school-based football intervention, the "11 for Health" (11fH) programme, on cardiorespiratory health, musculoskeletal fitness, health knowledge and well-being among Pakistani school children. The main questions it aimed to answer were: * Does the programme enhance Pakistani schoolchildren's cardiorespiratory health and physical fitness, including blood pressure, resting heart rate, aerobic capacity, horizontal jumping ability, agility, 30-m sprint, postural balance, BMI and waist circumference? * Does it improve their health knowledge and well-being? Researchers compared students who participated in the "11 for Health" intervention to those who continued their regular school curriculum. 254 fifth- and sixth-grade students (126 boys, 128 girls) from five schools in Islamabad participated in this study, allocated to an 11-week intervention group, a 5-week intervention group, and a control group. Researchers tested all groups before and after the intervention. Cardiorespiratory health and physical fitness were assessed with standardized tests. Health knowledge and well-being were measured with validated Urdu questionnaires.

Mindfulness in a College Physiology Course

This proposed study aims to evaluate whether integrating mindfulness into an undergraduate biology course (Mindful Physiology) influences students' trait and applied mindfulness, well-being, and physiological stress reactivity. The primary questions are 1. Would completing the Mindful Physiology course increase applied mindfulness? 2. Would completing the class increase trait mindfulness? 3. Would completing the class increase subjective well-being? 4. Would completing the class reduce physiological stress response to an acute social stressor?

Yoga, Meditation and Mindful Eating Intervention in University Students

The aim of this study is to learn whether a program that combines yoga, meditation, and mindful eating can help reduce stress, anxiety, and depression, and improve mindfulness in university students. The main questions the study aims to answer are: * Does participating in yoga, meditation, and mindful eating sessions lower students' levels of stress, anxiety, and depression? * Does the program improve students' mindfulness and general well-being? What will happen in the study: Participants will: * Attend weekly sessions of yoga, meditation, and mindful eating for 32 hours total. * Practice physical postures (Asanas), breathing exercises (Pranayama), relaxation, and meditation. * Receive short lessons about mindful nutrition and healthy lifestyle habits. * Complete questionnaires before and after the program to measure stress, anxiety, depression, and mindfulness.

Effects of Virtual Reality With Multisensory Stimulation on Emotional and Behavioral Disorders in Individuals With Acquired Brain Injury and Disability Requiring Institutional Care: a Single Case Experimental Design (SCED) Study.

Acquired brain injuries (ABIs) frequently cause emotional and behavioral disorders that impair independence and quality of life, particularly in institutions. Virtual reality (VR), already used in various mental and neurological disorders, offers therapeutic potential that remains largely unexplored in this context. Multisensory devices offer enhanced immersion that can potentially increase the relaxation and calming effect. Their use in specialized care home (SCH) could provide additional support for care. The main objective of the study is to measure the effect of an 8-week multisensory VR relaxation program on the most significant emotional and behavioral disorders in adults with acquired brain injury living in SCH. The SCED method with multiple baselines across subjects (ABA) is used with three adult residents with ABCI and behavioral disorders living in SCH. The study consists of three phases (baseline, intervention, follow-up), during which the three main emotional and behavioral disorders of each resident are assessed weekly based on observations made throughout the week. Additional measures include the assessment of the socio-emotional profile by the care team (ECCSEG) and the emotional distress experienced by residents (QOLIBRI), collected twice per phase. The intervention consists of eight weeks of VR relaxation (VirtySens®), with two 15-minute sessions per week. All measurements taken during the experiment will be anonymized and used only by the investigators, who are fully aware of the European GDPR (General Data Protection Regulation) concerning the protection of personal data.

Cocreating Action to Improve Rationality in the Health System

Despite widespread recognition of social, economic, or environmental health determinants, health action remains heavily dominated by individual-level solutions (e.g., medication, patient counselling, vaccination). This study aims to stimulate changes in health system functioning by demonstrating how the cocreation of actions to address psychological well-being, cardiovascular health, and antimicrobial resistance from within the community can alleviate the burden on primary care services, reduce medicalisation and increase health equity. The scientific approach uses mixed methods and incorporates theory from multiple disciplines. This study will appraise how the current system addresses psychological well-being, cardiovascular (CV) health, and rational use of antibiotics using a population survey, a survey of patients collecting their medication at community pharmacies, aggregate health service indicators on medication consumption and primary care consultations, and qualitative methods exploring stakeholders' perceptions.The investigators will undertake community-based participatory research to engage citizen scientists in the cocreation of community-led actions to promote psychological well-being, CV health, and prevent antimicrobial resistance. The design, implementation, and evaluation of the actions will apply an assets-based approach and apply theories and frameworks from implementation science in an iterative manner over 3 years. Finally, the impact of the cocreated actions will be analysed, considering effectiveness and broader contextual issues such as initiative adoption, implementation, and maintenance. The investigators will use a before-after comparison of survey indicators, an interrupted time-series analysis of health service data and qualitative analysis. The goal is to demonstrate how the integration of community action with attention to the social determinants of health, can lead to a more rational approach to health care and ultimately improve health and health equity.

Light in Healthcare Environment (Ljus i sjukhusmiljö)

The goal of this clinical trial is to learn if light can enhance the feeling of well-being and sleep quality in Radiographers. It will also find out if there is an optimal recipe for light. The main questions it aims to answer are: * Will alertness, energy levels, and sleep quality increase in radiographers when the lighting is differed? * What light recipe is the most beneficial for the personnel? Researchers will compare no enhanced light environment to different enhanced light environment to see if the enhanced light is beneficial for radiographers. Participants will: * Will work in an enhanced light environment or a non-enhanced light environment * Answer surveys * Take saliva sample

Nonviolent Communication for Parents

This randomised controlled trial (RCT) aims to evaluate the effectiveness of face-to-face Nonviolent Communication (NVC) intervention in improving parents' mental well-being and NVC skills, reducing parenting stress, depression and anxiety symptoms, and child emotional and behavioural problems. A total of 172 parents with primary-school-age children will be recruited and randomly assigned to an intervention group or a waitlist control group. The intervention group will receive six weekly 1.5-hour face-to-face NVC training sessions delivered by trained social workers. Five to ten social workers will be trained by professional NVC trainers through a train-the-trainer workshop, including three sessions. Each social worker will be assessed before (TTT1), after (TTT2) the workshops and 10 months (TTT3). Assessments for participants will be conducted at baseline (T1), immediately post-intervention (T2), and at three-month follow-up (T3). After completing the assessments, the waitlist control group will receive the same sessions. Qualitative interviews will be conducted to explore participants' experiences and perceptions of NVC.

Community Park-Based Programs for Health Promotion: Fit2Play Prospective Cohort Study

The Fit2Play prospective cohort study examines the effects of a park-based youth physical activity afterschool program on youth participant fitness and mental health outcomes. Duke will perform a secondary analysis of the data collected as part of the Fit2Play prospective cohort study run by Miami-Dade County Parks and Recreation.

Yoga in Women With Surgical Menopause After Gynecological Cancer

This randomized controlled trial investigates the effects of yoga on quality of life, sleep quality, and spiritual well-being in women who have entered surgical menopause after gynecological cancer surgery. Yoga is expected to be a supportive intervention for symptom management and to improve overall well-being in this patient population.

Impact of a Physical Activity Intervention on Sleep Quality, Mental and Physical Well-Being in Health Sciences Students

This randomized controlled trial aims to compare the effects of a regular weekly physical activity program versus a "Weekend Warrior" activity pattern on sleep quality, physical well-being, and mental well-being in sedentary university students. Participants will be randomly assigned to one of the intervention groups or to a control group and assessed at baseline and after the intervention.

Intergenerational Mealtime at a Shared Site: A Small-scale Trial

The goal of this study is to find out whether having children and older people who attend an intergenerational center eating lunch together on a regular basis may be an improvement over continuing to eat lunch with their generational peers in separate dining rooms at the center. Specifically, the study analyzes the functioning and potential impact of an intergenerational dining room in terms of healthy eating, nutrition, self-evaluation of health and well-being, relational care, nutritional knowledge, and intergenerational attitudes. For this purpose, it sets up, in an intergenerational center, a dining room attended by children aged 2-3 years and older people aged 75 years and older who had previously been taking their lunch in separate dining rooms at the center. The main questions this study aims to answer are: * Does eating lunch at the intergenerational dining room improve the intake of healthy foods by children and older people compared to eating at their usual separate dining rooms with their peers? * Does this type of intergenerational dining room serve as a space for nutritional education of children and older people? * Does the experience of eating together have a positive influence in terms of children's attitudes towards older people and vice versa?

Intensive Care Unit Resident Scheduling Trial

Many patients, doctors and others worry that tired doctors provide worse patient care, may not learn well and become burnt-out. In response to these concerns, some countries changed their laws to limit work-hours for doctors in training ('residents'). In Canada, most residents work six or seven 24-30h shifts each month. A recent Canadian report ordered by Health Canada said that making good decisions about resident work-hour rules was "significantly limited by quality evidence, especially evidence directly attributable to the Canadian context." Creating this evidence is the main goal of this research. The pilot study in 2 intensive care units(ICU) found that shorter shifts may be worse for patients, and for residents were more tiring than expected but improved wellbeing. Learning was not assessed. Previous studies on resident work-hours report similar findings: conflicting effects for patients, benefits for resident wellbeing, inconsistent and under-studied effects on learning. Overall, these results are not conclusive and confirm the need for a larger study. The current study will provide high-quality Canadian evidence. The investigators will compare two common ICU schedules used in Canada: resident shifts of 16h and 24h. ICU patients are very sick, there is little margin for error: they need doctors who know them well and are thinking clearly. The effects of each schedule on patients and residents will be measured. For patients, mortality rates and harm caused by care in ICU will be studied. For resident education, their learning about managing common illnesses in ICU, to do basic ICU procedures, and communicate with families will be studied. For resident wellbeing measures will include sleepiness, other fatigue symptoms, and burnout. Investigators will study both resident and patient outcomes so that Canadians can understand trade-offs linked to changing schedules. With this knowledge, Canadians can expect safer care for today's patients and better-trained doctors for the patients of tomorrow.

Inforcing Spiritual Care: Enhancing Well-Being and Competency in Psychiatric Nurses

This study was done to evaluate the effectiveness of spiritual care education program in enhancing the well-being and competency of psychiatric nurses.

Addressing the Mental Health and Emotional Well-being of Immigrants Through a Scalable Intervention

We will study the impacts of offering access to an emotional well-being phone app to Hispanic U.S. immigrants in psychological distress. Our primary outcome is participants' psychological well-being.