Clinical Research Directory

Randomized Controlled Trial on Precision Mental Health

The current study aims to evaluate the effectiveness of different online psychological interventions, including guided and unguided transdiagnostic cognitive behavioural therapy, and unguided mindfulness-based intervention, on mental well-being in comparison to waitlist control. It is hypothesized that participants with the guided psychological intervention will show (H1) a greater reduction in mental health symptoms, and (H2) better mental well-being compared with participants with unguided psychological intervention and the control condition.

The IGNITE Study on Concentrated Investment in Black Neighborhoods

Black Americans in the US fare worse across nearly every health indicator compared to White individuals. In Philadelphia, the location of this study, these health disparities culminate in a stark longevity gap, with average life expectancies in poor, predominantly Black neighborhoods being 20 years lower than in nearby affluent, predominantly White neighborhoods. The investigators will conduct a cluster randomized controlled trial (RCT) of a suite of place-based and financial-wellbeing interventions at the community, organization, and individual/household levels that address the social determinants of racial health disparities. At the community level, the investigators address underinvestment in Black neighborhoods by implementing vacant lot greening, abandoned house remediation, tree planting, and trash cleanup. At the organization level, the investigators partner with community-based financial empowerment providers to develop cross-organizational infrastructure to increase reach and maximize efficiency. At the individual/household levels, the investigators increase access to public benefits, financial counseling and tax preparation services, and emergency cash assistance. The investigators will test this "big push" intervention in 60 Black neighborhood microclusters, with a total of 720 adults. The investigators hypothesize that this "big push" intervention will have significant impact on overall health and wellbeing.

Camouflaged WeChat-based Intervention for Abused Women

Intimate partner violence (IPV) is a major public health issue and human rights threat worldwide, especially for Chinese immigrant women victims in Hong Kong. Interventions that address negative physical and emotional outcomes from IPV could therefore play a crucial role in enhancing empowerment, social support, and healthy lifestyle among these women. The overall objective of this pilot mixed methods study is to determine the feasibility and acceptability of a camouflaged WeChat mini-program-based WOMEN Health intervention for women victims of IPV. This study will evaluate the feasibility and acceptability of a camouflaged WeChat mini-program-based WOMEN Health intervention for women victims of IPV.

Integrative Adolescence Research Programme (IARP)

This study aims to understand child health during adolescence. We will examine the role of lifestyle (e.g. physical activity), growth trajectories and other environmental factors that can influence the development of phenotypes in adolescence which confer risk for later physical and mental disorders. With this study, we will develop a deeper understanding of adolescent health and well-being and their main determinants in the local Singaporean context, identify levers for early interventions to mitigate challenges to adolescent health and well-being and enhance protective factors for adolescents to do well in life, contribute to society and maximize their potential.

Psychiatric Outcomes of Unruptured Intracranial Aneurysms (POUIA)

The impact of cerebrovascular procedures on patients experiencing anxiety and depression is not well studied despite the high prevalence of these mental health disorders. Unruptured Intracranial aneurysms (UIAs) have a prevalence of approximately 3% and an annual risk of 1-2% in the general population. Despite the high risk of fatality following aneurysm rupture with a rate of 40-50%, the overall aneurysm growth and rupture risks are rare (less than 3% per aneurysm per year) and many patients can be observed with serial follow-up imaging over years. Nevertheless, due to the gravity of the bad consequences of aneurysm rupture, simply informing many patients of UIA diagnosis has been found to result in worse outcomes of health-related quality of life. This study aims to investigate the impact of awareness of untreated UIA on the patients' mental health utilizing the Hospital Anxiety and Depression Scale (HADS) tool.

COVID-19 Health Adjustments in Nutrition, General Wellness, and Exercise

The purpose of this study is to find out whether the COVID pandemic has affected participants' current physical activity, fitness, blood pressure, sleep, and mental stress to better understand its long-term health effects. To complete this study, participants will visit the Neurovascular Physiology Laboratory (NVPL) at the Indiana University School of Public Health Bloomington two times, requiring a total commitment of about 6 hours. Visit 1 involves completing screening questionnaires, a consent document, and additional questionnaires about participant health behaviors (e.g., sleep and physical activity) and general mental and physical health. After the visit, participants will also start tracking their sleep and physical activity using wearable devices for 14 days, diet for at least 3 days, and blood pressure and urine for 24 hours. Visit 2 is a second data collection visit, where participants will return the wearable devices. The investigators will measure participants' body composition, take measures of their cardiovascular health, and participants will complete a fitness test on a stationary cycle (exercise bike). The investigators will collect a 24 hour urine sample and take a blood sample to measure participants' blood glucose, electrolytes, hydration biomarkers, and markers of inflammation, as well as to study immune cells. The investigators will take participants' blood pressure at rest and during a hand-in-cold water test, which helps assess how participants' nervous system responds to stress. A full-body scan will measure participant body composition including bone density, muscle mass, and body fat percentage. Finally, participants will complete a cycling test that gradually increases in intensity to measure cardiovascular fitness. Risks involve potential pain or bruising from blood draws, discomfort from blood pressure cuffs, stress from vigorous cycling, and psychological stress from questionnaires. There's also a slight risk of severe cardiovascular events occurring during exercise and loss of data confidentiality. Finally, the cold water test may result in a rare but noted situation where the body's nervous system overreacts to the cold stimulus, leading to a drop in blood pressure and heart rate. Participants will be monitored by trained staff during all procedures to ensure safety.

Future Leaders Program: Testing a Youth Leadership, Engagement, and Mindfulness Program

The current study tests the feasibility and effectiveness of a youth intervention designed to provide meaningful leadership opportunities through the acquisition of leadership skills as well as mindfulness practice, LEAP: Leadership, Engagement, and youth Action Program with Mindfulness. The goal of this project is to determine whether the Leadership, Engagement, and youth Action Program with Mindfulness (LEAP) curriculum, which was developed with youth, is a feasible and effective intervention for fostering leadership and well-being. The investigators seek to understand whether LEAP can support wellbeing for youth as a strategy to increase youth mental, emotional, and behavioral (MEB) health.

Artificial Intelligence Powered Mental Health Support Tool For Physicians In Training

The purpose of this pilot study is to evaluate the acceptability of an artificial intelligence powered mental health support tool for mental health wellness amongst physicians in training. The primary research procedures are: The primary research procedure will be the utilization of artificial intelligence powered mental health support session through a web browser for physicians in training to address symptoms related to depression and anxiety. A pre and post intervention survey, evaluating depression symptoms with the standardized PHQ-9 questionnaire and anxiety symptoms with the standardized GAD-7 questionnaire will be conducted to assess changes in mental health wellness. The study will enroll physicians in training, including Internal Medicine residents and Gastroenterology fellows. The study includes at least 4 sessions. The total study duration for each subject is 3 months.

Reducing Pregnancy Risks: The Mastery Lifestyle Intervention

This randomized controlled trial will test an intervention called the Mastery Lifestyle Intervention (the MLI) that was developed from data of 1000+pregnant Hispanic women related to risks of preterm birth. The investigators will deliver a psychoeducational intervention that is manualized over 6 group sessions. The investigators will also have a usual care group that receives standard prenatal care. The investigators plan to enroll 238 pregnant women and start the study with them at 14-20 weeks gestation. The investigators will also test the biological response of the intervention by measuring Corticotropin Releasing Hormone, progesterone, estriol, and test for cotinine. The investigators will also determine any effect on infant outcomes at delivery.

QOL and Mental Health Using APD With Remote Monitoring System

Although peritoneal dialysis (PD) is a representative renal replacement therapy along with hemodialysis, number of PD patients decreases every year. Among the various contributing factors for such trends, the essential issue that the patients should perform dialytic therapy by themselves is thought to be critical for the patients to avoid choosing PD as primary dialytic therapy. In particular, unlike hemodialysis, the patients with PD have troubles in getting timely medical advice in their daily life, although continuous advice are essential for maintaining therapy. Thus, remote monitoring and control system is believed to be useful in PD therapy. Automated PD (APD) is a good option because of its convenience and improved accessibility. So, in Korea, although the rate of incident PD patients was decreased, the proportion of APD were rapidly increased (3.7% in 2001 vs. 39% in 2018, Korean Society of Nephrology (KSN) data) In the COVID-19 pandemic, the investigators should improve Remote therapy monitoring (RTM). Technologies that collect medical information and transmit it to health care providers for patient management, have the potential to improve the patients' outcomes without visiting hospital receiving automated peritoneal dialysis (APD) at home. However, there are only a few retrospective studies and no prospective study about remote patients monitoring programs in APD. Remote medical service is currently illegal in South Korea. However, recently the Korean government has approved remote medical service in only a few areas of Gangwon province, including Wonju city, which belongs to our institution. Thus, the investigators aim to use such a benefit to investigate the 'Quality of Life (QOL)' in Korean patients undergoing APD. The investigators plan to compare the various clinical indexes, including mainly QOL, mental health focusing depression, and volume-nutritional status between the patients with previous classic APD and APD combined by the SharesourceTM system (Baxter Co.).

Emotional Recovery Post-Stroke

The purpose of this study is to evaluate whether adding an emotional wellness component to occupational therapy (OT) and/or speech therapy (ST) telerehabilitation improves overall emotional well-being and activity participation for people with stroke.

Jump Start Plus COVID-19 Support

The purpose of the study is to further develop and examine the Jump Start Plus COVID Support (JS+CS) program, which encourages improved psychosocial functioning by promoting resiliency in childcare centers.

The Family Stress Study - Chronic Stress and Child Adiposity: Testing a Bio-behavioural Model

The Family Stress Study is following families with young children in Guelph, Hamilton and surrounding areas over 3 years to understand how chronic stress impacts children's weight gain over time and how this association is mediated by alterations in children's cortisol production and weight-related behaviours.

Parenting in 2 Worlds Multisite Trial

This research study will test the effectiveness of a culturally grounded parenting intervention called Parenting in 2 Worlds (P2W). This intervention is designed for American Indian / Alaska Native (AI) parents/guardians of adolescents who reside in urban areas. This will be a multi-regional effectiveness trial across four regions: Northeast (Buffalo/Niagara), Midwest (St. Paul/Minneapolis), Mountain (Denver), and Southwest (Phoenix). There are four specific aims. First, this study will test the effectiveness of Parenting in Two Worlds (P2W) as compared to an informational family health intervention, Healthy Families in 2 Worlds (HF2W), in improving parenting and family functioning. Second, this study will test if the relative effectiveness of P2W, compared to HF2W, varies by parent's/guardian's level of socioeconomic vulnerability, experiences of historical loss, or AI cultural identity. Third, this study will examine if P2W can reduce adolescent (ages 12 - 17) risky health behaviors including substance use, depressive symptoms, suicidality, and risky sexual behaviors. Fourth, this study will examine whether positive changes in parenting and family functioning that result from P2W lead to positive changes in adolescent's health behaviors.

Qoyangnuptu: Peer Mentor

The goal of this clinical trial is to learn about the impacts of participating in a peer mentor program in a Southwestern Tribal Community. The main questions it aims to answer are: * In American Indian/Alaska Native communities with unique cultural characteristics, how should a youth-focused sociotechnical behavioral health intervention be designed to encourage sustained engagement and positively impact indicators of behavioral health?; * How can interactive technical interventions be designed to best support sustained community engagement in a challenged network environment? Participants will: * Be trained as peer mentors * Be trained in how to use the QI App to communicate with mentees * Guide daily conversation prompts with a group of 3 mentees via the QI App * Provide daily encouragement to mentees to engage with mindfulness activities on the QI App

Qoyangnuptu: Qoyangnuptu Intervention (QI) App

The goal of this clinical trial is to learn about the impacts of using a mobile health app, the Qoyangnuptu Intervention App (QI App) a Southwestern Tribal Community. The main questions it aims to answer are: In American Indian/Alaska Native communities with unique cultural characteristics, how should a youth-focused sociotechnical behavioral health intervention be designed to encourage sustained engagement and positively impact indicators of behavioral health?; How can interactive technical interventions be designed to best support sustained community engagement in a challenged network environment? Participants will: * Receive daily guidance and encouragement to use the app from an anonymous, trained peer mentor * Be able to ask their peer mentors questions in a monitored one-on-one chat in the QI app or in a monitored group chat in the QI app * Log their mood and stress level on the app once per day * Practice mindfulness skills as directed in the QI app, including guided breathing, meditation, drawing, coloring, and walking * Practice Hopi cultural activities like running using the QI app to help track progress towards team mileage goals

Effects of the 5 Ways to Wellbeing Course Effects of the 5 Ways to Wellbeing Course

Norway and other Western industrialized countries are facing major challenges in terms of preventable health problems, high work absence, largescale demographic changes and rising social inequalities in health. This project addresses the need for effective means to meet these important challenges. The project will scientifically evaluate The 5 Ways to Wellbeing course (5Ways), a novel measure aiming to promote wellbeing and integration, health and work adherence. Subjective wellbeing is systematically and prospectively related to important individual and societal outcomes, including social connectedness and integration, innovation, productivity, work performance, healthy behaviours, health and longevity. Promotion of wellbeing may therefore contribute to address the urgent societal ailments of today. Intervention effects and cost effectiveness of the 5Ways will be examined in-depth in four real-life settings, using quantitative methods. Specifically, we will investigate course impact wellbeing, health and work adherence among users of The Norwegian Labour and Welfare Administration (NAV) and clients in Healthy Life Centres. If effective, the course may be implemented nationwide and contribute to increase wellbeing and work participation. Findings from the study may thus contribute to enable municipalities and workplaces to make better priorities for promoting work presence, reducing suffering and improving mastery and quality of life among their inhabitants.

Health in Work - a Measure for Increased Coping and Work Inclusion

Health in work - a measure for increased coping and work participation -An effect analysis of a health- and work environment intervention at the workplace. Part 1:quantitative data collection The main objective of this study is to investigate the effect of the workplace intervention in the new Norwegian national programme Health in work (HelseIArbeid) through a pragmatic cluster-randomized study. The main hypothesis is that this interdisciplinary health and welfare intervention at the workplace reduces sick leave and improves mastering of common health problems more efficiently than a conventional welfare intervention. More specifically, it is hypothesized that the Health in work intervention has a better cost-effectiveness in terms of sick leave, use of health services and coping with common health problems indicated by an increased health-related quality of life.

Support Groups in the Metaverse for Ukrainian Refugees

The goal of this clinical trial is to test the efficacy of support groups held in the Metaverse, designed to promote mental health and well-being in Ukrainian refugees. Participants: * will be allocated to one of three conditions: (1) Metaverse support group (intervention); (2) In-Person support group (intervention); or (3) Waitlist. * will be asked to participate in 5 support group sessions, once per week, for each intervention condition. The Metaverse support groups will be compared with the In-Person support groups and with the Waitlist, to test: * the efficacy of the Metaverse condition compared to the In-Person condition. * the efficacy of the intervention conditions compared to the waitlist.

Internet Assisted Career-Oriented Soft-skills Training for Transition Age Youth with Mental Health Conditions

The purpose of this study is to evaluate the effectiveness of an internet- assisted Career-Oriented Work-Related Soft-skills Training (iCareer) intervention, infused with cognitive behavioral therapy, targeting individuals ages 16-24 with mental health conditions, to improve employment outcomes. The overall objective is to help transition-age youth (TAY) with psychiatric disabilities achieve optimal employment outcomes as part of successful transition to adulthood. Findings will have implications for enhancing and developing pre-employment services for TAY with psychiatric disabilities.

Healthy Early Life Moments in Singapore

This study aims to assess whether an integrated continuum of care from the preconception period, across maternity until the first 18 months of life, can promote maternal metabolic and mental health, as well as offspring health, among overweight and obese women.

The Effect of Multi-Strategy Approaches on Limiting Digital Exposure

In the digital age, university students are increasingly immersed in a technology-driven environment where smartphones, social media, and various digital platforms play a central role in their daily lives. While these technologies offer significant benefits, such as enhanced connectivity, access to information, and educational resources, they also pose potential risks to mental health. Excessive screen time, constant connectivity, and the pressure to maintain an online presence can lead to negative outcomes, including anxiety, depression, sleep disturbances, and reduced academic performance.

Examining Engagement Predictors of Health and Fitness App Uptake and Subscription in the General Population

This will be a 24-week prospective study that will incorporate user base data of WayBetter Inc.'s app, "WayBetter," to examine user mHealth app engagement. The primary objective of this study is to examine predictors (i.e., socio-demographics, past health behaviours, psychological determinants, app engagement metrics) of (a) initial six-month subscription and b) subscription renewal rates at six months for the WayBetter app. The secondary objective is to characterize WayBetter app engagement over the first 24 weeks of app use. Participants will be asked to complete a survey that aims to collect the information regarding individual-level socio-demographics, previous health behaviours, and behavioural/personality traits. App engagement metrics will be collected from the WayBetter app.

Reconstructing Schoolyards With Greenery to Increase Schoolchildren's Physical Activity and Mitigate Climate Changes

By reconstructing schoolyards with greenery, physical activity levels among children can be increased at the population level and also mitigate health and environmental risks resulting from rising climate changes in urban areas. The overarching purpose of the proposed project is to: i. increase physical activity levels among school-aged children, independent of socioeconomic factors, and thus affect short- and long-term health outcomes on a population level ii. establish an evidence-based bottom-up approach for schoolyard reconstructions iii. evaluate the cost-effectiveness of schoolyard reconstructions with greening on health outcomes and its environmental impact