Clinical Research Directory

The Weight of Victory: Exploring Short- and Long-term Health Outcomes in Former Male & Female Elite Athletes From Weight-sensitive Sports

The health of former elite athletes has been identified as a critical research gap where there is limited knowledge about both short- and long-term consequences after ending their careers. The transition phase from an active elite career to everyday life has been shown to be particularly problematic, yet this issue has been little studied among former Norwegian elite athletes. Furthermore, questions remain regarding the health of athletes from weight-sensitive sports, such as weight-class, aesthetic, and certain endurance sports. These athletes face specific challenges related to maintaining a certain physique and frequent changes in body weight during their active careers. This group has been shown to be vulnerable to a range of problematic health outcomes related to low energy availability, and little is known about the long-term effects of a career involving this. Therefore, the overall purpose of the project is to map the mental and physical health of former elite athletes. At the same time, there will be a particular focus on the differences between weight-sensitive and less weight-sensitive sports, different types of sports, gender, as well as previous dieting and eating behaviors.

Palestinian ParentText for Crisis: A Parenting Chabot in War and Displacement

The primary aim of this research is to evaluate if ParentText for Crisis helps improve the following outcomes among Palestinian caregivers living in Jordan: a.) Improving caregiver mental health; b.) Improving positive parenting practices; c.) Reducing violence against children

Stress Management Training for Nursing Professionals in a Tertiary Care Center in Nepal

The goal of this clinical trial is to learn if stress management programs can help alleviate existing and prevent future symptoms of stress in nursing professionals working in a tertiary care center in Nepal. Researchers will compare the treatment group (exposed to stress management training) to the control group (not exposed to stress management training) to see if 1. Stress management sessions lead to reduction of levels of stress among nurses at tertiary level hospital in Nepal. 2. To compare the pre and post training stress levels among participants of intervention and control group Participants will Fill out the Depression, Anxiety and Stress Scale 21 and the Perceived Stress Scale before either being exposed to a 4-session stress management training (treatment group) or not being exposed to such training (control). All participants (both groups) will fill out the Depression, Anxiety and Stress Scale 21 and the Perceived Stress Scale for pre-post comparative measure.

French Validation of the Recovery Assessment Scale (RAS-FR)

The VAL-RAS-FR study aims to cross-culturally adapt, validate, and develop derived versions of the Recovery Assessment Scale (RAS), an internationally used self-report measure of subjective recovery in mental health. The study will include 260 adult psychiatric patients receiving care at EPSM Metz-Jury in both inpatient and outpatient settings. Participants will complete the French version of the RAS (RAS-FR), the WHOQOL-BREF, and additional self-report questionnaires. A subgroup of participants will complete the RAS-FR again after one month to assess test-retest reliability. The study will also explore existential aspects of recovery through the development of the RAS-FR-EX (Existential Extension) and support the development of a shorter version, the RAS-FR-SF (Short Form), for clinical and research purposes.

A Natural History of Cardiometabolic Disease Among US Bhutanese: Developing the Cross-Sectional Bhutanese Community of Central Ohio Health Study to Understand Acculturation as Synergizing Socioenvironmental and Biobehavioral Risk Factors Propagating ...

Background: As of 2021, almost 45 million people in the United States were foreign-born immigrants. South Asians, including people from Bhutan, are the fastest-growing immigrant subgroup in the US. Their income and education levels are higher than the US average. Yet they have worse physical and mental health outcomes than their White US-born counterparts. These risks include type 2 diabetes and obesity. Objective: This natural history study will explore how life experiences and environmental factors affect heart health and metabolism among Bhutanese people living in the US. Eligibility: Adults aged 18 years or older who identify as Bhutanese and live in the US. Design: Participants will be recruited and screened by the Bhutanese Community of Central Ohio (BCCO). They will have 1 visit to the BCCO s Arogya Clinic in Reynoldsburg. The visit will last 2 hours. Participants will take a survey; they may use either English or Nepali. They will answer questions about their background; their experiences living in the US; and how their customs and habits might have changed. They will also be asked about their experiences with discrimination; their mental health and well-being; their community; quality of life; and overall physical health. The survey will take 60 minutes. Participants will also speak with a researcher. They will be asked how they feel about providing biological samples; these may include saliva, blood, and urine. Their answers will be audio recorded.

Innovative Health Intervention for Ethiopian Migrant Domestic Workers in the Middle East

Migration is a complex phenomenon with profound health implications. Every year, more than 350,000 Ethiopian women migrate to the Middle East legally, and many others illegally, seeking domestic work. Economic crisis, rising unemployment, and internal conflict contribute to this massive migration. Nevertheless, MDWs in the Middle East are subject to overwork; mental, sexual and reproductive health challenges; and limited healthcare access. Studies on MDWs are mostly exploratory or cross-sectional; longitudinal and intervention studies are lacking. Thus, this implementation science protocol outlines a study to develop, implement, and evaluate a multi-component health intervention for Ethiopian MDWs in the Middle East. The intervention integrates peer-support, digital skills training, self-help groups, and community empowerment, guided by risk stratification and using a mobile application. A cluster randomized controlled trial (RCT) will assess the intervention's population-level impact and cost-effectiveness over 24 months. A process evaluation will run in parallel to explore mechanisms of implementation and identify strategies for better optimization. The study has three research questions (RQs): RQ1 - What individual and work characteristics predict psychological distress among Ethiopian MDWs in the Middle East? To address this question, a cross-sectional survey will be conducted among MDWs in selected Middle East countries using a 21-item validated psychological distress scale (Depression, Anxiety and Stress Scale \[DASS-21\] as the outcome measure. RQ2 - What is the effectiveness and impact of INNOVETH interventions among Ethiopian MDWs in the Middle East? Under this research question, the investigators aim to conduct pre-departure assessment, baseline survey, midline evaluation, and endline evaluation of the INNOVETH implementation. Process evaluation will also be conducted as the intervention proceeds. Pre-departure assessment: a survey will be conducted among MDWs before their departure to the Middle East countries. Baseline assessment: a cross-sectional survey will be conducted among Ethiopian MDWs three months after they migrate to the Middle East countries. Midline evaluation: an interim survey will be conducted after 12 months of MDWs' departure. Impact evaluation: after 24 months of implementing the intervention, endline survey will be conducted to assess programme population-level effects. Process evaluation: the process evaluation will document intervention implementation, perceptions of feasibility and acceptability of the intervention throughout the trial period. RQ3 - What is the cost-effectiveness of the INNOVETH interventions Under this research question, the investigators will assess the cost-effectiveness of the INNOVETH project, including providing guidance on maximal costs for a given level of effectiveness. Cost-effectiveness will also be interpreted against relevant willingness -to-pay (WTP) thresholds to determine value for money. Further, we will also examine the overall benefits of INNOVETH intervention in terms of quality of adjusted life years. Overall, this project aims to improve mental, sexual reproductive health of Ethiopian MDWs in the Middle East. Results will be shared via peer-reviewed journals, policy briefs, stakeholder workshops, and open-access platforms. The project period is 4 years (Nov 2025 to October 2029).

Reducing Unmet Mental Health Need of African-American Children

The purpose of this study is to compare two versions of school-based mental health screening to improve the receipt of mental health services among elementary school students.

Brief Virtual Mindfulness-based Group Intervention With Social Support for Perinatal Individuals

This is a feasibility and acceptability study for 4- week virtual mindfulness-based intervention with social support for perinatal individuals at higher risk for substance use. This study builds on the longitudinal collection of questionnaire data from pregnant and postpartum people during the COVID-19 pandemic. Each closed virtual support group will meet weekly for 4 weeks using a video conference platform. Groups will be focused on grounding, thinking patterns, self-compassion and self-care. This approach will foster increase awareness of wellbeing as well as social support between group participants. Primary outcomes include the feasibility and acceptability of this group-based intervention for perinatal individuals.

Optimizing HIV Pre-exposure Prophylaxis (PrEP) Among Women Who Use Drugs in Tanzania

This study is testing two different approaches to help women who use drugs in Tanzania take and continue using HIV prevention medication called pre-exposure prophylaxis (PrEP). Women who use drugs face a higher risk of HIV infection, but many do not start or continue PrEP due to barriers like stigma, mental health challenges, and lack of support. The study will enroll 200 women who use drugs in Dar es Salaam, Tanzania. These women will be randomly assigned to one of three groups: Motivational Interviewing for PrEP (MI-PrEP) Only - Women in this group will receive two one-hour counseling sessions focused on HIV prevention, PrEP education, and problem-solving to help the women start and continue using PrEP. Common Elements Treatment Approach (CETA) + MI-PrEP - Women in this group will receive the same MI-PrEP counseling sessions plus additional mental health counseling (up to 14 sessions) tailored to the women's individual needs, addressing issues like depression, anxiety, trauma, and substance use. Treatment as Usual (TAU) - Women in this group will receive basic information on PrEP, mental health, and harm reduction, along with optional referrals to PrEP or drug treatment clinics. The study will evaluate feasibility of administering MI-PrEP and CETA+MI-PrEP and how well these interventions help women start and stay on PrEP, as well as the intervention's impact on mental health and drug use. Researchers will also interview participants and counselors to understand the participants and counselors experiences with the program. The goal is to find effective ways to support PrEP use among women who use drugs and to develop a model that could be used in similar settings to reduce HIV risk. This pilot study is approved by ethics committees in the United States and Tanzania, and results will be shared with communities, policymakers, and researchers.

Impact of Device Free Summer Camp on Adolescent Mental Health and Wellbeing

The goal of this clinical trial is to understand if attendance of a device-free summer camp, representing a shift from a digital environment to one that is device free and involves in person social interaction, can change mental health status and brain physiology in teens age 12-17. The main question it aims to answer is: * How much is aggregate mental health and its various dimensions and components changed at the end of the camp attendance relative to the start of camp. * How much is brain physiology, as measured by EEG change, changed at the end of camp relative to the start of camp. Participants are recruited from among teens signed up to attend 2 or 3.5 week sessions a summer camp in Maine.

BasketballRx: Game Changing Health

The goal of this study is to learn if BasketballRx, a basketball and health program, works well for children and teens who are overweight or have obesity. The study will also look at whether the program helps children build healthy habits, improve their health, and feel better. The main questions the BasketballRx clinical trial aims to answer are: 1. Is the BasketballRx program easy for children and families to take part in and complete? 2. Do children show changes in their healthy habits, physical health, or emotional well-being after completing the program? Participants will: * Attend 6 BasketballRx sessions over 2 months * Take part in health lessons and basketball activities * Learn about healthy eating, exercise, sleep, and ways to manage stress * Have their height, weight, waist size, blood pressure, and heart rate checked * Answer questions about how they feel and their healthy habits

The Effect of MediYoga on Sleep Quality, Blood Pressure, and Quality of Life in Older Adults With Hypertension:

The goal of this Randomized Controlled Trial is to test if an intervention consisting of Yoga can increase quality of sleep and health related quality of life and decrease BP. Secondary to explore and describe the implementation of a yoga intervention and the participants' experiences and perspectives on the intervention in a process evaluation. The main question it aims to contribute knowledge about intervention of Yoga in a home environment for individuals with hypertension aged 65 years or older. Participants will (if they got selected into one of the two interventions groups), participate in Yoga exercises delivered by an app for 2 times a week for 10 weeks. Researchers will compare the intervention groups with the control group to see if Medi yoga has an effect in older people with hypertension.

Trial Phase: Syndemic Adapted Medly Uganda

The purpose of this study is to evaluate the effectiveness of the Syndemic-Adapted Medly Uganda (SAMU) in improving mental health care among adults living with HIV and hypertension in Uganda. In sub-Saharan Africa (SSA), there is a high prevalence of depression and anxiety among people living with HIV (PLHIV) as well as alcohol use disorder (AUD). PLHIV who experience depression are less likely to link to HIV care, adhere to antiretroviral therapy, and achieve viral suppression. Building on research conducted to adapt Medly Uganda for mental health using a syndemic framework, this study aims to assess the effectiveness of SAMU on mental health screening and diagnosis. This will be accomplished through a two-arm trial in which 1. participants will be enrolled, screened, re-screened, and assessed for diagnosis and linkage to care for depression, anxiety and AUD and 2. evaluate the factors impacting sustained engagement in the SAMU program, through mixed methods.

Relationship Checkups to Reduce Veteran Suicide Risk

This study compares two approaches to working with Veterans that have a mix of mental health and relationship concerns in primary care. One approach is a 3-session couple-based program called the Brief Relationship Checkup (BRC). BRC has shown promise improving relationship health in Air Force primary care (including some mental health symptoms related to relationship functioning) but has never been tested for individuals with significant mental health concerns. The other approach is a high-quality delivery of three sessions of Co-Located Collaborative Care (CCC) with the Screened Veteran only. This program is the current standard of care for Veterans reporting mental health concerns in primary care (including mental health concerns related to their relationship) but has never been tested for individuals struggling with relationship concerns. The goal is to compare the benefits of the couples-based program vs. the individual-based program when it comes to reducing suicide risk factors at the relationship level and the individual level.

Khanya Ekhaya: A Home-Based Intervention

Mental health conditions, such as depression, anxiety, and harmful alcohol use are prevalent among people with chronic diseases, including HIV, and contribute to poor engagement in care. There is a need to address untreated mental health problems. Community health workers (CHWs) are frontline workers who play a central role in supporting vulnerable individuals to stay in care, including seeking people living with HIV who are newly initiating antiretroviral therapy (ART) or re-initiating after a period of care disengagement. CHW-delivered interventions are promising for improving engagement and retention in care. Yet, these programs rarely address mental health -a significant barrier to chronic disease care engagement and treatment. An approach that moves beyond providing care in the clinic setting is needed. Community-delivered mental health care shows promise for integration into broader community health care services for people with chronic conditions, such as HIV. However, as CHWs are taking on more mental health care roles and community-based work, our team's preliminary research has demonstrated that high levels of stress and burnout are important considerations for successful implementation of these models.

Digital Mental Health for Asian Americans

Aim 1: Assess clinicians' receptiveness and potential use of Anise's online platform digital tools for managing sociocultural stressors and revise the tools for implementation. We will recruit 8 new clinicians (intervention group) who will receive training and provide feedback on the digital tools. Aim 2: Evaluate the initial efficacy of the online platform digital tools for managing the impact of sociocultural stressors with 64 Asian American clients. The intervention group clinicians (receiving training and using the digital tools) and newly recruited 8 clinicians (not receiving training and not using the digital tools) for the control group will work with 4 clients each. The clinical outcome data of the clients will be analyzed to examine differences in the client prognosis between the control and intervention group. A successful outcome of this project will be digital materials that effectively address the impact of sociocultural stressors for Asian Americans on Anise Health's digital health platform.

Effect of a Telephone Reminiscence Intervention on Mental Health

The goal of this study is to learn whether a telephone-based program that helps people share life memories can reduce loneliness and improve mental well-being, life satisfaction, and social support in older adults and their caregivers living in rural areas. This study has two parts. In the first part, researchers will gather feedback from a small group of older adults and informal caregivers to see if the updated telephone reminiscence program works well and is easy to use. In the second part, researchers will test the telephone reminiscence program in a clinical trial study to see whether the updated telephone reminiscence program reduces loneliness and improves social support, life satisfaction, and mental well-being in older adults and their caregivers. The researchers will also examine how the program impacts how often and for what reason you reminisce. The main questions this study aims to answer are: * Does the telephone reminiscence program improve social support, life satisfaction, and mental well-being and reduce loneliness in rural older adults and their caregivers? How does the telephone reminiscence impact how often and for what reason participants reminisce? * How often and how long do participants use the program? * How satisfied are older adults and informal caregivers with the program? In this study researchers will compare participants who begin the telephone reminiscence program right away with participants who start the program after a 12-week waiting period to see whether starting the program earlier leads to better outcomes. Participants will: * Take part in telephone calls 3 times a week that invite older adults to talk about their life experiences. * Answer brief survey questions about social support, loneliness, and mental well-being, and life satisfaction over time. * Include both older adults and their informal caregivers, who may also participate by recording questions in their own voice.

Understanding the Role of Doulas in Supporting People With PMADs

Detailed Description The doula-led intervention developed during the first phase of this project will be pilot tested for feasibility. Following the recruitment procedures described in the recruitment and retention plan, approximately 75 participants will be enrolled into the study. Twenty-five of the participants will receive regular doula care and 25 of the participants will receive care from a doula trained in the PMAD doula training throughout their pregnancy, childbirth, and postpartum time period, following the intervention procedures developed in Aim 2 of this study. Twenty-five women will not receive care from a doula and will receive perinatal care as usual. Women in all groups will take surveys via REDCap during their enrollment in the intervention, at 1 month postpartum, 3 months, and 6 months postpartum (at the conclusion of the intervention). All participants who receive the PMAD doula intervention will complete checklists after each session with their doula, to assess fidelity to the intervention. Participant communication with their doula via patient notebook will also be assessed for fidelity to the intervention.

Maternal Health Assessment in Pediatric Care

The major goal of this study is to develop and pilot M-HARP (Maternal Health Assessment and Referral Integrated into Pediatric Care). M-HARP will adapt a successful US-based health screening and referral protocol to fit the needs of new mothers at Clínica de Familia La Romana, Dominican Republic.

Virtual Reality to Reduce Pre-procedure Anxiety Prior ECT

Lack of patient knowledge about ECT (electroconvulsive therapy) is a leading cause of treatment fear with 60% of ECT patients reporting high levels of anxiety. The purpose of this study is to determine if using Virtual Reality (VR) to allow patients' to experience a virtual ECT education session before treatment is useful in lowering treatment anxiety and increasing knowledge about ECT if compared to standard treatment. In addition, measuring heart rate and blood pressure levels before ECT treatment will allow us to assess changes in anxiety levels. Individuals who choose to participate will be placed (participant will have a 50% chance to be placed in either group) to view either a virtual reality video to experience a virtual ECT session, or to receive standard preparation, i.e. a discussion with a psychiatrist. Before and after this session participants will be asked to complete a measurement of their anxiety level and knowledge about ECT (ECT Attitude \& Knowledge Questionnaire). Just before ECT treatment, blood pressure, heart rate and anxiety level will be measured. Participants will also complete cognitive and depression assessments. This study will help to develop a relationship between healthcare providers and patients and their families to help with education before ECT treatment.

Reducing Stigma and Building Employability Skills for Young People With HIV in Zambia

The goal of this clinical trial is to learn if a program called Kupambana can improve mental health and HIV care outcomes in young people with HIV in Zambia by combining stigma-reduction support with financial and job-skills training. The main questions it aims to answer are whether Kupambana is feasible and acceptable to young people with HIV and whether it improves mental health, reduces stigma, and improves progress along the HIV care continuum, such as staying in care and taking HIV medicine as prescribed. Researchers will compare young people who participate in Kupambana with those who receive a one-time financial literacy training session (usual care) to determine whether Kupambana leads to greater improvements in stigma, mental health, and HIV care outcomes. Participants will complete a baseline questionnaire and then be randomly assigned to either the Kupambana program or the one-time financial literacy training. Those assigned to Kupambana will attend eight weekly peer-led support group sessions focused on reducing HIV- and poverty-related stigma, receive a voucher for technical and vocational education and training, and attend a one-time financial literacy session. Those assigned to the comparison group will attend only the one-time financial literacy session. All participants will complete follow-up surveys at the end of the program and again 3 and 6 months later.

Classroom Exercise Frequency and Mental Health in Medical Students

This 16-week, three-group, nonrandomized interventional study evaluated whether the weekly frequency of a brief classroom-based physical exercise program was associated with changes in mental health and physical activity among 105 undergraduate medical students at Universidad Tecnologica de Pereira, Colombia. EG2 (n=35) received two exercise sessions per week, EG1 (n=37) received one session per week, and CG (n=33) received no exercise intervention. Anxiety, depression, stress, and physical activity were assessed at baseline and after 16 weeks.

Family Mental Health Family Navigator Project (FMHN)

This study will focus on developing and testing a family-based mental health navigator intervention, the Family Mental Health Navigator (FMHN), to evaluate whether the intervention combined with mHealth is preliminary efficacious in improving mental health service initiation and engagement for publicly-insured youth.

Compass for Care: A Theory-driven Mobile Solution to Promote Well-being Among Caregivers of Individuals With ADRD

In the US, the over 11 million Americans currently providing unpaid care to a family member, relative, or friend with Alzheimer's disease or a related dementia (ADRD) are over 6 times more likely than the general population to suffer from depression (33.9% vs. 5%), and nearly 60% rate their emotional distress as high or very high. The purpose of this Phase II research is to continue the successful work of the pilot development and testing by conducting a rigorous scientific study of the effects of Compass for Care, a digital program that customizes behavior change guidance for using five self-care behaviors critical to ADRD caregiver well-being: 1) taking time to recharge; 2) finding information about your loved one's diagnosis and needs; 3) discovering your strengths and limits; 4) exploring outside help; and 5) seeking emotional support.