Clinical Research Directory

Resources, Inspiration, Support and Empowerment (RISE) for Black Pregnant Women

Perinatal Mood and Anxiety Disorders (PMADs) encompass a range of mental health disorders that occur during pregnancy and up to one year postpartum. Approximately 13% of women experience PMADs. This rate doubles for those with adverse perinatal outcomes (APO) and triples in Black women. Recent research points to racism as one significant source of these health disparities. Cultural adaptations to improve communication with providers decrease rates of depression in minority patients as well as improve adherence to treatment, insight and alliance. Discrimination stress and worries about experiencing medical consequences are thought to increase systemic inflammation, a mechanism known to drive mental and physical symptoms. Inflammation has been implicated in both PMADs and APO, suggesting a shared underlying etiology. Evidence from our work suggests that inflammation contributes to the pathophysiology of PMADs. The proposed pilot randomized control trial will allow the investigators to build on promising preliminary results and identify whether our culturally relevant mobile Health (mHealth) intervention is effective in improving outcomes among Black pregnant women randomized to the intervention compared to a control group. The culturally relevant modules include building communication and self-advocacy skills and provide a support network. The primary objective of this research is to provide guidance for clinical care of Black women during the perinatal period, with the goal to improve mental health and physical health outcomes. A secondary goal is to examine novel inflammatory signatures that change as a function of the intervention to reduce PMADs in this population. As inflammation may be diagnostic of PMADs, identification of its role may shed light of potential intervention targets and provide critical knowledge to improve women's long-term health. PMAD symptoms will be assessed prospectively in 150 Black pregnant women, half of whom will be randomized to receive the culturally relevant mHealth intervention. The investigators hypothesize that women in the intervention group will have reduced rates of PMADs and APOs, an increase in adherence to mental health treatment and will report increased self-advocacy skills, increased communication with providers, and reduced levels of discrimination related stress. Participants will also have improved biological risk indicators including lower circulating C-reactive protein and a transcription profile of differentially expressed inflammatory genes, marked by a decreased activity of inflammatory transcription factors from blood spots. Given the high burden of both PMADs and APOs among Black mothers and the numerous consequences on maternal and child outcomes, it is imperative that investigators develop and implement effective interventions, and test the biological mechanisms that might drive these effects. This work is interdisciplinary, building on a network of community advocates to implement a novel mHealth intervention informed by real world experiences designed to enhance self-advocacy, reduce stress and prevent adverse outcomes

Effect Of Electroacupuncture With Local Anesthesia On Pain And Stress During Impacted Lower Third Molar Surgery

This randomized controlled trial investigates the effect of electroacupuncture as an adjunct to local anesthesia on perioperative pain and stress during ambulatory surgical extraction of impacted lower third molars. Participants will be randomized into three groups: electroacupuncture, sham acupuncture, and control. Pain intensity and perceived stress will be assessed using validated scales, while biological stress and nociceptive markers (salivary cortisol, alpha-amylase, and substance P), as well as hemodynamic parameters (blood pressure and heart rate), will be measured. The study aims to provide an integrated evaluation of the effects of electroacupuncture on subjective, biological, and physiological indicators of perioperative response in oral surgery.

Occupational Balance, Time Management and Stress in Double Major Students

This study aims to examine the relationship between occupational balance, time management, and perceived stress in university students enrolled in a double major program. Participants who voluntarily agree to participate and meet the inclusion criteria will complete online questionnaires assessing their socio-demographic characteristics, occupational balance, time management skills, and perceived stress levels.

Virtual Reality-Based Transitional Care for ICU Survivors

This study aims to evaluate the effectiveness of a virtual reality (VR)-based transitional care program for adult survivors of intensive care unit (ICU) care. ICU survivors frequently experience relocation stress, anxiety, pain, and physiological instability after transfer from the ICU to general wards, which may increase the risk of unplanned ICU readmission. Participants will be randomly assigned to receive either standard transitional care or additional VR-based intervention sessions during their ICU stay. The VR intervention is designed to provide psychological support, environmental orientation, and stress reduction. Primary outcomes include short-term physiological indicators within 48 hours after ICU transfer. Secondary outcomes include pain, relocation stress, and unplanned ICU readmission within 7 days.

Building Community Resilience Program

Established in 2021, NYCEAL consists of approximately 40 organizational partners and 120 Community Health Workers (CHWs). Over the next four years (2024-2028), NYCEAL will work with this network to implement the following intervention: Building Community Resilience Program (BCR). To assess the impact of this intervention, an implementation research framework will be used, and pre- and post-surveys conducted, and other process evaluation measures collected. Changes in outcomes measures such as stress, resilience, overall wellbeing, and other related outcomes for participants in the BCR program will be measured for community healthcare workers and/or frontline workers that receive educational workshops.

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.

Facial Yoga in Menopausal Women

Purpose: The purpose of this study is to evaluate the effects of a structured facial yoga-based behavioral intervention on perceived stress, cognitive control, cognitive flexibility, and salivary cortisol levels in women during the menopausal period. The study aims to determine whether a non-pharmacological and non-invasive behavioral intervention can support psychological and cognitive functioning and reduce biological stress responses in menopausal women. Design: This study is designed as a randomized, controlled, pretest-posttest experimental trial with a post-intervention follow-up assessment. Eligible participants will be randomly assigned to either an intervention group or a control (usual care) group. Outcomes will be assessed at baseline, immediately after the intervention, and at follow-up to evaluate both the immediate and sustained effects of the intervention. Method: A total of 100 menopausal women aged 45-65 years will be recruited from a menopause outpatient clinic and randomly allocated to either the intervention group or the control group. The intervention group will participate in a 12-week online facial yoga program consisting of two 60-minute sessions per week. In this study, facial yoga refers to a non-pharmacological and non-invasive behavioral intervention focusing on facial myofascial relaxation, breathing regulation, and body awareness for stress regulation and cognitive functioning. The program will include facial myofascial relaxation techniques, basic yoga postures suitable for all physical levels, and structured breathing exercises. All sessions will be conducted online in a group format, and no audio or video recordings will be taken. The control group will continue to receive routine outpatient care during the study period and will be offered the facial yoga program after the completion of follow-up assessments, upon request. Data will be collected at three time points: at baseline prior to the intervention, immediately after completion of the 12-week intervention, and at 8 weeks following the intervention as a follow-up assessment. Perceived stress, cognitive control, and cognitive flexibility will be assessed using validated self-report questionnaires. Salivary cortisol samples will be collected under standardized morning conditions at each assessment point to evaluate biological stress response. Hypotheses: H1: Menopausal women participating in the facial yoga intervention will demonstrate a significant reduction in perceived stress levels compared to the control group at post-intervention and follow-up assessments. H2: Menopausal women participating in the facial yoga intervention will demonstrate a significant reduction in salivary cortisol levels compared to the control group at post-intervention and follow-up assessments. H3: Menopausal women participating in the facial yoga intervention will demonstrate a significant improvement in cognitive control and cognitive flexibility compared to the control group at post-intervention and follow-up assessments.

Neurobiological Mechanisms of Stress in Youth With Chronic Widespread Pain

Chronic widespread pain (CWP) is a common chronic pain condition in youth and often associated with significant pain-related and psychosocial impairment. Understanding the neurobiological mechanisms that may underlie pediatric chronic pain and pain-related impairment can inform future treatments to ameliorate patients' suffering, making it a critical area of empirical investigation.

Self-Affirmation Intervention After Mastectomy

This randomized controlled trial aims to evaluate the effect of a structured self-affirmation intervention on pain, depression, anxiety, and stress levels in patients undergoing mastectomy. The study will be conducted in two parallel groups, with the intervention group listening to an audio recording of positive self-affirmation statements. Primary outcomes will be assessed using the Visual Analog Scale and the Depression Anxiety Stress Scale (DASS-21). The goal is to provide evidence-based strategies to reduce psychosocial burden after mastectomy.

Stress and Blood Pressure Management for Caregivers

Due to health and wealth disparities, no demographic group is more at risk than African American women for the double jeopardy of stress from caregiving for persons living with dementia (PLWD) and stress associated with hypertension (HTN). This double jeopardy puts those they care for in jeopardy as well: Reduced quality of life and longevity, disability, cognitive decline, and stroke associated with HTN1 impede caregiving activities and resultant health and well-being for persons living with Alzheimer's disease and related dementias (ADRD). Although successful multi-component interventions have addressed ADRD caregiver stress (REACH II) and the Savvy Caregiver program, to our knowledge there are no interventions that target the complexity of chronic caregiving stress and HTN self-care for African American women caregivers of persons living with ADRD. This project will test two interventions for their effectiveness in improving outcomes for the target group: Mindfulness in Motion (MIM) and the Dietary Approaches to Stop Hypertension (DASH). MIM includes mindful awareness and movement from a seated position, breathing exercises, healthy sleep, and guided mindfulness meditation. The DASH component will be tailored for Black Americans. It uses a critical thinking approach that involves problem solving, participant-centered goal setting, health coaching, reflection, and development of self-efficacy (confidence) to promote physical activity and healthy eating. Solid empirical evidence demonstrates its effectiveness in reducing blood pressure among mixed-race samples.

The Effect of Cartoon Character-Printed Band Use During Burn Dressing on Fear, Stress, Pain, and Physiological Parameters in Children: A Randomized Controlled Trial

This randomized controlled trial aims to evaluate the effect of using cartoon character-printed medical bands during burn dressing procedures on children's fear, stress, pain, and physiological parameters. Burn dressing is often a distressing and painful procedure for pediatric patients, which may lead to increased anxiety, physiological instability, and negative treatment experiences. In this study, child-friendly cartoon-printed adhesive bands are used as a non-pharmacological intervention to provide distraction and emotional comfort during burn dressing. By incorporating familiar and visually engaging designs, the intervention seeks to reduce children's perception of pain, alleviate stress, and improve physiological stability (heart rate, oxygen saturation, and respiratory rate) during the procedure. Participants will include children aged 7-11 years receiving burn care in a pediatric burn unit. They will be randomly assigned to either the intervention group (cartoon-printed band use) or the control group (standard plain band use). Fear, pain, and stress will be assessed using validated scales before, during, and after the dressing procedure. Physiological parameters will be measured using a pulse oximeter. The study is expected to contribute to the development of child-centered, non-pharmacological methods that make medical procedures less stressful and more tolerable for pediatric patients. Results may guide the design of more comforting and engaging treatment environments in pediatric burn care.

Adaptive Music Therapy for Psychosocial and Cognitive Functions of Older Adults

The proposed study is a pilot study that aims to understand if the Pi Electronics adaptive music intervention (AM) is effective to promote positive psychosocial and cognitive outcomes, over and above a traditional music intervention (TM) among healthy older adults. This study will contribute to the ongoing literature on the benefits of music interventions and provide insight on how emerging technology can enhance the therapeutic effects of music as a viable intervention for older adults. The study will adopt a three-arm randomized controlled trial (RCT). Eligible participants will be randomized into one of three groups: traditional music therapy group (TM), Pi Electronic's adaptive music program (AM), and a waitlist control group (CG). Informed consent will be collected from all participants. All three groups will complete outcome measures at three sessions: pretest, posttest, and at a three-month follow-up, but only the TM and AM group will receive music between the pretest and posttest sessions, spanning for 4 weeks, with 4 music therapy sessions per week, and each session lasting 30 minutes. Data will be analyzed for each outcome variables to understand the group differences in the performance on the psychosocial and cognitive outcome measures. The study will also validate the Pi Electronics EEG headset with the BioSemi, 64-channel EEG system.

Health Surveillance at Constructor University Bremen (CUB) and Among HAW-Hamburg Employees

The aim of Health Surveillance is to analyze and describe the state of health of students at Constructor University, key influencing factors and individual resources by using mixed-method design.

Personalized Music Therapy for Preterm Infants

Preterm infants in the Neonatal Intensive Care Unit (NICU) face environmental and clinical stressors that may affect physiological stability and development. This pilot randomized crossover study tests Personalized Music Therapy (PMT) based on recorded parental voices versus Quiet Rest. Outcomes include tissue oxygenation index (TOI) via near-infrared spectroscopy (NIRS) and heart rate (HR), respiratory rate (RR), and oxygen saturation (SpO2). Each infant completes two Periods (PMT and Quiet Rest) in randomized order, separated by a 2-day washout. Parental stress is measured at discharge using the Parental Stressor Scale: Neonatal Intensive Care Unit (PSS:NICU). Findings inform feasibility, variance estimates, and protocol refinements for a larger trial.

A Trial of a Positive Psychology Intervention for Older Adults (RESET)

The heightened vulnerability to COVID-19 of African American older adults in Detroit, Michigan and other marginalized communities is linked to systemic racism experienced over the life course. Structural inequities also magnify the pandemic's impact on older adults' physical and psychosocial functioning. Many older adults in Detroit, burdened by poor health even before the pandemic, face a downward spiral of increased distress, reduced physical and social activity, and physical deconditioning. RESET (Re-Engaging in Self-care, Enjoying Today) is a self-management and resilience-building intervention led by community health workers (CHWs) at the Detroit Health Department (DHD). The central hypothesis of this study is that RESET, with components that include group telephone calls, a podcast series, and activity trackers, will improve psychosocial and physical functioning at 2 and 8 months. Specific aims are: 1) With input from a Community Advisory Board, modify RESET for group delivery and refine content after testing in a mini-pilot (n=10). 2) Conduct a randomized, controlled trial to assess the impact of RESET (compared to a one-time /telephone wellness check) on PROMIS-29 Psychosocial Score (a weighted combination of distress, fatigue, pain, social participation and sleep) among 456 primarily African American older adults age 50 and over who are at elevated risk of poor functioning. 3) Collect qualitative (interview) data from participants and other stakeholders, and use this data to better understand trial results, as well as to assess community impact and inform a dissemination toolkit.

Virtual Reality-Based 360° Clinic Walkthrough for Reducing Examination Anxiety in Preschool Children

This prospective, double-blind, randomized controlled trial investigates whether a short, 360° virtual reality (VR) pre-examination walkthrough can reduce anxiety, behavioral distress, and physiological stress responses in preschool children undergoing routine outpatient physical examination. A total of 100 children aged 3-5.5 years were randomized to either a VR group, which viewed a 3-minute real-clinic 360° video via VR goggles, or a control group, which experienced routine waiting only. Primary outcome measures include the Face-Legs-Activity-Cry-Consolability (FLACC) score and crying duration during examination. Secondary outcomes include heart and respiratory rate changes, Wong-Baker Faces Pain Rating Scale (WBS) scores, parent satisfaction, and physician-rated examination ease. The study aims to determine whether immersive, procedure-specific VR preparation can improve examination experience and cooperation while reducing stress for both children and caregivers.

The Effect of Laughter Yoga on Individual and Organizational Outcomes in Nurse Managers

The goal of this clinical trial is to learn if laughter yoga can improve both individual and organizational outcomes in nurse managers. The main questions it aims to answer are: * Does laughter yoga lower burnout and stress levels in nurse managers? * Does laughter yoga improve work-life quality and job performance? * Does laughter yoga help nurse managers make better decisions and solve problems more effectively? * Does laughter yoga lower compassion fatigue and support positive approaches to workplace conflict? Researchers will compare a laughter yoga group with a control group to see if there are meaningful differences. Participants will: * Join structured laughter yoga sessions for a defined period (weekly sessions). * Complete surveys before and after the program about stress, burnout, work-life quality, decision-making, problem solving, job performance, compassion fatigue, and conflict approaches. * Continue their usual work while attending sessions.

Foundational Programs to Combat Clinician Stress

This is a prospective, randomized, controlled clinical trial in which clinicians from University of Pennsylvania Health Systems (UPHS) including Penn Medicine- Lancaster General Health (LGH) and Massachusetts General Hospital (MGH) are offered a well-known program to help reduce clinician burnout: Sudarshan Kriya Yoga (SKY) Breathing and Sahaj Meditation Intervention.

Testing Adapted Self-Help Plus (SH+) for Stress and Well-Being in International Students at a U.S. University

The goal of this clinical trial is to learn if an adapted version of Self-Help Plus (SH+), a stress management program developed by the World Health Organization, can reduce stress and improve well-being in international students at a U.S. university. The main questions it aims to answer are: Does SH+ reduce perceived stress, anxiety, and depressive symptoms in international students? Does SH+ improve feelings of social support, self-efficacy, and adjustment in a new cultural environment? Participants will: Attend a two-day in-person workshop that includes animated videos, interactive activities, and group discussions. Complete three surveys (before the workshop, right after, and six weeks later) about stress, mood, and well-being. Optionally, take part in a short interview to share feedback about their experience.

Feasibility Trial of Functional Clothing, Moderate Exercise, and Health Information for Stress Reduction and Behavior Change in Okinawa

This study is a pilot randomized trial conducted in Yomitan Village, Okinawa, Japan. The purpose is to evaluate whether three simple, low-cost interventions can help reduce stress and support healthy behavior change in community-dwelling adults. The interventions are: (1) providing health information through educational leaflets, (2) wearing functional clothing designed to support physical comfort, and (3) practicing moderate exercise using a simple manual. A total of 45 adults, aged 20 to 65 years, with overweight or pre-metabolic syndrome will be recruited. Participants will be assigned randomly into one of the three groups. The study duration is eight weeks. Outcomes include fatigue scores, mood states, sleep quality, and heart rate variability measured by a smart ring. Data will be collected at baseline and after eight weeks of intervention. This study aims to test whether these approaches are feasible, safe, and acceptable for residents. The results will help design larger studies in the future and provide evidence for community-based prevention programs that are easy to adopt in daily life.

Tele-Wellness Supported App for Family Child Care Home Providers and Families to Promote Health, Family Engagement, and School Readiness Amid COVID-19

The investigators aim to deliver a tele-wellness supported app to Baltimore City's Family Child Care Home (FCCH) providers who are caring for children of Essential Personnel. Once a pre-survey is conducted, login information will be assigned to 30 Family Child Care Home providers and parents the FCCH serve. Providers and Parents will receive self-care and parenting/parent engagement support through the app and through a tele-wellness service, Ask a Nurse, provided by community health nurses at the Johns Hopkins School of Nursing. Children will have access to gamified learning materials in early literacy, math, social-emotional learning, and nutrition.

Halitosis, Sleep and Mental Health in Bariatric Surgery Candidates

This study aims to evaluate psychological distress, sleep quality, and halitosis in obese patients during the preoperative period of bariatric surgery. A total of 110 adults will be assessed using validated questionnaires and a portable halitosis detector. The results may contribute to improving strategies for comprehensive care in this population.

Caring for Providers to Improve Patient Experience (CPIPE) Trial

The activities described in this proposal are aimed at addressing health care provider stress and unconscious bias to improve quality of maternal health care, particularly related to the person-centered dimensions of care-i.e. care that is respectful and responsive to women's needs, preferences, and values. The investigators focus on health provider stress and unconscious bias because they are key drivers of poor-quality care that are often not addressed in interventions designed to improve quality of maternal health care. The investigators plan to (1) test the effectiveness of an intervention that targets provider stress and bias to improve PCMC; (2) assess the cost-effectiveness of CPIPE; (3) examine the mechanisms of impact of CPIPE on PCMC; and (3) assess impact of the CPIPE intervention on distal outcomes including maternal health seeking behavior and maternal and neonatal health.

The Nuestros Días ("Our Days") Study

The goal of this observational study is to understand how contextual, individual-level, and cultural factors influence the daily and long-term well-being of caregivers of relatives with memory problems or dementia. The study focuses on caregivers from the Hispanic and Latino community. The main questions it aims to answer are: * What daily factors increase (i.e., risk factors) or decrease (i.e., protective factors) the daily odds of depression and anxiety symptoms reported by caregivers? * How do these symptoms vary over time? * Do variations in depression and anxiety symptoms predict distal health outcomes? Participants will: * Complete an online baseline survey to understand their caregiving situation. * Fill out daily surveys online for three weeks about their caregiving experiences and well-being. * Complete two follow-up surveys, along with daily surveys, six and twelve months after the baseline survey. All the study information and surveys can be completed in English or Spanish based on the participant's preference.