Clinical Research Directory

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.

Functional Foods for Health

The gut plays an important role in supporting the immune system, and certain dietary components such as probiotics (beneficial bacteria) and prebiotics (fibres that feed beneficial bacteria) can help to maintain gut and immune health. Alginate is a natural fibre extracted from brown seaweed that is widely used in foods which may help support beneficial gut bacteria and regulate inflammation. Ongoing psychological stress is known to affect immune function and increase inflammation in the body. This study will investigate whether a daily jelly containing alginate support gut health and improve immune responses compared to a placebo in adults experiencing higher levels of chronic stress. We are recruiting participants with elevated chronic stress to assess whether a functional jelly containing alginate, can help to reduce markers of inflammation, by mediating a change in gut microbiota composition.

AI-Guided Personalized Relaxation for Hemodialysis Patients

Patients undergoing maintenance hemodialysis frequently experience impaired health-related quality of life, anxiety, and difficulties in coping with the long-term demands of treatment. Artificial intelligence (AI)-guided interventions may provide personalized psychological support and promote adaptive coping through tailored relaxation strategies. This randomized controlled mixed-methods trial evaluates the effectiveness of an AI-guided personalized relaxation intervention delivered through a smartphone application among adults receiving maintenance hemodialysis. Participants are randomly assigned to either an intervention group receiving AI-guided personalized relaxation in addition to routine hemodialysis care or a control group receiving routine care alone. The 6-week intervention includes individualized breathing exercises, mindfulness practices, guided imagery, progressive muscle relaxation, and adaptive feedback generated according to participant characteristics, emotional responses, and engagement patterns. The primary outcome is health-related quality of life measured using the Kidney Disease Quality of Life-36 (KDQOL-36™). Secondary outcomes include anxiety symptoms measured by the Generalized Anxiety Disorder-7 (GAD-7), coping strategies measured by the Brief COPE Inventory, and user acceptance of the AI-guided intervention. Qualitative interviews are conducted with intervention participants to explore their experiences, perceived benefits, feasibility, and acceptability of the intervention. The study aims to determine whether AI-guided personalized relaxation can improve quality of life, reduce anxiety, and enhance coping among patients undergoing maintenance hemodialysis while providing insight into the acceptability and feasibility of integrating AI-supported psychosocial interventions into routine dialysis care.

Effectiveness of a Stress Reduction Intervention in Caregivers of Allogeneic Hematopoietic Stem Cell Transplant (HSCT) Recipients

Background: \- People who have an allogeneic hematopoietic stem cell transplant (HSCT) need help as they recover. Being a caregiver can be stressful to the body and mind. Researchers want to find ways to reduce this stress. Objective: \- To see how a stress reduction intervention affects the stress levels and health of an HSCT caregiver. Eligibility: \- Adults age 18 and older who plan to be an active caregiver for a person having their first allogeneic HSCT at the NIH Clinical Center. An active caregiver is someone who will be caring for the person from just before admission for the HSCT until at least 6 weeks after. Design: * Participants will be put in either the intervention group or the control group. * All participants will get the usual caregiver education given to all patients and caregivers having a stem cell transplant at the NIH Clinical Center. * All participants will have 2 study visits. They will give blood samples. They will have health assessments and brief physical exams. They will fill out study questionnaires and have an exit interview. * The intervention group will get an MP3 player. It will have an audio file with a stress reduction intervention on it. Participants will do this intervention daily. It takes 20 minutes. They will do gentle stretches and breathing exercises. They will get a diary to track their practice. * The intervention group also will have follow-up phone calls 2 and 4 weeks after their first clinic visit. * The person getting the HSCT will not be actively involved in the study. * The study will last about 2 months.

Health Surveillance at Constructor University Bremen (CUB)

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.

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.

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.

Single-Session Psychotherapy for Young Kids Through Patient Engagement Techniques

The goal of this clinical trial is to compare outcomes between participants in the single-session psychotherapy for young kids (SPYKids) conditions and participants in the services as usual (SAU) condition. The main questions it aims to answer are: * What is the feasibility and acceptability of SPYKids compared to services as usual? * What are the changes in child mental health between the SPYKids group compared with the SAU group? Participants will * Fill out questionnaires at baseline, immediately post-program, approximately one month after the baseline assessment, and three months after the baseline assessment * Meet with a parent coach in a virtual 90-minute session to discuss coping strategies relevant to their identified concerns Researchers will compare participants in the SPYKids group with participants in the Services as Usual group to see if there are changes in child well-being, parent well-being, and parent self-efficacy.

Self-Help Plus (SH+) for Stress Reduction in Social Service Workers: A Pilot RCT

This is a two-arm, stratified cluster-randomized controlled pilot trial evaluating the feasibility and preliminary effectiveness of the World Health Organization's Self-Help Plus (SH+) intervention for stress reduction among social service workers employed by the Istanbul Provincial Directorate of Family and Social Services (ASHP). Four institutions (clusters) are randomized 1:1, stratified by service type, to receive either SH+ plus Enhanced Care as Usual (ECAU) or ECAU only, with a target of 50 participants (25 per arm). The primary aim is to assess feasibility indicators (recruitment, session attendance, retention, and acceptability) to inform a future full-scale definitive trial. Preliminary effects on perceived stress and related mental health and well-being outcomes are examined as secondary outcomes.

Brief Mindfulness Chatbot Intervention for Cancer Patients

This study tests a new digital tool for hospitalized cancer patients. The tool is a chatbot on LINE, a popular messaging app. The chatbot is called Mindbot. Mindbot leads a 10-minute mindfulness practice each day. The practice uses breathing exercises and virtual reality (VR). Adult cancer patients in the hospital ward can join. Participants are randomly placed into one of two groups. One group uses Mindbot every day during their hospital stay. The other group receives usual hospital care through the hospital's existing health app. Researchers measure mindfulness, stress, and heart rate variability (a measure of body stress) before and after each practice. They also collect saliva samples to check a stress hormone called cortisol. Researchers track fatigue and cancer symptoms too. These measurements happen at three time points: hospital admission, hospital discharge, and the first follow-up clinic visit.

Testing the Efficacy and Mechanisms of an Adapted Resilience Building Intervention in People Aging With HIV

This study will examine the mechanisms and efficacy of a resilience building intervention in older people living with HIV.

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.

The Stony Brook University Calm-Mom Study

The present trial will evaluate the feasibility, acceptability and preliminary efficacy of 2 different internet-delivered programs for prenatal maternal stress. The Stress Managment and Resiliency Training Program (SMART-Mom program), an 8-session Cognitive Behavior Therapy (CBT) based mind body program and the Mama Support Program, an 8-session social support group program. Sixty pregnant women (\<20 weeks Estimated Gestational Age) will be screened and either enrolled in the online SMART Mom Program or the Mama Support Program. Outcomes, including maternal perceived stress, depression, and anxiety will be assessed at post-treatment, three, and six months post program completion. Potential impact on infant health outcomes will be assessed via post-delivery electronic medical record review.

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.

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 59 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.

Just-in-Time Support for Smoking, Vaping, and Eating Urges During High-Stress Moments Among Gender and Sexual Minority Adults in Dhaka

Gender and sexual minority adults in Bangladesh experience high levels of stigma-related stress. Acute stress can trigger strong, affect-driven urges to smoke, vape, or engage in stress-attributed eating. These urges can rise and fall within minutes to hours, operating outside the reach of conventional clinic-based interventions delivered days or weeks later. This pilot micro-randomized trial (MRT) evaluates whether delivering a brief, culturally adapted support message via smartphone during moments of high self-reported stress reduces the intensity of the urge for the participant's pre-specified target behaviour, relative to no message. Over a 24-day period, 115 participants will be scheduled for up to 5 ecological momentary assessments (EMA) per day. Whenever a participant reports an acute stress level of 5 or higher (0 to 10 scale) and satisfies pre-specified privacy, safety, behavioural, and spacing criteria, the app randomizes with probability 0.5 to deliver either a brief support message or no message. By contributing multiple randomized decision points over time, each participant serves as their own micro-control. The primary outcome is the intensity of the urge for the participant's pre-specified target behaviour, measured 45 to 60 minutes after randomization. An exploratory urge assessment is also collected 10 minutes after randomization; comparing the two time points will help establish whether the support message's effect is immediate, delayed, or both, and will inform the choice of follow-up window for a future, fully powered trial. Prior to trial launch, all EMA items, message content, notification logic, and digital safety protocols will be developed and tested with community members, reviewed by a Community Advisory Board, and locked. As a pilot optimization trial, its objectives are to estimate the short-term causal effect of the prompt, to identify the contexts in which that effect is larger or smaller, and to establish whether momentary assessment and just-in-time intervention research can be delivered safely, privately, and acceptably in this high-stigma setting. The study does not evaluate long-term behavioural maintenance and does not claim to address the underlying structural stigma and discrimination that produce minority stress.

Dietary Supplement With Magnesium, Vitamins, Rhodiola and L-theanine Stressed Subjects: Randomized Study Versus Placebo (MAGRITTE)

The aim is to study the effect of a dietary supplement on stress and pain through questionnaires and follow-up of physiological parameters, and functional Magnetic Resonance Imaging (fMRI) in stressed healthy subjects versus stressed healthy subjects without treatment.

Virtual Reality for Pain and Fear in Children With Burns

Burn injuries are very painful for children, especially during dressing changes when the wound is cleaned and re-bandaged. This procedure, while necessary, can cause pain, fear, and distress that may make children afraid of future treatments. Virtual reality (VR) is a technology that uses a headset to show an immersive, interactive 3D world. It can distract children from painful medical procedures. This study aims to find out if using VR during burn dressing changes can reduce pain, fear, and behavioral distress in children aged 6 to 12 years. Half of the children will receive standard burn care plus VR distraction during their dressing change. The other half will receive standard care only. The study will take place at the Burns and Plastic Surgery Center, Mansoura University, Egypt. Children will be recruited from both inpatient wards and outpatient clinics. Pain will be measured using a number scale, fear using a faces scale, and distress will be observed throughout the procedure. It is expected that children who use VR will report less pain, show less fear, and display less distress during their dressing changes compared to children who receive standard care alone.

Effects of Progressive Muscle Relaxation on Stress and Bowling Skills in Medium Fast Bowlers

The goal of this clinical trial is to learn if a 4-week Progressive Muscle Relaxation (PMR) protocol can manage psychological stress and improve performance in male cricket medium-fast bowlers aged 16-30 years. The main questions it aims to answer are: 1. Does a 4-week PMR protocol significantly reduce perceived stress scores compared to standard training? 2. Does a 4-week PMR protocol significantly improve ball release speed and bowling accuracy? Researchers will compare an experimental group receiving a structured PMR protocol prior to warm-ups to a control group following standard traditional training (generalized warm-ups, stretching, and shadow bowling) to see if the relaxation intervention leads to lower perceived stress, higher bowling speed, and improved bowling accuracy. Participants will: 1. Complete the 10-item Perceived Stress Scale (PSS) at baseline and after the 4-week period. 2. Deliver six balls at a designated target pitch and stump zone while being timed by a hand-held radar gun to measure baseline and post-intervention speed and accuracy. 3. Depending on group assignment, either attend 2 sessions per week of a structured, contract-relax progressive muscle relaxation protocol or attend 2 sessions per week of traditional warm-up and stretching drills.

Stress and Anxiety Before Biopsy, After Biopsy Results, and During Treatment in Patients With Suspected Bone or Soft Tissue Cancer

This prospective observational study will follow adults who are scheduled for a clinically indicated biopsy because of a suspected solid tumor involving bone or soft tissue. The period before biopsy, the disclosure of pathology results, and the start of treatment may be associated with changing levels of psychological stress and anxiety. The purpose of the study is to compare psychological stress and anxiety in the same participants at three points in their care: before biopsy, after the pathology result or diagnosis is explained, and at treatment initiation. The investigators hypothesize that psychological questionnaire scores will differ across these three time points and may be associated with age, sex, disease stage, metastasis status, and treatment type. Participants will complete the Hospital Anxiety and Depression Scale, Perceived Stress Scale, and Distress Thermometer. The study team will also collect relevant demographic and routine clinical information from medical records. The study will not assign any biopsy, diagnostic procedure, or treatment. All diagnostic and treatment decisions will be made by the treating clinical team as part of routine care.

Fascial Yoga in Menopausal Women

Aim: The aim of this study is to evaluate the effects of a structured fascial yoga-based behavioral intervention on perceived stress, cognitive control, and cognitive flexibility in menopausal women. The study aims to determine whether a non-pharmacological and non-invasive behavioral intervention can support psychological and cognitive functioning and reduce perceived stress in menopausal women. Design: This study is designed as a randomized controlled, pretest-posttest experimental study with a post-intervention follow-up assessment. Eligible participants will be randomly assigned to either the intervention group or the control group receiving usual care. 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 60 menopausal women aged 45-65 years will be recruited from the menopause outpatient clinic and randomly assigned to either the intervention group or the control group. The intervention group will participate in a 12-week online fascial yoga program consisting of two 60-minute sessions per week. In this study, fascial yoga is defined as a fascia-focused, non-pharmacological, and non-invasive behavioral intervention that includes myofascial release techniques, breath regulation, body awareness, and basic yoga practices to support stress regulation and cognitive functioning. The program will include myofascial release techniques, basic yoga postures suitable for all physical fitness 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. After completion of the follow-up assessments, the fascial yoga program will be offered to participants in the control group upon request. Data will be collected at three time points: at baseline before the intervention, immediately after completion of the 12-week intervention, and at the follow-up assessment 8 weeks after the intervention. Perceived stress, cognitive control, and cognitive flexibility will be assessed using validated self-report questionnaires. Hypotheses: H1: Menopausal women participating in the fascial yoga intervention will show a significant reduction in perceived stress levels compared with the control group at post-intervention and follow-up assessments. H2: Menopausal women participating in the fascial yoga intervention will show a significant improvement in cognitive control and cognitive flexibility compared with the control group at post-intervention and follow-up assessments.

Psychoeducational Course for Suicide Prevention

The plan is to include patients with a history of increased risk of suicide. In the aftermath of an episode of imminent suicide risk, patients will receive a psychoeducational course that entails information on different aspects of suicide-related topics, identifying triggers and detecting early warning signals for increased suicide risk. The course culminates in working on completing a individual safety plan to prevent an future increase in suicide risk. The course will incorporate both patients and their next of kin. The psychoeducational course will be compared to a control group where the patients receive one individual session with focus on a safety plan to evaluate the intervention. Both groups will receive treatment as usual (TAU) during both the acute phase and follow-up. The study will be conducted as a randomized controlled trial.

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.

Biology, Identity & Opportunity Study

This study will implement an intervention designed to promote ethnic and racial identity development. It is hypothesized that the intervention will have positive effects on ethnic-racial identity development, stress biology (including sleep hours and quality and diurnal cortisol profiles), emotional well-being, executive functioning, and academic outcomes, particularly for minority youth.