Clinical Research Directory

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.

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.

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.

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.

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.

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.

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.

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.

Better Lifestyle Counseling for African American Women During Pregnancy

The purpose of this randomized controlled trial is to establish the effectiveness of a culturally targeted and individually tailored behavioral intervention to promote maternal glucose metabolism in African American women.

Expressive Writing on Stress-Related and Work-Related Outcomes Among Chinese Nursing Interns

The goal of this interventional study is to assess the effects of an intervention on stress-related and work-related outcomes among Chinese nursing interns. The main questions it aims to answer are: * Does expressive writing reduce clinical practice stress and improve coping strategies in nursing interns? * Does expressive writing increase work engagement and perceived professional benefit among nursing interns? Participants in the intervention group and control group will perform expressive writing and neutral writing, respectively, based on different given instructions. In both groups, writing will last for 10-15 minutes each time, twice a week, for nine weeks. Researchers will compare the outcomes of the two groups to see if there are differences between clinical practice stress, coping strategies, work engagement, and perceived professional benefit.

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.

Effects of NICU Scenario-Based Simulation on Nursing Students' Perceived Stress, Satisfaction, Self-Confidence, and Learning: A Mixed-Methods Study

This mixed-methods study examines the effects of neonatal intensive care unit (NICU) scenario-based simulation training on third-year nursing students' perceived stress, learning satisfaction, self-confidence, and simulation-based learning experiences. All eligible participants will receive a high-fidelity simulation session involving a NICU scenario that includes therapeutic communication with a postpartum mother, neonatal emergency intervention, and support for mother-infant interaction. The simulation protocol consists of prebriefing (3 minutes), environmental orientation (3 minutes), scenario-based simulation (10 minutes), and debriefing using the PEARLS model (30 minutes). Quantitative data will be collected before and after the simulation using validated scales. Qualitative data will be gathered through semi-structured focus group interviews following the simulation. The study aims to provide evidence on the effectiveness of NICU simulation-based education in nursing training.

MOTHER3SENSE Study

This randomized controlled trial aims to compare the effects of maternal voice, touch, and scent on pain and stress levels in newborns during a routine heel lance procedure. Newborns will be randomly assigned to one of three intervention groups or a control group. Pain and stress responses will be assessed using validated neonatal pain and physiological measures. The findings of this study may help identify effective, low-cost, and non-pharmacological interventions that can be used to reduce pain and stress in newborns during routine clinical procedures.

Feasibility of the 5-Step Method in the U.S.

The purpose of this study is to see if it is possible (feasible) to introduce a behavioral intervention for family members affected by a relative's misuse of drugs and/or alcohol in the United States. The intervention is called the 5-Step Method. It will be a randomized control trial, with a total of 24 participants, and 12 in each group. The study lasts for approximately 12 weeks for the participant. The intervention group will receive a self-help handbook of the 5-Step Method, and the control group will not. Although the control group will not receive an intervention from the research team, they are allowed to look for and use any currently available program for affected family members (for example, Al-Anon, or Nar-Anon) during the study period. The study is being done because the 5-Step Method has not been used or evaluated in the U.S. (or the creators are unaware that it is in use here). There are two aims (objectives): (1) to see if it is feasible to introduce the 5-Step Method into the U.S.; (2) to look at trends in the baseline and followup survey scores to see if there is evidence of preliminary participant response.

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.

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.

AI-Guided Relaxation for Hemodialysis Anxiety

This study aims to evaluate whether a relaxation program guided by Artificial Intelligence (AI) can help reduce anxiety and improve coping mechanisms for patients receiving maintenance hemodialysis. Patients undergoing dialysis often face significant psychological stress and physical discomfort. This research uses a randomized controlled trial (RCT) with a parallel-group, pretest-posttest controlled design to compare patient well-being before and after using the AI-guided intervention. Participants will engage with an AI system designed to provide personalized relaxation techniques during their dialysis sessions. The study uses a mixed-methods approach. Quantitative: Researchers will use standardized scales to measure changes in anxiety levels, depression, coping strategies, and perceived relaxation. Qualitative: Researchers will conduct interviews with participants to understand their personal experiences, how they engaged with the AI technology, and how it influenced their ability to manage the stress of their treatment.

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.

MindWalk Intervention for Older South Asian Caregivers of People With Cognitive Disabilities (CD)

Older South Asian family caregivers experience elevated psychological stress and limited physical activity (PA) due to caregiving responsibilities and additional factors such as lack of access to services, cultural/linguistic barriers, stigma and discrimination. South Asian family caregivers are especially underserved and are a growing ethnic group in the US. Both PA and cognitive training (CT) have shown to improve cognitive function in older adults who experience cognitive function decline because of psychological stress. However, there are no studies using this approach for this population. We propose a randomized control trial pilot study to address this gap. Driven by a Community Advisory Committee (CAC) we will develop this 12-week mindful walking intervention using a participatory methodology in partnership with UIC's Cognition Behavior and Mindfulness Clinic that combines the PA of walking and the CT through mindfulness. We will recruit fifty participants and will randomly and equally assign 25 people to the intervention and 25 people to the control group. The intervention will include: 1) a mindful walking training followed by 2) a prescribed mindful walking regimen, 3) self-reporting of adherence to regimen by the participants using activity logbooks and use of a user-friendly PA tracker (Fitbit) for daily step count, and 4) personalized text messages with reminders and motivational messages for participants to do the mindful walking as prescribed including a weekly check-in call or text message for accountability. The primary aim of the proposed pilot study is to evaluate the feasibility and acceptability of the protocol and intervention implementation. A secondary aim will evaluate the intervention to examine preliminary efficacy in reduction of psychological stress, improvement in cognitive function, increase in physical activity, and increased self-efficacy (self-efficacy for coping with stress, self-efficacy for physical activity, and overall self-efficacy). The findings of this pilot project will provide evidence-based data to support a larger scale study proposal for future funding such as the National Institute on Disability, Independent Living, and Rehabilitation Research (NIDILRR) field initiative award, or the National Institute of Health (NIH) Research Project Grant (R21 NIH Exploratory/Developmental Research Grant Award) award, especially National Institute on Aging (NIA) grants.

Daoist Zhanzhuang and Human Flourishing

This project investigates the impact of Daoist Zhanzhuang (sometimes spelled as Chan Chuang) on human flourishing, and explores the physiological, psychological, and spiritual mechanisms. This study will be a two-arm randomized controlled trial, with mixed-methods and repeated-measures assessment of outcome variables. The two arms will include an active control condition (i.e., sham wall squat) and the Daoist Zhanzhuang condition. Outcome variables will include physiological measures of heart rate variability and inflammatory biomarkers, psychological scales of human flourishing variables, phenomenological interviews of mystical experiences, and daily ecological momentary assessment of human flourishing and mysticism. Randomly assigned into two conditions, 120 participants will complete a three-week intensive practice phase with 9 in-person sessions, followed by a nine-week self-guided practice phase with 4 in-person check-in sessions, and 3 follow-up practice and assessment sessions. Complete assessment (physiological measures, psychological scales, and phenomenological interviews) will be administered at five time points: T1 at about two weeks before the intervention, T2 at the end of the three-week intensive practice, T3 at the end of the 3-month intervention, T4 at the 6-month follow-up, and T5 at the 12-month follow-up. In addition, daily ecological momentary assessment of flourishing variables and practice-induced experiences will be administered daily after the practice for the entire 3-month intervention period.

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.