Clinical Research Directory

Short-Term Mindfulness Intervention for Anxiety and Maternal Attachment in NICU Mothers

This randomized controlled study aims to evaluate the effects of a short-term mindfulness-based stress reduction (MBSR) program on anxiety levels and maternal attachment in mothers whose infants are admitted to the Neonatal Intensive Care Unit (NICU). A total of 33 mothers will be recruited and assigned to intervention and control groups. The intervention group will receive a structured four-session mindfulness program, while the control group will receive standard care. Data will be collected using the Maternal Attachment Scale and the State-Trait Anxiety Inventory. The findings are expected to provide evidence on the effectiveness of mindfulness-based interventions in reducing anxiety and improving maternal-infant bonding during the postpartum period.

Essential Oil Inhalation and Acute Stress Response in Healthy Adults

This randomized, double-blind, placebo-controlled study evaluates the acute physiological and subjective responses to essential oil inhalation in healthy adults. Participants are assigned to inhale either an essential oil or a placebo via an aroma stick during standardized laboratory procedures designed to induce temporary psychosocial stress (Trier Social Stress Test - Group version) and during a guided relaxation session. Physiological responses, including heart rate, heart rate variability, and electrodermal activity, are measured using a wearable sensor. Subjective stress and affect are assessed using validated questionnaires and visual analog scales. The purpose of this study is to characterize short-term autonomic and self-reported responses associated with essential oil inhalation under controlled experimental conditions. This study is exploratory and is not intended to diagnose, treat, or prevent any medical condition.

Effect of Ashwagandha Root Extract on Stress, Anxiety, and Sleep Quality in Adults Experiencing Minority Stress

Sexual and gender minority adults often experience elevated levels of chronic stress due to stigma, discrimination, and social adversity, commonly referred to as minority stress. This persistent stress is associated with increased anxiety, mood disturbances, impaired sleep quality, and reduced quality of life. There is a need for safe, non-pharmacological interventions that can support mental well-being in this population. This randomized, double-blind, placebo-controlled study is designed to evaluate the efficacy and safety of Ashwagandha (Withania somnifera) root extract in reducing stress and improving anxiety and sleep quality in adults experiencing minority stress. A total of 80 adults aged 18 to 45 years who self-identify as sexual or gender minorities and report moderate to high perceived stress will be enrolled. Participants will be randomly assigned to receive either Ashwagandha root extract (300 mg capsules taken twice daily) or an identical placebo for 8 weeks. Efficacy will be assessed using validated psychological and quality-of-life questionnaires, including the Perceived Stress Scale, Depression Anxiety Stress Scale, Pittsburgh Sleep Quality Index, and other mood and minority stress measures. Salivary cortisol will be measured as a biological marker of stress. Safety will be evaluated through monitoring of adverse events throughout the study.

Exploring the Decision to Drink (More) Alcohol Following Manipulations of Stress and Social Context

This preregistration documents an experiment examining the effects of acute stress and social context on alcohol-related decision-making. The study uses a 2x2 factorial design (stress vs. control × social vs. alone) with dyadic recruitment.

Effectiveness of a Waitlist App "Stappvoorstap" During Mental Healthcare Waiting Times

This study evaluates the effectiveness of Stappvoorstap, a mobile self-management application designed for adults on mental health waiting lists in the Netherlands. The app helps users monitor daily stress levels, recognize personal stress patterns, and provides coping strategies, relaxation exercises, and supportive resources. Using a multiple baseline single-case experimental design, participants use the app for 4 weeks while completing weekly questionnaires measuring perceived stress, coping self-efficacy, and quality of life. The study aims to determine whether the app can reduce stress and improve wellbeing during the waiting period before mental healthcare treatment begins.

COVID-19 Pandemic Impact on Alcohol (PIA) - A Natural History Study

Background: The SARS-CoV-2 virus has caused a pandemic infection called COVID-19. It is a global threat to people, communities, and health systems. Researchers are concerned about the mental health effects of the pandemic. They want to learn more about how it is affecting people s alcohol use and problems, and how it may continue to affect them over time. Objective: To study the impact of the COVID-19 pandemic on alcohol use and consequences in individuals across the spectrum of alcohol use and those with alcohol use disorder. Eligibility: Participants who have been screened under the NIAAA Screening, Assessment and Management Protocol (14-AA-0181) Design: Participants will complete a baseline survey by phone. It will ask about alcohol use, alcohol dependence, and stress. It covers 2 time periods: the 12 months before the pandemic started and the time since it started. Participants will get an ID code and a link to an online survey. They will complete the online survey within a week of the phone survey. Participants will complete a series of online surveys over 24 months. For the first year, surveys will be completed weekly for the first 4 weeks, then biweekly for the next 8 weeks, and then every 1-2 months for the rest of the year. For the second year, surveys will be completed every 6 months. Surveys will cover the following topics: * Alcohol use and its consequences * Other substance use * Stress * Impact of the COVID-19 pandemic * Pain * Physical health * Sleep * Quality of life. Because the course of the pandemic may change, the frequency of the surveys may change. Participation lasts 2 years.

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.

The Eswatini PRISM Study on Adolescents Living With HIV

Adolescents living with Human Immunodeficiency Virus (ALHIV) are at an increased risk of experiencing psychological distress and adverse mental health outcomes, particularly in low- to middle-income countries (LMICs). Although interventions aimed at promoting resilience have demonstrated potential in enhancing psychosocial outcomes among adolescents with chronic illnesses in high-income settings, there is a paucity of evidence from LMICs. This study protocol aims to outline a comprehensive framework for evaluating the feasibility, acceptability, and effectiveness of the Promoting Resilience in Stress Management (PRISM) intervention in comparison to standard psychosocial care among ALHIV in a LMIC, such as Eswatini (formerly known as Swaziland). Additionally, it seeks to gather qualitative insights from both participants and PRISM coaches regarding the PRISM program. Exploratory outcomes under investigation are psychological distress, resilience, and HIV health-related quality of life. We hypothesise that: 1. Participants in the PRISM intervention group will experience reduced psychological distress compared to those in the control arm. 2. Participants in the PRISM intervention group will report improved HIV health-related quality of life after receiving the intervention compared to the control group. 3. Participants in the intervention arm will have higher resilience scores after receiving the intervention compared to those receiving usual psychosocial care.

Horse-assisted Intervention, Heart Rate Variability & Stress

In this study, the effects of an animal-assisted intervention on people with increased stress levels are investigated. The data collected will be compared with those of participants with high stress levels but without animal-assisted intervention (participants only observe nature) and with a control group consisting of people without stress exposure. The study will be performed in the following setting: Questionnaire examination on chronic stress, questionnaire on current well-being and heart rate variability (HRV) measurement before the horse-assisted intervention, one HRV measurement and one questionnaire examination (POMS) on current well-being after the horse-assisted intervention, one questionnaire (POMS) on current well-being 5 days after the horse-assisted intervention.

Cerebrovascular Health and Resilience in Midlife

This study examines cardiovascular responses to a brief psychological challenge under laboratory conditions among adult volunteers. The study volunteers are asked to complete two study sessions. In one session, the volunteers are asked to provide demographic and health-related information via questionnaires and an interview. In that session, volunteers would then be asked to undergo evaluations of their body composition, blood pressure, heart rate, and other signs of cardiovascular function and health. Lastly, volunteers would be asked to take part in a brief and challenging psychological task after a period of rest while cardiovascular activity is measured. In the other session, volunteers are asked to undergo magnetic resonance imaging and to complete neuropsychological tests of memory, attention, and processing speed. In addition to these two sessions, volunteers are asked to complete online questionnaires. The study is designed to examine associations between transient changes in cardiovascular activity induced by the psychological task, measures of overall cardiovascular health, and measures of cerebrovascular health measured by magnetic resonance imaging. Study results are expected to provide new information about the relationships between cardiovascular activity changes to psychological challenges and cardiovascular and cerebrovascular health in adults.

Psilocybin-Assisted Therapy for Intergenerational Trauma

This is an open-label psilocybin-assisted therapy study that will examine the safety and tolerability of psilocybin-assisted therapy in the offspring of genocide survivors with mood and anxiety disorders. The study will also investigate the efficacy of psilocybin-assisted therapy in reducing symptoms such as depression, anxiety and stress, as well as changes to the psychological effects of parental exposure to genocide, and changes to psychological resilience.

Effect of Adding Progressive Muscle Relaxation to Physical Therapy Program on Fatigue, Mobility and Stress Among Individuals With Traumatic Lower Limb Amputation in the Gaza Strip

Lower limb amputation is a life-altering condition with profound physical and psychological consequences, including fatigue, impaired mobility, stress, and asymmetrical weight-bearing. These challenges are particularly severe in conflict-affected settings like the Gaza Strip, where access to rehabilitation services is limited. This study aims to evaluates the effect of adding Progressive Muscle Relaxation (PMR), a simple and cost-effective relaxation technique, to standard physical therapy on Fatigue, mobility, weightbearing distribution and stress outcomes among adults with unilateral traumatic lower limb amputation in Gaza. Study design: RCT with 60 participants will be randomly assigned to either (1) a control group receiving standard physiotherapy or (2) an intervention group receiving standard physiotherapy plus PMR. Outcomes will be measured using validated instruments: Fatigue Severity Scale (FSS), 2-Minute Walk Test (2MWT), Perceived Stress Scale (PSS-10), and dual bathroom scale method for weight-bearing distribution. Assessments will be conducted at baseline, post-intervention (6 weeks), and follow-up (8 weeks). The study aims to determine whether integrating PMR into rehabilitation improves fatigue reduction, functional mobility, stress management, and weight-bearing symmetry compared to physiotherapy alone. Findings will contribute to evidence-based rehabilitation strategies for amputees in low-resource, high-stress environments.

RELIEF OF PSYCHOEMOTIONAL STRESS USING XENON SEDATION

The goal of this clinical trial is to propose for implementation and evaluate the effectiveness of xenon sedation for the relief of psychoemotional stress disorder before the operation of refractive laser vision correction patients with high anxiety and stress instability who underwent xenon analgosedation before refractive laser vision correction. The main question\[s\] it aims to answer are: 1. To develop a method of xenon sedation in patients with a high level of psychoemotional stress before surgery - refractive laser vision correction. 2. To evaluate the effect of inhaled xenon anesthesia in a sub-narcotic dose on the duration of surgery, satisfaction of surgeons and patients with anesthesia, the level of postoperative pain in patients in comparison with anxiolytics. The following will be studied: the level of preoperative anxiety, the dynamics of glycemia and blood cortisol levels, heart rate variability, electrical microamplitudes of the ECG signal, the anti-stress and analgesic effect of xenon. If there is a comparison group: the researchers will compare \[the group with xenon sedation and the control group\] to see if there is \[an anti-stress effect of xenon in patients before laser vision correction\].

Psychosocial, Environmental, and Chronic Disease Trends in Puerto Rico

The overall goal is to identify trends and longitudinal associations in psychosocial, food-related, and cardiometabolic risk factors that can guide public health priorities and future research needs aimed at reducing cardiovascular-related disparities in Puerto Rico. To this end, investigators will establish 'PROSPECT: Puerto Rico Observational Study of Psychosocial, Environmental, and Chronic disease Trends', an island-wide, longitudinal population cohort of 2,000 adults (30-75 years) in PR recruited with a community-wide sampling strategy, and assessed in a network of several partner clinics across the island. The study will collect comprehensive data on multiple psychosocial, dietary, and food-related factors, CVD biological markers, and medical record data, with follow-up at 2-years, and will assess variations by urban-rural area and by timing before-after Maria.

Strategies for Pregnancy Achievement

The purpose of pilot study application is to build on the investigators' previous work that established the prospective association between stress and infertility. Specifically, the investigators hope to collect the preliminary data necessary to make them competitive to submit a R01 application to NIH for funding of a full-scale randomized controlled trial of an internet-based stress management program to examine its efficacy in decreasing stress and increasing pregnancy rates among women who have tried to get pregnant for 6-12 months without success. The program called Stress Free Now (SFN) was developed at the Cleveland Clinic and has been shown to be effective in lowering stress in a variety of populations. The program introduces concepts of mindfulness and cognitive-behavioral therapy to assist individuals in managing their stress levels. The intervention includes Internet-based interaction, daily emails and recommended relaxation practice of at least four days per week. Using targeted Facebook Ads and other recruitment modalities, the investigators will randomize 40 women ages 18-34 who have been trying to conceive for 6-12 months without success. The PI has been enrolling women in a similar study using this mechanism and has found it to be an efficient and cost-effective method of identifying potentially eligible individuals. Women will be randomized to SFN or a wait list control condition and will be followed for up to three months post-randomization with weekly journals as they try to conceive. The primary outcome of this randomized controlled trial is stress level, as measured by salivary alpha-amylase, while the secondary outcome will be pregnancy rate at the end of the three-month follow-up period.

Effect of Aerobic Exercise With Synchronous Music on Functions Among Medical Students

Researchers invite participants to volunteer to participate in this cross-sectional, interventional study. This research examines the effects of 8-week aerobic exercise of different intensities combining synchronized music on psychology, attention, and executive function among Chinese college students, and also validates the reliability and validity of the Chinese version of Brief College Student Hassles Scale, the Perceived Stress Scale for Medical Students, Brief Multidimensional Students'Life Satisfaction Scale, Positive Thinking Skills Scale, Attentional Function Index, Procrastination Assessment Scale-Student and Behavioral Assessment of the Dysexecutive Syndrome-College version, providing a research basis for aerobic exercise to improve the cognitive function and mental health level of Chinese college students. Participants will be invited to participate in the intervention study, in which participants will be assigned to the intervention group and control group. Participation in this study will last approximately 8 weeks for a total of 24 sessions, 40 minutes each session, and participants will not be forced to participate in this study if they do not wish to. This study will include up to 134 participants who will be assigned to the intervention and control groups in a randomized manner.

A Randomized Controlled Evaluation of a Compassion-course for Healthcare Professionals

The aim is to investigate whether an internet-based compassion course of five modules contributes to reducing stress of conscience and work-related stress, increase the experience of professional quality of life and self-compassion in healthcare professionals.

Trauma and Cardiometabolic Health in an American Indian Community

Volunteers for the study are asked to participate in two laboratory sessions. In the first laboratory session, volunteers are asked to provide a blood sample which will be used to measure factors related to health. Participants also complete questionnaires related to demographic and health-related information and undergo evaluations of their body composition. In the second laboratory visit, participants are asked to have cardiovascular, neuroendocrine, and inflammatory activity measured during a brief period of rest and during a short challenging psychological task. Participants will also complete questionnaires. The study is designed to examine the associations between experiences such as trauma and resiliency with changes in bodily systems during a challenge and current health.

The Associations of Psychological Stress With Therapy Efficacy and Prognosis of Lung Cancer (STRESS-LUNG)

This is the prospective, observational cohort study (STRESS-LUNG) to explore the associations of psychological stress with progression, efficacy of immune checkpoint inhibitors (ICIs) and prognosis of Lung Cancer. The participants including the patients diagnosed with advanced non-small-cell lung cancer (NSCLC) who received the first-line therapy or neoadjuvant therapy of ICIs; patients diagnosed with advanced small-cell lung cancer (SCLC) receiving the first-line therapy ICIs; patients diagnosed with early small-cell lung cancer (SCLC) receiving surgery.

Psychological Response and Readiness Associated With OCD of the Knee

This study primarily aims to determine whether patients diagnosed with osteochondritis dissecans (OCD) of the knee experience psychological stress due to their diagnosis and treatment plan. Secondarily, this study aims to determine whether knee OCD patients experience a change in stress and depression as they progress through their standard-of-care treatment plan, and whether they have impaired psychological readiness for return to sport.

Parental Stress and Attachment in Preterm Infants

Introduction: Advances in neonatology mean a significant reduction in mortality in premature infants as well as an increase in the risk of morbidity in the medium, short and long term. Furthermore, previous studies have linked prematurity, as an associated risk factor, with possible alterations in the bonding between the child and his or her mother in the first years of life. The possible impact that the stay in the neonatal unit may have on the mental health of the parents is noted. In fact, several studies have shown that the hospital environment of neonatal units may contribute to increased stress and anxiety in mothers. On the other hand, prematurity is one of the causes of referral to Child Development and Early Care Centres, to address their development in the first years of life, as well as for family support. One of the functions of early childhood professionals is to guarantee the development of a secure attachment between the child and his or her caregivers. Little is known about whether maternal stress levels can influence mother-child interactions and thus influence the attachment relationship in the early years of life. Objective: to analyse the association between mothers' stress level due to preterm birth and attendance at a Child Development and Early Care Centre and child development and patterns of mother-child interactions.

Fitness Buddy Program to Boost Physical Activity in University Students

This study explores whether a peer-supported "fitness buddy" program can help first-year university students increase physical activity levels and improve mental well-being. Over 12 weeks, participants will form small exercise groups, choose enjoyable activities (such as jogging, cycling, or yoga), and support each other through shared goals and regular check-ins. A professional coach will offer weekly guidance on exercise safety, injury prevention, and motivation strategies, but the actual workouts will be conducted by the students. The investigators aim to determine if this peer-based approach helps reduce stress, anxiety, and depressive symptoms, while boosting self-esteem and social connectedness. Students in a control group will receive usual campus resources without structured group support. By comparing outcomes at the start, after the 12-week program, and again at follow-up, the study will assess whether peer-led, knowledge-supported exercise can sustainably enhance both physical and mental health during the critical transition into university life.

Effectiveness of Stress Self-management Health Education Based on IMB Theory Among Nursing Students

The aim of this cluster randomized controlled study is to test the effectiveness of IMB stress self-management health education on nursing students registered in first semester. The main question aims to answer are: Does IMB stress self-management health education program improving stress in nursing students? Researcher will compare wait-list group without any intervention to experimental group which received IMB stress self-management health education, to see if IMB stress self-management health education works to improving stress among nursing students. Participants will Attend IMB stress self-management health education program once a week for 8 weeks. In addition, complete questionnaires at pre-intervention, post-intervention, 1-month post-intervention, 3-months post-intervention, 6-months post-intervention.

A Digital Active Aging Training Program for Older Adults

The proposed project aims to develop and validate a multi-dimensional digital active aging program integrated with resilience to promote the biopsychosocial functions of older adults aged 60, including Chinese older immigrants in Canada (Study 1) and English-speaking White Canadian older adults (Study 2). The proposed study takes a typical pretest-training-posttest design. Pretest and posttest: a battery of outcome measures on physical, psychological, and social functions will be administered to all participants. Data will also be used to identify sociodemographic risk predictors for outcome variables (i.e., biopsychosocial functions and resilience). Training: the participants will be randomly assigned to three arms to receive 4 weeks of 16 training/practice/control treatment sessions delivered via Zoom. In the "active aging with resilience (AR)" condition, participants will complete physical, cognitive, and social engagement training modules, starting with a 30-min resilience-building module. The traditional "active aging" (AA) training involves the same multi-domain active aging training without the initial resilience-building module. The "workshop training" (WT) control condition involves workshops following the same 4-week schedule on aging-related topics.