Clinical Research Directory

Visual Art Therapy on Caregiver Burden

This study aims to determine the effect of Zentangle practice on perceived caregiver burden, stress levels, and burnout among family caregivers of patients receiving palliative care. Zentangle is a visual art therapy method used for meditative purposes by promoting creativity and focused attention in individuals under stress, which can facilitate mental relaxation, stress relief, and mindfulness. The study is designed as a randomized controlled experimental trial with a pretest-posttest design. The sample consists of 60 family caregivers of patients hospitalized in a palliative care unit, randomized into an intervention group (n=30) and a control group (n=30). Participants in the intervention group receive a two-week meditative art therapy intervention based on the Zentangle method, while data are collected through face-to-face interviews using validated psychological scales before and after the intervention period.

A Multi-Dimensional Comparative Study of Exercise Psychological Experience Under AI Fitness Companion and Human Coach Paradigms

This study conducted a comparative analysis of subjective exercise experiences between an AI-based fitness companion and traditional human coaching among 98 university students participating in a standardized 20-minute functional circuit training session. Participants were evaluated across three psychological dimensions: Emotional Resonance (ER), Interactive Dynamics (InD), and Embodied Presence (EP). The results indicated that human coaching elicited significantly higher levels of Emotional Resonance, whereas AI-based companions demonstrated superior performance in Interactive Dynamics. No significant differences were observed in Embodied Presence, suggesting that contemporary AI systems can provide spatial immersion and body-awareness comparable to human coaches. These findings indicate that AI and human coaches offer distinct psychological strengths, suggesting that AI should be viewed as a complementary, scalable tool for exercise guidance rather than a direct replacement for human emotional support.

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.

Effect of Mandala Coloring on Menopausal Attitude, Perceived Stress and Mindfulness

Menopause is a natural life stage associated with hormonal changes that may affect women physically and psychologically. During this period, women may experience increased stress levels, negative attitudes toward menopause, and decreased mindfulness. Mandala coloring is a structured art-based intervention that may promote relaxation and improve psychological well-being. This randomized controlled trial aims to evaluate the effect of mandala coloring on attitudes toward menopause, perceived stress, and mindfulness levels among menopausal women.

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.

Descriptive Study of Biological Stress and Perceived Stress at the Center 15

The purpose of this study is to describe biological stress (cortisolemia) and perceived stress in Emergency Call Center Operators and Doctors while processing a center 15 call.

Effects of L-Theanine and Hericium Erinaceus Gummies on Psychological, Cognitive, and Sleep Quality in University Students

The THEA-HEAL Trial is an 8-week randomized controlled study investigating the effects of a daily gummy supplement containing L-theanine and Hericium erinaceus (Lion's mane mushroom) extract on stress, anxiety, cognitive performance, and sleep quality in university students in Malaysia. University life can be a stressful period associated with increased psychological distress, sleep problems, and difficulty concentrating. In this study, eligible participants aged 18-25 years were randomly assigned to either receive the active gummy supplement or no supplementation. The intervention group consumed gummies twice daily, providing a total daily dose of 180 mg L-theanine and 300 mg H. erinaceus extract. The main purpose of the study is to determine whether this nutraceutical combination can help reduce stress and anxiety and improve cognitive function and sleep quality compared with no supplementation. Additional outcomes include physical activity levels and dietary intake. Findings from this study may provide evidence on the potential role of functional food-based supplements in supporting mental well-being and cognitive health in young adults.

Psychological Impacts of Exercise Snacks Versus Traditional Exercise: A Comparative Study

This study investigates the comparative psychological impacts of a high-frequency "Exercise Snacks" (ESG) protocol versus a traditional continuous exercise (TEG) regimen on healthy young adults. Utilizing a randomized controlled trial design over a 4-week longitudinal period, 180 participants were allocated into two groups of 90, with a standby recruitment protocol employed to ensure sample size stability. The intervention was standardized to equate total weekly exercise volume at 90 minutes. The TEG cohort performed 30-minute continuous cycling sessions three times per week, whereas the ESG cohort executed 15-minute distributed cycling sessions six times per week. To ensure physiological homogeneity and precision in workload prescription, individual baseline maximal aerobic capacity was assessed via incremental cardiopulmonary exercise testing. Based on these individual thresholds, exercise intensity for both cohorts was rigorously maintained at 40% of their respective maximal aerobic capacity throughout the intervention. Psychometric outcomes were evaluated within 24 hours of the intervention's conclusion, focusing on three dimensions: Perceived Stress, Decision Fatigue and Cognitive Load, and Physical Activity Enjoyment. By applying Lazarus and Folkman's Transactional Model of Stress and Coping, Sweller's Cognitive Load Theory, and Self-Determination Theory, this research examines how fragmented exercise protocols interact with daily workflow and self-regulatory resources. The findings provide critical insights into the real-world viability, behavioral resistance, and psychological divergence associated with high-frequency, fragmented exercise routines compared to conventional models.

Can Increased Medical Competence Reduce State Anxiety in Junior Doctors in the Emergency Department?

This randomized controlled trial investigates whether an adaptive e-learning program on acute and time critical medical conditions can reduce state anxiety and improve the competence of junior doctors working in emergency departments. Junior doctors assigned to frontline shifts will be enrolled and randomized into two groups: an intervention group receiving the e-learning program within the first six weeks of employment and a control group receiving standard onboarding with delayed access to the program. The primary outcome is the change in state anxiety levels, assessed using the State-Trait Anxiety Inventory (STAI-6). Secondary outcomes include perceived self-efficacy during shifts and self-assessed competency improvements.

Theta Healing-Based Intervention in Women With Polycystic Ovary Syndrome

This randomized controlled study aims to evaluate the effect of a Theta Healing-based intervention on fertility concerns, self-compassion, and body image in women diagnosed with Polycystic Ovary Syndrome (PCOS). Participants will be randomly assigned to intervention and control groups. The intervention group will receive a structured 5-day Theta Healing-based online intervention program, while the control group will continue routine care. Outcome measures will be assessed at baseline and 6 weeks after the intervention.

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.

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 2,500 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.

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.

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.

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.

Ego-Tucking: Exploring the Psychological Mechanisms of the "Fo-xi" Phenomenon Among University Students

The objective of this cross-sectional study is to explore the multi-dimensional factors influencing the shift toward "Ego-Tucking" (Fo-xi) mindsets among the contemporary student population. By utilizing a comprehensive structured questionnaire, the research aims to quantify how individual experiences, family dynamics, and macro-social environments contribute to behavioral changes and psychological defense mechanisms in the face of intense academic and professional competition.

Feasibility and Benefits of Digital Services During the COVID19 Pandemic

As a result of the pandemic, hygiene and distancing rules must be followed in Health care/ rehabilitation clinics to ensure the safety of patients and staff. This has led to extensive changes in the therapy processes, including a reduction in group sizes and maintaining distances within the groups, resulting in a reduction in the range of therapies available to individuals, since the number of employees remains unchanged and cannot be increased at will and in the short term due to the lack of qualified staff. In order for the treatment/rehabilitation goals to be achieved nonetheless, new forms of implementation of therapy programs must be developed in addition to organizational adjustments. Digitalization can be a significant support in this respect. The majority of patients in psychosomatic rehabilitation possess smartphones, meaning that the necessary infrastructure for the utilization of digital offers is available and can be used to the greatest possible extent. The use of digital measures within the therapeutic services supports the independence of the patients, as they can use the digital offers independently and flexibly in their own time. How should Health care/rehabilitation services be designed in light of the SARS-CoV-2 pandemic and which services have the potential to buffer future crises: What general recommendations can be derived for the design of such services for routine care? What are support measures to encourage social participation and return to work?

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.

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.

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.

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.