Clinical Research Directory

Mandala Coloring in Late Pregnancy

Anxiety, depression and poor sleep are common in the last months of pregnancy and often occur together. Medication options during pregnancy are limited, so simple, safe non-drug methods are needed. Mandala coloring is an art therapy technique in which a person colors circular patterns; it helps focus attention on the present moment and may have a calming effect. This randomized controlled trial will examine whether mandala coloring during the third trimester reduces depression, anxiety and stress, improves sleep, and reduces fear of childbirth. It will also look at birth outcomes and the childbirth experience. Pregnant women at 28 weeks of gestation who attend the obstetrics outpatient clinics of Malatya Training and Research Hospital will be randomly assigned to a mandala coloring group or a control group. Women in the mandala group will color two mandalas a week at home for 8 weeks (16 mandalas in total, about 20-30 minutes per session). Women in the control group will receive routine antenatal care only and will be offered the mandala materials after the study ends.

Bisoprolol Versus Cognitive Behavioral Therapy for Stress in Patients on Peritoneal Dialysis

Patients on continuous ambulatory peritoneal dialysis (CAPD) often have chronic stress and anxiety. This pilot study compared two ways to reduce stress in adults on CAPD: cognitive behavioral therapy (CBT) and the beta-blocker bisoprolol. Each patient received one treatment for 30 days. The main question was whether either treatment lowers morning blood cortisol, a stress hormone. The study also compared changes in blood pressure, pulse rate, anxiety score, and sleep quality.

Feasibility Pilot of Remote Mindfulness Training Across Multiple Sites (REFORM Pilot)

This is an operational feasibility pilot preceding the main REFORM multi-site randomized controlled trial. Approximately 60 adults across three sites will be randomized equally to one of four remotely delivered audio-guided mental training programmes and will complete 12 sessions over approximately one month. The purpose of the pilot is to assess the feasibility and functioning of the study procedures, including the Qualtrics survey and randomization workflow, participant adherence and experience, Camera HRV data collection and transfer, compensation procedures, and blinding materials. Pilot outcomes will be summarized descriptively. The pilot is not designed for confirmatory efficacy testing. Pilot participants will be excluded from all confirmatory analyses of the subsequent main REFORM trial, and pilot data will not be used to calibrate the Bayesian stopping design, nuisance parameters, or Wave 1 recruitment target.

Multiple Sclerosis Severity and Caregiver Health Outcomes

This cross-sectional observational study aims to investigate the associations between multiple sclerosis (MS) severity and caregivers' sleep quality, physical activity, body awareness, perceived stress, and caregiver burden. A total of 68 caregivers of patients with MS will be recruited from Başkent University Hospital. MS severity will be assessed using the Expanded Disability Status Scale (EDSS), while caregiver health outcomes will be evaluated using validated questionnaires. The findings are expected to provide insight into the multidimensional impact of MS severity on caregiver health and well-being.

Feasibility of a Mind-Body Intervention for Optimism

This pilot study tests whether three brief mind-body activities can be delivered remotely to midlife adults, and whether they show early signs of improving cardiovascular health, emotional well-being, and stress. The activities are an emotional well-being writing exercise, two minutes of chair-assisted squats, and five minutes of slow-paced breathing. Insufficiently active adults aged 40 to 65 years are randomly assigned to one of eight groups. The groups cover every combination of the three activities, including one group that receives none. Participants complete their assigned activities in live Zoom sessions with a research assistant on five weekdays per week for four weeks (20 sessions). Blood pressure, heart rate, heart rate variability, a small blood sample, and questionnaires on emotional well-being and stress are collected at in-person visits before and after the four weeks. Participants also rate how they feel immediately before and during each activity.

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.

Internet Intervention for Well-Being and Work-Family Conflict in Dual-Earner Couples

The goal of this clinical trial is to learn if an online program treats stress in working couples. The main questions it aims to answer are: * Does the 3-week online program lower stress for participants? * Does doing the program together work better than doing it alone? * Does the program lower conflict between work and home life? * Does the program improve job and family satisfaction? Researchers will compare four groups (both partners, only women, only men, and a waitlist) to see if doing the program together works best to lower stress. Participants will: * Fill out online surveys at the start, after 3 weeks, and 6 months later. * Use a 3-week online program to manage time and lower stress. * Read short texts and track their daily habits. * Talk and plan with their partner if placed in the joint group.

A Persian AI-Based CBT Chatbot and Voice Analysis System for Managing Perceived Stress

This pilot randomized controlled trial aims to evaluate a Persian-language artificial intelligence (AI)-based cognitive behavioral therapy (CBT) chatbot designed to support adults in managing perceived stress. A total of 120 adults will be randomly assigned to one of three groups: an AI-based CBT chatbot intervention, active mental health educational content, or a waitlist control. The intervention period will last 14 days. The study will evaluate the feasibility, acceptability, safety, and preliminary effectiveness of the AI-based CBT chatbot for perceived stress management. As a separate research component, voice recordings will be collected from participants at baseline and at the end of the study. These recordings will be used solely as research data to train and evaluate an artificial intelligence model for stress detection. The voice-based model will not be used to guide, modify, personalize, or influence the study intervention, chatbot responses, participant allocation, or clinical decision-making during this trial.

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.

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 \[an anti-stress effect of xenon in patients before laser vision correction\].

Meditation Apps for Stress Management in Black Women

This randomized remote pilot study will evaluate the feasibility, acceptability, and preliminary effects of two meditation and mindfulness applications among approximately 40 Black women ages 35-64 experiencing moderate to high stress. Participants will be randomly assigned in a 1:1 ratio to Exhale™, a culturally adapted meditation app designed for Black women, or Levelhead, a general mindfulness app. Participants will be asked to complete at least one session using their assigned app per day, lasting approximately 5 minutes or longer, at least 5 days per week for 4 weeks. Participants will complete online questionnaires at baseline and after the 4-week intervention. Daily Remind messages and weekly study check-ins will support engagement. Outcomes include recruitment, retention, adherence, assessment completion, satisfaction, usability, perceived stress, race-based stress, sleep, depression, anxiety, cultural relevance, and brief participant feedback.

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.

Presurgical Illustration and Psychological Stress in Mandibular Third Molar Surgery

The aim of this clinical trial is to evaluate the influence of presurgical patient's diagrammatic illustration of mandibular third molar (Wisdom tooth) surgery on degrees of psychological stress.

The Effect of Mindfulness in Inflammation Markers (MLR, NLR, PLR), Stress, Anxiety, and Depression Rate Among Survivors of Tidal Flooding in Sayung Demak

Tidal flood disasters in coastal areas cause chronic psychological stress due to economic, social, and residential disruption. Psychological stress is closely linked to systemic inflammatory responses-marked by elevated Monocyte-to-Lymphocyte Ratio (MLR), Neutrophil-to-Lymphocyte Ratio (NLR), and Platelet-to-Lymphocyte Ratio (PLR)-which are associated with depression and anxiety symptoms. Mindfulness interventions, particularly body scan techniques, have been shown to reduce psychological distress and modulate immune responses, but empirical evidence on coastal flood survivors in Indonesia remains limited. This study aims to evaluate the effectiveness of a community-based mindfulness body scan intervention on inflammatory biomarkers (MLR, NLR, PLR) and psychological parameters (stress, depression, anxiety, trauma, sleep quality, and resilience) among tidal flood survivors in Sayung, Demak. Participants will undergo baseline blood work and psychometric assessments, receive an 8-day mindfulness body scan intervention, and complete post-intervention evaluations.

The Effect of Mindfulness in Inflammation Markers (IL-6, TNF-A, CRP and Cortisol) Among Survivors of Tidal Flooding in Sayung Demak

Recurrent tidal flooding (rob) in the coastal areas of Sayung District, Demak Regency, poses a continuous environmental threat that inflicts housing damage, economic instability, and prolonged socioeconomic uncertainty on local residents. These chronic stressors frequently trigger significant psychological distress, including elevated levels of stress, anxiety, and depression, while simultaneously activating systemic inflammatory pathways and dysregulating the hypothalamic-pituitary-adrenal (HPA) axis. Mindfulness body scan is a structured, non-pharmacological mind-body technique that involves directing non-judgmental attention to physical sensations across the body. Within a psycho-neuro-immunological framework, mindfulness practice is hypothesized to reduce physiological stress responses, promote autonomic nervous system balance, and downregulate pro-inflammatory pathways. This randomized controlled trial evaluates the effectiveness of a structured 8-day mindfulness body scan intervention on both biological inflammatory markers and psychological outcomes among tidal flood survivors. Participants recruited from Sayung 1 Primary Health Center will be randomly allocated into two groups: 1. Intervention Group: Receives structured 8-day Mindfulness Body Scan training. 2. Control Group: Receives standard health monitoring. All participants will undergo baseline and post-intervention assessments, which include venous blood sampling to analyze key inflammatory and stress biomarkers-Interleukin-6 (IL-6), Tumor Necrosis Factor-alpha (TNF-α), C-Reactive Protein (CRP), and Cortisol. In addition, psychometric instruments will evaluate changes in depression, anxiety, stress, sleep quality, and overall quality of life. The primary objective is to determine whether a short-term mindfulness body scan practice can effectively reduce systemic inflammation and improve post-disaster psychological well-being in coastal communities.

NeuroFinance Human Stress Trial During Financial and Informational Volatility

The NeuroFinance Human Stress Trial (NFHST-2026-001) is a decentralized observational clinical study designed to evaluate how financial market volatility, economic uncertainty, digital media exposure, and information-driven stress environments affect human physiologic and behavioral health. Participants will undergo remote monitoring using wearable biosensors, cardiovascular telemetry devices, sleep tracking systems, heart rate variability monitoring, and behavioral analytics platforms. The study will use artificial intelligence and machine learning systems to analyze relationships between external financial and informational events and biologic stress responses, including autonomic nervous system activity, sleep disruption, cardiovascular strain, emotional resilience, and inflammatory signaling. The goal of the study is to develop predictive digital biomarkers and AI-assisted forecasting systems capable of identifying stress-related physiologic deterioration before clinical manifestation.

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.

Emotional Regulation and Stress Coping Program for Nursing Students During Clinical Placements

The goal of this clinical trial is to learn whether REGULA-T, a group-based emotional-skills program, improves stress coping and emotion regulation in nursing students during their clinical placements. The program is aimed at nursing students aged 18 or older enrolled in supervised clinical placements. The main questions it aims to answer are: Does it reduce their difficulties in regulating emotions and improve their perceived emotional intelligence and coping strategies? Does the program reduce perceived stress and anxiety in students during their placements? Researchers will compare students who take part in the REGULA-T program with students who follow the standard curriculum (waiting-list control group, who are offered the program after the study) to see whether the program improves emotional wellbeing during clinical placements. Participants in the program will: * Attend a 9-session emotional-management workshop held in two modules across the academic year, timed to coincide with their clinical placements * Have access to an on-demand individual support service throughout the year * Complete online questionnaires before their placements begin and again after they finish * Optionally take part, after the final questionnaires, in an online group discussion about their experience Participants in the control group will follow their standard curriculum, complete the same online questionnaires at the same two time points, and be offered the program once the study is complete.

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.

Pandemic Acceptance and Commitment Therapy (Pan-ACT): Telehealth Delivery With Older Veterans

Older adults have been disproportionately impacted and distressed by the novel coronavirus (COVID-19) pandemic. Social distancing and stay-at-home orders have increased older adults' risk of social isolation and loneliness that will has led to a pandemic-induced fear of being in close proximity to other people. These fears and avoidant behaviors will have lasting effects if not treated with effective, safe, and convenient psychological interventions. This study will evaluate the acceptability and feasibility of delivering a small group intervention, called Acceptance and Commitment Therapy (ACT), through a telehealth modality to Veterans ages 60 and older who are experiencing pandemic-related emotional and physical distress. ACT helps decrease emotional suffering, improve well-being and promote positive behavior change by increasing one's psychological flexibility through the practice of mindfulness, acceptance, and values-based behaviors. The knowledge gained from this study will be used to better tailor the invention to meet the needs of older Veterans in an era of post-pandemic recovery.

Sleep More, Stress Less: 90-Day Trial of Neuralli Mood

This decentralized, single-arm study evaluates the effects of 90 days of daily Neuralli Mood supplementation on perceived stress, sleep disturbance, mood, anxiety, depressive symptoms, happiness, and occupational burnout in adults experiencing stress or occasional sleep disruption. Participants serve as their own controls, completing validated self-report measures before beginning supplementation and again after the 90-day intervention, with safety and adherence check-ins during the study.

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.

Severe Asthma, MepolizumaB and Affect: SAMBA Study

This is a real-life pragmatic non-randomised study to explore the impact of mepolizumab on the emotional and affective outcomes of patients with severe eosinophilic asthma and their partners. It will be conducted in two quantitative stages (Phases 1 and 2) with an additional third qualitative component (Phase 3).

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.