Clinical Research Directory

Metacognitive Bibliotherapy for Anxiety, Depression, and Metacognitions in University Students

This study tests whether reading a structured self-help book (bibliotherapy) can reduce anxiety, depression and stress and change unhelpful thinking patterns in medical and health-sciences students. Students in health programs face heavy academic and clinical demands and are at increased risk of emotional distress. A thinking style called the Cognitive Attentional Syndrome (worry, rumination, threat monitoring and unhelpful coping) is thought to link stress to anxiety and depression. Metacognitive therapy targets this thinking style, and low-intensity self-help books may make these principles accessible to students. A total of 165 students at İstanbul Nişantaşı University will be randomly assigned to one of three groups: two groups each receive a different self-help book and read it at their own pace over 8 weeks, and the third group (waitlist) receives the books after the study ends. All participants complete short online questionnaires (DASS-21, CAS-1, MCQ-30) at the start, at week 4 and at week 8, and receive brief telephone calls at weeks 2, 4 and 6 to confirm participation.

Influence Of Different Relaxation Techniques On Stress Level For Patients With Bruxism Using Salivary Biomarkers.

This study will compare the effect of three different physical therapy techniques on stress level on patients with bruxism by assessment of morning salivary biomarkers.

Stress Through Audition: Uptake, Recovery, Oscillations During Nature Exposure

The protocol the investigators propose aims to address certain gaps by developing a multimodal paradigm, based on: * Induction of acute stress via the Maastricht Acute Stress Test (MAST), a standardised protocol recognised for its effectiveness in activating both the HPA axis and the autonomic nervous system. * A 10-minute auditory exposure to two types of soundscapes (natural vs urban), designed in accordance with ecological standards (recordings taken from real-world environments and featuring representative natural and anthropogenic sound components, with the aim of making the stimulus as close as possible to real-life experiences). * A battery of synchronised, multimodal measurements, including hormonal measurements (salivary cortisol at 10 time points), continuous autonomic nervous system measurements (HR, HRV, BP), a high-density EEG and analysis via EEG Source Imaging (ESI), a battery of cognitive tests typically sensitive to stress (Continuous Visual Attention Task, N-back, Delay Discounting Task), and a light polysomnography study conducted at home to assess delayed effects on sleep. This design will enable the investigators to examine, as comprehensively as possible, the dynamics of post-stress recovery across several levels of analysis (biological, cerebral, cognitive and behavioural). It will also enable the investigators to identify the specific effects of the sound environment on each of these levels. By cross-referencing neurophysiological, hormonal and behavioural responses, we hope to document how natural sound environments actively regulate stress and cognition and to explore the mechanisms involved. This project could pave the way for applications in mental health, preventive neuroscience, acoustic urban planning and non-pharmacological interventions, by providing a rigorous scientific foundation to support recommendations for the design or management of stress in professional, educational or clinical settings.

Stress Management Intervention for Young Turkish Women

This pilot study aims to evaluate the feasibility and probable impact of a low intensity psychosocial intervention program designed to help individuals to manage their stress levels. Consequently, this study will implement and measure the feasibility, randomization, retention, assessment procedures, and preliminary effects of the Self-Help Plus (SH+) program developed by the World Health Organization. This intervention, which has been used among immigrants and has proven to be effective, is intended to be implemented for the first time among distressed young Turkish-speaking women in Türkiye (ages between 18 and 29). Participants who will receive this intervention program will be compared with others in the control group who experience similar stress levels but will not receive SH+ during the trial period. Participants in the control group will receive SH+ after the completion of follow-up assessments at 3 months.

CBT-Based Stress Management Program for Healthcare Students

This study aims to evaluate the effectiveness of a cognitive-behavioral-based stress management skills program for healthcare students. The study will use a mixed-methods design and will include intervention, placebo, and control groups. Approximately 90 healthcare students will participate in the experimental phase. The intervention group will receive a 9-session cognitive-behavioral-based stress management program designed to help students recognize and manage stress, identify dysfunctional thoughts, and develop effective stress management and coping skills. The study will assess changes in perceived stress and coping skills before and after the program and at follow-up. Qualitative interviews and group discussions will also be conducted to explore students' experiences and perceptions of stress management and the program. It is hypothesized that students who participate in the stress management program will show improvements in perceived stress and coping skills compared with students in the placebo and control groups.

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.

Implementing BEAM: A Scalable Digital Mental Health Program, for Families of Children Referred to Neurodevelopmental Services

Families of children with neurodevelopmental differences (NDDs) experience disproportionately high levels of parenting stress and mental health difficulties, including elevated depression, anxiety, and caregiver burden. These challenges are often compounded by increased caregiving demands, system navigation stress, and limited access to timely, tailored mental health supports. Parental mental health plays a critical role in family functioning and child outcomes; however, existing services for families of children with NDDs are frequently fragmented, inaccessible, or focused primarily on child behavior rather than caregiver well-being. As a result, many caregivers experience unmet mental health needs that persist throughout early and middle childhood. To address this gap, our team developed BEAM (Building Emotional Awareness and Mental Health), an app-based parenting and mental health intervention that integrates psychoeducation, peer support, progress monitoring, and coached support. Clinical trials evaluating BEAM with parents of young children have demonstrated promising improvements in parental depression, anxiety, and parenting stress, as well as reductions in harsh parenting practices. Building on this evidence base, the current trial examines the implementation and outcomes of BEAM delivered as-is to families of children with NDDs (BEAM-NDD), without content adaptation, to evaluate its feasibility and effectiveness within this high-need population. This trial uses a single-arm pre-post design to evaluate BEAM-NDD among parents and caregivers of children with diagnosed or suspected neurodevelopmental differences. Primary aims are to (1) assess feasibility and acceptability of BEAM-NDD, including recruitment, retention, engagement, satisfaction, and perceived unmet needs; (2) examine changes in caregiver mental health and parenting outcomes following program participation; and (3) explore individual differences in engagement and outcomes to identify for whom BEAM-NDD may be more or less effective. Participants will complete a 12-week intervention delivered through the BEAM app, consisting of weekly parenting and mental health videos, progress tracking, a moderated peer forum, and optional peer-coaching support. Assessments will be completed at baseline prior to program initiation (T1), immediately post-intervention (T2), and at follow-up (T3). By evaluating BEAM-NDD within real-world service contexts, this trial aims to determine whether an existing evidence-based digital parenting and mental health intervention can support caregiver well-being among families of children with NDDs without requiring adaptation. Findings will inform the scalability and sustainability of BEAM-NDD as an accessible mental health support for families facing long waitlists, limited specialized services, or geographic barriers to care.

Effects of Mechanical Massage on Sleep Quality, Immunity, and Stress

This bicentric, randomized, single-blind clinical investigation aims to evaluate the effects of a multisession mechanical massage (endermologie) program on sleep quality, immune function, and stress levels in individuals experiencing high levels of stress. The investigational device is the LPG Cellu M6 Alliance (LPG Systems), a CE-marked Class IIa medical device. Endermologie is a non-invasive mechanical stimulation technique that uses motorized rollers and flaps to mobilize the skin and underlying tissues. All treatment sessions will be performed by a trained therapist. Participants will be randomly assigned to either an experimental group or a sham control group and will undergo 10 sessions of endermologie, with or without mechanical massage, respectively. Sleep quality, psychological status, cognitive performance, heart rate variability, perceived well-being, muscle and joint pain, immune-related parameters, and body composition will be assessed throughout the study. Sleep will be monitored during the experimental period using an actigraph and a sleep diary.

Effect of an ACT-based Intervention to Reduce Anxiety in Medical Students

Objective: To evaluate the association between ACT-process with negative psychological variables in a cross-sectional design, and to evaluate the effect of an ACT-based intervention to diminish anxiety in a sample of medical students. Methods: An ACT-based intervention was designed to diminish anxiety in medical students and implemented in 4 in-person sessions, the pre-test and post-test measurements were performed one week before and one week after the first and last sessions respectively. The control group received a mental health psychoeducational intervention of 90 minutes. The students were intentionally assigned to each study group based on schedule availability. The cross-sectional study was performed with the pre-test measurements in the students of both groups.\<

Feasibility of Implementing the Internet-Delivered Stress Recovery Intervention FOREST for Healthcare Staff in a Real-World Healthcare Setting

The aim of the study is to assess the feasibility of implementing the internet-delivered stress recovery intervention FOREST for healthcare staff in a real-world healthcare setting and to obtain preliminary estimates of changes in stress recovery and mental health outcomes.

Mindfulness Intervention for Emotional Distress: An EEG Study

This is a randomized controlled trial examining the efficacy and neural mechanisms of a standardized Mindfulness Intervention for Emotional Distress (MIED) in adults with subclinical emotional distress. One hundred and sixty participants will be randomly assigned to either an 8-week MIED program or an 8-week Progressive Muscle Relaxation (PMR) active control. The primary aim is to evaluate whether MIED reduces anxiety symptoms and reshapes multilevel emotional processing as measured by multimodal EEG (resting-state FAA/theta, Fast Periodic Visual Stimulation, and event-related potentials). Assessments occur at baseline (T1), post-intervention (T2), and 1-month follow-up.

Caring for Dementia Caregivers in Ethnic Immigrant Communities

Many caregivers of people with Alzheimer's disease or other dementias-especially those in immigrant communities who don't speak English well-don't get access to helpful, proven support programs. To address this, the investigative team adapted an existing caregiver support program (called the Savvy Caregiver Program) to better fit target group's culture and language. This new version, called K-Savvy, is a 6-week online program taught in Korean. In an earlier small study, K-Savvy worked well: caregivers found it helpful, were willing to use it, and showed fewer symptoms of depression. Now, the investigative team wants to study it more carefully to see how well it really works and why. The study has two main goals: Goal 1: The investigative team will measure whether K-Savvy improves caregivers' well-being-specifically whether it reduces stress and depression and helps them feel more positive about caregiving. The investigative team will also look at why it works, focusing on whether it changes how caregivers think about their situation (for example, feeling less overwhelmed and more confident). Goal 2: The investigative team will talk directly with caregivers and program instructors to understand their experiences with K-Savvy. This will help the investigative team learn what worked well, what didn't, and why.

Effectiveness of A Mindfulness-centered Stress Management AI Chatbot to Reduce Stress and Enhance Mental Health Among Men Who Have Sex With Men in China

The goal of this randomized controlled trial is to evaluate the effectiveness of a mindfulness-centered stress management AI chatbot in reducing perceived stress and enhancing mental health among Chinese men who have sex with men (MSM). The main questions it aims to answer are: 1. Does the AI chatbot show a greater reduction in perceived stress compared to standardized psychoeducational materials? 2. Does the AI chatbot improve mental health outcomes, including depressive and anxiety symptoms, subjective well-being, and emotion regulation? Researchers will compare the AI chatbot to a control group receiving psychoeducational materials to see if the chatbot works to reduce stress and improve mental health. Participants will: 1. Be randomized to use the AI chatbot (recommended at least 2 sessions per week, 10-15 minutes per session) or read psychoeducational materials (2 times per week) for 4 weeks. 2. Complete online self-report questionnaires at baseline, post-intervention (Week 4), and 4-week follow-up.

Cellphone Access for Lowered Maternal Anxiety and Stress in Cesarean Sections

This study looks at whether allowing mothers to use their personal cellphone during a planned cesarean section (C-section) under spinal anesthesia can reduce stress and anxiety and improve their overall birth experience. During a cesarean section under spinal anesthesia, the mother is awake, which can sometimes cause feelings of anxiety or stress. Women taking part in this study will be randomly assigned to one of two groups. One group will be allowed to use their cellphone freely during the surgery, while the other group will follow the usual hospital practice, which does not allow cellphone use in the operating room. All medical care, anesthesia, and surgical procedures will be exactly the same for both groups. The study will measure mothers' anxiety levels before surgery, during the operation, and within 24 hours after delivery using simple questionnaires. Mothers will also be asked about their satisfaction with their birth experience. In addition, the study will assess stress levels of a close family member (such as a partner) shortly after the delivery. Participation in this study is voluntary and involves minimal risk. Allowing or not allowing cellphone use does not affect medical care in any way, and participants may withdraw at any time without any impact on their treatment. The results of this study may help hospitals improve patient-centered care and make cesarean deliveries a calmer and more positive experience for mothers and their families.

Smartphone Climate Adaptation and IPV Intervention for Women in Informal Settlements in Kenya

This study is testing a smartphone-delivered program to help women living in informal settlements in Kenya manage intimate partner violence (IPV) and stress related to extreme weather events. Women in these communities often face high levels of violence from partners, challenges caused by climate-related events, and limited access to support services. Participants will be randomly assigned to either a mobile intervention or a comparison condition. The mobile program provides short, tailored sessions that help women learn safety planning, coping skills, and strategies for adapting to climate-related stress. The program also offers tools to improve communication and strengthen social support. The main goal of the study is to see whether this smartphone-based approach can reduce the frequency and severity of IPV over 12 months. The study will also examine changes in stress levels, self-confidence in handling problems, social support, and safety behaviors. Results from this study may help create accessible, scalable support for women experiencing IPV and climate-related stress in similar settings.

Effects of Brief Nature Exposure on Brain Functioning and Stress Reactivity

This study is focused on understanding the impact of time spent in nature (relative to an urban control) on stress, neural, and cardiac functioning in people experiencing high levels of stress, depression, and anxiety.

SanaMente: A Peer-Led Program to Reduce Health Disparities in Rural Latino/a Communities

The goal of this clinical trial is to evaluate the feasibility, acceptability, and preliminary effectiveness of the SanaMente peer-led mental health and lifestyle program for rural Latino/a adults with chronic medical conditions and mental health concerns. The main questions it aims to answer are: * Is the SanaMente program feasible and acceptable for rural Latino/a adults with chronic medical conditions and mental health concerns? * Does participation in the SanaMente program improve mental health outcomes (depression, anxiety, and stress), healthy lifestyle behaviors (sleep, physical activity, and nutrition), and overall well-being? This is a single-arm pilot study without comparison group. Participants will: * Participate in the 6-8 week SanaMente peer-led group program. * Complete surveys at baseline, mid-program, and post-program assessing mental health, lifestyle behaviors, overall well-being, and program satisfaction. * Complete an exit survey and have the option to participate in a focus group to provide feedback on the program's usability, acceptability, perceived impact, and suggestions for improvement.

Longitudinal Study of Neighborhood Social Event Attendance at Renovated Parks and Changes in Sleep, Stress, and Well-being

The goal of this study is to learn whether participating in community social and cultural events in renovated neighborhood parks can improve sleep, stress, mood, and overall well-being in adults aged 18 and older who live near participating parks. The main questions the study aims to answer are: 1. Does participation in community park events lead to improvements over time in sleep, stress, mood, and other aspects of well-being? 2. Are greater levels of event participation associated with greater improvements in these outcomes? Participants will: * Wear a wearable ring device (Oura Ring) most of the time for about six months to measure sleep and physical health indicators * Attend free community events at or near their neighborhood park, such as social, cultural, or physical activity programs * Complete online surveys at the beginning and end of the study about well-being and mental health * Complete brief weekly surveys on mood and study park use * Attend two in-person visits for basic physical measurements (e.g., height, weight, blood pressure) and device setup/return

Immersive VR to Reduce Stress, Anxiety, and Pain During PICC/Midline Placement

Medical and technological advancements allow increasingly complex invasive procedures to be performed on hospitalized patients, improving their survival rates and prognosis. However, these interventions impact physical, emotional, and psychological health. In this scenario, post-hospitalization syndrome (PHS) emerges as a concerning phenomenon characterized by functional, emotional, and social decline after discharge. Invasive procedures such as surgeries or prolonged use of catheters not only compromise physical integrity but also contribute to disorders like anxiety, depression, and post-traumatic stress. In fact, between 20% and 30% of patients admitted to the Intensive Care Unit (ICU) develop symptoms compatible with post-traumatic stress disorder. This underscores the need for a comprehensive approach focused on psychological and social well-being during and after the hospital stay. Despite humanization initiatives, few hospitals successfully implement them due to a lack of objective evaluations and clinical recommendations that justify their necessity. In this regard, venous catheterization (VC) is the most prevalent invasive procedure. The pain, anxiety, or fear caused by this technique triggers physiological and psychological alterations that can interfere with the successful insertion of the device. This stress response induces vasoconstriction, reducing the caliber of the vein, which increases technical difficulty, elevates the risk of complications, raises healthcare costs, and negatively impacts patient satisfaction. Natural outdoor environments have been shown to reduce stress, enhancing well-being and health in the general population. In this sense, the use of immersive virtual reality (IVR) to achieve immersion in virtual nature could help not only by diverting attention away from the painful or anxiety-inducing stimulus during invasive procedures but also by providing pleasant stimuli that could have a physiological impact. The objective of this study is to evaluate the impact of IVR on stress and anxiety during VC using validated clinical scales, measuring the caliber of the vessel to be punctured, and determining salivary biomarkers of stress, well-being, and pain. Confirming this hypothesis will provide the evidence to integrate virtual reality into the National Health System as a standard tool for more humanized and innovative care.

Effect of Magnesium-, Vitamin C- and Grape Seed Extract-Enriched Date Bars on Perceived Stress and Salivary Cortisol Levels in Young Women

This randomized controlled trial aims to evaluate the effect of a 4-week daily consumption of a functional date bar enriched with magnesium, vitamin C, and grape seed extract on perceived stress and salivary cortisol levels in healthy young women. Participants will be randomly assigned to either an intervention group receiving the enriched bar or a control group receiving a placebo bar identical in appearance and taste. Primary outcomes include changes in salivary cortisol levels and perceived stress (PSS-14).

Effect of Participating in a Study of Causes of Pregnancy Loss on Mental Health Outcomes: A Target Trial Emulation Using the COPL Cohort and Danish National Registries

Pregnancy loss is the most common severe pregnancy complication and is associated with significant mental health sequelae, including depression and anxiety. Standard care in Denmark does not include systematic follow-up or aetiological investigation after pregnancy loss. The Copenhagen Odense Pregnancy Loss (COPL) Cohort offered extensive aetiological investigations, and a dedicated clinical follow-up visit 4-10 weeks post-loss. This is a target trial emulation (TTE) designed to estimate the causal effect of COPL participation on women's mental health outcomes one year after pregnancy loss. We will emulate a target trial comparing (1) enrolment into COPL versus (2) standard pregnancy loss care. The study population comprises women aged ≥18 years with a confirmed intrauterine pregnancy loss (ICD-10: DO020, DO021, DO030-DO034) before 22 weeks' gestation treated at Danish public hospitals between November 2020 and April 2025. The primary outcome is new-onset affective disorder (ICD-10: F32\*-F39\*), neurotic/stress-related disorder (F41\*, F43\*, F48\*), or dispensing of antidepressant (N06A\*), anxiolytic (N05B\*), or sedating (N05C\*) medication within 12 months of pregnancy loss diagnosis. All data will be sourced from Danish National Registries. The difference-in-differences estimator will serve as the primary analytical approach, complemented by instrumental variable analysis (hospital of treatment as instrument) and regression discontinuity design. Inverse probability of treatment weighting will be used to control for measured confounders. Results will be reported as risk ratios and risk differences with 95% confidence intervals. Sensitivity analyses will include per-protocol estimation and exclusion of women with treatable findings identified in COPL.

Bonding Before Birth: A mHealth Intervention for First-time Expectant Couples

Emotional regulation is a key component of reducing parenting stress, a sense of self-efficacy, and thus successful parenting, child outcomes, and productivity amongst working parents. However, few interventions begin building these necessary components in pregnancy prior to the extremely stressful period immediately post-partum, where little trait and behavioural modification occurs. More importantly, most interventions overlook the importance of having both partners, despite fathers/partners playing a significant role in influencing maternal stress and mood symptoms. This goal of this study is to examine whether short weekly exercises delivered through a mobile app can help first-time parents feel better emotionally during pregnancy. These exercises are designed to help people manage their emotions and stress. Researchers want to know if doing these exercises, along with getting weekly feedback and encouragement, can reduce signs of depression and improve emotional control. Expecting mothers and fathers who are having their first child may be able to join the study if they meet certain conditions. Participants should be planning to stay in Singapore for the next two years and be comfortable using a smartphone and answering questions in English. Participants may benefit from learning new ways to manage stress and emotions, which could help improve their mental health. Participants will wear a Fitbit watch to track activity. They will complete a short weekly survey about their well-being during pregnancy and a monthly survey about their work productivity until six months after the baby is born. They will also answer online surveys about their health, relationships, and background at the start, three times during pregnancy, and three times after birth. In addition, they will visit the research lab twice to take part in tasks that measure thinking and behaviour.

The Green Room: Virtual Nature for Mental Well-being in the Acute Psychiatry Ward

This study evaluates the feasibility, acceptability and clinical impact of a virtual reality (VR)- based nature intervention in an acute psychiatric inpatient unit. Participants are randomly assigned to recieve VR nature sessions (using Nature Treks VR on Meta Quest 3) in addition to standard care, or standard care alone. The primary outcome is change in percieved stress (PSS-19) from admission to discharge. The study uses a mixed-methods design combining randomized controlled trial with a qualitative phase.

Nature-based Outdoor Activities for Promoting Stress Resilience in Employees

The goal of this randomized controlled trial (RCT) is to assess the impact of a nature-based workplace intervention on stress resilience in full-time employees in Hong Kong. The main question it aims to answer is: Does a nature-based group activity intervention improve stress resilience in employees? Researchers will compare the intervention group (participants who attend three nature-based group sessions) to the control group (participants who receive no intervention and continue their usual routines) to see if the nature-based activities lead to greater improvements in stress resilience compared to no intervention. Participants will complete baseline measurements (questionnaires, blood pressure, and heart rate variability) one week before the first session. If assigned to the intervention group: Attend three one-hour group sessions at a nearby park (once every two weeks, 8:00-9:00 AM) involving mindful walking, gentle movement, nature observation, breathing exercises, and group reflection If assigned to the control group: Continue their usual daily routines with no specific activities Complete follow-up assessments (same measurements as baseline): immediately after the second session and one week after the third session Primary measurement: HRV Secondary measurements: Blood pressure, Perceived stress scale (PSS) and the Difficulties in emotion regulation scale (DERS).