Clinical Research Directory

High-Intensity, Low-Frequency Periodic rTMS Over the Right Dorsolateral Prefrontal Cortex on Cardiac Autonomic Regulation in Women With Recurrent Pregnancy Loss and Anxiety

The goal of this clinical trial is to determine whether high-intensity, low-frequency periodic repetitive transcranial magnetic stimulation (rTMS) applied to the right dorsolateral prefrontal cortex (DLPFC) can modulate cardiac autonomic regulation in women with recurrent pregnancy loss (RPL) and comorbid anxiety. The main questions it aims to answer are: Does 120% resting motor threshold (RMT) rhythmic low-frequency rTMS reduce heart rate during stimulation time windows compared with sham stimulation? Does 120% RMT rTMS alter heart-rate-variability (HRV) spectral power at the target frequency (0.0167 Hz) compared with sham stimulation? Researchers will compare active rTMS with sham rTMS to determine whether the active intervention produces measurable changes in cardiac autonomic activity. Participants will: Undergo a single session of rTMS or sham stimulation consisting of 20 consecutive stimulation time windows (each 60 seconds: 40 seconds of 1-Hz stimulation plus 20 seconds of rest) targeting the right DLPFC; Have continuous electrocardiography (ECG) recordings collected during the entire stimulation session; Complete clinical and psychiatric assessments before participation.

An Online Intuitive Eating Program for Pregnant Women With Obesity to Support Well-Being

The goal of this feasibility randomized controlled trial is to assess the feasibility, acceptability, and demand, as well as preliminary effects of an evidence-based Intuitive Eating (IE) intervention among pregnant women who have obesity. The main questions we aim to answer are: RQ1: What is the feasibility (acceptability and demand) of implementing an Intuitive Eating Intervention among pregnant and postpartum women? RQ2: How does participation in the Pregnancy Intuitive Eating Intervention (PIE-I) impact key maternal health outcomes (i.e., gestational weight gain, intuitive eating behaviors, dietary quality, body image, and mental health) compared to a wait-list control? Researchers will compare the Pregnancy Intuitive Eating Intervention (PIE-I) intervention group with the wait-list control to see what impact the PIE-I has on maternal well-being. Participants randomized to the intervention group will complete the 8 week asynchronous IE intervention and have an opportunity to interview at the end of the study.

Researching Resiliency in Stressful Experiences (RISE) Program for Men Leaving Incarceration

The investigators are conducting a randomized controlled trial to assess the impact of Resiliency in Stressful Experiences (RISE) - a comprehensive trauma-based program for young men releasing from a southeastern state's prisons. The investigators are assessing whether treating trauma and providing other transitional supports - such as employment assistance - as young men return home will help to improve their community stability and enhance their psychological well-being, in turn, resulting in less likelihood that a person will become incarcerated in the future.

Treatment of Parental Anxiety Virtual Reality (VR)

The purpose of this study is to determine if non-invasive distracting devices (Virtual Reality headset) are more effective than the standard of care (i.e., no technology based distraction) for preventing anxiety in parental and pediatric populations. The study will be conducted in the general inpatient area, Emergency Department and Heart Center.

THE EFFECT OF MINDFULNESS IN INFLAMMATION MARKERS (IL-6, TNF-Α, 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.

Supporting Families in the ICU

The overarching goal of our work is to test the effect of high-quality spiritual care for ICU family surrogates on outcomes of psychological and spiritual well-being and medical decision making. Our team has developed an approach to high quality spiritual care intervention for ICU surrogates, called the Spiritual Care Assessment and Intervention (SCAI) framework, which is delivered by a chaplain interventionist to ICU surrogates.

Activating Voice Journaling for Mental Health With Voice Biomarkers

This retrospective observational study evaluated the relationship between voice characteristics and self-reported mental health symptoms using longitudinal data collected through the Kintsugi Voice Journaling app. Participants provided voice recordings and completed the Patient Health Questionnaire-9 (PHQ-9) and Generalized Anxiety Disorder-7 (GAD-7) over time. The study analyzed previously collected data to evaluate whether voice biomarkers could be associated with symptoms of depression and anxiety.

Approach-Avoidance, Computational Framework for Predicting Behavioral Therapy Outcome (AAC-BeT)

Depression and anxiety disorders rank in the top ten causes of years lived with disability. Less than 50% of patients experiencing long-lasting improvements to current gold-standard treatments. Two gold-standard behavioral interventions include behavioral activation, focused on enhancing approach behavior towards meaningful activities, and exposure-based therapy, focused on decreasing avoidance and challenging negative expectations. While these interventions have divergent treatment targets, there is little knowledge to inform which strategies should be used in the frequent case of comorbid anxiety and depression. Approach-avoidance decision-making paradigms focus on assessing responses when faced with potential rewards and threats, tapping into processes important for both anxiety and depression as well as behavioral activation and exposure-based therapy. For this study, investigators will recruit individuals reporting both anxiety and depression symptoms and randomize them to one of three different interventions: (1) behavioral activation, (2) exposure-based therapy, and a non-specific therapy approach (3) supportive therapy. Participants will complete clinical, self-report, behavioral, and functional magnetic resonance imaging (fMRI) assessments before and after therapy. Investigators will use a computational approach to model factors that may influence one's behavior during approach-avoidance decision-making, including drives to avoid threat versus approach reward and confidence versus uncertainty in one's decisions. This project will accomplish the following aims (1) Determine how changes in brain and behavior responses during approach-avoidance conflict relate to changes in mental health symptoms with the different therapy approaches, (2) Determine the degree to which baseline brain and behavior responses during approach-avoidance conflict predict response to the different therapy approaches, above and beyond the influence of demographics and baseline symptom severity. In addition, by including peripheral blood draws and measures of grace matter volume, the project will also accomplish the following aims: (1) Determine whether kynrenine metabolites measures peripherally may be beneficial as a biomarker of treatment response and (2) determine whether there is an association between change in kynurenine metabolites and changes in gray matter volume with treatment. Results will enhance understanding of how different psychotherapy approaches (behavioral activation, exposure-based therapy) may impact brain responses and decisions when faces with potential reward versus threat and approach versus avoidance drives. In addition, results will have important implications concerning the potential for a more personalized approach to psychotherapy, enhancing knowledge of which types of therapy strategies may be most beneficial for which individuals.

Postoperative Anxiety and Depression Among Older Chinese Patients

A multicenter, prospective observational study to describe the socioeconomic characteristics and the occurrence of postoperative anxiety and depression in the Chinese old population.

No Time to Wait: Single Session Intervention

Mental health problems in youth are prevalent, but early intervention effectively reduces symptoms, substance abuse risk, suicide, and comorbidities. In Hong Kong, however, only 26% of people with common mental disorders seek services, and even then, they face long delays-e.g., 90 weeks (90th percentile) for stable cases in public psychiatry clinics (Hospital Authority, 2024). Barriers include high costs, transportation issues, stigma, and preference for self-help, creating a strong need for scalable, accessible digital solutions, especially for youth. Single-Session Interventions (SSI) offer promise as brief, time-efficient tools that provide immediate support with minimal engagement burden. Online SSIs are often free, publicly available, and evidence-based. Research shows they reduce symptoms (moderate effect size Hedges' g = 0.32; 58% chance of better outcome vs. control), improve functioning, and boost satisfaction. They work well for specific phobias and acute stress. Yet, their real-world acceptability, effectiveness outside trials, and integration with public services remain understudied-particularly for children/adolescents on waitlists. This pilot study evaluates an online single-session psychotherapy for youth (children/adolescents) on Hong Kong public psychotherapy waitlists, targeting depression and anxiety symptoms. It extends prior work by: Targeting two key constructs prominent in Asian contexts: Alexithymia - difficulty identifying/describing emotions; affects \~10% generally but 36% of Hong Kong adolescents (higher in females). It worsens depression, lowers well-being, complicates therapy, and reduces help-seeking. Fixed mindset (vs. growth mindset) - Asian groups show lower growth mindset levels; growth mindset buffers mental health issues (meta-analysis r = -0.220 with anxiety/depression/stress) and promotes better emotional regulation and treatment engagement. Examining how SSI influences acceptability and expectancy toward subsequent face-to-face psychotherapy. Hypotheses: SSI will reduce depression/anxiety symptoms more than treatment-as-usual. SSI will increase acceptability and positive expectancy for future in-person treatment. Change mechanisms-perceived behavioral control and emotional control-will mediate and sustain post-intervention outcomes. Overall, the study aims to test SSI as a bridge intervention to bridge service gaps, address culturally relevant barriers, and inform scalable mental health strategies in resource-constrained settings like Hong Kong's public system.

Collaborative Care for Anxiety and Depression in Epilepsy

This is a randomized effectiveness/implementation trial comparing a 24-week neurology-based collaborative care intervention to usual neurology care among 60 adults with epilepsy.

Yintang Acupressure During Labor in Primiparous Women

This randomized controlled study evaluated whether acupressure applied to the Yintang point during labor affects labor duration, pain, anxiety, and childbirth satisfaction in primiparous women. A total of 104 women were randomly assigned to either the Yintang acupressure group or the sham light-touch control group, with 52 participants in each group. Participants in the intervention group received five acupressure sessions during labor and the early postpartum period. Participants in the control group received routine midwifery care and light touch at a non-therapeutic forehead location. Labor duration, pain intensity, anxiety, and childbirth satisfaction were compared between the groups.

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.

The Effect of Animated Movies and Storybooks on Fear and Anxiety Levels in Children With Type 1 Diabetes

This study aims to evaluate the effects of animated films and story books on the fear and anxiety levels of children with newly diagnosed type 1 diabetes.

Identifying Parents in Child Welfare Services Who Need Mental Health Support: Depression and Anxiety Symptoms

The main aim of this study is to examine the occurrence of mental health symptoms among parents referred to the Swedish child welfare services for child maltreatment and other family related risks. Additionally, to examine any variables associated with parents' levels of depression and anxiety. Parents will respond to questionnaires administered by social workers. The level of depression and anxiety will be descriptively and statistically compared to clinical and normative samples. Additionally, statistical analyses will examine variables associated with parents' mental health symptoms.

Screening to Identify Parents in Need of Mental Health Support: A Feasibility Study in Child Welfare Services

The main aim of this study is to evaluate the feasibility, preliminary effects and experiences of the Collaboration-Screening-Referral approach (in Swedish: Samverkan-Screening-Hänvisning - SSH) when used with parents referred to the Swedish child welfare services. The SSH is an approach to screen parents for symptoms of mental illness using structured questionnaires, establish intra-agency collaboration, and refer to mental health services. Additionally, to increase social workers and competence in assessing and handling mental illness through receiving training in the SSH and administering the screening to parents. The main questions the project aims to answer are: * Are parents engaged with child welfare services willing to undergo screening for symptoms of depression and anxiety? * How have the implementation of the SSH proceeded and to what degree is it sustained? * How do parents and social workers experience the SSH? * Do social workers' behaviors, knowledge and competence relevant to supporting parents with mental illness increase when implementing the SSH? Social workers answer questions before and after their training and after 6 and 12 months. Additionally, social workers and parents will be interviewed. Qualitative and quantitative within-group analyses will be conducted to examine experiences and preliminary effects of the SSH.

Supporting Family Caregivers of Persons With Dementia

Based on preliminary work, whereby investigators examined pain management challenges and needs of caregivers of hospice patients with dementia, this team designed a cognitive behavioral intervention informed by the relational model of stress, entitled ENCODE (Empowering Caregivers of Patients with Dementia) to assist caregivers in effectively identifying and communicating their pain management challenges and needs. The investigators propose a 5-year randomized clinical trial in which caregivers of patients with Alzheimer's Disease and Related Dementias (ADRD) will be randomly assigned to a group receiving standard hospice care with the addition of "friendly video-calls" providing social support (attention control group) or a group receiving standard hospice care with the addition of the ENCODE intervention (intervention group).

Evaluating Buspirone to Treat Opioid Withdrawal

The investigators propose a rigorous, Phase II, three-group, placebo-controlled double-blind randomized controlled trial (RCT) to evaluate the efficacy of buspirone for both withdrawal and craving among individuals with opioid use disorder (OUD) undergoing a standardized stepwise taper. During this 10 to 12-day residential study, participants with OUD will be enrolled, stabilized on a short-acting opioid, undergo an opioid stepwise taper, and complete a post-taper observation period where participants will have the opportunity to initiate long-term buprenorphine or extended-release naltrexone.

Diphenhydramine as an Adjunct to Moderate Sedation for Procedural First Trimester Abortions

This single center, double blind, randomized controlled trial will evaluate whether adding intravenous diphenhydramine to a standard moderate sedation regimen improves pain control during first trimester procedural abortion. Participants undergoing uterine aspiration at less than 13 weeks gestation will be randomized 1 to 1 to receive standard moderate sedation with midazolam and fentanyl plus either diphenhydramine 50 mg intravenously or matching placebo. The primary outcome is participant reported pain during uterine aspiration measured by a 100 mm Visual Analog Scale.

The Effect of Using Virtual Reality Glasses and Gaming Cards on Fear, Anxiety, and Physiological Parameters in Children Administered Inhaler Medication

This study aims to evaluate the effects of using virtual reality headsets and play cards during the administration of inhaler medication in pediatric patients. The primary goal is to determine how these distraction methods influence children's fear, anxiety levels, and physiological parameters (such as heart rate and oxygen saturation). The study population consists of pediatric patients aged between 4 and 6 years. Data collection for the targeted sample size of 150 children commenced in September, and the recruitment process is currently ongoing.Children receiving inhaler treatments often experience fear and anxiety, which can negatively affect their treatment compliance and vital signs. In this study, participants are divided into different groups to compare the effectiveness of virtual reality headsets and traditional play cards as distraction tools.

BasketballRx: Game Changing Health

The goal of this study is to learn if BasketballRx, a basketball and health program, works well for children and teens who are overweight or have obesity. The study will also look at whether the program helps children build healthy habits, improve their health, and feel better. The main questions the BasketballRx clinical trial aims to answer are: 1. Is the BasketballRx program easy for children and families to take part in and complete? 2. Do children show changes in their healthy habits, physical health, or emotional well-being after completing the program? Participants will: * Attend 6 BasketballRx sessions over 2 months * Take part in health lessons and basketball activities * Learn about healthy eating, exercise, sleep, and ways to manage stress * Have their height, weight, waist size, blood pressure, and heart rate checked * Answer questions about how they feel and their healthy habits

Reducing Fear of Cancer Recurrence in Danish Colorectal Cancer Survivors

Cognitive therapy has been shown to reduce fear of cancer recurrence (FCR), mainly in breast cancer survivors. The accessibility of cognitive behavioural interventions could be further improved by Internet delivery, but self-guided interventions have shown limited efficacy. The aim of this study is to test the efficacy of a therapist guided internet-delivered intervention (TG-iConquerFear) vs. augmented treatment as usual (aTAU) in Danish colorectal cancer survivors.

AI-Based Personalized Exercise Prescription Through Mobile Health on Physical Activity and Health Outcomes in Older Adults: A Feasibility Study

The purpose of this research is to investigate the feasibility, acceptability, appropriateness, and preliminary efficacy of a wearable and artificial intelligence-driven mobile application-based exercise prescription grounded in self-determination theory (SDT) and behavioral change techniques (BCTs) among older adults. As no data exists on the feasibility of AI-driven exercise programs grounded in SDT and multiple BCTs specifically for older adults, this will be a pioneering study to explore the feasibility of wearable and AI-driven exercise program protocols and the rates of acceptance and appropriateness of the exercise prescription intervention among older adults. In addition, this study will test the preliminary efficacy of the intervention on physical activity (PA), mental health, and quality of life. This study follows the National Institute of Health (NIH) stage model, and it represents stage 1b of the NIH stage model, which emphasizes the feasibility and actionable processes for delivering a new health intervention. Specifically, this study will: 1.Evaluate the research protocol feasibility of a wearable and AI-driven mobile application-based exercise prescription grounded in SDT and BCTs (of goal setting, self-monitoring, graded task, and demonstration) on older adults over 8 weeks 2. Evaluate the acceptability and appropriateness of a wearable, AI-driven, mobile application-based exercise prescription grounded in SDT and BCTs among older adults over 8 weeks. 3. Evaluate the preliminary impact of a wearable and AI-driven mobile application-based exercise prescription grounded in SDT and BCTs on older adult PA (steps per day and daily duration of light PA and Moderate-vigorous PA), sedentary time, sleep, mental health (depression and anxiety), and quality of life.

Effect of a Single Immersive Virtual Reality Session on Preoperative Surgical Fear and State Anxiety

To determine whether a single 20-minute immersive VR nature session delivered in the immediate preoperative period reduces surgical fear and state anxiety in patients scheduled for bariatric surgery.