Clinical Research Directory

Mindfulness in a College Physiology Course

This proposed study aims to evaluate whether integrating mindfulness into an undergraduate biology course (Mindful Physiology) influences students' trait and applied mindfulness, well-being, and physiological stress reactivity. The primary questions are 1. Would completing the Mindful Physiology course increase applied mindfulness? 2. Would completing the class increase trait mindfulness? 3. Would completing the class increase subjective well-being? 4. Would completing the class reduce physiological stress response to an acute social stressor?

The SENSE Study: Surgical ENvironment Stress Evaluation

Surgical procedures such as total hip and knee arthroplasty require a complex set of physical and cognitive skills, expert execution, and inevitably place a high stress load on the surgeon. While the primary focus of healthcare is typically aimed at the patient, the high physical and mental stress placed on surgeons is of equal significance and should be addressed in order to support surgical teams. Robot-assisted surgery is purported to improve surgical outcomes for both patients and surgeons, particularly by improving surgical efficiency and reducing physical and cognitive load on the surgeon. This stress load typically requires a combination gross and fine motor skills, physical exertion, spatial cognition, executive functioning, inhibitory-control, decision-making, communication and team management. Robotic assistance can reduce some of the cognitive load experienced during these processes, although it is also likely to be replaced by new thought-processes (e.g. numerical reasoning, coordinating screen and patient inputs, etc) that require equally important levels of training and expertise. Numerous studies have explored the effects of conducting surgery on surgeon stress, but these are largely limited to measuring heart rate variability. A few research groups have implemented fNIRS brain imaging in surgical settings to study the effects of different operating methods on cognitive stress in clinicians, demonstrating the potential of this technology in understanding more about cognitive processes and cognitive load involved in surgery. However, these have not yet been implemented in the context of orthopaedic surgery.

CommunityRx-Dementia + Peer Navigation (CRxDpeer)

The CRxDpeer intervention, delivered by a trained peer navigator, in practice called a "peer mentor", includes three evidence-based components: (a) focused education about common social (e.g., food and housing insecurity) and caregiving (e.g., respite and end of life care) needs, (b) activation of personalized community resource information for social and caregiving needs through delivery of a resource list (HealtheRx) at the baseline encounter and coaching on how to communicate with service providers, coordinate services and manage social support (e.g., connect with their peer navigator, reach out to friends or relatives for support, identify support groups, etc.) and (c) ongoing navigation-focused support meant to boost the baseline intervention, including a series of proactive text messages over 12 months. During this time, the subject can respond to and communicate with the peer navigator for ongoing support.

A Mindfulness-based Intervention for Sexual Assault Survivors

The goal is this pilot randomized trial is to learn if intervention 1 is feasible and acceptable. As a secondary goal, we aim to learn if intervention 1 reduces alcohol misuse and tobacco use in sexual assault survivors. The main questions it aims to answer are: * Is intervention 1 feasible to implement? * Is intervention 1 an acceptable intervention among the primary population, sexual assault survivors? * Does intervention 1 reduce alcohol misuse and tobacco use? Researchers will compare intervention 1 to an attention-placebo control group (e.g., online resources on healthy eating and nutrition). Participants will: * take online surveys at baseline, 1 month follow-up, and 3-month follow-up * answer text-message questions at baseline and post-test * view and engage in an educational program

Disrupted Connections: The Impact of Acute Stress on Memory Integration

The goal of this study is to better understand how stress impacts people's ability to learn across their experiences and link new information to what they already know. The investigators will compare performance on a memory task between stressed and non-stressed participants. This memory task requires people to integrate knowledge across learning experiences (think: having to "connect the dots", draw inferences, and generalize your knowledge to new situations and scenarios). Cortisol, the brain's primary stress hormone, will be measured at multiple points throughout the study to measure stress levels. The investigators hypothesize that: 1. Stress will disrupt performance on the memory task by interfering with memory processes that enable linking of related memories. 2. Higher cortisol levels, which reflect a greater stress response, will relate to greater deficits in memory performance across participants. This research has broad implications for understanding how stress impacts the ability to learn and retain new information, particularly in high-stress environments like schools and workplaces. Additionally, this work may provide insights into the cognitive difficulties experienced by individuals with psychiatric disorders, where stress can worsen memory and learning challenges.

The Effect of Using a Stress Ball During Transrectal Ultrasound-Guided Prostate Biopsy on Anxiety, Pain, and Hemodynamic Variables

The Effect of Using a Stress Ball During Transrectal Ultrasound-Guided Prostate Biopsy on Anxiety, Pain, and Hemodynamic Variables

Effects of Feel Free® Classic Tonic on Stress and Pharmacokinetics in Healthy Adults

This study is being conducted to assess the effects of the Feel Free® Classic Tonic on stress in healthy adults. The goal is to see whether the tonic can help reduce self-perceived and physiological stress and provide information on how its ingredients are processed in the body.

Evaluating Stress Management Among Allogeneic HCT Caregivers

The purpose of the study is to understand whether different stress management interventions impact stress among HCT cancer caregivers and patients.

The Impact of Music Medicine on Preterm Brain Development and Behavior

The investigators are conducting a two-site randomized control trial with the aim of defining the impact of music (M) without or with parent voice (MPV) on very preterm infants' acute and cumulative stress, intranetwork connectivity on term brain MRI, and language and other neurodevelopmental outcomes at two years corrected age. This is based on the hypothesis that infants in MPV arm are expected to experience the greatest benefit compared with infants receiving standard care.

ACT Together: Implementing a Web-Based Program With Brief Coaching for Parents of Children With Disabilities in Pediatric Outpatient Clinics

The goal of this clinical trial is to evaluate the feasibility, usability, and preliminary benefits of implementing ACT Together for parents of children with disabilities in pediatric outpatient clinics. ACT Together includes six self-paced, web-based modules and brief weekly one-on-one coaching sessions led by a trained occupational therapist. The program is based on acceptance and commitment therapy (ACT), which teaches practical skills to help people handle stress and difficult thoughts or feelings while taking steps toward what matters to them. The main questions this study aims to answer are: * Can parents and occupational therapists complete the study activities as planned (e.g., module completion, coaching sessions, and surveys)? * Is the program usable and acceptable/appropriate/feasible to implement in this setting? * Do parents show improvements in mental health and coping-related outcomes after participating in the program? * What are the experiences and perspectives of parents and therapists regarding the program? Parents as participants will: * Complete six self-paced web-based modules and brief weekly individual phone coaching sessions with a trained occupational therapist working in pediatric outpatient clinics. * Complete online questionnaires before starting and after completing the program. * Take part in one online interview about their experiences and perspectives on the program. Occupational therapists as participants will: * Complete therapist training materials and deliver brief individual phone coaching sessions to parent participants, including completing a post-session checklist. * Complete brief online questionnaires before starting and after delivering the program. * Take part in one online interview about their experiences and perspectives on the program.

The Effects of Yoga on Pregnant Women

It is thought that a yoga intervention administered to pregnant women will reduce stress levels, enhance sexual quality of life, and positively affect sleep habits. According to the power analysis results, the study must include at least 70 pregnant women (35 in the experimental group and 35 in the control group). Data will be collected through a Personal Information Form, the Perceived Stress Scale (PSS), the Sexual Quality of Life Questionnaire-Female (SQLQ-F), and a Sleep Habits Form. In this study, the yoga practice will be administered to the pregnant women in the experimental group by the researcher.

Coping With Asthma Throughout Life Management Program

The purpose of this study is to determine if the Coping with Asthma through Life Management (CALM) intervention, designed to help Black adult with asthma cope with stress, is feasible and acceptable.

Assessing MB-Spirit for Psychological Well-being

The goal of this clinical trial is to learn if a new behavioral intervention, MB-Spirit, can improve well-being in stressed adults. The main questions it aims to answer are: 1. Can MB-Spirit improve well-being? 2. What brain changes accompany participation in MB-Spirit? Participants will: 1. Be enrolled in an online course that meets for two hours every week for 8-weeks. 2. Complete questionnaires before and after the course. 3. Complete an MRI scan of their brain before and after the course. Participants will be randomized to either take the course right away, or be put on a wait-list. Those on the wait-list will undergo the testing at 2 timepoints before they start the program.

BALANCE Study: Beneficial Effects of A Diverse Prebiotic Fibre bLend on Affect, iNflammation, Cognition, and the Gut microbiomE

This clinical trial will investigate whether a powdered prebiotic fibre blend, at two doses, can improve perceived stress levels in healthy adults with mild-severe stress levels.

The Effect of Mindfulness on Vascular Inflammation in Stable Coronary Disease

This study aims to evaluate the effect of 8 weeks of a stress reduction intervention on atherosclerotic plaque inflammation in adults with stable coronary artery disease, as quantified by positron emission tomography (PET) with 18F-fluorodeoxyglucose (FDG) in individuals with increased psychosocial stress.

Exercise Effects on the Neurobiology Underlying Stress-related Eating Behaviors in Veterans

The purpose of this study is to learn more about how common lifestyle interventions, such as exercise, affect how our brains respond to performing thinking tasks and to viewing pictures of foods and various other objects. The investigators are also interested in how changes in hormones that might be different in men and women could affect how lifestyle interventions change these brain responses.

Aromatherapy for Mental Health Promotion in IVF Patients

The experience of infertility can cause significant emotional instability, especially for patients awaiting In Vitro Fertilization (IVF) treatment, generating anxiety, stress, and depressive symptoms. This study is a randomized clinical trial assessing the effectiveness of aromatherapy in improving mental health and quality of life in women undergoing infertility treatment. 120 participants will be randomized into three groups (Intervention, Placebo, and Control). The intervention involves the inhalation of true lavender essential oil (Lavandula angustifolia) for four weeks.

Photobiomodulation, Heart Rate Variability, and Acute Stress

Photobiomodulation (PBM) is a form of light therapy that uses red or near-infrared light to influence biological processes. In prior studies, PBM has been shown to improve various physiological functions, including tissue repair, inflammation, and cognitive performance. However, little is known about its impact on autonomic nervous system regulation. Thus, the goal of this study is to evaluate the effects of PBM on vagal activity, as measured by heart rate variability (HRV), in healthy adults undergoing experimental stress.

ACT-based Parenting Program for Caregivers of Children With Hearing Loss Post-cochlear: A Pilot Randomised Controlled Trial

The purpose of the proposed pilot randomized controlled design study is to evaluate the feasibility, acceptability, and potential effectiveness of using a videoconferencing-based individual Acceptance and Commitment Therapy (ACT) approach to enhance the mental well-being and parenting competence of parents of children with hearing loss post-cochlear implantation over a three-month period after the intervention has taken place.

Effects of Probiotic Supplementation on Stress and Anxiety in Students

This randomized, double-blind, placebo-controlled study evaluates the efficacy and safety of an 8-week probiotic supplementation (Lactobacillus plantarum LP140 and Bifidobacterium breve BB010 in total daily dose 1 × 10¹⁰ CFU or matching placebo) in reducing perceived stress and anxiety, and improvement related psychological parameters in healthy university students during the examination period. The primary outcome is the change in Perceived Stress Scale (PSS-10) score at week 5 and week 8 of interevention compared to placebo. The secondary outcomes are the changes in DASS-21 subscales (Stress, Anxiety, Depression), State-Trait Anxiety Inventory - State version scale (STAI-S), Sense of Coherence Scale (SOC-29), Pittsburgh Sleep Quality Index (PSQI), self-reported gastrointestinal symptoms (Likert scale) and incidence of adverse events during the 8-week lasting interventional study.

Sleep Well Firefighters: An App-based Program to Improve Sleep, Cognition, and Behavioral Health in Firefighters

The purpose of this pilot study is to examine the feasibility and acceptability of an app-based sleep program designed to help firefighters improve their sleep.

Decreasing Stress Via Virtual Reality and Binaural Beats in Non-Clinical Adults

This study is a non-clinical substudy conducted within the DESTRESS research program (NCT05036538), which investigates the effects of relaxation interventions on physiological and psychological parameters. While the main DESTRESS trial focuses on cardiac surgical patients, this additional study arm examines the same interventions in a non-clinical adult population under controlled conditions, independent of disease-, surgery-, or medication-related influences. Participants are randomly assigned to one of several experimental conditions and take part in a single approximately 30-minute session. Depending on group allocation, the session may include exposure to natural soundscapes, natural soundscapes combined with binaural beats, virtual reality-based natural environments, virtual reality combined with binaural beats, or a control condition without a relaxation intervention. The primary aim of the DESTUD-Study is to assess the feasibility and potential stress-reducing effects of these non-pharmacological relaxation approaches in a non-clinical setting and to support the interpretation of findings from the clinical DESTRESS trial. Physiological responses, including heart rate variability and electrodermal activity, as well as self-reported stress measures, are collected before, during and after the conditions.

Effect of Daily Humiome® Post LB Intake on Wellbeing in Older Individuals With Moderate Stress Levels

The placebo-controlled, double blind parallel intervention trial "PostWelLB" aims to test whether 3 months of daily supplementation with the postbiotic product "Humiome® Post LB" (HPLB; 340 mg / day) can reduce self-reported stress (PSS10 questionnaire)- in an older (50 - 75 years; all genders) population in France.

Exploring PTSD Symptoms, Barriers and Facilitators to Mindfulness

The purpose of this study is to investigate justice-involved Black/African American female adolescents' (JI BAFAs; N=35) self-reported outcomes: stress, posttraumatic stress disorder (PTSD), recidivism, etc., as well as their parents/caregivers' (P/Cs; N=35) stress and pre- and post- intervention results along with their views of an adapted intervention.