Clinical Research Directory

A Randomized Controlled Trial to Assess the Impact of Live and Recorded Music-Based Interventions on Pre-operative Stress, Mood, Pain and Biomarkers, in Neurosurgical Patients (Music-STAR Trial)

The study plans to enroll a total of 132 patients. The goal of this study is to measure pre-and post-music intervention changes in patients' vital signs, serum- and plasma-level biomarkers by broad-spectrum proteomics analysis, metabolic analysis, and perceived pain, anxiety, and mood states as measured by validated questionnaires (STAI-S, POMS-SF, and VASP). We will collect demographic information on each participant. Participants will also complete the Brief Musical Experience Questionnaire (BMEQ) to investigate potential links between susceptibility to music-induced anxiolysis and prior musical training, preference and exposure.

Assessing MB-Spirit for Psychological Well-being

The goal of this clinical trial is to test two new behavioral interventions designed to reduce stress and improve spiritual well-being in stressed adults. The main questions it aims to answer are: 1. Can the program decrease stress and improve spiritual well-being? 2. What brain changes accompany participation in the programs? Participants will: 1. Be randomized to either a live online course that meets for 90 minutes every week for 8-weeks, or to a self-paced program. In the self-paced program, participants will receive materials once a week and can work through them at their own pace. Both programs are designed to decrease stress and improve well-being. 2. Complete questionnaires before and after the course. 3. Complete and interview before and after the course. 4. A subset of people will be randomized to 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.

Mindfulness-Based Intervention With a Supplement for Stress-Related Problems in College Students Across Multiple Sites (4SITE)

The investigators hope to add to the feasible, acceptable, and effective interventions that offer reductions in depression, anxiety, and stress for students at U.S. colleges and universities, the majority of whom experience mental health problems but the minority of whom who receive adequate mental health support. By studying the extent to which a multi-modal supplement boosts effects for a mindfulness-based intervention (and comparing both to an active health education control program) to reduce depression, anxiety, and stress, the proposed research seeks to rigorously investigate complementary and integrative health interventions and their roles in improving health.

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).

Digital Single Session Intervention for Youth Mental Health

The aim of this study is to test the effectiveness of a single-session, digital intervention teaching the principle of practicing the opposite, when administered to youths on the waitlist for psychotherapy, with usual waitlist procedures as a control condition.

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 Pre-Breastfeeding Breathing Exercises on Maternal Anxiety, Well-being, and Infant Stress in Mothers Whose Infants Are in the Neonatal Intensive Care Unit

Aim: This study was conducted to examine the effects of breathing exercises on maternal anxiety, well-being, and infant stress. Materials and Methods: The research was initiated in a hospital in eastern Turkey between November 2024 and November 2026, after obtaining ethical committee and institutional approvals. The study population consisted of mothers whose babies were hospitalized in the neonatal intensive care unit (NICU) of that hospital.The generally available G\*Power 3.1.9.7 for Windows software was used to calculate the sample size. Similar literature studies were referenced when determining the sample size of the research (Shamsdanesh et al., 2023). Furthermore, after the research is completed, a post-hoc power analysis will be performed on the main dependent variable, maternal anxiety level (MAL), to determine the power of the study (approximately 35 experimental, 35 control). The aim of the research is to ensure that the resulting sample size has sufficient statistical power to reveal the effect being examined. The research data is collected using a Demographic Information Form, prepared by the researcher through a literature review, the State and Trait Anxiety Inventory, the Psychological Well-being Scale, and the Neonatal Stress Scale. Mothers perform this exercise three times a day for two days (days 1 and 2), under the supervision of a researcher. The four-square breathing exercise is a non-pharmacological pain reliever that has been shown to be beneficial in conditions other than pain. Each breathing exercise lasts 5-10 minutes. Mothers in the experimental group are given a questionnaire before the start of the study and after the exercise on days 1 and 2. Mothers in the control group are given only a questionnaire before the start of the study, at the end of day 1, and at the end of day 2. Mothers in the control group do not perform the four-square breathing exercise and receive routine hospital care. At the end of both days, mothers in the control group who wish to practice the breathing exercise are given the opportunity to do so.

Developing Field Tools for Real-Time Assessment of Exposure to Psychosocial Stress and Drug Use in an Outpatient Treatment Population

Background: \- Researchers are interested in developing more accurate methods to assess environmental influences on psychological stress and drug use. One key to a more accurate assessment of environmental influences is minimizing the delay between exposure and reporting. Portable devices such as personal digital assistants (PDAs) and global positioning system (GPS) units may be able to provide a more real-time image of these factors. Objectives: \- To assess the use of PDAs to measure stress and drug use, and GPS units to assess the effects of neighborhood environment in an outpatient treatment population. Eligibility: * Individuals from 18 to 75 years of age who are current heroin users seeking treatment for addiction and who spend most of their time in Baltimore city. * Participants must be able to visit the research and treatment center at least three times per week for regular tests. Design: * Participants will be in the study for approximately 28 weeks (7 months). * A series of three laboratory session examining responsiveness to standardized stressors will occur both early in treatment and will be repeated late in treatment. * Participants will undergo 18 weeks of daily methadone maintenance. Urine samples will be collected three times weekly. * To track drug use, stress, and geographical location (a measure of environmental risk), each participant will carry a PDA and a GPS unit for 16 of the 18 weeks. Participants will make entries (1) each time that they use a drug and (2) each time they feel overwhelmed, anxious, or stressed more than usual. Participants will also make three random-signal-triggered recordings per day and one brief (end of day) recording. * Retrospective self-report questionnaires on drug use and stress will be given regularly. * After 18 weeks of methadone maintenance, participants will discontinue carrying the PDA and GPS unit and will have the choice of transferring to a community clinic or undergoing a 10-week taper from methadone at the research clinic. Participants who stay for the taper will continue to provide urine samples, but only once a week.

Effectiveness of a Sound Bowl Meditation on Caregiver Stress and Anxiety

Being a primary caregiver for a family member or friend can be physically and emotionally demanding leaving little time for the unpaid caregiver's professional pursuits, personal appointments, and self-care. Primary caregivers are often overwhelmed, and experience stress, anxiety, depression, and sleep disturbances. Passive activities that require no physical or mental exertion may provide support and can help improve overall well-being. Sounds from crystal sound bowls and other instruments combined with guided meditations have been found to promote relaxation and to reduce stress and anxiety. Participants can sit in a chair or lie on a yoga mat, supported by pillows and blankets, to enhance comfort and rest. Eye masks can also be used to minimize light and promote peacefulness. The purpose of this study is to assess if a weekly Sound Bowl Meditation, offered over the course of 6 weeks and provided by a certified Sound Bowl practitioner, can help decrease caregiver stress and anxiety related to the role as a primary caregiver.

Effect of Yoga and Values Clarification on Stress, Comfort, and Emotional Regulation in Parents of Children With Special Needs

Parents of children with special needs often experience high levels of stress and difficulties in emotional regulation, which may negatively affect both their well-being and parent-child interactions. This study aims to evaluate the effect of a Comfort Theory-based yoga and values clarification intervention on emotional regulation, comfort, and perceived stress levels in these parents. This randomized controlled study will include three groups: a yoga intervention group, a values clarification group, and a control group. Participants will be randomly assigned to groups. Data will be collected using the Emotion Regulation Scale, Perceived Stress Scale, and General Comfort Questionnaire. The intervention is expected to improve emotional regulation and comfort levels while reducing perceived stress among parents of children with special needs. The findings may contribute to the development of effective nursing interventions to support caregiver well-being.

Comparative Effects of Four Brief Breathwork and Mindfulness Interventions on Anxiety and Psychological Flexibility: A 4-Arm RCT

This four-arm, single-blind randomized controlled trial examines the effects of four brief daily 5-minute practices over 28 days on psychological flexibility and physiological variables in Spanish-speaking adults. Participants will be randomly assigned to one of four groups: Box Breathing, Cyclic Sighing, Mindfulness focused on exhalation with the syllable "AH", or Conscious Cyclic Sighing. Outcomes include state and trait anxiety (STAI), positive and negative affect (PANAS), psychological flexibility (MPFI-24, Psy-Flex), and physiological variables (heart rate, respiratory rate, heart rate variability). Assessments are conducted at baseline, daily during the 28-day intervention, at post-intervention (day 31), and at 2-month follow-up.

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.

Pilot Study Evaluating the Impact of Stress Reduction on Atherosclerotic : Heart and Mind Study

The plot study aims to evaluate the effect of 8 weeks of stress reducing intervention on atherosclerotic plaque inflammation in adults, as quantified by positron emission tomography (PET) with fluorine-2-deoxy-D-glucose (FDG) in individuals with increased psychosocial stress.

Biomarkers of Environment Sensitivity

Most of the common mental disorders are heritable to a certain extent but environmental factors have an important role influencing whether the disorder will develop or not. These factors can be negative (e.g. loss of job or death of a loved one) that increase the risk of disorders but also positive (e.g. friends that provide support in need or doing sport regularly) that prevent the development of symptoms. This study investigates whether those who are sensitive to negative impacts may be also more sensitive to positive circumstances. If this is true, improving the environment of these people, for example offering psychotherapy, may help them more than to those who are not sensitive to the environment. More than 500 000 participants' genetic data is used to investigate which genetic factors are associated with sensitivity to environment. This information will be used to determine genetic sensitivity to environment in independent participants who went through functional magnetic resonance brain imaging. Therefore, the study will examine whether sensitive and non-sensitive peoples' brain respond differently to positive and negative stimuli. Finally, tests will determine how sensitivity to environment influences the effectiveness of an intervention that psychologists use to improve stress coping in young adults. This method aims to identify biomarkers to predict the effectiveness of this intervention. In summary, the study will enhance the understanding of why some people are more sensitive to environmental influences and how this information can be utilized to select the most suitable therapy for them.

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.

Social Factors in the Mental Health of Young Adults: Bridging Psychological and Network Analysis

The central goal of this project is to produce a novel, precise, and comprehensive account of social factors in young adult mental health - using a novel combination of network nominations, ecological momentary assessment, and neuroimaging methods. To that end, the investigators will collect data from two successive classes of college undergraduates (i.e., classes of 2023 and 2024) over the course of their collegiate tenure.

Smartphone-based Cognitive Emotion Regulation Training for Unpaid Primary Caregivers of Persons With Alzheimer's Disease

Alzheimer's Disease (AD) and Alzheimer's Disease-Related Dementias (ADRD) not only exact a heavy toll on patients, they also impose an enormous emotional, physical, and financial burden on unpaid, often family, caregivers. The strain of providing care for a loved one diagnosed with AD, often across several years, is associated with elevated depression risk and poorer overall health. Emotion regulation skills represent an ideal target for psychological intervention to promote healthy coping in ADRD caregivers. The project seeks to use an experimental medicine approach to test the efficacy and biobehavioral mechanisms of a novel, relatively brief, targeted, scalable, smartphone-based cognitive emotion regulation intervention aimed at improving psychological outcomes (i.e., reducing perceived stress, caregiver burden, and depressive symptoms) in ADRD unpaid primary caregivers as well as examine potential benefits of the caregiver intervention on quality of life in care recipients. Cognitive reappraisal is the ability to modify the trajectory of an emotional response by thinking about and appraising emotional information in an alternative, more adaptive way. Reappraisal can be operationalized via two primary tactics: psychological distancing (i.e. appraising an emotional stimulus as an objective, impartial observer) and reinterpretation (i.e., imagining a better outcome than what initially seemed apparent). The project will investigate the efficacy and underlying biobehavioral mechanisms of a novel, one-week cognitive reappraisal intervention in this population, with follow-up assessments at 2 weeks, 4 weeks, and 3 months. ADRD unpaid primary caregivers will be randomly assigned to receive training in either distancing, reinterpretation, or a no regulation natural history control condition, with ecological momentary assessments of self-reported positive and negative affect, remotely- collected psychophysiological health-related biomarkers (i.e., heart rate variability data) using pre-mailed Polar H10 chest bands, and health-related questionnaire reports. Distancing training is expected to result in longitudinal reductions in self-reported negative affect, longitudinal increases in positive affect, and longitudinal increases in HRV that are larger than those attributable to reinterpretation training and no-regulation control training.

Impact of Increased Parent Presence in the Neonatal Intensive Care Unit on Parent & Infant Outcomes

The purpose of this pilot study is to compare parent and infant outcomes and unit outcomes pre and post a planned unit-wide intervention aimed at increasing parent presence in the Neonatal Intensive Care Unit (NICU). The FCC intervention will consist of communicating an expectation that all NICU parents be present at minimum 4 hours/day versus the current practice of telling families to "come as much as they can" that has resulted in inconsistent parent presence.

30-Day MoonBrew Sleep & Stress Study

This study aims to assess how consuming MoonBrew each evening for 30 days impacts sleep quality and stress levels. Poor sleep and high stress often go hand-in-hand, worsening overall health. By using validated self-reported outcome measures, this study bridges the gap between anecdotal evidence and scientific proof (without requiring a connected health device), contributing valuable insights into natural solutions for better sleep.

The Cracking Consciousness Study With Monroe & Neuphoria

You've explored the Monroe Focus levels. But, Bob Monroe said, "You might believe something, but you won't understand it until you can measure it with objective data." Now, for the first time, we can measure them. In partnership with Neuphoria, we're launching a groundbreaking EEG study to define Higher States of Consciousness. Join the World's First higher states of Consciousness Study.

A Behavioral Activation Intervention Administered in a College Freshman Orientation Course

The transition from high school to college is a developmentally sensitive period that is high risk for escalations in alcohol use. Although risky drinking is a common problem among freshmen, engagement in treatment services is very low. The proposed study will test a behavioral activation intervention that addresses factors limiting participation in standard treatment services by targeting alcohol use indirectly, by directly addressing concerns most relevant to incoming college freshmen, and by integrating an intervention into the college curriculum.

Influence of Resentment and Forgivingness on Quality of Life in People Living With HIV

Life stress is strongly associated with poor mental and physical health and its effects explain significant morbidity and mortality. Forgiveness is one of the factors that can influence the effects of stress on health. By definition, forgiveness is the release of negative feelings, emotions, and behaviors - and possibly the release of positive feelings - toward an offender. Numerous studies have shown that forgiveness is associated with several mental and physical health benefits. The literature argues that high levels of propensity to forgive (trait) predispose that person to experience forgiveness (state) more often. In other words, a stronger forgiving disposition is believed to increase the experience of forgiveness, which, in turn, mitigates the negative effects of stress. Forgiveness is therefore a coping style that can play a beneficial role in the stress-health relationship. Patients living with HIV (PLHIV) are patients particularly exposed to stress, not only because of their chronic pathology but also because of the stigma attached to this disease. Very few studies have studied the impact of forgiveness (state or trait) on the physical health of PLHIV and even fewer the impact of an intervention promoting the disposition to forgive. The objective of this prospective observational monocentric study is to show in a very secular country that forgiveness has an effect on well-being as well as on other health parameters.

Effect of Peer Mentorship on Stress in First-Year Nursing Students

This study aims to evaluate the effect of a peer mentor-mentee program on perceived stress levels among first-year nursing students. Starting university and adapting to nursing education may be stressful for first-year students due to new academic, social, and environmental demands. Peer mentoring may help students adapt to university life, receive academic and social support, and cope more effectively with stress. This study was designed as a non-randomized controlled experimental study with a pretest-posttest design. The study population consists of first-year nursing students enrolled at the same institution. Students in the experimental group will participate in an eight-week peer mentor-mentee program supported by fourth-year nursing students who serve as mentors. The program includes guidance on adaptation to university life, academic processes, time management, problem-solving, communication, and coping with stress. Mentor-mentee meetings will be conducted face-to-face or online according to student availability. Students in the control group will receive the university's routine orientation and standard academic advising services. The main hypothesis of the study is that first-year nursing students who participate in the peer mentor-mentee program will have different post-intervention perceived stress levels compared with students in the control group. Perceived stress will be assessed before and after the intervention using the Perceived Stress Scale. The effectiveness of the mentoring process will also be evaluated using the Peer Mentorship Evaluation Scale.

Virtual Reality Intervention for Stress, Resilience, and Blood Pressure Management in Black Women - Realist Women Study

The Realist Women Study wants to see if a special program using virtual reality can help Black women deal with stress and improve Black women's heart health. The study team wants to see if using virtual reality (VR) can help with stress of Black women. The investigator will look at things like sleep, stress, and how well the VR works. The investigator also wants to know about any problems Black women might have using virtual reality.