Clinical Research Directory

Feasibility and Acceptability of an E-learning Dialectical Behavior Therapy Skills Course

Dialectical behavior therapy (DBT) is a comprehensive, third-wave psychological intervention designed for patients with complex and severe behavioral, emotional, and interpersonal dysfunction. DBT has since been adapted to shorter, briefer, "skills training" formats, which have been effective for a number of mild-to-moderate mental health conditions, including depression and anxiety. Moreover, internet-delivered formats of DBT (iDBT) have similarly started to build support for their effectiveness, although there are fewer studies on digital formats. One study found that over 12 weeks, iDBT was deemed acceptable (e.g., 50% of participants were still active after 4 weeks) and there were improvements in multiple symptom domains, such as depression, anxiety, suicidality, functional disability, as well as alcohol and substance dependence. In the current study, the investigators will examine the feasibility, acceptability, and potential efficacy of a new iDBT intervention, packaged as an online e-learning skills course, with adult participants. The study is a pilot trial as iDBT has never been tested in this format through formal research. Thus, this pilot study aims to examine whether this course is usable, practical, and potentially useful to others in the future. The investigators will recruit up to 40 individuals with mild-to-moderate depression and anxiety for an 8-week study. Following a phone screen to determine eligibility, participants will complete a baseline session where they will provide consent, complete a brief interview and questionnaires, and register for the e-learning skills course. Over the course of 8 weeks, participants will be exposed to material adapted from a DBT manual in a self-guided manner. Participants will complete follow-up assessments at 4 and 8 weeks.

Epi-Genetic Modulators of Fear Extinction in Alcohol Dependence

Background: \- Researchers want to learn if people with alcohol dependence have more difficulty learning to feel calm, or learn to fear things more easily. They also want to study how early life stress (ELS) affects the ability to learn to feel calm. Objective: \- To see if people with alcohol dependence and/or ELS have a harder time learning to feel calm than people without these. Also, to see if DNA is changed by ELS and if this change affects fear conditioning and extinction. Eligibility: * Adults ages 21-65 with and without an alcohol use disorder (AUD) and with and without ELS. * Healthy volunteers. Design: * Participants will be screened with: * Medical history * Physical exam * Blood and urine tests * Psychological tests * Treatment for symptoms of alcohol withdrawal, if needed * Healthy volunteers will have 1 overnight visit (2 days, 1 night). AUD participants will stay at the clinic for about 4 weeks. * Participants will: * Rate alcohol use/craving, depression, anxiety, and childhood trauma. * Have psychophysiological measures: electrodes and mild electric shock. * Have a functional magnetic resonance imaging (MRI) scan. Participants will lie on a table in a metal cylinder with a coil over their head. In the first scanning session, they will see pictures, do a simple task, and may get shocks. Participants will also do a second scanning session in which they will perform the aforementioned fear conditioning and extinction task, as well as a facial expression matching task, an affective word processing task, and a task measuring valuation of monetary rewards. * Answer questions about their emotions (some participants). * Have blood drawn from an arm vein or intravenous (IV) line. * AUD participants will get a dexamethasone pill. The next day, they will get a hormone injected in and have blood drawn from an IV line. * AUD participants will have 3 follow-up visits with questions and blood and lab tests.

Perioperative Stress Management in Outpatient Surgery With L-tyrosine Supplementation (SPOT)

Patient undergoing surgery is exposed to many stressors: diachronic (gesture anticipation), synchronic (intraoperative aggression) and historical (subject's personality). Reducing the level of stress experienced is a factor for improving the quality of the surgical gesture and the simplicity of the follow-up. The previous methods used were intended to reduce the body's reactivity to aggressions through anaesthesia consultation and L-Tyrosine supplementation. Currently with the progression of outpatient surgery and the need for early rehabilitation, L-Tyrosine supplementation is suppressed to improve recovery. Some patients, however, have a high level of stress that may require anxiolysis when the ideal treatment does not exist (ineffective hydroxyzine, benzodiazepines having many side effects). The strategy of this work is to improve the body's ability to respond to stressors, by administering l-tyrosine with no impact on waking or returning home.

Effects of Moderate Exercise and Cyclic Sighing on Stress, Cognition and Physiological Markers in Young Adults

This study investigates the effects of moderate physical exercise and cyclic sighing (breathing training) on stress, cognition, and physiological markers in young adults. It is a randomized cross-over trial with two interventions. Each participant will take part in two intervention sessions: 1. Moderate-intensity physical activity (PA): 15 minutes of stationary cycling at 65-75% of maximum heart rate (HRmax). 2. Breathing training (CS): 15 minutes of cyclic sighing, a technique involving inhaling, pausing briefly, taking a deeper breath, and exhaling slowly. A one-week washout period between sessions is planned to minimise carry-over effects and to ensure participants' physiological state is similar before the next session. During this week, participants will wear Polar Ignite wrist-worn devices to monitor physical activity and sleep. A total of 30 participants (you adults) will be enrolled. Measurements performed before and after each intervention include: * EEG using Emotiv EPOC Flex Gel (32-channel device): 2 minutes with eyes open, 2 minutes with eyes closed, during the interventions, and while performing cognitive test (N-back). * Heart rate variability (HRV) using the Polar H10 sensor. * SUDS - Subjective Units of Disress Scale for perceived stress. * N-back test for cognitive performance using Emotiv App. * Blood pressure (systolic and diastolic) and heart rate. * Pain threshold measured with a dolorimeter. * PANAS-SF - Positive and Negative Affect Schedule. Baseline questionnaires completed by participants the day before the study: * PSS-10 - Perceived Stress Scale (Cohen, Kamarck, Mermelstein). * MAAS - Mindful Attention Awareness Scale * Psychological well-being - short version * Mini-COPE - Coping with Stress Inventory * Sleep quality and average sleep duration * Chronotype questionnaire (morningness-eveningness) * GPAQ - Global Physical Activity Questionnaire * Pittsburgh Sleep Quality Index The study aims to understand how brief interventions like moderate exercise and breathing techniques affect stress, cognitive performance, and physiological responses in young adults.

Psychological and Physiological Effects of Three-Minute Breathing Space Meditation in UPM Postgraduate Students

Postgraduate students often experience psychological distress linked to academic demands, deadlines, research uncertainty, and financial or social pressures, and international students may face additional adjustment challenges. This study tests whether a brief, low-burden mindfulness practice - a three-minute Breathing Space Meditation (BSM) session, done four days a week for 8 weeks - can reduce stress, anxiety, and depression in postgraduate students at Universiti Putra Malaysia, compared with an active control activity that is matched in format and contact time but does not involve mindfulness training. Participants are randomly assigned to one of the two groups and are grouped by whether they are local or international students. The study also looks at whether the intervention affects stress hormone (cortisol) levels, a marker of inflammation (C-reactive protein), and a brain-wave measure linked to mood, and it collects brief daily check-ins on mood, stress, sleep, and academic pressures over the 8 weeks.

Intranasal Oxytocin Intervention for Caregivers to Persons With Dementia

More than 15 million family caregivers provide support for individuals with Alzheimer's disease (AD) or related dementias. This number is expected to grow with the increasing population of persons with dementia (PWD). Stress in caregivers to older adults with chronic diseases is already a significant public health issue because it is associated with multiple negative physical and mental health outcomes for the caregiver (e.g., depression, cardiovascular disease) and can negatively impact the health of the PWD as well. Importantly, stress levels are even higher in female than male caregivers and in caregivers to PWD than other chronic conditions that affect older adults. There are numerous interventions to improve well-being in caregivers to PWD, but only two have been shown to moderately improve caregiver depression and quality of life in the PWD. However, both of the interventions are time and energy intensive. One promising candidate to reduce stress and improve quality of life is the endogenous neuropeptide oxytocin (OXT). Intranasal OXT interventions have been shown to successfully reduce stress and increase quality of life in other populations, including patients with borderline personality disorder, Post-traumatic Stress Disorder (PTSD), Anxiety Disorder, and Depressive Disorder. This study will assess the efficacy and safety of intranasal oxytocin (OXT) to improve the quality of life and reduce chronic stress levels in the caregivers to PWD. Participants will be randomly enrolled to one of three groups: 12 IU intranasal oxytocin, 24 IU intranasal oxytocin or placebo. The study drug will be administered daily for 21 days.

Effect of a Brief Mindfulness-Based Training on First Clinical Day Stress in First-Year Nursing Students

This randomized controlled trial examines the effect of a brief hybrid mindfulness-based training on perceived stress and mindful attention awareness during the first clinical day of first-year nursing students. The training consists of four sessions (two face-to-face and two synchronous online) delivered over the two weeks before the first clinical day. Perceived stress is measured with the Perceived Stress Scale for Nursing Students on the day before the first clinical day and at the end of that day; mindful attention awareness is measured with the Mindful Attention Awareness Scale before the training and at the end of the first clinical day.

Stress Modulation and Dynamic Balance

This three-arm, parallel-group, randomized controlled trial (RCT) investigates whether dual-task therapeutic exercises (dynamic balance + cognitive task) improve perceived stress and dynamic balance in 72 healthy university students (19- 22 years) compared to traditional balance training alone or a control group receiving low intensity exercises. The dual-task group performs the same dynamic balance exercises (e.g., backward walking, tandem gait, single-leg reaches) while simultaneously engaging in cognitive tasks (verbal fluency, arithmetic, or working memory). The intervention lasts 6 weeks (2 sessions/week, 20-30 min each). Primary outcomes are Perceived Stress Scale (PSS-10) scores and objective dynamic balance indices (anterior/posterior/lateral deviation, overall stability) measured via the Balance check 636 device. Assessments occur at baseline and post-intervention by a blinded assessor. The study addresses a gap: no prior trial has examined combined effects of dual-task training on both stress modulation and balance in this population.

Aimmune Longitudinal Collaboration Study

This study will include healthy households around the Irvine, CA area (based local to employees) and Tempe, AZ and Philadelphia, PA sites that will be instructed to take a daily fiber supplement (2.5 tablespoons of chia seeds \[\~10.3g of fiber\] which is one serving) for two months. Participants will use a stool sampling tool to facilitate ease of stool collection, or they may donate at a study site. Half of participants will add chia seeds to their diet at the beginning of the study and then return to their baseline diet for the second half of the study; half of participants maintain their baseline diet for the first half of the study and add chia seeds to their diet at the second half of the study as a cross-over design. Households (or individual participants, if their household is not participating) will be chosen at random to decide who implements the intervention in the first half versus the second half of the study. Data measurement including metabolomics and sequencing of stool samples, blood sampling for biobanking, stool IgA analysis, stress and diet evaluations will occur initially and throughout the study. Lifestyle questionnaires including but not limited to diet surveys, stress, or depression screening may be collected through electronic forms or telephonically. During enrollment, participants may be asked to complete questionnaires focused on medical, family, dietary, and social histories. At the end of the study, donor microbiota samples from individuals that are IgA low (undetectable) throughout the study will be evaluated from the presence of microbes that can degrade IgA. If investigators find this is the case, investigators will screen for microbes that can degrade IgA. For individuals that show persistent high fecal IgA or show a substantial improvement in IgA, investigators will transplant fecal samples or spores from fecal samples into germ-free mice to further understand the microbiome and pathophysiology relationship. For the latter, the investigator's hypothesis is that fiber exposure of a specific type will reprogram the microbiome to stimulate IgA broadly to the entire microbiome as occurs with pectin derivative treated mice. The investigator's goal will be to isolate the microbes that respond to fiber to alter levels of IgA in the gut lumen.

Ecological Momentary Assessment of State-Dependent Decision-Making and Metacognition Across a Psychopathology Continuum

Background: Making decisions during daily life is a complicated behavior. Even simple choices can be affected by a range of emotions, stresses, and moods. Mental health issues such as depression and anxiety can lead people to make decisions that have negative effects on their lives. Learning how changes in feeling affect a person's decisions may help researchers find ways to help them make more positive choices. Objective: To learn how changes in a person's feelings and emotions affect their decisions. Eligibility: People aged 18 to 55 years who are healthy or who have some level of depressive, anxiety, substance-related, or addictive disorders. Design: All study activities can be done remotely; participants may use a smartphone app, a website, or telehealth. Participants will have a baseline visit. They will complete tasks that require decisions; these tasks are like games they play on their phone. They will also answer questions about their habits, how they feel, their sleep quality, and any problem behaviors. They may wear a smartwatch during the study; it will record data such as their movements and heart rate. For 12 weeks, a study app will prompt participants to respond. They will be asked to answer questions about how they are feeling, any problematic behaviors, or big life events; they will be asked to complete tasks that require making decisions. They may record a video or audio clip describing their day and how they feel. For 3 of the 12 weeks, participants will get prompts up to 6 times per day. For 9 weeks, they will get up to 3 prompts per day. They will have an end-of-study visit to discuss their experiences.

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.

Digital Intervention for Physical Activity

The present study will assess the effects of a four-week digitally delivered intervention on physical activity and depressive symptoms among adults experiencing at least moderate depressive symptoms. The main questions this research aims to answer are: * Does a digitally-delivered intervention increase physical activity levels? * Does a digitally-delivered intervention reduce symptoms of depression? Researchers will compare an intervention promoting physical activity to a passive control (does not receive the intervention) group to see if the intervention reduces depressive symptoms and increases physical activity levels. Participants will: * Visit the laboratory at two separate time points before group assignment, separated by one week of physical activity monitoring * Be randomly assigned to complete four weeks of a digital intervention prompting engagement in physical activity or have their mental health symptoms monitored over four weeks (i.e., passive control group) * Visit the laboratory at two separate time points after the intervention, separated by one week of physical activity monitoring

Surviving Daily Life

The primary goal of this project is to evaluate the feasibility of a 14-day mobile daily diary study among racially diverse breast cancer survivors. Further, the investigators will examine the validity and reliability of the daily stress and daily cognitive performance measures among breast cancer survivors. This pilot project will recruit 30 racially diverse breast cancer survivors (Asian, Black, Latina, and white; ages 40 and older; at least five years post-diagnosis) who are patients at the Sidney Kimmel Comprehensive Cancer Center. The daily diary survey questions will be available in English, Spanish, and Chinese to accommodate the preferred language of the target participants.

Mindfulness-Based Education For Women With Polycystic Ovary Syndrome

Polycystic ovary syndrome (PCOS), also known as polyendocrine metabolic ovarian syndrome (PMOS), is the most common endocrinologic disorder to affect women. Despite this, the disease's pathophysiology remains unclear. This has hindered the diagnosis of the disease and the appropriate treatment for millions of individuals. The long-term health sequelae associated with PCOS, future directions, and areas of needed research in this often-overlooked disease. Women with PCOS may experience menstrual symptoms, increased stress, and difficulties in managing the physical and emotional effects of the condition. Supportive approaches that improve symptom management and quality of life may be beneficial in addition to routine care. The aim of this randomized controlled study is to evaluate the effect of mindfulness-based PCOS education on menstrual symptoms, stress levels, and quality of life in women with PCOS. The study will examine whether a structured mindfulness-based education program can support women in managing PCOS-related symptoms and improving their overall well-being. Women diagnosed with PCOS who meet the study eligibility criteria will be invited to participate. Participants will be randomly assigned to either the intervention group or the control group. Participants in the intervention group will receive a mindfulness-based PCOS education program, while those in the control group will receive routine care without it. Researchers will assess participants' menstrual symptoms, stress levels, and quality of life using validated measurement tools before and after the intervention. The findings of this study will provide information about the potential role of mindfulness-based education as a supportive approach in the management of PCOS and may contribute to the development of patient-centered education programs for women with PCOS.

Peer Mentoring and Perceived Stress in First-Year Nursing Students

This study aimed to evaluate whether participation in a peer mentor-mentee program was associated with changes in perceived stress among first-year nursing students. Starting university and adapting to nursing education may be stressful for first-year students because of new academic, social, and environmental demands. Peer mentoring may support students' adaptation to university life by providing academic, social, and practical support. This study used a controlled quasi-experimental pretest-posttest design involving first-year nursing students enrolled at the same institution. Students in the intervention group participated in an eight-week peer mentor-mentee program supported by fourth-year nursing students who served as mentors. The program included guidance on adaptation to university life, academic processes, time management, problem-solving, communication, and coping with stress. Students in the control group received the university's routine orientation and standard academic advising services. Perceived stress was assessed before and immediately after the eight-week intervention using the Perceived Stress Scale. The primary outcome was the change in perceived stress from baseline to post-intervention. Participants in the intervention group also completed the Peer Mentorship Evaluation Scale after the program to evaluate their experience of the mentoring process.

Effects of Root Extract Ashwagandha (KSM-66) on Perception of Recovery and Muscle Strength in Adolescents Aged 11 to 19 Engaged in Grassroots Football

This study will test whether six weeks of ashwagandha (KSM-66 root extract), helps teenage footballers recover and improve strength. Very little research has looked at young people aged 11 to 19, despite increased usage in this cohort. About 50 to 60 male and female players from grassroots clubs in Sussex, Surrey and Greater London will be randomly assigned to take a daily capsule of either 450 mg ashwagandha or a placebo in an unblinded fashion. Before and after the six weeks, players will do tests at their usual training site: saliva samples to measure the cortisol, grip strength, a 1 km time trial, and short questionnaires on recovery, sleep, stress and soreness. The results will show whether ashwagandha changes stress, strength, performance and perceived recovery over six weeks.

Chatbot Effectiveness for Improving Mental Health and Reducing Stress in Nursing Students

This study aims to evaluate the effectiveness of using a chatbot to improve mental health and reduce stress among nursing students during their internships. The study will be conducted through convenient sampling of nursing students from a technology university in southern Taiwan. Students will be divided into experimental and control groups to compare differences in mental health and stress levels after receiving support from the chatbot. Expected outcomes include gaining a better understanding of the fundamental characteristics of nursing students and their mental health and stress levels during internships. The results are expected to demonstrate that the chatbot can aid nursing students in handling typical internship issues, stress, and challenges, as well as in accessing mental health resources.

Randomized Controlled Trial of a Behavioral Training App

The investigators propose addressing and evaluating the efficacy of a behavioral, contingency management app by conducting a randomized controlled trial (RCT) that will evaluate the app compared to a placebo app control group. Participants will be randomly assigned to immediate intervention using the treatment condition or to a placebo app condition. Participants will not know which condition they are assigned to until after the study completion; they will also not know that they are using the treatment app until after the study completion. The sample will consist of 100 families of school-age children (ages 6-12) who display significant behavioral problems. The treatment app is a task management platform containing a self-directed rewards system through which caregivers can assign token rewards to their children for completing routine tasks (e.g., cleaning their room, completing homework). Participants in the placebo app condition will have a similar user experience, however, tokens are assigned non-contingently (dispensed daily, rather than based on task completion). While participants will not be required to complete any tasks or behaviors in the app as part of their participation in the study, they will be asked to use the app at least once per day for 8 weeks. Given the self-directed nature of the treatment app (parents decide how frequently they access the app-based rewards system and how many tasks they assign to their child), parent involvement in the intervention will vary slightly in duration. However, based on the literature and routine practice, we anticipate parents will log in at least once a day to assign tasks to their child and follow up on completed rewards. Assessments (see details below) will occur at baseline, weekly during the intervention, and at the end of the study. The study will take about 8 weeks in total to complete once participants have been enrolled in the app.

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.

Effect of Smart Watch Monitoring on Stress Levels Among Nursing Students During Older Adult Clinical Training

This randomized controlled trial aims to evaluate the effectiveness of smart watch monitoring in reducing stress levels among nursing students during older adult clinical training. Nursing students often experience psychological stress during geriatric clinical practice due to complex patient care and clinical responsibilities. Participants will be randomly assigned to either a smart watch monitoring group or a control group receiving usual clinical training. Stress levels will be assessed using validated instruments, while physiological indicators, including heart rate variability (HRV), will be monitored in the intervention group. The findings will determine whether smart watch monitoring can support stress management and improve students' well-being during clinical training.

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

Development of a College Student-Delivered Cognitive-Behavioral Therapy (CBT) Intervention for Rural High School Students

This research is being done to find out the effectiveness, feasibility, and acceptability of a college student-delivered cognitive-behavioral therapy (CBT) intervention in high schools in rural Schuylkill County, Pennsylvania to treat mental health problems (i.e. depression and anxiety) in adolescents. This project will respond to the need for evidence-based, acceptable, accessible, and low-cost adolescent cognitive-behavioral interventions that lead to long-term improvements in adolescents' mental health outcomes.

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?

GUT-FEELINGS: Using Citizen Science for Large-Scale Prebiotic Clinical Trials for Mental Wellness in Adults

The goal of this study is to evaluate the effects of different products in participants experiencing feelings of anxiety. The main question it aims to answer is: \- Do these products affect feelings of anxiety and related wellness outcomes compared with a placebo? Researchers will compare participants taking active products to those taking a placebo to see whether the active products influence feelings of anxiety and related outcomes, and to monitor safety. Participants will: * Be randomly assigned to receive either an active product or a placebo (an inactive look-alike). * Take their assigned product or placebo without knowing which group they are in until the study is completed. * Complete evaluations and tasks to track safety, feelings of anxiety, and related health outcomes.