Treatment Trials

413 Clinical Trials for Various Conditions

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COMPLETED
Effectiveness of Mindfulness Protocols Among OT Students
Description

The research will study the effectiveness of mindfulness protocols for OT students to decrease stress and re-engage in meaningful occupations after becoming disengaged.

COMPLETED
Designing a Mobile App to Support Academic Success for Student Veterans
Description

Compared to civilian students in higher education, student Veterans have high rates of mental health disorders (PTSD: 40% vs. 9% and Depression: 24% vs 12.1%). As a result, Veterans with mental health disorders can be more likely to experience academic issues, such as lower enrollment rates and slower degree attainment on average. In addition, student Veterans with mental health disorders can experience substantial challenges with the already-difficult transition to the student role, with difficulties related to education planning, academic skills, and mental health management. Though many student Veterans could benefit from programming embedded in supported education interventions, current in-person VA supported education treatments are often difficult to access - or not available locally - for these Veterans. In addition, there is no widely available, VA-specific online or mobile-app based resource for students, which is a substantial gap in resources for student Veterans. The goal of this project is to develop and evaluate a comprehensive mobile app for student Veterans with mental health disorders. This intervention will use the principles of Veteran supported education research and manualized treatments to develop a personalized academic success app, VetEd, to address a variety of academic and psychiatric symptom-related educational barriers for student Veterans. Specifically, VetEd will provide a resource to (1) orient student Veterans with mental health disorders to successfully transition to the role of student as defined by their self-created educational roadmap, which will include helping students acquire (2) academic skills, (3) mental health management skills, and (4) up-to-date information on psychiatric, academic, and financial resources to help them successfully meet higher-education expectations. This overall study will involve three aims: 1) Developing a Veteran-centered educational support app to help student Veterans with mental health disorders to identify their perceived academic needs, app preferences, and evaluate Veteran-centered content; 2) Testing and iteratively revising the VetEd app (n =15) by assessing app software, content, human-computer interface, usability, satisfaction data, and preliminary exploration of changes in educational functioning (course activity completion, academic self-efficacy, and retention; and 3) Completing final revisions of the VetEd app for a future grant application of a larger RCT. This pilot project is significant and innovative in three key respects: (1) it extends services based in previous, effective supported education research to address both psychiatric and academic concerns for Veterans with mental health disorders; (2) is potentially cost-effective and easy to disseminate nationally; and (3) focuses on improving Veterans' academic functioning and quality of life is substantially different than current VA mobile app offerings. Results from this pilot project will inform the development of a Merit Review application for a larger, randomized clinical trial of VetEd with student Veterans.

COMPLETED
Sleep, Physical Activity, and Dietary Habits Among High School Student-athletes and Non-athletes During an Academic Semester
Description

Adolescent's poor sleep habits have been linked to adverse outcomes. Recent advances in activity tracking have provided researchers with cost-effective and non-invasive measurements of sleep in a free-living environment. The primary objective is to determine the mean differences in Fitbit accelerometer sleep quantity (mins) between High School student-athletes and non-athletes during a competitive academic semester over continuous monitoring for two weeks.

COMPLETED
Evaluating a Travel App's Influence on College Student Commuting to Campus
Description

The Cluster Randomized Controlled Trial (cRCT) portion of the study will focus on evaluating the use of information, marketing, and incentives to shape student travel behavior to campus through the three channels identified in Ajzen's (1991) framework.

Conditions
COMPLETED
Longitudinal COVID-19 Antibody Testing in Indiana University Undergraduate Students
Description

The primary goal for this study is to assess whether receiving the results of an antibody test changes protective behavior to avoid SARS-CoV-2 infections (i.e., mask-wearing, physical distancing, limiting close contacts/avoiding crowds, hand-washing, avoiding contact with high-risk individuals). While studies have been published on the cross-sectional relationship between risk perception and other demographic characteristics and health behaviors that are protective for SARS-CoV-2 infection (see citations), there have been no studies showing the effect of receiving information about antibody positivity on protective behavior. Not only can results from this study be used to better model transmission, a better understanding of college student's risk perception around SARS-CoV-2 infections has implications for future vaccination strategies as well. There are concerns that a desire to return to "normal" life in combination with reduced perception of risk could have negative consequences for uptake of vaccination (Johns Hopkins Center for Health Security 2020 report, The Public's Role in COVID-19 Vaccination: Planning Recommendations Informed by Design Thinking and the Social, Behavioral, and Communication Sciences). The antibody test used in this study is named 'SARS-CoV-2 IgM/IgG rapid assay kit (Colloidal Gold)'. It provides a fast, on-site, and accurate detection of IgM/IgG antibodies against SARS-CoV-2, with positive results of IgM antibodies indicating a recent infection, while positive results of IgG antibodies signaling a longer or previous infection. It can detect IgM and IgG antibodies against SARS-CoV-2 in human specimens of serum, plasma, or venous whole blood.

COMPLETED
Effectiveness of a Multimodal Mindfulness Program to Alleviate Graduate Student Stress
Description

The purpose of this pilot study is to develop and assess a multimodal mindfulness activity program for physical and occupational therapy students intended to teach management of stressors impacting educational performance. This study will use a two group, randomized controlled design in which approximately 25 students will be randomized to an intervention group and 25 to a control group. Intervention will be implemented in an 8-week period with pre- and post-study measures administered at 1-week prior to and 1-week following intervention.

Conditions
COMPLETED
CREATION Health Assessment Tool for College Students
Description

CREATION Health encompasses eight whole-person care principles: Choice, Rest, Environment, Activity, Trust, Interpersonal-Relationships, Outlook, and Nutrition. An existing initial tool consisting of 74 items related to the eight CREATION Health principles and college students' wellbeing were generated by subject/methodology experts. To develop the CREATION Health Assessment Tool for College Students (CHAT-CS), this initial tool needs to be finalized through item reductions and validations in the population of college students.

COMPLETED
Probiotics on Stress-associated Gastrointestinal Function in University Students
Description

The purpose of this research study is to evaluate the effect of a daily supplement of probiotics (Lactobacillus gasseri KS-13, Bifidobacterium bifidum G9-1, Bifidobacterium longum MM-2) on stress-associated gastrointestinal function in university students during the time of semester exams.

Conditions
COMPLETED
APPSPIRE App in Preventing Students From Smoking
Description

This trial studies how well APPSPIRE, a smartphone app, works in preventing students from smoking. Technology-driven intervention programs, such as the APPSPIRE app, have the potential to increase access to health behavior treatments and therapies, such as tobacco cessation support, and provide effective prevention messaging.

RECRUITING
Surgical Operating Room Enhancement Curriculum for Medical Students
Description

The goal of this clinical trial is to assess whether integrating an enhanced Surgical Operating Room (OR) curriculum into the medical student program improves knowledge and proficiency in gynecologic surgical techniques and procedures among medical students at Wayne State University. The main questions it aims to answer are: Does the Surgical Operating Room Enrichment Course increase medical students' knowledge and comfort with gynecologic surgical procedures? Does participation in the course improve students' clinical perceptions and management of gynecologic emergencies? Researchers will compare students who participate in the Surgical Operating Room Enrichment Course (intervention group) to those who complete the standard rotation (control group) to see if the enhanced curriculum leads to greater improvements in knowledge and clinical skills. Participants will: Attend virtual didactic lectures covering gynecologic anatomy, perioperative care, surgical techniques, and management of gynecologic emergencies Complete pre- and post-training surveys assessing knowledge, skills, and perceptions related to gynecologic surgery This study involves approximately 60 medical students, with participation being voluntary and all responses de-identified.

NOT_YET_RECRUITING
This Study Will Compare Force Production in Double-leg Squats of College Students Before and After a Standardized Foam Rolling Session
Description

This study is a within-subject controlled trial . The investigators will compare unilateral force production in a bodyweight double-leg squat before and after a standardized foam rolling session with the use of Vald ForceDecks. TheForceDecks use sensors embedded within separate plates to record the forces exerted. Participants will have their weight, height, and dorsiflexion range of motion measured prior to performing 3 double-leg squats. Participants will then be instructed on the foam rolling technique. They will perform the technique on each quadriceps group and will state their pain level at 30 seconds and at 2 minutes using the VAS pain scale.

NOT_YET_RECRUITING
Co-Creating Active Middle School Communities to Increase Student Physical Activity
Description

The purpose of this study is to identify community-level barriers and facilitators for active transport and leisure physical activity and to co-create and test the effectiveness and longer-term sustainability of community-based physical activity intervention strategies in middle schools. Participation in this study may help the investigators and scientific community better understand and address child physical activity and health. This study will collect information about middle school children's physical activity behaviors, habits, knowledge, and activity. The UTHealth School of Public Health is leading the study together with the University of Texas at Austin.

NOT_YET_RECRUITING
Mind-Body Conditioning Course for University Dance Students
Description

Mindfulness in Motion (MIM) is an eight-week evidenced based program designed specifically to help participants learn practical stress reduction, burnout and resiliency building techniques. Content includes didactic instruction, community-building group discussion, mindfulness practices, and gentle yoga. Weekly themes include Willingness to Daily Practice, Mindful Sleep, Vision of Self, Supported by the Breath, Mindful Eating and Yoga, Movement Through Balance, Awareness of Sensation, Clarity and Release, and Staying Grounded and Moving Forward. An Ohio State University endorsed, ADA compliant companion smartphone app reinforces weekly content and offers a variety of individual mind-body and mediations practices. The evidence-based MIM content has been tailored to meet the physical, mental, and emotional needs of student Dance majors at The Ohio State University and integrated into the Dance 2802 course content as Mind-Body Conditioning for second year students. Over the course of the second year student's fall semester, this study will evaluate the effectiveness of this integrated course content on students' perceived stress, burnout, resilience, musculoskeletal injury and discomfort, and weekly respiratory rates. After the semester long course is completed, the students will also assess how well the Mind-Body Conditioning course content was integrated into the required first year seminar for University Dance majors.

COMPLETED
Effects of Virtual Reality Exercise on Promoting Physical Activity and Health Among College Students
Description

The purpose of this research is to examine the effectiveness of a 4-week immersive-virtual reality (VR) exercise bike intervention on college students' physiological outcomes (physical activity levels, cardiovascular fitness, and body composition) and psychological outcomes (situational motivation, situational interest, mood states, and depressive symptoms).

RECRUITING
Stress Management for College Students
Description

The goal of this clinical trial is to learn if a virtual task can reduce distress in college students. The main questions it aims to answer are: 1. Will those who complete the virtual task have less distress? 2. Will men and women both benefit equally from the virtual task? Researchers will compare the virtual task to a control task (another virtual task that we expect will not impact distress) to see if distress differs. Participants will spend 20 minutes engaging in the virtual task (or the control task) on 3 different days all within one week. They will complete a survey about their well-being before starting the first virtual task and again \~6 weeks afterward.

ENROLLING_BY_INVITATION
Extending the Reach of Evidence-based Practices to Support Student's Attention and Behavior Through Technology
Description

The purpose of this study is to integrate digital health (dHealth) technology into the Collaborative Life Skills Program (CLS), an established, school-based behavioral intervention for students with ADHD, to make the program accessible to schools that serve students from low-socioeconomic (SES) backgrounds. Existing evidence-based interventions for students with ADHD are often inaccessible in schools with limited resources to support implementation. By adapting CLS to include a dHealth tool-CLS-D-investigators aim to improve the feasibility of intervention implementation in schools with limited resources and mitigate disparities in access to evidence-based interventions among students with ADHD who are from low-SES backgrounds.

NOT_YET_RECRUITING
Digitally Prompted Parenting: A Text Message Parent-Based Alcohol Intervention for Incoming College Students
Description

This pilot randomized controlled trial (RCT) will evaluate both the feasibility and efficacy of Digitally Prompted Parenting (DPP), a text-message based parent intervention (tm-PBI) designed to prevent and reduce alcohol use among first-year college students. In this study, parents of incoming first-year students will receive risk-reducing text messages during the first 10 weeks of the Fall semester, which they can forward to their students. The trial uses a longitudinal design to compare drinking outcomes between students whose parents receive the DPP messages and those whose parents receive an established alcohol PBI (the active control condition). The investigators hypothesize that students in the DPP group will report lower levels of alcohol use and fewer alcohol-related consequences after the intervention compared to those in the active control group.

COMPLETED
Effects of an Urban-gardening Nutrition Intervention for Food Insecure College Students
Description

The goal of this clinical trial is to learn if an urban gardening nutrition education program can have positive health effects on food insecure college students. The main question it aims to answer is to determine whether an 8-week urban-gardening nutrition intervention can improve fruit and vegetable intake, nutrition knowledge, Body Mass Index (BMI) and body fat percentage in college students with food insecurity. Participants will: Fill out a questionnaire regarding demographics, food insecurity, fruit and vegetable intake, nutrition knowledge, self-efficacy and health beliefs. Allow researchers to measure height, weight and body fat percentage Participate in a 1-hour education cooking or gardening session once a week for 8 weeks Receive text message reminders for meeting dates

NOT_YET_RECRUITING
Evaluation of an Expectancy Challenge Intervention for Food and Alcohol Disturbance Among College Students
Description

This study aims to create and test an intervention that helps college students re-evaluate their beliefs about food and alcohol disturbance (FAD) and, in turn, reduce how often they engage in it or intend to in the future. The main questions it aims to answer are: 1. Does the intervention help students have less positive beliefs about the effects of FAD and more negative beliefs about its effects? 2. If college students' beliefs about FAD change, does that lead them to engage in it less often or plan to do it less? 3. Will college students who engage in FAD sign up for the study, complete it, and feel that the intervention is helpful and valuable? Participants will take part in one 2-hour in-person laboratory-based study session where they will fill out surveys, learn about FAD, and engage in exercises designed to challenge their existing beliefs about it. They will also complete a follow-up survey online one month after their in-person study visit.

RECRUITING
Student Wellness 2.0
Description

In this randomized controlled study, investigators plan to assess the impact of a mobile health app with positive psychological combined with wellness coaching on college student mental health outcomes. The study aims to differentiate the effectiveness of combining mobile health and wellness coaching compared to wellness coaching on its own. The goal is to improve our understanding of the optimal combination of traditional in-person and digital interventions on diverse student populations, as well as better understand the causal impact of the mobile health app on well-being.

NOT_YET_RECRUITING
Mindfulness-Based Interventions Targeting First-Generation College Student Retention in Rural Environments
Description

The goal of this randomized control group is to learn about effective treatments for college students experiencing anxiety and/or depression. The main questions this clinical trial aims to answer are: 1) Can mindfulness-based treatments increase retention rates among first-generation college students? 1) Can mindfulness-based treatments decrease anxiety and/or depression among first-generation college students? Participants will be randomly assigned to one of two intervention groups: mindfulness meditation or psychoeducation. Researchers will compare outcomes from each group to explore treatment differences.

RECRUITING
Mindful Minds: Mindfulness-Based Neurofeedback for Underrepresented College Students
Description

The study examines the efficacy of a mindfulness-based neurofeedback protocol designed to improve academic performance and reduce performance anxiety in racial and ethnic minority college students. Using NeuroSky and BrainTrain technology, the intervention incorporates mindfulness principles to enhance participants' self-regulation skills. Continuous heart rate variability (HRV) data is collected to assess stress levels, sleep, and exercise. The research aims to explore the acceptability and feasibility of this approach, with the goal of addressing academic performance and anxiety in this population.

COMPLETED
Testing the Efficacy of a Brief Alcohol Intervention Among College Students
Description

Individuals will be recruited to participate in a randomized controlled trial to test the efficacy of a prevention program aimed at reducing alcohol use among college students. If randomized to the intervention, participants will view personalized content based on their alcohol use and chosen identity and learn about various topics related to alcohol use, including ways to reduce their use. Control participants will be directed to a website where information regarding mental health and substance use may be found. Baseline mental health, alcohol use, and related constructs will be assessed. Participants will complete a 3-month follow-up survey to assess the efficacy of the tool in symptom reduction.

NOT_YET_RECRUITING
Evaluating Telehealth Delivery of Brief Alcohol Screening and Intervention for College Students
Description

This research study will test the efficacy of a telehealth version of the Brief Alcohol Screening and Intervention for College Students (BASICS), which is the gold standard prevention and intervention approach to target heavy alcohol use on college campuses across the United States.

ENROLLING_BY_INVITATION
Interventions for PSU Among College Students
Description

This project proposes to evaluate the feasibility and effects of behavioral intervention strategies on problematic smartphone use among college students. The project proposes to evaluate three behavioral intervention components- self-reflection via actively monitoring phone usage, increasing engagement in non-smartphone activities, and contingency management (i.e., financial incentives) - on short-term and long-term reductions in problematic smartphone use (PSU) among college students. The research team will develop a mobile application, referred to as the app, to collect data on a subject's daily phone usage and activity engagement. The app will comprise three features, with specific sets of features being activated during different phases. * Feature 1: The app will autonomously track the time spent on the apps categorized as social media and gaming. * Feature 2: The app will display the daily amount of usage on social media and gaming apps, with an option for a subject to confirm their acknowledgment of the daily time spent. * Feature 3: The app will display an option for subject to confirm their engagement in the alternative activities as planned.

RECRUITING
Examining Executive Functions in Medical Students Across Different Types of Study Breaks
Description

This study aims to expand on previous findings and compare the effects of an active break (ten minutes of walking or upper body movement), a digital break (ten minutes of phone use), and no break on memory and attention in medical students after a prolonged period of studying. The List Learning Task, Stroop Test, and Sustained Attention to Response Task will be administered to measure memory, executive function, and attention, respectively. Information on how different types of breaks affect memory and attention may prompt medical students to be more mindful and intentional of the way they spend their time in between studying.

RECRUITING
Taking Action for College Students
Description

The goal of this research is to investigate whether a peer-delivered illness self-management program called Taking Action can help college students with serious mental illnesses. Participants will be randomly assigned to either the experimental condition (Taking Action) or the control condition (information only). Participants in the experimental condition will attend five 2.5-hour Taking Action sessions. Participants will complete three interviews (baseline, post-intervention, and follow-up) to assess how well the program works, is liked, and benefits students clinically and academically. The investigators seek to test the following hypotheses: Compared to controls, students who do the Taking Action program will report greater improvements in mental health self-management attitudes, skills, and behaviors and will report greater improvements in mental health symptoms and recovery, and better academic outcomes.

RECRUITING
The Student Wellness and Emotional Growth Resiliency (SWAG-R) Program
Description

The purpose of this research study is to provide a free 6-week, online psychological coaching program to NSU undergraduate students to help with anxiety, depression, and stress, while improving quality of life and healthy coping skills.

COMPLETED
The Effect of Music Listening on Nursing Students
Description

The purpose of this study is to explore the effect of sedative and stimulative music listening on physiological responses among nursing students.

RECRUITING
Nature IDEAS Study: an RCT to Increase Time Spent in Nature Among University Students
Description

This project will first examine nature opportunities, belonging and benefits with a multi-state nature-based intervention with a focus on students of color. In light of the syndemic, 'nature deficit disorder' and poor mental health, the investigators anticipate several far-reaching impacts that will (a) test a nationally useful standardized way to quantify exposure; (b) invest in nature resources and accessibility on campuses; and (c) promote the mental health and therapeutic benefits of nature among young adults. These will lead to understanding the nature exposure and mental health interplay and techniques for quantifying and encouraging nature exposure to treat the on-going youth mental health crisis. Including HBCUs and an hispanic-serving institution is expected to result in heightened visibility of underlying disparities, including structural racism and land-based violence and discrimination, that have contributed to current-day nature gaps and dismantled nature relationships for students of color.

Conditions