Treatment Trials

14 Clinical Trials for Various Conditions

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COMPLETED
Summative Assessment of the BurntOut 3D Simulation With Medical Students
Description

Burnout is a common problem for medical students and is associated with stress-related health problems and also potentially affects the quality of care delivered to their patients. Among the health problems commonly associated with burnout are substance use problems, and alcohol is the substance most often misused. The purpose of the evaluation is to document whether an educational intervention incorporating aspects of virtual reality (VR) via a 3D online simulation experience prevents or improves the primary endpoint of burnout and the secondary endpoints of burnout-related factors in medical students. The investigators will also will evaluate student satisfaction with the intervention to determine if it meets our standard of success. The hypothesis is that the intervention will improve the primary clinical endpoint of burnout from pre-intervention to post-intervention as measured by the Maslach Burnout Inventory, a validated inventory that is widely used to measure burnout. The related factors that will be measured as secondary clinical endpoints include quality of life, substance use (alcohol and drugs), depression, and resilience. Due to evidence that these endpoints are linked to burnout, the investigators also hypothesize that the measures will improve pre- to post-intervention. Satisfaction of the target audience after completing the simulation intervention will also be evaluated. The evaluation will be prior to and after use of the simulation by medical student participants, using a pre-/post intervention, wait-list control, parallel design.

COMPLETED
Meditation for Burnout in PA Students
Description

This study investigates the feasibility and effects of an app-based mindfulness meditation intervention for PA students.

RECRUITING
Storytelling and Mindfulness for Graduate Student Wellbeing
Description

The purpose of this study is to evaluate an intervention for improving Science, Technology, Engineering, and Math (STEM) graduate student wellbeing. Participants will be recruited from the University of Wisconsin-Madison graduate student body. Data will be collected from participants for up to 2 years, and the investigators anticipate that the study will last for 4 years.

COMPLETED
The Effect of Community Building Through Virtual, Team-Based Exercise on Burnout
Description

This study is a randomized controlled trial that will look at whether virtual, team-based exercise improves burnout, sense of community, and mentorship connections among medical students, residents, fellows, and physicians.

UNKNOWN
Characterization of Medical Student Burnout Using Remote Physiologic Monitoring
Description

A reliable method for monitoring stress and burnout among medical students is critically needed. To address this gap, our team aims to utilize the cost-effective WHOOP strap 4.0 wearable device to continuously capture stress-relevant physiologic data (i.e., sleep hours, heart rate variability, respiration rate, resting heart rate) among up to 50 third-year medical students at 24 Sidney Kimmel Medical College at Thomas Jefferson University for 6 months.

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
Investigating the Effects of Osteopathic Manipulative Treatment on Stress Management in Medical Students
Description

The goal of this clinical trial is to evaluate stress biomarkers, subjective stress levels, and cognitive function in medical students. The main question\[s\] it aims to answer are: Does regular osteopathic manipulative treatment affect stress in medical students? Does regular osteopathic manipulative treatment affect cognitive function in medical students? Participants will be split into two groups, control and treatment, and undergo a designated protocol for six weeks. The treatment protocol will include weekly sessions of three OMT techniques: paraspinal inhibition, rib raising, and condylar decompression. Concurrently, participants' salivary cortisol levels will be collected weekly and analyzed using an Invitrogen ELISA Immunoassay Kit. Additionally, cognitive function will be assessed weekly via Lumosity, while stress levels are gauged using the College Student Stress Scale (CSSS) survey. Researchers will compare one cohort of medical students who receive weekly OMT and another cohort of medical students who have weekly check-ins without OMT to see if OMT can affect changes in stress biomarkers, subjective stress scales, and cognitive function.

SUSPENDED
Trial to Evaluate the Efficacy of a Manualized Reflective Writing Program for Clinical Phase Physician Assistant (PA) Students.
Description

The following will be an open label controlled efficacy trial of the effects of longitudinal participation in an existing reflective writing program for medical students on burnout in physician assistant students.

COMPLETED
CircaHealth Development and Evaluation
Description

This study evaluates the feasibility, acceptability, and efficacy of an online education course about circadian rhythms and health. Half of participants will be enrolled into the online course and the other half will receive materials on sleep hygiene as a control.

ACTIVE_NOT_RECRUITING
Well-being in Students and Teachers Study
Description

The goal of this randomized trial is to test the effectiveness of two universal classroom-based mindfulness social and emotional learning (SEL) programs (one for students and one for teachers) by examining behavioral outcomes on 5th and 6th grade students and their teachers. The main questions it aims to answer are: * What are the singular and combined effects of a mindfulness-based SEL education programs for teachers and their students on the development of students' and their teachers' social, emotional, and cognitive competence, and well-being? * Can mindfulness-based SEL education programs for students and teachers foster the creation of caring, inclusive, equitable, and collaborative classroom contexts? * Can mindfulness-based SEL education programs support the development of students' and teachers' prosocial attitudes, mindsets that positively impact student learning? * Are the effects durable beyond the end of the programs with regard to the singular and combined mindfulness-based SEL interventions? A total of 24 classrooms will be randomized into one of three study conditions: 1. Mindfulness SEL program for Educators only 2. Mindfulness SEL program for Educators and Mindfulness SEL program for Students in combination, and 3. "Business as usual" (comparison groups in which regular classroom SEL curricula is implemented). Data will be obtained via multiple objective and subjective methods (e.g., self- and teacher-reports, peer behavioral assessments) from different sources (e.g., self-, peer-, and teacher-reports). Data will also be collected to monitor implementation of the two programs. To explore the ways in which these two programs impact student, teacher, and classroom outcomes, data will be analyzed to compare students and teachers in the three conditions. In Phase One (year one), the investigators will conduct an experimental "outcome" study to examine the singular and combined effects of the two programs by comparing pre-test and post-test measures across the three conditions. In Phase Two (year two), the investigators will conduct a six-month follow up with those teachers and students who participated in Phase One in order to determine the degree to which the program effects are durable after the program has ended.

COMPLETED
The Impact of the MUSE Meditation Device on Student Registered Nurse Anesthetists
Description

The question this study is designed to answer is whether or not the use of a MUSE Meditation Device lowers student registered nurse anesthetist's perception of stress, anxiety, and burnout within the Mayo Clinic Doctorate of Nurse Anesthesia Practice Program.

ACTIVE_NOT_RECRUITING
Pomegranate Supplementation and Well-Being Among Medical Students and Residents
Description

Medical students and residents have high rates of mental distress and burnout related to the intellectual and time demands of their training. Research shows that physiological stress on the body can be a result of fatigue and high stress work, and is associated with experiences related to mental distress. Pomegranate is a fruit that is known to contain a variety of antioxidant substances that can reduce physiological stress. This study will look at the potential for pomegranate supplementation to reduce physiological stress and improve well-being in medical students and residents.

COMPLETED
Compassion Training and Mindfulness Training for Social Well-Being and Mental Health
Description

Study Design, Aims, and Population: The present study is a three-arm randomized controlled trial (RCT). The primary aim is to test the relative efficacy of two 8-week online interventions - Compassion Cultivation Training (CCT) and Mindfulness-Based Stress Reduction (MBSR) - in promoting diverse university students' social well-being (i.e., reduced loneliness, and enhanced social connectedness and perceived social support) compared to a Waitlist (WL) control group. The secondary aim is to examine the effects of CCT versus MBSR on the mental health of diverse university students compared to the WL group. Mental health is defined in this research as both positive mental health (i.e., happiness, positive emotions, meaning and purpose) and negative mental health (i.e., stress, anxiety, and depression). Additionally, another aim is to enroll 75% students of color and 50% male identifying students, whose social well-being and mental health is currently understudied, to better represent the sociodemographic diversity of the university student population in the literature. Study Rationale: The COVID-19 pandemic triggered widespread disruptions in social connections and relational bonds that robustly support a variety of mental and physical health-protective processes. University students' social well-being may have been especially impacted as universities provide a central context for socialization. At the same time, the pandemic exacerbated a pre-existing rise in cases of mental health conditions in university students. If found effective, online-based CCT and MBSR might serve as scalable psychological interventions to foster social thriving and mental health among diverse university students.

COMPLETED
Brief Mood Enhancement Intervention
Description

The purpose of the current study is to test the efficacy of two brief, behavioral interventions intended to improve burnout among doctoral-level graduate students (n = 102). Specifically, individuals will be randomly assigned to one of three intervention conditions: 1) Reward: a brief intervention to help participants increase engagement in healthy and rewarding values-driven behaviors, 2) Approach: a brief intervention to help participants identify and decrease emotion-driven avoidance of important goals, or 3) Control: a control condition that involves monitoring only. Multilevel modeling will be used to assess changes in burnout, mood, and stress, following the interventions, controlling for participants' individual baseline levels of these variables.