107 Clinical Trials for Various Conditions
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.
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.
In this pilot study, the investigators plan to examine how the combination of wellness coaching and a mobile health app that promotes positive psychology activities can improve the overall well-being of college students. With these tools, the investigators hope to better understand the relationship between digital intervention and coaching and determine how it may improve the mental health of students. The study team also hopes to investigate how mental health can impact academic performance.
WestEd and its partners Efficacity and the Oregon Youth Authority (OYA), are conducting a randomized controlled trial of an innovative teen pregnancy prevention program, Healthy U, for youthful male offenders. This study involves male teenagers (age 14-19) at high risk for involvement in risky sexual behavior, including teen pregnancy. The innovative, non-curricular, technology-based intervention, Healthy U, is self-directed, low-cost, user friendly, and offers great promise in reaching incarcerated youth. The purpose of this study is to test this intervention on a population of young men incarcerated at the OYA who will soon be released into the community. The intervention is tailored to this population by updating the design, videos, and examples to best reflect the youth in the study, and OYA staff are being trained to facilitate the self-guided intervention.
This study will evaluate whether the evidence-based Wellness framework paired with an evidence-based Partnership compared to Wellness alone will improve middle school students\' social, emotional/behavioral, and academic functioning.
The purpose of this pilot randomized trial is to determine (1) the effectiveness of the Polar M400, used in combination with a twice-weekly Facebook-delivered Social Cognitive Theory-based health intervention, in the promotion of more healthful physical activity and nutritious eating behaviors over 12 weeks in college students versus a comparison group; and (2) the validity and reliability of the Polar M400 in the assessment of free-living (i.e., non-laboratory based) physical activity (in this case, steps per day and daily durations of moderate and vigorous physical activity) and energy expenditure.
This study aims to investigate the feasibility and efficacy of online student wellness courses for improving medical student mental health and well-being.
The purpose of this research is to find effective ways of well-being promotion in higher education settings. A unique mindfulness training was developed that includes cognitive, emotional, social, and spiritual components. The training is being delivered during class-time of the following courses: Personal Development and College Success, Understanding Health Behavior, and Health Promotion and Disease Prevention. The objective of the study is to explore the training in regard to dosage effects and the incremental effect of spirituality. While the proximal targets of the intervention are well-being and stress, the ultimate targets are grades and persistence in college. The hypotheses to be tested are: * Mindfulness training will increase the well-being and decrease the stress, anxiety and depression symptomology of the participants. * Mindfulness training will increase the functioning of the participants measured through GPA and hours spent in community engagement. * The "mindfulness training with spiritual components" will have a greater impact than the "mindfulness only training" on well-being. The study is designed as an experimental longitudinal study using a 2 X 3 factorial repeated measures design. The 2 level factor is mindfulness and mindfulness plus spirituality. The 3 level factor is the dose of the intervention (i.e., control, one class a week, and two classes a week).
This study seeks to investigate the effects of an online single-session intervention on college student mental health and well-being. Undergraduate students from the University of Pennsylvania and Harvard will be randomized to a 30-minute single-session intervention or a study skills control group. Students' depressive symptoms, anxiety symptoms, positive and negative affect, and subjective well-being will be assessed up to 12 weeks post-intervention.
The goal of this clinical trial is to evaluate the impact of SkillTalk among educators, parents, and students. The main question\[s\] it aims to answer are: * What is the impact of SkillTalk on student sexual-health related outcomes? * What is the impact of SkillTalk on educator microskills? Educator participants will use an online microskills training platform for one week. Parent participants will be asked to use a parent-specific online microskills training platform for one week. Youth participants will not be asked to do anything outside of "business as usual." Researchers will compare the treatment groups to the control groups to measure the impact of SkillTalk.
The goal of this study is to prevent prescription opioid misuse among high school athletes by developing, demonstrating the feasibility, and evaluating the outcomes of an innovative digital intervention.
This project aims to enhance AN university students' behavioral health by supporting their cultural identity development. While the connection between cultural identity and behavioral health is becoming clearer, comparably less research has explored methods of enhancing identity development. Consequently, the investigators will pilot a cultural identity development program for AN students at the University of Alaska Anchorage (UAA). This intervention is based on extant scientific literature, local findings from focus group with AN students, and traditional wisdom from AN Elders. The eight-week Elder-facilitated program incorporates storytelling, experiential learning, connection, exploration, and sharing of identity, cultural strengths, life paths, and rootedness in who they are in order to remain grounded when they face changes and challenges. Approximately 40 to 50 AN university students will be recruited for the intervention. Participants will be randomized, with half the participants receiving the intervention in the Fall 2020 semester and half the students receiving the intervention in the Spring 2021 semester. We hypothesize that engaging in this intervention will strengthen AN students' cultural identities, strengths, and sense of community; improve their behavioral health, as evidenced in higher self-reported wellbeing, and lower substance use, depression, anxiety, and suicidal ideation symptoms; and support their academic persistence and achievement. Outcomes will be tested via mixed design analyses of covariance. Moreover, program feasibility will be examined through a process evaluation, which will entail thematic analyses of six focus groups with program participants (n=40-50) and with the Elders who facilitated the program (n=5).
The goal of this study is to compare the efficacy and mechanisms of change of two self-help books for college student mental health in a randomized controlled trial. One book is based on mindfulness-based stress reduction (MBSR), and one is based on acceptance and commitment therapy (ACT). This study will test the following hypotheses: 1. The ACT and MBSR books will both be feasible and acceptable with college students as evidenced by equivalently high satisfaction and engagement rates. 2. The ACT and MBSR books will be equally effective in improving mental health and well-being among college students. 3. The ACT book will produce larger improvements in valued action, and the MBSR book will produce larger improvements in mindfulness. 4. Valued action will be a stronger predictor of improvements in mental health in the ACT condition and mindfulness will be a stronger predictor of improvements in the mindfulness condition.
The overarching goal of this study is to improve the delivery of an established, evidence-based intervention (cognitive-behavioral therapy-CBT) in Michigan schools through different implementation strategies designed to better educate school professionals. Specifically, the study will assist the ongoing Transforming Research into Action to Improve the Lives of Students (TRAILS) Program by evaluating different ways to educate school professionals (SPs) to improve their delivery of CBT to high school students and ultimately improve student mental health outcomes in the state of Michigan. The three educational approaches are Replicating Effective Programs (REP), Coaching, and Facilitation.
1. Briefly describe the purpose of this protocol: This study is designed to evaluate the effectiveness of an educational training video on the topic of health literacy for medical students. 2. Briefly summarize how participants are recruited: OHSU medical students attending mandatory trainings on the topic of health literacy during the 1st and 2nd years of medical school will be invited to participate in the study. 3. Briefly describe the procedures subjects will undergo: Completion of a short self-administered anonymous survey before and after viewing a 23-minute video about health literacy. 4. If applicable, briefly describe survey/interview instruments used: A 12-item pre-test questionnaire and 13-item post-test questionnaire designed to assess individuals' knowledge about health literacy, and intended clinical practices with respect to health literacy. 5. If this is a clinical trial using an experimental drug and/or device, or an approved drug and/or device used for an unapproved purpose, briefly describe the drug and/or device: n/a 6. Briefly describe how the data will be analyzed to address the purpose of the protocol: Demographics and responses to individual items will be reported as frequencies and percentages within the sample. The investigators will use a chi-square analysis to stratify responses by demographic groups and t-tests to measure possible changes over time.
College counseling centers (CCCs) are being faced with increasing demands for services to meet the treatment needs of their students, in the context of increasingly severe cases and declining resources. Innovative, cost effective solutions are needed. The proposed project seeks to meet these needs by testing a web-based guided self-help version of Acceptance and Commitment Therapy (ACT), an evidence-based transdiagnostic therapy found to effectively treat a range of psychological problems. An ACT program would provide a means of implementing effective treatment for the range of problems in the CCC setting, while the guided self-help format would reduce counselors' workload, improving cost-effectiveness and reducing waiting lists. This would both treat students and train counselors in how to implement the ACT intervention. Three self-help lessons have been developed, as well as a counselor portal to review students' use of the program and to receive training on implementing ACT guided self-help. The study is a pre-post, open(i.e., non-randomized) feasibility trial with 20 counselors and 60 clients from multiple CCCs throughout the country.
This proposed study aims to evaluate whether integrating mindfulness into an undergraduate biology course (Mindful Physiology) influences student applied mindfulness and stress regulation. The primary questions are 1. Would completing the Mindful Physiology course increase applied mindfulness? 2. Would completing the course increase self-efficacy in stress regulation? 3. Would completing the course reduce perceived reactivity to acute stressors?
The goal of this clinical trial is to learn if a single-session digital intervention (SPARK Coping) is acceptable, usable, and demonstrates a preliminary signal of efficacy in reducing symptom-related distress and increasing positive treatment-seeking attitudes among college students reporting subthreshold symptoms associated with risk for psychosis. Research questions inclue: * Does SPARK Coping reduce symptom-related distress and increase positive treatment seeking attitudes (primary outcomes) relative to a waitlist control condition? * Does SPARK Coping increase adaptive coping and reduce internalized stigma (primary targets) relative to a waitlist control condition? Researchers will compare provision of SPARK Coping to a waitlist control condition and collect data from participants on each of the variables described above. Participants will: * Complete questionnaires and surveys remotely at the start of the study and two weeks later * Be offered access to the SPARK Coping intervention either after completion of their baseline assessment (intervention arm) or after two weeks (waitlist control arm).
Integrative-Mind-Body Skills Group (I-MBS-G) is an 8-week group that teaches skills to build inner resources for effective mood management. This group incorporates a holistic approach to wellness through meditation and mindfulness practices, guided imagery, breath and body awareness, and relaxation techniques. Mind-body approaches have demonstrated effectiveness in reducing stress mood symptoms and improving quality of life. The study hypothesis is that the Mind-Body Skills taught in the group will reduce mood symptoms in graduate and medical students.
Mindfulness interventions are increasingly offered to undergraduate students at universities world-wide, however the evidence base is very limited. The objective is to evaluate effects of a customized mindfulness intervention (called Mindfulness-Based College) on undergraduate student health. A superiority randomized controlled trial with parallel groups will be performed with 30 participants in each arm. Participants will be randomly assigned to Mindfulness-Based College or health education waitlist control. Investigators will be blinded to treatment allocation. Participants will be assessed at baseline, 10 weeks, and six months. The primary outcome is a college health summary score, including seven evidence-based determinants of health particularly relevant to college student well-being: body mass index, physical activity, diet, alcohol consumption, sleep quantity, perceived stress, and loneliness. Primary intention-to-treat analyses will evaluate whether MB-College vs. control is associated with the summary score, utilizing generalized linear models. Secondary analyses will evaluate which, if any, of the seven determinants of health are driving associations.
This pilot study tested the feasibility of utilizing an adaptive intervention strategy for college students who are suicidal when first seeking treatment at a campus clinic. Right now, the typical strategy may rely on a "one size fits all" approach, but in fact suicidal students vary greatly on what and how much they need. This study will pave the way for subsequent larger trials for clinical decision making (trying one approach, and if that doesn't work, another) to be empirically developed and tested in a subsequent large-scale multisite trial with the goal of maximizing resources in overburdened college counseling centers. This pilot study followed by a subsequent large-scale trial could eventually significantly impact service delivery to suicidal college students at college counseling centers.
This investigation will examine the feasibility of delivery and effect on resilience, depression and anxiety of a 90-day Heartfulness Practice delivered virtually for health care students. It is hypothesized that by providing this program on-line, students will be able to attend easily and complete the sessions. It is also hypothesized that those students who participate in the meditation program will increase resilience.
The interprofessional practice \& education curriculum for the students to be employed in this study will include five modalities in a scaffolded structure progressing from low- to high-fidelity experiences over a two-year period: (1) classroom didactic sessions; (2) simulation laboratory sessions; (3) standardized patient sessions; (4) community-based clinical case conferences; and, (5) community-based interprofessional rotations. Clinicians will experience many of the same learning experiences as the students, but will differ in the level of education and its focus. Clinicians and faculty will be taught the concepts of interprofessional practice \& education, the same as the students, but they will also be taught how to educate students using interprofessional practice \& education.
Inaccurate perceptions of the severity of an exposure may result in unnecessary visits to the Emergency Department or Health Care Facility which can result in crowding of Emergency Departments, unnecessary utilization of valuable health care resources, unnecessary treatments, and or mistakes / errors resulting in harm to the patient. Inaccurate perceptions about the severity of an exposure can result in delays in proper evaluation and treatment resulting in harm or in some cases death of the patient.
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).
The goal of this intervention study is to compare two different simulation modalities (standardized patient and manikin-based) in nursing student education. The main aim is to determine the effect of new scenarios on cultural awareness levels in two different types of simulation modalities and to determine the effect of new scenarios on social determinants of health knowledge levels in two different types of simulation modalities. Participants will assign to two groups and will attend simulation sessions.
The study aims to evaluate whether use of a mobile mental health app improves outcomes of depression and anxiety for students.
In the current study, the researchers propose to develop and pilot test a Bharatanatyam (i.e. Indian classical dance) program called Mindful Kala with the hopes of decreasing stress and increasing psychosocial well-being, mindfulness, cultural competence, and connectedness amongst a group of college students. The investigators hope that this program can help students cultivate well-being during the challenging and stressful time of COVID-19.
Electronic Bridge to Mental Health for College Students (eBridge) is an online intervention that screens students for mental health concerns that include elevated suicide risk and facilitates their linkage to mental health (MH) services. EBridge is designed to work on computers, tablets, and smartphones (iOS, Android) and is easily adaptable to evolving technologies in the future. It incorporates motivational interviewing (MI) principles and draws from health behavior models that emphasize autonomy and self-determination. Following a web-based screen using standardized scales to identify students at elevated risk, eBridge offers students options for personalized feedback (provided online in a conversational format adherent with motivational interviewing) and corresponding online with professionals trained in motivational interviewing and knowledgeable about university and community resources. Ebridge is being conducted at four universities: the University of Michigan, the University of Nevada-Reno, the University of Iowa, and Stanford University.
The goal of this research study is to learn how middle and high school students react to an interactive website called ASPIRE ( A Smoking Prevention Interactive Experience) and health information online and what their preferences are when using ASPIRE. Researchers hope to use the results of this study to design more effective online health programs to provide middle and high school students with up-to-date information about tobacco use, meditation, and general health and well-being.