451 Clinical Trials for Various Conditions
The goal of this clinical trial is to learn if consuming a higher protein diet that includes one serving of beef each day, in combination with resistance exercise, improves wellbeing in postmenopausal women. It will also tell us about how higher protein intake changes body composition and blood values related to health. The main questions it aims to answer are: * Does higher protein intake combined with resistance training improve mood and sleep in postmenopausal women? * What other health benefits to postmenopausal women experience when the follow a higher protein diet and participate in resistance exercise? Researchers will compare three groups 1) postmenopausal women living their daily lives as usual, 2) postmenopausal women consuming a higher protein diet, and 2) postmenopausal women consuming a higher protein diet and participating in resistance training. Participants will: * Consume a higher protein diet for 16 weeks * Participate in an at-home resistance training for 16 weeks * Keep a diary of their food intake, sleep habits, and mood * Have health assessments every 4 weeks
The primary goal of this study is to demonstrate that digital mental health interventions for children, such as Mightier, can have an impact on caregiver functioning, including parenting stress, overall wellbeing, and work engagement. Participants will be caregivers of children who are using Mightier, a video-game based heart rate biofeedback intervention used to build emotion regulation. Caregivers will be asked to complete a short survey prior to their child's first play and then complete that survey two more times, at 8 weeks and 12 weeks post baseline. The pre-post self report design will allow us to observe changes during Mightier use and relate those changes to overall engagement with the intervention.
The purpose of this study is to examine the implementation and effectiveness of the psychosocial eHealth intervention, My Wellbeing Guide, on the proposed primary outcome, depressive symptoms, in patients diagnosed with cancer who receive care at Northwestern Medicine and the University of Miami Health System. Eligible patients will be directly contacted by the study team for recruitment. The intervention includes cognitive behavioral therapy management strategies for health-related stress in the form of animated videos, interactive activities, and written content. The intervention will be delivered via an online application over an 7-week period. Intervention participants will also complete four assessments: baseline (at the beginning of the research study), post-intervention (7 weeks after baseline), a 6-month follow-up, and a 12-month follow up. Participants are randomized into either an intervention application (described above) or a control application (which will provide links to helpful resources for patients with cancer, such as the contact information for cancer support services at Northwestern University and the University of Miami, and the link to the National Cancer Institute website, and the American Cancer Society website.) Control participants will also complete four assessments: baseline (at the beginning of the research study), post-intervention (7 weeks after baseline), a 6-month follow-up, and a 12-month follow up.
The investigators propose to implement a comprehensive Pediatrician Wellbeing Program initiated through and aligning with departmental faculty development and mentorship processes and goals. The Investigators hypothesize that a wellbeing intervention that incorporates an innovative health coaching model to cultivate individual behavior change supportive of one's own and others' wellbeing will lead to improvements in self-reported wellbeing.
The study evaluates the effectiveness of yoga practices on reducing stress, negative emotion, anxiety, and depression and on increasing positive emotion, wellbeing and resilience. The study uses randomized wait-list control. All U.S. undergraduate students in 4-year universities and colleges age 18 or older are eligible to participate.
Physical inactivity has reached pandemic proportions and is associated with increased morbidity, mortality, and healthcare costs. Of particular concern is that most middle to older age adults fall far short of recommendations for health enhancing physical activities. This research takes a novel approach to tackling this problem by combining mindfulness with behavioral strategies in a unique 'Mindful Movement' program offered collaboratively with the YMCA.
The purpose of this study is to compare the impact of yoga, pain education, and yoga nidra with pain acceptance intention to yoga, pain education, and relaxing music on pain intensity, well-being, and sleep quality. This is a pilot study trial of individuals with chronic low back pain. Participants will attend two sessions in the laboratory (week 1 and week 8) and complete their assigned intervention 2 x per week for 6 weeks at home. Participants will be randomized to either receive yoga postures targeting the low back, pain education, and yoga nidra with pain acceptance intention and motor imagery or yoga postures targeting the low back, pain education, and relaxing music.
The goal of this study is to gather feedback on a potential program that collects and shares real-world information to help create products and services to support people who have substance use disorders.
The goal of this clinical trial is to see how giving direct cash support affects the health of pregnant women and their babies in the U.S. Many families, especially those with low incomes, face challenges during pregnancy and after childbirth. This study will explore whether financial help during these times leads to better health. The main questions this research aims to answer are: * Does extra money during pregnancy and a baby's first months improve the baby's growth and overall health? * How does financial support affect a mother's physical and mental health before and after birth? * Does having extra money help moms get better healthcare and make healthier food choices for themselves and their babies? Participants in this study will be randomly assigned to either a high cash or low cash group. They will be enrolled in the study and asked to complete: * A baseline survey * A follow-up survey 12 months after enrollment * A final survey 18 months after enrollment In addition, participants' medical records will be reviewed, and some may be selected for a qualitative interview to share more about their experiences. This research is being done in partnership with The Bridge Project, a program that helps moms in need. The goal is to find better ways to support the health of moms and babies facing financial hardship.
The goal of this 15-month cluster clinical trial is to compare a resilience and stress management program to a physical activity program for early childhood education (ECE) staff on change in well-being. It will also look to see if changes in well-being continue over time. The study sample will include 80 child care centers. Including 80 ECE center directors and approximately 560 ECE center staff. Some ECE centers will receive only the remotely delivered Resilience program. This program works with ECE staff and helps them recognize and strengthen their resilience assets and resources. Other ECE centers will receive only the remotely delivered Physical Activity program that will focus on staff physical activity habits and strength training. There will be 3 months of active program participation and 12 months of a maintenance period where participants will only have access to program materials.
This project aims to address stress, anxiety, burnout, and depression among medical trainees using a web-based intervention that teaches cognitive behavioral therapy (CBT)-based skills to increase resilience. The intervention is a web application ("OptimalWork", optimalwork.com) that includes a "MasterClass" consisting of about 20 interactive modules to be completed over four weeks (five days/week, 15-25 minutes/day). These modules teach principles and skills of CBT in an interactive manner and give tailored recommendations for how to apply and develop these skills in one's work and personal life. Participants who enroll in the study will be randomly assigned to either the MasterClass intervention or an active control (podcast listening) condition, and the control group will be given access to the MasterClass after 8 weeks. Measurements of well-being at baseline, 4 weeks, 8 weeks, 12 weeks, and 16 weeks will be compared between the groups as the primary outcome. Participant engagement as measured by MasterClass module completion and qualitative feedback will also be collected to guide future efforts at large-scale implementation in medical trainees and healthcare workers.
The goal of this clinical trial is to evaluate if the treatment with BTL-699-2 device is able to improve mental well-being in adults above the age of 22 years. The main question it aims to answer is: Does the treatment with BTL-699-2 device improve mental well-being? Participants will be asked to: * Undergo four treatments * Complete the Warwick Edinburgh Mental Well-being Scale * Complete the Therapy Comfort Questionnaire * Complete the Subject Satisfaction \& Mental Wellness Questionnaire
The purpose of this study is to examine the feasibility, acceptability, preliminary efficacy, and candidate gut-brain mechanisms of an optimized positive psychology (PP) intervention for patients with irritable bowel syndrome (IBS), entitled "WISH," compared to an educational control intervention.
The Effects of Mindfulness Practice with Tao Art ("Love Peace Harmony" Calligraphy and Song) on Well-being - Controlled Randomized Study The goal of this controlled randomized clinical study is to learn if a Tao Calligraphy Mindfulness Practice works to improve Well-being. The main questions it aims to answer are: * Does Tao Calligraphy Mindfulness practice improve these three aspects of well-being in adults: (1) Perceived Stress, (2) the Social Connectedness, and (3) Peace of Mind? * Will any improvement in the Perceived Stress Scale (PSS), the Social Connectedness Scale (SCS), and the Peace of Mind Scale (PMS) in adults be statistically significant? Investigators will compare the values of these three scales at the beginning of the mindfulness practices to their values at three months of practice and control groups. Participants will: * be randomized into practice and wait-list control groups * complete the set of three questionnaires upon entry into the study - (the baseline or zero time point; at the 3-months time point, and at the six-months time point * practice the mindfulness techniques with Tao Calligraphy and Tao Song for a minimum of thirty minutes daily
This clinical trial evaluates the impact of a Mindfulness-Based Stress Reduction (MBSR) program adjusted to include Christian principles on well-being in Black adult cancer survivors. Cancer survivors face a unique set of challenges that includes not only physical but also mental and spiritual well-being. Concerns related to both diagnosis and treatment profoundly impact the quality of life of Black cancer survivors. Mindfulness-based interventions (MBIs) have been shown to be effective in improving psychological resilience, reducing anxiety, and enhancing the quality of life among cancer survivors. However, there is little research focusing on these interventions among Black adult cancer survivors. Research has shown that interventions that include cultural experiences, such as the role of religion, spirituality and faith, are more effective in maintaining psychological well-being in Black men. A MBSR program adjusted to include Christian principles may improve the well-being in Black adult cancer survivors.
The objective of this placebo controlled randomized research is to demonstrate the health benefits of a carotenoid nutritional supplement as compared to placebo in terms of nutrient levels, quality of life, feelings, of wellness, brain health, energy, immunity, and appearance.
This study is testing the acceptability and efficacy of an AI enabled mental health chatbot (Elomia) as a resource of college student wellness.
The goal of this clinical trial is to learn how well two community-based self-management programs work in people with chronic back or neck pain from populations that have been minoritized based on race, ethnicity, or income. The main question it aims to answer is: How well does a community-based self-management program teaching mind-body skills such as mindfulness and cognitive behavioral approaches (Partners4Pain) work for reducing pain intensity and interference with general activities and enjoyment of life compared to a community-based self-management program focused on general health and wellbeing (Keys to Wellbeing)? Participants will be asked to do the following: * Attend 2 screening visits to learn about the study and see if they meet the requirements to participate. * Be randomly assigned to one of the two community-based self-management programs. * Attend 9 weekly self-management program sessions (90 minutes each) * Complete surveys about their pain and overall health at 2 months (after the programs end), 4 months, and 6 months. Funding for the project is provided through the National Center for Complementary and Integrative Health (NCCIH) and the National Institute of Neurological Disorders and Stroke (NINDS) through the NIH HEAL Initiative (https://heal.nih.gov/), R33AT012309.
We will study the impacts of offering access to an emotional well-being phone app to Hispanic U.S. immigrants in psychological distress. Our primary outcome is participants' psychological well-being.
The purpose of this study is to develop a brief assessment and need-based behavioral intervention for addressing aging-specific concerns in older adults with lung cancer. The long-term goals of this research include identifying the unique concerns of these patients, providing patients with behavioral skills to address their symptom management needs, and enhancing patient engagement with healthcare specialties targeting aging-specific concerns. In the first phase of this study, participants (12 patients with lung cancer, 6 caregivers, 12 providers) will be asked to participate in two individual interviews (each 30-45 minutes in length) via teleconference. During the first interview, participants will be asked to provide feedback on the current version of the assessment and behavioral intervention. Participants will be asked to describe strengths and weaknesses of the materials, topics to add or remove, and any other suggested changes. After the research team has made changes to the materials, participants will be invited to complete a second interview to provide feedback on the updated materials. In the second phase of the study, 16 older adults with lung cancer will complete the revised assessment and participate in the behavioral intervention, in order to a) evaluate the feasibility and acceptability of the program and b) measure change in depression, anxiety, pain, and dyspnea.
The goal of this proposed research is to collect pilot data to test the hypothesis that treatment with a novel form of closed-loop digital meditation (MediTrain) will lead to a greater magnitude of gains in cognitive abilities in patients with mild cognitive impairment (MCI), compared to OA without cognitive impairment, and will lead to improvements in quantitative measures of sleep.
This clinical trial assesses the acceptability and feasibility of a virtual group Meaning-Centered Psychotherapy for Cancer Caregivers (MCP-C) and its effect in improving the wellbeing of caregivers of patients with advanced cancer. Caregivers often suffer from significant existential distress, which includes feelings of hopelessness, demoralization, burden, loss of meaning and dignity, and a decreased will to live. MCP-C seeks to help caregivers connect to meaning and purpose despite the challenges of caregiving and helps caregivers understand how sources of meaning may help with symptoms of burden and reduce despair. Participating in MCP-C may help improve sense of personal meaning, spiritual well-being, and mood in caregivers of patients with advanced cancer.
This study is being done to see if the Healthy Minds Program app helps adolescents with elevated depressive symptoms. Up to 200 participants will be on study for 20 weeks.
This study aims to investigate whether daily consumption of Gainful Daily Performance Greens for four weeks contributes to improved scores of wellbeing and focus in healthy adults, as compared to a control group of non-supplement takers. The research question will be addressed by evaluating participants' responses using the World Health Organization's WHO-5 Wellbeing Index and the Mindful Attention Awareness Scale.
Several studies have shown that self-valuation (also known as self-compassion) strongly predicts burnout in physicians. Although effective, existing self-compassion cultivation programs designed for physicians have significant time commitments and, historically, have had low physician participation rates. With occupational burnout among US physicians at an all-time high, there is a compelling and urgent need to identify pragmatic approaches to address low levels of self-valuation in physicians. This study aims to test the impact of a brief mindset intervention that frames daily food choices as an opportunity to demonstrate self-kindness on self-valuation and burnout in physicians over 6 weeks. Instilling a mindset shift that enables physicians to practice self-valuation as part of their existing, daily routine amidst extreme time pressures is a pragmatic and potentially powerful vehicle to promote self-valuation for physicians.
This study is a 2-arm cluster randomized controlled trial with approximately 1,200 youth aged 14-19 years to assess the effectiveness of Yes and Know, a sexual health education program. To be eligible, participants must be 14-19 years old and English-speaking. Those in the treatment arm will receive Yes and Know, a synchronous virtual program delivered over multiple sessions totaling nine hours, along with asynchronous online activities and resources. Those in the control arm will receive a similarly structured program focused on nutrition education. Participants will complete brief online surveys at baseline and at 3 and 12 months after the synchronous sessions. The study will assess the program's effectiveness in reducing the prevalence of unprotected sex among youth and improving short-term outcomes, such as knowledge of reproductive health and healthy relationships, self-efficacy, and the use of reproductive health services.
The goal of this feasibility study and clinical trial is to learn if an evidenced-based breathwork and meditation intervention (SKY Breath) will improve the mental and physical well-being of individuals with Parkinson's Disease (iPD) in stages 1, 2, and 3, under the age of 75 and their care partners. The main questions it aims to answer are: * Objective 1: Can the SKY Breath practice be designed and implemented to specifically cater to the unique needs of individuals with Parkinson's Disease and their care partners. * Objective 2: Will the SKY Breath practice decrease stress levels (a contributor to increasing PD symptoms) for individuals with Parkinson\'s Disease (iPD) and their care partners as measured through self-reported surveys to improve overall well-being and quality of life. * Objective 3: Will the SKY Breath practice in part alleviate the emotional stress and physical burden experienced by care partners of PD patients, promoting their resilience and well-being. Participants will be asked to learn the SKY Breath and Meditation practice over the course of 4 days (2.25 hours each morning), practice SKY every day for 4 weeks and keep a log of time spent doing SKY. The participants will complete a series of surveys before learning the practice and then after at weeks 1, 4 and 8. The series of surveys will take about 20 minutes.
This is a hybrid single-group clinical trial that will last 12 weeks. Participants will take 2 capsules daily with the first meal of the day in the morning. Participants will undertake blood tests at Baseline and Week 12. Study-specific questionnaires will be completed at Baseline, Week 4, Week 8, and Week 12. Cognitive Battery Testing will take place at Baseline, Week 4, Week 8, and Week 12.
Older people with HIV (OPH) often live with significant mental health challenges such as social isolation, loneliness, and depression. The objectives of this study are to develop and test the usability and feasibility of a technology-based psychosocial intervention program designed to: enhance social engagement and support; facilitate resource access and education; reduce loneliness; and improve well-being among older adults with HIV who are long-term survivors (diagnosed with HIV ≥ 20 years). The program, Connecting Older Positive People to Enhance Health and Resilience (COPPEhR), will build on Dr. Sara Czaja's PRISM (A Personal Reminder and Information Management System for Seniors) platform, and will be an easy-to-use software application (app), preloaded onto a standard device, designed to support social connectivity, memory, and access to resources for older adults at risk for isolation and the programs and services available at the Center for Special Studies (CSS) at Weill Cornell Medicine (WCM). This protocol covers Phase 2 of the study, which will be a pilot randomized controlled efficacy trial will compare the COPPEhR intervention to a device-only control condition. Participants in the control condition will receive the same device as those in the COPPEhR condition without the COPPEhR application. The specific aims of this developmental project are to evaluate the feasibility, usefulness, and usability of a state-of-the art technology-based multicomponent COPPEhR intervention for aging adults with HIV. Our hypothesis is the COPPEhR intervention will be feasible, usable and useful. The hypothesis is that those that use the COPPEhR app will experience less loneliness, less depression, and less social isolation and more social support, more resilience, and more connectivity than those that do not use the COPPEhR app.
Homelessness is a complex social issue and requires a dedicated workforce of helping professionals, including nurses and social workers. Secondary traumatic stress is common in this workforce and contributes to poor professional quality of life, burnout, and job turnover. These factors undermine the health and well-being of homeless service providers and threaten the stability of this critical workforce. The purpose of this study is to evaluate "Storytelling Through Music," an innovative 6-week, multi-dimensional intervention, to improve well-being among homeless service providers.