39 Clinical Trials for Various Conditions
The goal of this is to investigate the effect of a Manual Standardized Stress Acupuncture (MSSA) protocol as an adjunct treatment to a short-term mindfulness therapy for perceived stress and general health in service members (i.e., active duty military personnel and veterans). The specific aims of this study are Aim 1) To evaluate the effectiveness of a brief MSSA as an adjunct treatment with a short-term Mindfulness-Based Stress Reduction (MBSR) compared with MBSR alone for perceived stress and general health in service members. Aim 2) To describe any perceived benefits of MSSA as an adjunct treatment with MBSR compared with MBSR alone for perceived stress and general health. Participants will be asked to complete an informed consent if eligible for the study and randomized into two groups: 1) Participants in the experimental group will receive MSSA in addition to MBSR. 2) Participants in the control group will receive MBSR only. Researchers will compare experimental and control groups to see if the interventions mitigated perceived stress and improved the health of the participants.
The purpose of this study was to compare the impact of 700 mg daily ashwagandha (Withania Somnifera) in healthy college students on sleep, stress and food cravings to healthy college students taking placebo.
Higher education students 18 years or older will participate in 8- virtual mindfulness meditation sessions over 3 to 4 weeks (minimum of 3 sessions per week). Each session will be 30 minutes long, 15 minutes for guided mindfulness meditation run by researchers, followed by a short discussion period to understand mindfulness meditation better. Before starting the mindfulness meditation session, baseline data will be collected.
Rationale: Healthcare workers that care for patients with COVID-19 are at increased risk for stress-related symptoms. When these symptoms are chronic, they can result in burnout and other mental health conditions that can exacerbate the current national health crisis. Social distancing can limit the accessibility of mental health services. Feasible and effective interventions are needed to reduce stress-related symptoms and promote resilience in this population, while adhering to federal and local guidelines to mitigate the transmission of SARS-CoV-2. Objectives: To investigate the feasibility and efficacy of a combined nature-based and virtual mindfulness intervention on stress-related symptoms and psychological resilience in healthcare workers that care for patients with COVID-19. Both components are reported to reduce levels of perceived stress and increase psychological resilience; however, the potential additive effect of their combined delivery is unknown. Methods: Ninety healthcare workers will be randomized into one of three groups: Nature+Mindfulness (n=30), Nature only (n=30), and Control (n=30). All participants will undergo assessments at baseline (week 0), post nature intervention (\~week 1), and post mindfulness intervention (\~week 3). The two intervention groups will have one final assessment at 2-month follow-up (\~week 11). Perceived stress is the primary endpoint and will be assessed with the Perceived Stress Scale. Secondary endpoints include sleep quality, burnout, posttraumatic stress, anxiety, depression, mindfulness, self-efficacy, and psycho-social-spiritual healing. Anticipated Results: We anticipate that participants in the Nature+Mindfulness group will have greater reductions in stress-related symptoms and greater increases in psychological resilience compared with the Nature only and Control groups.
Due to the COVID-19 global health pandemic, many people are likely experiencing increased stress. Many obstetrics and gynecology patients are additionally experiencing increased stress due to the healthcare changes the COVID-19 pandemic has caused including delayed or canceled elective surgeries, visitor restrictions, and telemedicine visits instead of in person clinic visits. Mindfulness meditation is a self-management strategy that can be utilized by anyone to assist with the management of stress. Mindfulness meditation mobile applications, such as the "Calm" app, can be used to help manage stress, especially during this uncertain time. The investigators propose a prospective randomized controlled trial evaluating perceived stress, anxiety, and sleep disturbance in the investigators outpatient OB/Gyn patients at Banner Women's Institute, with the use of a 30 day trial of the mindfulness meditation app, "Calm." All patients would ultimately receive a 30 day free trial of the mobile meditation app, however the intervention group would receive the 30-day free trial immediately and the control group would receive the 30-day free trial after the study period which is 30 days after enrollment. The investigators additionally want to evaluate the feasibility of using the mobile app, including looking at adherence to use of the app and patient satisfaction with use of the app.
Introduction: Although the physiologic response to stress is necessary for mammals to survive, prolonged stress response as a result of perceived stress can lead to allostatic load and loss of resilience to future stressors. To mitigate the consequences of allostatic load, researchers have investigated the effects of acupuncture as a promising intervention. Objectives/Aims: The purpose of this study is to explore the feasibility and effect of a standardized stress acupuncture (SSA) approach on perceived stress in U.S. military personnel. Specific aims include the following: a) to determine feasibility of recruitment for SSA and implementation of study procedures in preparation for a methodologically rigorous study, b) to determine the acceptability of SSA treatment in a sample of military personnel with perceived stress, and c) to assess perceived stress and general health before and after SSA. Methods and Analysis: This is a single-arm, single-site study protocol to assess feasibility of SSA in a total of 15 patients with perceived stress. Upon IRB approval and written informed consent, the participants will receive 4 weekly sessions of SSA which consists of 6 acupuncture points. Demographic information and attrition of participants will be monitored throughout the study. Patient-reported questionnaires including Acupuncture Expectancy Scale, Perceived Stress Scale, and SF-36 will be administered at baseline and then at the completion of the study. Descriptive statistics, reliable change indices (RCI), and Wilcoxon Signed-Ranks tests will be conducted to assess the magnitude of changes in scores. Military Relevance: The three most common disability conditions in the military include musculoskeletal, psychiatric, and neurological body systems. Among these problems, however, mental health disorders remain a significant contributor to disability and suicide. Given the role of perceived stress in disability and suicidality in the military, intervening early before service members become at risk for severe injuries, hospitalizations, and chronic disability could help decrease burdensome problems.
The purpose of this study is to conduct a prospective analysis to determine the relationship between disease activity of noninfectious uveitis and stress.
This study will describe the perceptions of support and distress outcomes of single/lone parents of a child with cancer. Background: * Parents and families of children with chronic illnesses have stressors, including financial stress, role strains, separations, and interruptions in daily routines and plans for the future. All of these experiences may lead directly and indirectly to parental stress. * The number of families headed by single or lone parents is increasing. Little work has been done to better understand if the needs of parents who are providing care for a child on their own differ from parents who do not classify themselves as lone. Identifying parents who may need additional support within a pediatric oncology setting is very important so that appropriate support is provided. Objectives: - To better understand the social, emotional, and practical effects of lone parents on children with cancer. Eligibility: * All parents whose child has been diagnosed with cancer between 6 and 18 months before enrolling on the study. * Participants must be able to speak and read English Design: * Parents will be asked to complete a questionnaire during one of their child s clinic or hospital visits. * The questionnaire will ask about the parenting experience since the child was diagnosed with cancer. It will ask about the support the parent has received from family and friends since the diagnosis. * The questionnaire will take approximately 20 minutes to complete.
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.
A pilot intervention wait-list control study evaluating the effectiveness of a worksite, on-demand virtual reality mindfulness intervention. Outcomes of interest include perceived stress, burnout, work engagement, resilience and respiratory rates. System usability of the VR mindfulness program and integration into the clinical workday will also be assessed for both groups.
Due to the COVID-19 global health pandemic, many people are likely experiencing increased stress. The well-being of physicians in training may be significantly impacted by this pandemic. Meditation is a self-management strategy that can be utilized by anyone to assist with the management of stress. Meditation mobile applications, such as the "Calm" app, can be used to help manage stress, especially during this uncertain time. The investigators propose a prospective evaluation of perceived stress, anxiety, burnout and sleep disturbance in the house staff at Banner University Medical Center Phoenix, with the use of the mobile meditation app, "Calm." The investigatros additionally want to evaluate the feasibility of using the mobile app, including looking at adherence to use of the app and physician satisfaction with use of the app.
This research will examine whether an Internet-based mindfulness program for stress management produced positive outcomes for participants and is technologically feasible
This study is testing the acceptability and efficacy of an AI enabled mental health chatbot (Elomia) as a resource of college student wellness.
This research seeks to improve the Midlife Black Women's Stress Reduction and Wellness Intervention (B-SWELL), a program designed to lower heart disease risk in midlife Black women. The B-SWELL leverages stress reduction to facilitate the adoption and adherence to healthier lifestyle behaviors. This research study will use choice to increase engagement and minimize the effect of social determinants of health on research participation among midlife Black women. A comparative clinical trial will be conducted. Midlife Black women (ages 45-64) who reside in the Greater Cincinnati area will be recruited for participation. Women are eligible if they self-identify as Black/ African American, are between the ages of 45-64, and are willing to commit to the requirements of the study (e.g., attend 8 weekly sessions and 4 phone interviews). Participants will be randomly placed (like the flip of a coin) into either the B-SWELL or WE group. Both the B-SWELL and WE groups are 8-week programs that focus on healthy lifestyle behaviors and heart disease awareness. Women will have the choice to participate in person or virtually. Survey phone interviews will be conducted at baseline, 8-, 12-, and 16-weeks. Data collected will provide information about adherence, healthy lifestyle behaviors, and cardiovascular health. Heart health will be measured using the American Heart Association's Life's Essential 8 metric. Outcome measures include heart disease awareness, Life's Essential 8 score, stress, self-efficacy, depressive symptoms, and symptoms.
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 healthcare profession of dental hygiene can be a highly stressful academic path and occupation. Physical stressors can quickly lead to postural disturbances and musculoskeletal disorders (MSDs) due to instrument grasping while under muscle tension, working with vibrating instruments, and performing repetitive micromovements. Chronic, high stress levels have the potential to lead to burnout, fatigue, and other health problems, which can impact a student's ability to perform well in their clinical rotations and didactic studies and may translate into their workforce experiences after graduation. The purpose of this study is to determine whether a relationship exists between Barre stretching and reported stress and pain levels among entry-level dental hygiene students. This study will be a 6-week experimental randomized control trial (RCT) where participants will be assigned to a 15-minute Barre stretching and breathing video two times a week for the experimental group or control group. The continuous dependent variables in this study will be the reported stress levels and reported pain levels of the entry-level dental hygiene students. The independent variable will be the Barre stretching intervention. The participants will include students at two universities enrolled in an entry-level dental hygiene program as first-year students. Baseline data collection for each participant will be obtained, and the study will be analyzed using descriptive statistics, a paired t-test and independent t-test. The statistical significance level will be set at p=0.05.
The goal of this clinical trial is to examine the impact of the Communities Organizing for Power through Empathy (COPE) intervention in adults in communities having recently experienced or at risk of experiencing disaster. The main questions it aims to answer are: * How does the COPE intervention affect individual mental health? * How does the COPE intervention affect protective factors like coping and social support? * How does the COPE intervention affect community resilience? * How does delivery of the COPE intervention in partnership with a broad-based organization affect participant recruitment and retention, as well as outcomes? Participants will participate in the three session COPE intervention. Researchers will compare individuals who participate in the COPE intervention to individuals who participate in house meetings to see if the COPE intervention improves mental health, coping, social support and community resilience. Researchers will also examine factors that affect implementation and intervention delivery.
This research study will examine the effects of the Transcendental Meditation (TM) technique on academic physician burnout, depression, insomnia, perceived stress, and resilience through a mixed methods approach.
The current study utilized a randomized controlled trial, conducted in a real-life setting, to determine whether, how, under which conditions, and for whom, infusing various levels of human-animal interaction (HAI) in a 4-week, university-based stress prevention program provides an effective approach to prevent negative ramifications of university students stress, promote student executive functioning and learning, while safeguarding animal welfare. This study will examine effects of sole exposure to evidence-based stress prevention content, hands-on HAI with registered PET Partner teams, or combinations thereof on students' moment-to-moment well-being and longer-term functioning in socioemotional, cognitive and physiological domains.This study will also develop a comprehensive coding system and measure the dynamic nature of behavior of participants, handlers and animals during university- based animal assisted activities, as well as the HAI environment. The data and analyses will then be utilized to inform the development of a quantitative measure to capture of the quality of human animal interaction in various settings to experimentally determine causal pathways underlying program effects on humans and animals.
Hypothesis: Relaxation Response training is an effective intervention in reducing the prevalence and severity of burnout and its components from baseline levels among physicians receiving the training intervention. The intervention is hypothesized to moderate the relationship between Areas of Worklife (AWS) and burnout by improving physician's ability to cope with the demands of their workplace. This increased coping ability is hypothesized to reduce burnout. Physician practices are as unique as the individual practitioners and the environment in which they practice. Traditional instruction of relaxation or self-care techniques has required participants to travel to locations remote from the workplace. The time commitment required for this behavior is additive to the time required to learn the intervention and of itself may induce extra stress increasing the potential for burnout. This study proposes that bringing the intervention to the workplace will increase provider willingness to participate and diminish the stress introduced by deployment of the intervention. Since inpatient and outpatient medicine have different practice characteristics and demands on the time of the practitioners, this study will need to develop and test the logistics necessary to bring the training to the different physician populations.
The goal of Cancer PRevention through Enhanced EnvironMenT (Cancer PREEMpT) is to test whether a comprehensive intervention that improves the neighborhood built and social environment can reduce community-level cancer risk in persistent poverty (PP) areas. Our overall hypothesis is that enhancements of the living environment (both built and social) will lower cancer risk through several mechanisms. Built environment improvements will impact walkability (through improved lighting, sidewalks, green space) and access to preventive care (through a mobile wellness van and community health workers), which will stimulate health-related behaviors (physical activity, cancer screening). These improvements will also positively impact safety (through blight removal, traffic calming), social cohesion (through opportunities for socialization), and collective efficacy (through improved neighborhood perceptions). Social environment improvements will increase social cohesion (through community-led events) and collective efficacy (through a Community Leadership Academy and community grants), which will improve public safety as well as facilitate health-related behaviors (physical activity, prevention/wellness). Both types of improvements (built and social environment) will help reduce chronic stress, which will lower the PP community's cancer risk.
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
The purpose of this prospective single-center, blinded\*, randomized, proof-of-concept study is to determine whether OnabotulinumtoxinA (BOTOX®) injections will change the level of stress perceived by generally healthy adult female participants. It is hypothesized that BOTOX® injections will be associated with decreases in perceived stress levels, measured by scores on the Perceived Stress Scale (PSS) questionnaire. The primary outcome measure is a chronological decrease in PSS scores between any two points of the study period. Comparison of the placebo- and BOTOX®-treated participant scores will either support or disprove the study hypothesis. Qualified participants who meet the study requirements, including a one-time completion of basic laboratory testing before treatment. The treatment visit starts on day-1 of a 12-week period, which consists a total of four clinic visits and one online visit, which involve: * vital signs and Body Mass Index (BMI) measurements * basic/interval history and physical * 2 Perceived Stress Scale (PSS) questionnaires * injection of 64 units of either BOTOX® or sterile salt solution * stay for 60-minutes after treatment for monitoring and to complete study tasks
Young adults (aged 18-30) with a concussion history (defined as experiencing a concussion within the past five years but not within the past month) will complete a six-week mindfulness intervention. Throughout the intervention, participants will complete 10-20 minutes of mindfulness-focused exercises and meditations each day using the LoveYourBrain Foundation Meditation Library. Before the intervention, participants will complete a baseline assessment including demographics, concussion history, mental health history, mindfulness history, perceived stress, mindfulness, and concussion symptoms. Throughout the intervention, participants will complete weekly assessments measuring adherence and concussion symptoms. After six weeks, participants will complete a final, follow-up assessment with assessments for adherence, acceptability, feasibility, intervention perceptions, perceived stress, mindfulness, and concussion symptoms. This study's aim is to determine the acceptability, feasibility, usability, and effectiveness of a mindfulness intervention in young adults with a concussion history. The investigators hypothesize that participants who participate in the mindfulness intervention will report high adherence (complete five days of meditation per week), positive acceptability, positive feasibility, and positive intervention perceptions. Additionally, after completing the intervention, participants will report decreased perceived stress, increased mindfulness, and decreased concussion symptoms compared to before the intervention.
The goal of this pilot part of the study (Step 1) is to identify the optimal population of high and low anxiety and stress individuals who will differentially respond to a laboratory stress task as measured by changes in subjective stress response (affect), cognition, attention, and biological measures (autonomic and metabolite responses). Based on experience with different study populations, the investigator's believe that a healthy, homogenous population (Caucasian, women, premenopausal) with higher levels of state anxiety and perceived stress, and with greater responsiveness to laboratory stress tasks (which can also be used in the probiotic intervention study in Step 2) will provide the highest likelihood of identifying the underlying central mechanisms of stress responsiveness in Step 1 and then for the probiotic intervention in Step 2. For this pilot study, the investigator's will look at baseline measures to determine differences in responses to four subjective (affect/cognition/attention) stress tasks (primary endpoints) and biological (secondary endpoints) measures in a high stress group and a low stress group. If for Step 1 of the study, the investigator's are able to verify the stratification of the participants into high and low stress groups based on questionnaire data and show differences between participants with high and low perceived stress in psychological characteristics, lab stress tasks and potentially in biological responses, this will help to determine the optimal cut off values, and the optimal stress tasks to be conducted in the planned probiotic intervention study of Step 2.
CaringBridge (CB) is an online health community for people undergoing challenging health journeys. This platform provides an opportunity for individuals and their caregivers to rally support for a loved-one during a health journey. CaringBridge offers the opportunity for expressive writing through journal entries, wellbeing resources, participant health journey stories, and practical scheduling and communication tools to support community, healing, and wellbeing. Loving Kindness Meditation (LKM) is a systemized mind-body approach developed to increase loving acceptance and has been shown to increase resilience in the face of adversity. The aim of this study is to better understand how mind-body practices, like LKM, impact adult CB users
As a result of the COVID-19 pandemic, the degree of burnout and consequential negative psychological effects experienced by healthcare providers has been substantially exacerbated. Heart rate variability (HRV) biofeedback has long been used to assist with a wide variety of stress-related concerns. Building on evidence that HRV biofeedback has the potential to improve wellbeing, the purpose of this study is to pilot test and determine the feasibility of implementing a digital HRV biofeedback tool to improve disordered eating, mindful self-care (i.e., self-compassion, body appreciation, etc.), and perceived stress in healthcare providers. In addition to assessing acceptability and feasibility of the HRV biofeedback tool, the investigators will aim to establish 'proof-of-concept' for a conceptual model consisting of potential psychological constructs underlying the mechanisms of change for the intervention-namely mind-body awareness (i.e., interoception) and resilience. Our primary recruitment pool will include healthcare providers who reported elevated eating distress as a participant in an ongoing observational study of the health effects of theCOVID-19 pandemic on essential workers (CHAMPS).
An 8 week course of mindfulness education and practices will be presented to all staff, patients, and visitors voluntarily attending the thrice weekly presentations. The goal is to reduce staff stress, improve communication, enhance patient satisfaction, and improve quality of care.
Mindful meditation sessions have been associated with an improvement in mindfulness, perceived stress, psychological well-being, anxiety, hostility, and depression. Meditation has been associated with a decrease in autonomic sympathetic activity, heart rate, oxygen consumption and energy expenditure. Randomized controlled trials of online mindfulness and relaxation programs have been studied in patients with conditions such as irritable bowel syndrome, headache, depression, fibromyalgia, and insomnia. Nurses may benefit from such programs given levels of job stress. This study will determine whether an online stress reduction program that incorporates meditation with and without concomitant group support reduces burnout among nurses, including emotional exhaustion and depersonalization. The proposed research study will utilize Stress Free Now, an online stress reduction program developed by Cleveland Clinic Wellness Institute.
The aim of this study is to develop an intervention that will produce a sustained improvement in physical activity and chronic stress as a means to slow the menopause-related accumulation of visceral adipose tissue in mid-life women.