29 Clinical Trials for Various Conditions
College women are at risk for eating disorders, which have profound health impacts. Cross-sectional studies have shown that the use of dietary self-monitoring is associated with eating disorder risk among college students. However, causality cannot be established with cross-sectional studies. This study utilizes a randomized controlled trial design to examine how the use of a popular dietary self-monitoring smartphone application impacts college females' well-being, including eating disorder risk. We hypothesize those who are randomized to dietary self-monitoring will have a greater increase in eating disorder risk compared to the control group.
The purpose of this study is to evaluate the effectiveness of an internet- assisted Career-Oriented Work-Related Soft-skills Training (iCareer) intervention, infused with cognitive behavioral therapy, targeting individuals ages 16-24 with mental health conditions, to improve employment outcomes. The overall objective is to help transition-age youth (TAY) with psychiatric disabilities achieve optimal employment outcomes as part of successful transition to adulthood. Findings will have implications for enhancing and developing pre-employment services for TAY with psychiatric disabilities.
The purpose of this study is to test the impact of a 6-week theatre intervention rooted in African culture (Sankofa) on the wellness of girls (predominately African American) ages 8-18 receiving services at five Boys \& Girls Club Indianapolis sites. Theatre interventions are led by Asante theatre personnel and evaluated by the PI and occupational therapy graduate students. The theatre intervention being evaluated has been conducted for decades by an established theatre company with widespread community participation and anecdotal positive responses, but has not been scientifically evaluated to understand how it impacts wellbeing. This will be the first large-scale study of the mechanisms of change and of the impact of the theatre intervention in the community and will help to guide future therapeutic interventions using theatre with underserved populations. Research questions include: Is Sankofa a feasible and acceptable intervention for the target population? Does participation in Sankofa result in improved scores on wellness outcome measures, including the National Youth Outcomes Initiative (NYOI) survey? The study is funded by Asante Children's Theatre via the Central Indiana Community Foundation Women's Fund.
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.
This research study will test the effectiveness of a culturally grounded parenting intervention called Parenting in 2 Worlds (P2W). This intervention is designed for American Indian / Alaska Native (AI) parents/guardians of adolescents who reside in urban areas. This will be a multi-regional effectiveness trial across four regions: Northeast (Buffalo/Niagara), Midwest (St. Paul/Minneapolis), Mountain (Denver), and Southwest (Phoenix). There are four specific aims. First, this study will test the effectiveness of Parenting in Two Worlds (P2W) as compared to an informational family health intervention, Healthy Families in 2 Worlds (HF2W), in improving parenting and family functioning. Second, this study will test if the relative effectiveness of P2W, compared to HF2W, varies by parent's/guardian's level of socioeconomic vulnerability, experiences of historical loss, or AI cultural identity. Third, this study will examine if P2W can reduce adolescent (ages 12 - 17) risky health behaviors including substance use, depressive symptoms, suicidality, and risky sexual behaviors. Fourth, this study will examine whether positive changes in parenting and family functioning that result from P2W lead to positive changes in adolescent's health behaviors.
HeartBot is an app designed to enable people 14 years and older to use relaxation tools offered by Heartfulness. The study is conducted to examine the effect of the app on stress and emotional wellness in participants 14 years and older. Research Question: Does HeartBot affect the stress levels and emotional wellness in participants 14 years and older? Hypothesis: Participants who use HeartBot for 21 days will see a significant decrease in their stress levels and an improvement in emotional wellness.
This exploratory study brings together an interprofessional team, novel tools, and innovative, community-driven care delivery approaches to improve health equity among mother-infant dyads impacted by substance use disorder and high risk for poor health outcomes. This study will test a community-informed and community-based intervention using a fetal ultrasound protocol, motivational interviewing techniques, strength-based education, and healthcare coordination strategies to reduce health disparities faced by women and their children.
Study to support the mental and physical well-being of US health care workers during the COVID-19 pandemic and ensure high-quality care for patients through Stress First Aid.
Implementation of Tailored Collaborative Care for Women Veterans (CCWV) was designed to enhance primary care-mental health integration for women Veterans by tailoring services to women Veterans' and providers' needs and providing an evidence-based intervention, Coordinated Anxiety Learning and Management, to address anxiety and depression in a patient-centered approach. CCWV was implemented in two of the Women's Health Practice-Based Research Network sites, with careful attention to local tailoring and adaptation to enhance the fit of the care model in varied local contexts.
The Health Behaviors in School-age Children (HBSC) study is a consortium of investigators from 40 predominantly European and North American countries who conduct a common survey of early adolescent health behaviors every 4 years. The survey gathers information about nutrition, dieting practices, physical activity, injuries, violence, relationships with family and friends, perceptions of school as a supportive environment, alcohol and tobacco use and drug use among adolescents, and about the communities in which students live. The U.S. sponsors of the survey are the National Institutes of Health and the Health Resources and Services Administration. This is the fourth survey done in the United States. The objectives of the international HBSC study are: * To assess the prevalence of early adolescent health behaviors * To identify psychosocial factors associated with adolescent behaviors * To provide an opportunity for analyses of cross-national comparisons * To provide an opportunity for analyses of trends in the U.S. and cross-nationally In addition to the above, the survey includes additional questions designed to provide information about areas of specific national interest, including the following: * To assess the association of school, family, peers, and other environmental factors on health behavior and health status * To assess the prevalence and identify factors associated with obesity, diet and physical activity * To assess the prevalence and identify factors associated with bullying and risk behaviors. This is the fourth U.S. administration of the HBSC survey, previously administered in 1997-1998, 2001-2002, and 2005-2006. About 16,000 students in grades 5 thorough 10 at randomly selected public and private schools across the United States complete a 30- 40-minute survey. The questionnaires are anonymous; students are instructed not to put their name on the survey. When they finish the survey, they place it in an envelope and seal it. The envelopes are then put in a box. Reports do not include the names of participating counties, cities, school districts, schools, or students. The information collected from U.S. school children is compared with similar information collected from school children in 40 other countries. The survey is used to help set national priorities for school and youth programs, as well as to monitor the progress of these programs.
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
Text2Connect (T2C) proposes to test a text-based intervention designed to improve engagement with mental health treatment.
The goal of this trial is to compare two types of patient, public and clinician involvement (PPCI) in research: Consultative PPCI and Collaborative PPCI. The study team will compare these methods of PPCI in a randomized clinical trial (RCT) in which PPCI participants will engage with research teams on one of three real qualitative research interview studies addressing topics: 1) pediatric mental health, 2) cancer screening and 3) serious illness. Qualitative interviews are conversations with people about their experiences and perspectives. In all three qualitative studies, PPCI participants will help us at every stage of the research, from design (making choices about how to set up the study) through dissemination (sharing findings). The researchers do not know about any quantitative (numbers) evidence from RCTs about how well different PPCI approaches work. As far as the study team knows, this is the first RCT of PPCI approaches. Given this gap in knowledge, the research question is: How does a Consultative PPCI approach compare to a Collaborative PPCI approach in increasing engagement and partnership trust in research, particularly among historically underrepresented groups? The researchers' best guess (hypothesis), considering the information available, is that Collaborative PPCI will increase PPCI participant engagement, trust and the patient-centeredness of research more than Consultative PPCI.
The overarching goal of this work is to address the limited access to evidence-based health behavior and lifestyle interventions for youth and families most impacted by preventable chronic diseases, including obesity and type 2 diabetes. In the current project, we implement a small single-arm pilot and feasibility trial of Health Without Barriers/Salud Sin Barreras (HWB/SSB), a culturally-adapted, whole-family intensive health behavior and lifestyle intervention to 11-19-year-old adolescents and their families living in Northern Colorado. Objectives are refining the HWB/SSB community facilitator training, evaluating the feasibility and acceptability of HWB/SSB implementation, and characterizing changes in health outcomes among adolescent participants.
This quality improvement project aims to help outpatient mental health teams, known as Behavioral Health Interdisciplinary Program (BHIP) teams, adopt more collaborative care practices (consistent with the collaborative chronic care model or CCM). The investigators therefore aim to use two different implementation strategies -- centralized technical assistance and implementation facilitation -- to align BHIP teams' care practices more closely with the principles of the CCM.
The proposed research will use a community-based participatory research (CBPR) approach to engage with community organizations to design and implement a project that trains therapists to provide effective, supportive, and engaged therapy to two-spirit, transgender, and nonbinary (2STNB) clients most impacted by barriers in accessing mental health care. 10 2STNB licensed mental health therapists will be identified and 50 2STNB of their clients will be enrolled and can expect to be on study for 10-20 months.
Since December 2019 the world has been shaken with an enormous global threat: the Covid-19 pandemic. This new kind of coronavirus is generating an unprecedented impact both on the general population and on the healthcare systems in most countries. Health services are trying to expand their capacity to respond to the pandemic, taking actions such as increasing the number of beds; acquiring necessary equipment to provide intensive therapy (ventilators), and calling retired health professionals and health students so they can assist the overwhelmed health care workforce. Unfortunately, these organizational changes at health facilities, along with the fears and concerns of becoming ill with the virus or infecting their families, put an enormous emotional burden on workers in health services which may lead to negative outcomes on mental health in this population. Recent cross-sectional studies in China indicate that health service workers exposed to people with Covid-19 reported higher rates of depressive and anxious symptoms. This negative impact on mental health among health workers in China has also been informally reported in other countries where the Covid-19 pandemic has been devastating in its effects (such as Spain and Italy), as well as in countries where the pandemic is becoming a growing public health problem. This is particularly relevant in regions with fewer resources (Latin America, North Africa), where there are limited means and the response from the health system is usually insufficient. Moreover, it is necessary to study these negative effects longitudinally considering that some effects will appear over time (post-traumatic stress). The COVID-19 HEalth caRe wOrkErS (HEROES) study is a large, bottom-up, South-North initiative aimed to evaluate the impact of the COVID-19 pandemic on the mental health of health care workers (HCWs). HEROES encompasses a wide variety of academic institutions in 19 LMICs and 8 HICs, in partnership with the Pan American Health Organization (PAHO) and with support from the World Health Organization (WHO). The HEROES study is led by Dr. Rubén Alvarado at University of Chile, and Dr. Ezra Susser and Franco Mascayano at Columbia U Mailman School of Public Health.
Housing instability is both a cause and consequence of mental health problems. As such youth experiencing housing instability (e.g., homeless or marginally housed) have higher rates of mental health problems.Because of their circumstances, these youth also face significant barriers to mental health care and are therefore less likely to receive the treatment that they need. Mobile technology may offer a novel platform for increasing access to mental health care in this population. The primary goals of this pilot study are to (1) establish the feasibility and acceptability of delivering automated mental health interventions via smartphone technology, (2) examine the extent to which automated mental health interventions delivered via mobile technology improve mental health in homeless, marginally-housed, and exiting foster youth.
Mi Puente (or "My Bridge") is a culturally-tailored, interdisciplinary approach designed to support at-risk Hispanic patients and their caregivers pre- and post-hospital discharge as they navigate the multi-level barriers that contribute to inequities in health care access and use, and in turn, perpetuate disparities in cardiometabolic and behavioral health. Mi Puente utilizes a sustainable nurse + volunteer peer team-based model, bridging partnership between inpatient and outpatient care settings to meet the integrated (i.e., physical and behavioral) health needs of Hispanics who are hospitalized with multiple chronic cardiometabolic conditions and one or more behavioral health concern(s). Participants will be tested at Scripps Mercy Hospital - a large, non-profit, safety net hospital located in the US/Mexico border region of South San Diego County, California. The proposed randomized controlled trial will test Mi Puente versus Usual Care (evidence-based, best practice discharge procedures) in improving hospital utilization, patient-reported, and cost effectiveness outcomes. Electronic medical records (EMR) will be used to identify eligible patients and examine primary outcomes.
Adults with serious mental illness (SMI) frequently have unmet medical needs which place them at risk for adverse health outcomes. While there are proven ways to manage and/or prevent serious medical conditions common among this population, information is needed to understand their impact on outcomes that matter most for patients, particularly in community mental health centers (CMHCs) where most adults with SMI receive their care and rural areas where locating and receiving health care services can be challenging. The investigators will test two promising ways for promoting the health, wellness, and recovery of adults with SMI. One way will help patients manage their health and health care through self-management strategies, including the use of a web portal, and peer support (patient self-directed care) and the other through interactions with nurses during clinic visits (provider-supported integrated care). The investigators will compare the two interventions on three primary patient-centered outcomes (i.e. patient activation in care, health status, engagement in primary/specialty care). The investigators hypothesize that: 1. Patient self-directed care will result in improvement in patient activation. 2. Provider-supported integrated care will result in greater improvement in frequency in primary/specialty care visits. 3. Both interventions will result in significant improvements in the three primary outcomes. The investigators will collect information from patients, caregivers, and clinic staff at different points in time during the study. Patients will be asked to complete questionnaires and additional data on their service use will be gathered. Some patients and providers will also be interviewed about their experiences with care. The investigators will examine these data to learn if, how, and why the new services improve outcomes over time. This information will help us understand patient and other stakeholder views about the services and, if appropriate, ensure their continued and/or expanded availability.
This project evaluates the implementation and effectiveness of a care model to improve treatment for schizophrenia within the context of diverse VA practices and priorities. The project provides information to VA clinicians and managers about Veterans with schizophrenia or schizoaffective disorder who are overweight and/or who would like to return to competitive work. The project facilitates reorganization of care practices in order to get veterans needed and desired services around wellness and work. The project creates a platform that other clinical and research interventions can build upon to improve care, and is designed to inform a national strategy for implementing evidence-based care in schizophrenia.
Mental health vulnerability due to stress is increased in People of African Descent (PADs) in America due to disproportionate effects of racism, poverty, education, and criminal justice sentencing. Various meditation and mindfulness approaches have provided evidence of measured reductions in multiple negative dimensions of stress. However, the majority of these studies do not have an adequate representation of PADs or other marginalized groups and are not designed to be culturally relevant or community based. Music has been shown to alleviate multiple symptoms of stress and has been shown to be a preferred and effective support for meditation and mindfulness. However, its role in stress management in PADs engaged in meditation or mindfulness is seldom studied. This study aims to evaluate the effects of a virtual, community-based music mindfulness program on stress management in PAD community members with anxiety and depression during COVID19. 2c.a. Drum Circle Synchrony Study: This study will investigate the role that synchrony plays in subjective feelings of connection.
Mental health vulnerability due to stress is increased in People of African Descent (PADs) in America due to disproportionate effects of racism, poverty, education, and criminal justice sentencing. Various meditation and mindfulness approaches have provided evidence of measured reductions in multiple negative dimensions of stress. However, the majority of these studies do not have an adequate representation of PADs or other marginalized groups and are not designed to be culturally relevant or community based. Music has been shown to alleviate multiple symptoms of stress and has been shown to be a preferred and effective support for meditation and mindfulness. However, its role in stress management in PADs engaged in meditation or mindfulness is seldom studied. This study aims to evaluate the effects of a virtual, community-based music mindfulness program on stress management in PAD community members with anxiety and depression during COVID19. Music Mindfulness Study: Investigators will compare the effects of music-backed guided mindfulness mediation and guided mediation alone in alleviating anxiety and depression.
The purpose of this study is to look at mental health services for adults with depressed mood who were diagnosed with cancer at the age of 65 or older. This study will compare the usual approach for connecting older adults with depressed mood to mental health services with the Open Door for Cancer (OD-C) approach. We will find out if the OD-C approach is practical and useful for cancer patients who participate in the intervention and for providers who see or treat cancer patients.
The purpose of this study is to learn about ways to better support people living with HIV with their HIV treatment and cope with mental health challenges and/or substance use concerns.
The purpose of this study is to collect patients' experiences and feedback to better understand and improve mental health care using telehealth services. This is critically important as telehealth appointments, including both phone and video calls, continue to be offered for regular appointments to reduce in-person interaction as a preventive measure to help control the spread of COVID-19.
The purpose of this project is to develop and test the acceptance and clinical efficacy of a cognitive behavioral therapy (CBT)-based lifestyle intervention, to help manage obesity and diabetes-related health outcomes, provided through community health workers (CHWs) in Latino adults with type 2 diabetes (T2D). A collaboration with an established community-based organization named Sansum Diabetes Research Institute (SDRI), will provide an opportunity to develop, train and implement a culturally sensitive curricula for the CHWs that focuses on body weight and mental health (depressive symptoms and stress) among participants disproportionately impacted by T2D due to social, economic and community factors. Cultural sensitivity focuses on delivering health information based on norms, values, beliefs, environmental factors, and historical context that is unique to a racial/ethnic population. Therefore, for our curricula to be culturally sensitive it will include the following aspects: being primarily delivered in the Spanish language with English as needed, actively incorporate culturally relevant eating and physical activity recommendations, and encompass the foundational importance of familial and social relationships as part of the mental health component of the intervention. For this proposal, the specific aims of this project are: 1) develop a CBT-based lifestyle intervention that focuses on diet, activity, depressive symptoms, stress, and quality of life in collaboration with CHWs and participants from SDRI, and provide training for three CHWs to implement this intervention; 2) conduct a 26-week randomized controlled trial in 50 Latino adults with T2D in the SDRI organization to evaluate the efficacy of the CBT-based lifestyle intervention to improve weight- and diabetes- related health outcomes (body weight, glycemic control, blood pressure, lipid profile, depressive symptoms, stress, and quality of life); 3) evaluate the acceptance and delivery of the CBT-based lifestyle intervention in CHWs and participants with T2D. If successful, this study will establish the structure and content of a culturally sensitive, effective CBT-lifestyle, community-based treatment.
Randomized controlled trial of the effectiveness in managing diabetes and improving mental health through a telephonic layperson-delivered empathy and relationship-focused program for patients at a Federally Qualified Health Center (FQHC) against usual care.
The objective of this study is to compare the impact of the coronavirus disease (SARS-CoV-2, or COVID-19) on cognitive function in the population of patients who have been diagnosed, treated and recovered from the COVID-19 infection versus patients who have not been infected. Primary endpoint is to evaluate the percentage of cognitive decline observed in both study arms (subjects with or without COVID-19 history) using assessments of Cognivue Clarity, MMSE and MoCA. Secondary endpoint is to see the correlation of Depression and anxiety scales (i.e., Patient Health Questionnaire-9 (PHQ-9) and/or Geriatric Depression Scale (GDS)) and Cognivue scores while comparing the trend of difference between both study arms.