52 Clinical Trials for Various Conditions
This single-center, parallel-group randomized controlled trial will evaluate whether a seven-week, web-based "Online MedEd Intern Boot Camp" (OME-IB) program reduces burnout in incoming first-year residents at NYC Health + Hospitals/Harlem. Eligible participants are PGY-1 physicians starting in July 2025 in Internal Medicine, Pediatrics, Emergency Medicine, Surgery, Psychiatry, Infectious Disease, or Nephrology who have not previously completed U.S. postgraduate training. After consent and baseline surveys, approximately 26 interns will be randomized 1:1 (stratified by sex and specialty) to either (1) immediate access to the OME-IB platform plus 14 peer-facilitated, one-hour Zoom sessions on mental health, time management, documentation, and oral presentation over May-June 2025, or (2) usual residency orientation without Boot Camp access until study completion. The primary outcome is mean Maslach Burnout Inventory-Emotional Exhaustion (MBI-EE) score six months into residency. Secondary outcomes at six months include mean Copenhagen Burnout Inventory personal-burnout subscale, Mini ReZ supportive-work-environment/work-pace/resident-experience subscales, and Patient Health Questionnaire-9 (PHQ-9) depression score. Surveys are administered via REDCap at baseline (pre-intervention), three months, and six months; analyses follow an intention-to-treat approach with linear mixed models. Qualitative interviews will explore participants' experiences four months into residency. Findings will inform refinement of the OME-IB curriculum and future multi-site trials aimed at improving resident well-being.
The goal of this project is to improve school-based services by developing and testing an online training and consultation system to facilitate the use of measurement-based care (also known and referenced in original grant as routine outcome monitoring). Measurement-based care (MBC) is the target intervention because it is an EBP with extensive empirical support for its ability to improve mental health service outcomes and is a feasible and cost-effective option. Following the iterative development of the BOLT training and consultation package (phases 1-4), the investigators will conduct a randomized control pilot trial (phase 5) to test the (1) impact of the package on MBC knowledge, attitudes and use, (2) impact of varying degrees of consultation dosage on weekly assessments of MBC use, and (3) moderators and mechanisms of impact.
The study team is developing an e-learning course to train obstetric providers to address perinatal mood and anxiety disorders. The study team will conduct a formative evaluation of the e-learning course with 10 obstetric providers and revise/refine the course based on feedback and then conduct a summative evaluation using a cluster Randomized Controlled Trial (RCT). The three-arm cluster RCT will evaluate the effectiveness of 1) a virtual implementation protocol and e-learning/toolkit as compared to 2) e-learning/toolkit alone as compared to 3) treatment-as-usual. Effectiveness will be evaluated based on rates and quality of care for perinatal mood and anxiety disorders. Using 2:2:1 randomization, the study team will randomize a minimum of 15 to a maximum of 25 obstetric practices into three groups: (1) virtual implementation protocol plus e-learning/toolkit (n=6 to 10); (2) e-learning/toolkit alone (n=6 to 10); and (3) treatment-as-usual (n=3 to 5), which will yield a maximum of 1000 patient charts evaluated for care received from obstetric providers in the randomized practices. Charts from 40 patients per practice will be evaluated at 3 different time points.
The overall goal of this project is to develop and prototype-test a highly accessible program designed to enhance the mastery of Black American caregivers to provide care to family members or friends living with a dementia illness in a time of crisis. Participants will be asked a series of questions in a baseline interview, and then will be asked to partake in the CaRE course during a 6 to 8-week period.
The National Plan to Address Alzheimer's disease has identified education of dementia care providers as a top priority to address the need for quality care for the population of persons with dementia that will triple in the next 30 years. This study will test new online interactive training for nursing home staff that improves staff communication and also reduces behavioral symptoms of persons with dementia that they care for. Innovative approaches to reach care providers are essential to achieve implementation of evidence-based practices to improve care.
The purpose of the proposed study is to train mental health providers (MHPs) at lesbian, gay, bisexual, transgender, and queer (LGBTQ) community centers across the United States in evidence-based, LGBTQ-affirmative cognitive-behavioral therapy (CBT).
This research study will evaluate the CARES Dementia-Friendly Hospitals online training and certification program for Allied Health Workers (nursing assistants, dietary aides, housekeeping employees, hospital transporters, lab/x-ray techs, and unit secretaries) who work in a hospital or medical center. Participants who sign up for this study will complete two 1-hour assessments (on day 1 and day 45). Participants will be randomly assigned into either an "immediate group" (where Participants complete the online training as part of the research study) or a "control group" (where Participants receive access to the online training at the end of the study). The online training and certification will take Participants approximately 6 hours to complete. To participate, Participants must be an allied health worker working at a hospital or medical center, have access to a computer/tablet/smart phone with Internet access, be comfortable reading and speaking in English, and age 21 or older. Deadline to begin the study: January 31, 2020
The primary objective is to conduct a randomized controlled trial (RCT) to assess the impact of an online skills training module on 1) individual providers' self-rated confidence and comfort with and current practice of family centered care (FCC) skills; and 2) assess team performance of FCC and resuscitative care skills during simulated pediatric resuscitation scenarios.
Clinical social workers, doctors, outreach workers, and all other staff providing direct care to vulnerable populations face multiple challenges in obtaining and maintaining training and implementing evidence based practices in diverse community settings. Motivational Interviewing is a well-established evidence based practice that is challenging to implement across programs and agencies because it requires that skills gained from training be reinforced as a service provider employs the practice. This study builds on findings from a Phase I study. With funding from a Phase I Small Business Innovation Research grant from the National Institute of Health, the Center for Social Innovation developed the Motivational Interviewing Simulator: An Experiential Online Training Tool. The interactive, case-based, multiplayer web-based game allows service providers to deepen their skills in Motivational Interviewing (MI), a widely recognized evidence-based practice that supports people to make positive behavior changes related to health, wellness, mental illness, and addiction. The Phase II randomized controlled trial's primary aim is to assess the relative effectiveness of three interventions (MI Training Only; MI Training + eBook; MI Training + SIM) in increasing provider MI knowledge and skill retention over time. During Phase II of this study, we will recruit 180 providers from 18 community agencies serving individuals who live in supportive housing, many of whom have histories of mental illness, addiction, homelessness, and medical problems. After receiving a standardized two-day onsite MI training, participants will be randomized into one of three conditions: 1) MI Training Only; 2) MI Training + eBook (an online comparison with comparable information to the Simulator without the interactive elements); or 3) MI Training + Simulator. The longitudinal, mixed methods study will assess providers' acquisition and retention of MI knowledge and skills through surveys and coding of standardized client interviews; barriers and facilitators of MI implementation via focus groups; organizational-level data via key informant interviews and site visits; and client outcomes for 3,600 clients through surveys, administrative, data and focus groups.
There is a critical need to disseminate efficacious psychosocial treatments for mental disorders as there is a significant gap between evidenced-based approaches and common clinical practice. One example of the need to improve dissemination and implementation of psychosocial treatments is for adolescent Anorexia Nervosa (AN), a serious mental disorder with an incidence rate of about 1% that can become life-threatening. Based on outcomes from a series of randomized clinical trials (RCTs), the first-line treatment for adolescent AN is Family-based Treatment (FBT); however, very few therapists are trained to use FBT for AN. Further, while approximately 45-50% of US mental health outpatient providers are in private practice, little attention has been paid to how best to train this group. Care for adolescent AN, in particular, is provided in private practice at high rates, because specialist programs in non-private settings are few and not readily accessible. Motivations, incentives, and rationale for learning evidence-based treatments (EBTs) differ in this group compared to therapists embedded in an organization or health care system. In this application, we propose to use an online training strategy to study the adoption of FBT to better understand factors that limit or enhance uptake and implementation of this treatment in private practice. We developed and piloted a self-directed enhanced online training (ET-FBT) aimed at improving therapist skills and knowledge related to key components of FBT for AN that predict patient outcome in a group of therapists of which 64% were in private practice. We propose to build on these findings to examine the feasibility of new methods to retain therapists during supervision, assess fidelity, and collect patient outcomes from clinicians in private practice. Thus, our specific aims are: Aim 1: The overall aim of the study is to assess the feasibility of conducting a randomized clinical trial comparing two implementation strategies (online training vs webinar training) for training clinicians in private practice in FBT for AN. We predict that those randomized to online training will be retained, receive supervision, and provide patient data at higher rates than those who receive webinar training. Aim 2: Patient outcomes (reflecting therapist effectiveness) will be assessed by comparing patient weight gain from session 1 to 4 of FBT before and after training (target for training effect) and compared between randomized groups. We predict a moderate efficacy signal difference favoring those who are received the online training. because of increased training in key components in the online training program. Aim 3: Validate training effect by examining the association between therapist fidelity to FBT and patient outcomes. We predict that fidelity will be correlated (target validation) with patient outcome. The effects of therapeutic alliance, participation in supervision, and self-efficacy on both fidelity and patient outcome will be explored. Aim 4: Explore BL factors associated with implementation processes (e.g. prior training, experience, family work).The primary significance of this study is its potential to increase the availability of FBT--the most effective treatment for adolescent AN. Increased availability of FBT will decrease cost, hospitalization, morbidity, mortality, and chronicity of the disorder.
This study will use a data base of archived therapy sessions of family therapy for adolescent anorexia nervosa to determine the role of fidelity to treatment and outcome. In addition, it will develop a novel, more efficient way to train therapists in family therapy for adolescent anorexia nervosa and examine if it is feasible to conduct a trial comparing this novel training to standard, more intensive training.
The Ethical, Legal and Social Issues Substudy in relation to the Genotype Tissue Expression Project (GTEx) aims to describe tissue requesters' approach to discussions about donation to GTEx and to assess the determinants of families' and patients' willingness to donate to GTEx. It also explores ethical issues such as privacy, risks, and release of incidental findings and recommend best practices for conducting authorizations and training requesters.
The study targets three aims: Aim 1: focuses on PIs' and mentors' confidence in their ability to intervene on sexual harassment and their attitudes, perceptions, and knowledge (APK) about sexual harassment, civility, microaggressions, and unconscious bias. Aim 2: focuses on trainees' experiences of sexual harassment and microaggressions and civility, sense of belonging, well-being, productivity, and persistence in a research career. Aim 3: focuses on the culture and climate of the research learning environment.
Deaths relating to opioid overdose have rapidly increased over the past two decades. Due to the serious public health concern of the opioid epidemic, federal agencies recommend employing various harm reduction interventions. The implementation of Opioid Overdose Education and Naloxone Distribution (OEND) programs is effective in reducing opioid overdose mortality, yet these programs do not reach many high-risk individuals. Traditionally, OEND program venues are found in large, urban medical centers, drug treatment facilities, and needle exchange programs. Identifying unreached, high-risk individuals and providing training and naloxone kits through online recruitment could significantly expand access to this life-saving intervention. The primary goal of the current proposed project is to examine the acceptability and feasibility of online recruitment, online opioid overdose and naloxone administration education, and postal distribution of naloxone kits.
This study is testing a web-based "Intern Boot Camp" from Online MedEd to see if it can make the first year of residency less stressful for new internal-medicine doctors at Harlem Hospital. Right after orientation, residents are randomly placed into one of two groups: Intervention group - gets six months of free access to the Bootcamp videos plus twice-a-week, one-hour review sessions led by senior residents the first 6 months of residency Control group - gets the hospital's usual training and will receive the Bootcamp training starting at 6-month of residency. The main thing the researchers want to know is: Does using the Boot Camp lower burnout-especially emotional exhaustion-compared with usual training? They will also look at the PHQ-9 depression survey and how confident residents feel about four everyday skills: mental health self-care, time management, oral presentation, and medical documentation. Surveys are completed at the start of residency and again six months later. Findings will show whether giving residents structured, on-demand preparation improves their well-being and confidence during the toughest part of their training.
Child and adolescent behavioral health problems are related to the leading causes of youth morbidity and mortality. Parent-focused preventive interventions, such as GenerationPMTO (GenPMTO), effectively prevent behavioral health problems such as depression and conduct disorders. Unfortunately, parenting programs are not widely available nor well-attended. Pediatric primary care (PC) is a non-stigmatizing setting with nearly universal reach and, therefore, an ideal access point to increase availability. However, PC personnel are not trained to address behavioral health topics. Also, typical referral practices are inadequate. There is a need to develop effective referral practices in conjunction with increasing availability. There are also logistical barriers to attending in-person parenting programs, like the need for childcare and a large time-commitment. There is a need to overcome these logistical barriers with more accessible programs. The long-term goal is to prevent significant behavioral health problems by increasing access to GenPMTO.
The purpose of this study is to evaluate the feasibility and acceptability of a gatekeeper training called VA S.A.V.E. which was developed through a partnership between the VA and the PsychArmor Training Institute. Gatekeeper training teaches "gatekeepers" skills in how to identify a person with suicide risk, inquire about suicidal thoughts, and help make a connection to professional treatment. VA S.A.V.E. is a brief, novel online gatekeeper training that was created and designed specifically for Veterans and their family and friends. In this study, the investigators will recruit Veterans who have recently transitioned out of the military, as well as their family and friends. Participants in the study will be asked to complete a survey, watch the VA S.A.V.E. training, and complete several follow-up surveys over six months. A small subset of participants will also be invited to participate in an interview.
The purpose of this study is to see how people respond on a word completion task relates to how they behave and respond to situations in the real world. This is a two part research study. At time-point one, participants will fill out some brief personality surveys. They will also read several short scenarios and imagine how they would react and/or interpret these situations in real life. They will also complete a vocabulary task where they will sort word fragments based on type as quickly as they are able. Participants will be asked to return in 24-96 hours for part two where they will repeat a similar scenario reading activity as during time one and fill out a brief questionnaire about your recent behaviors.
This study evaluates Parenting Wisely (PW), an interactive, computer-based, online parenting program, through a formal randomized trial conducted in collaboration with the juvenile justice system (JJS), the primary market for such a program. Parents of 450 delinquent receiving JJS services as usual (SAU) will be randomly assigned to: PW plus a social networking online discussion forum, PW alone, or SAU. The investigators will also determine the potential marketability of the PW intervention to JJS programs based on the effects of PW on parent report and direct observation measures of parenting behaviors, adolescent behaviors, and family functioning, as well as measures of recidivism and cost savings. User satisfaction, program comprehension, receptivity, and parent self-efficacy will also be assessed. The investigators hypothesize that the two PW interventions (PW only and PW + Social Network) will produce greater reductions in disruptive behavior problems from baseline to 3- and 6-month assessments compared to SAU.
The purpose of this study is to compare an online 12-module intervention designed to improve emotion regulation and social relations via mindfulness training with a 12-module program that provides information about health behaviors to individuals with fibromyalgia. The mindfulness training program is expected to produce greater day-to-day improvements than the education condition in individuals' efficacy for coping with pain and stress, positive and negative affect, and positive engagement in social relations assessed via online diaries completed each evening during the intervention period.
The purpose of this study is to assess the effect of the Helpers Stay Quit training on abstinence over time of newly abstinent smokers, and on the interactions they have with their personal network related to smoking and smoking cessation.
The purpose of this research study is to examine the potential benefits of vortioxetine in combination with at-home computerized cognitive training program to improve cognition, such as memory, attention, and concentration. This study will compare the effectiveness of vortioxetine plus cognitive training versus placebo plus cognitive training.
Anxiety disorders are a major public health concern, having a profound impact on functioning, causing significant disability, loss of productivity and suffering. Effective treatments exist for these disorders, but few clinicians are trained in these methods. This project attempts to remedy this shortcoming by using web-based tools to facilitate access to this training, thus increasing the number of available therapists in order to help meet this unmet need.
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 clinical trial is to evaluate the efficacy of SkillTalk, a subscription-based microskills video training library designed to enhance the skills of high school sex educators to implement the frequently used core components of sexual and reproductive health (SRH) curricula. The overall goal of this study is to evaluate the impact of SkillTalk on educators' demonstrable sexual health education skills. Participants will be asked to: * Complete a consent form. * Attend two simulated classroom sessions, either in person or virtually, during which they will teach two prepared lessons that have will be provided to them. * Be video recorded while teaching. * Complete a baseline survey and a post-survey. * If assigned to the treatment group, they will be granted access to SkillTalk for one week to view the videos associated with the answering sensitive questions and using trauma-informed strategies skill sets. Researchers will compare the treatment group to the control group to see if SkillTalk has an impact on educators' demonstrable sexual health education skills.
Trichotillomania (TTM) remains one of the most poorly-understood and inadequately-treated conditions. Research has shown poor response inhibition (RI; the ability to inhibit inappropriate but potent response) as an important cognitive feature of TTM. Investigators have developed a computerized training program that aims to improve RI. Fifty children with TTM will be randomly assigned to (a) online 8-session RI training (n=25), or (b) 1-month waitlist condition (n = 25), and will be assessed at baseline, post-treatment, and 1-month follow-up. Investigators hypothesize that the online RIT will show greater improvement in TTM symptoms and RI capabilities at post-treatment and 1-month follow-up assessments, compared to the waitlist condition. This study will help develop an effective cognitive intervention program for TTM.
This is a research study that will assess the effects of a Pivotal Response Treatment Online Training Course (PRT-O) for training parents of children with Autism Spectrum Disorder (ASD). The study will specifically investigate whether participants can learn to deliver PRT effectively following participation in the Online training.
Chronic health conditions (CHC) commonly share the challenge of impaired health-related quality of life, negatively impacting the lives of millions of people in the United States. Long term effects for living with a chronic health condition are likely to include poor self-management behaviors, which are related to avoidance of disease related thoughts and feelings (e.g., health anxiety) and can be addressed directly with psychosocial interventions. With the focus on fostering values driven and meaningful behavior while accepting thoughts and feelings, ACT may prove to be a particularly effective approach for individuals coping with the challenging symptoms and effects of having a chronic health condition. Previous web-based ACT interventions for CHCs have focused on building ACT skills for a narrow subset of CHCs (e.g., breast cancer, diabetes, tinnitus). While there is added benefit for a self-help program for populations with specific stressors or conditions, there is also a high prevalence of comorbidity in CHCs, shared challenges in illness management and coping, and clear evidence that ACT works effectively across CHCs to improve quality of life. Thus, our goal of this research project is to evaluate a new 6 session, online, self-guided ACT program for adults with chronic health conditions broadly to improve their quality of life and wellbeing through a randomized controlled trial. The specific aims are: 1. To evaluate the feasibility of an initial prototype of ACT program for adults with CHC's as indicated by recruitment, retention, and adherence rates. 2. To evaluate the acceptability as indicated by self-reported program satisfaction and qualitative feedback following the course completion. 3. To identify ways to further refine the program based on participant self-reported satisfaction with sessions and open-ended text-based feedback. 4. To test the efficacy of the program on improving quality of life among adults with CHC's.
This phase I trial tests the feasibility, acceptability, and preliminary effectiveness of online dietary and resistance training to improve physical function in older (greater than or equal to 65-years old) cancer survivors. Declines in adequate protein and calorie intake results in faster loss of muscle mass and physical functioning in older adults. A novel approach to improving physical function in older cancer survivors (OCS) is to utilize online, tailored education and counseling from registered dietitians and exercise scientists, to improve dietary intake (protein intake, diet quality) and participation in resistance exercise. The purpose of this study is to help researchers learn whether an online dietary and resistance training intervention improves diet, exercise, physical function, and health outcomes in OCS.
The purpose of this research study is to test the feasibility and acceptability of an interactive counselor -led online family skills training as part of a behavioral weight loss program for Black Adults.