502 Clinical Trials for Various Conditions
Family members/support persons' engagement in mental health services has been linked to reduced burden and stress and improves engagement and outcomes in individuals in the early stages of psychosis. The goal of FAMES is to address low family member/support person engagement in services. FAMES will also address disparities in coordinated specialty care (CSC) by using a culturally responsive family engagement strategy to be delivered by family peers.
The purpose of this trial is to see if providing patients with alcohol-related liver disease with tailored alcohol use treatment options will increase engagement with treatment and correct possible misconceptions.
This study is a clinical trial that evaluates what drives patient engagement and tests the impact of two strategies-automated motivational push messaging and coach support-to improve engagement with an evidence-based mobile app intervention for depression and/or anxiety.
This study tests the impact of mindfulness vs. relaxation training on psychological threat and challenge, emotions/emotion regulation, motivation/engagement, and performance among undergraduates enrolled in introductory physics courses. Data used to compare groups will be collected from a variety of sources, including self-report surveys, experience sampling and daily diary assessments, physics learning activities, and academic records.
This pilot study is a precursor to a subsequent clinical trial that will test the impact of a set of automated motivational messages on patient engagement with a digital mental health intervention. The pilot study aims to systematically employ patient feedback to develop the automated motivational messages that will be used in the subsequent clinical trial.
This study will compare a 12-session behavioral activation (BA) intervention modified for first-episode psychosis (FEP) to usual community mental health care (i.e., treatment-as-usual; TAU) delivered over 6 months with a sample of Latinos with FEP and their families. Comparable family group sessions will also be delivered to participants in both conditions. It is expected that BA participants will show better engagement than TAU participants.
This project involves testing a brief mindfulness training program to reduce students' psychological threat and support motivation, engagement, and learning in introductory undergraduate physics courses. The investigators predict that, compared to a control condition, mindfulness training will reduce psychological threat and increase motivation, engagement, and learning in physics.
The objectives of this project are to to build sustainable regional communities of Intellectual or Developmental Disabilities (IDD) stakeholders to provide ongoing input to research priorities, methodological processes, and relevant person-centered health outcomes; leverage existing Special Olympic infrastructure to nationally disseminate the toolkit in order to increase participation and engagement in research and improve health outcomes; conduct comparative effectiveness trials that incorporate people with IDD focusing on their research priorities.
The study will enroll 90 participants in the "Impact of Challenging Engagement" study and assign them to one of three groups: high-demand photography, moderate-demand photography, and active placebo. These initial groups will allow us to collect data and address the feasibility of converting the project into a full trial. Participants will participate in one of three different engagement conditions for 15 hours per week, based on successful results from the initial Active Interventions for the Aging Mind (AIM) study - approved by University of Texas Southwestern (UTSW) Institutional Review Board (IRB) #072010-144. In the Impact of Challenging Engagement study, the lab will expand on the results of the AIM study to determine if high-demand activities result in any observable brain changes when compared to moderate demand or placebo activities. Behavioral and neural measures of cognitive change will be assessed, providing considerable insight into mechanisms of change. Participants will be characterized thoroughly in terms of behavioral tests of cognitive function, and a subset of subjects who meet neuroimaging criteria will undergo a functional magnetic resonance imaging (fMRI) procedure.
The project at the center of this proposal will leverage a pilot randomized design to examine initial feasibility and preliminary effects of augmenting usual mental health evaluation procedures with a structured person-centered assessment tool that specifically considers the cultural context of patient mental health problems (i.e., the Cultural Formulation Interview; CFI) on parent satisfaction, engagement and clinical child outcomes in the treatment of early child behavior problems. Additional analyses will explore whether traditional barriers (e.g., stigma, ethnic identity, and daily stress) moderate the effects of the CFI on satisfaction, engagement and treatment outcomes.
CCTG 594 is a controlled, unblinded, two-arm, randomized (1:1) clinical trial to evaluate the effectiveness of a clinic-based HIV ALERT specialist on improving endpoints of retention in care and maintenance of ART as compared to the current standard of care (SoC) in HIV primary care clinics.
In this study, patients who are scheduled for breast reconstruction consultation will be randomized into the intervention group (ChatGPT-generated patient education regarding possible reconstruction options) or the control group (usual patient education). All patients will complete a survey following their in-person consultation to assess their experience and overall satisfaction with the consultation process. Additionally, participating surgeons will complete a separate survey to evaluate their consultation experience, satisfaction, and to assess the accuracy and clinical utility of the ChatGPT-generated patient education materials. The surveys are designed to gather information on patient characteristics, organizational health literacy according to Brega et al. Other survey questions have been designed to meet the outcomes of this study and have not been based on previously published surveys.
The present work aims to test whether a single session intervention alters ambiguity aversion, both in terms of people's decision making and their brain responses to ambiguous choices.
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.
Atrial fibrillation (AF) affects 1 in 4 individuals during their lifetime and continues to increase in frequency and impact. Exercise intervention has established benefits to improve AF symptoms and burden in clinical studies. However, lack of access to exercise programs has limited therapeutic adoption. The growth of technology-driven health care and diagnostics, recognized as an emerging priority by the American Heart Association, offers an opportunity for a pragmatic and patient-centered approach to meet this need. EASE-AF is a prospective, interventional study with a sequential run-in control to evaluate if a digital health-driven, patient-centered exercise intervention improves AF symptoms and burden. The research team will enroll 120 patients with symptomatic, paroxysmal AF. The main impact of this study will be the establishment of evidence for a novel, pragmatic paradigm for a patient-centered, digital technology-driven personalized exercise intervention for patients with AF.
The goal of this clinical trial is to learn if this intervention (the CHOOSE Home intervention) is feasible and may lead to more home dialysis usage in a high-risk patient population. The main questions it aims to answer are: * Will there be an increase in home dialysis selection or initiation over study follow up? * Will there be a change in patient reported status of Health-Related Social Needs (HRSNs) and patient engagement at 1 year follow up? Researchers will compare the intervention group that will include interdisciplinary care (IDC) and the integration of a Community Health Worker (CHW) into the chronic kidney disease (CKD) care process to the IDC only control group. The research team will assess whether the intervention led to better social care navigation, enhanced patient engagement, and increased home dialysis use.
The goal of this clinical trial is to determine if artificial intelligence and machine learning (AI/ML) models can help address social needs in Medicaid enrollees. The main questions it aims to answer are: Can AI/ML models accurately identify social needs from administrative healthcare data? Can AI/ML models accurately predict which people will engage with social supports? Researchers will compare individuals who live in different regions to see if AI/ML models perform better than the status quo.
The goal of this clinical trial is to learn if adding patients' goals and concerns to measurement-based collaborative care can tailor care and provide a more holistic view of treatment, thereby improving engagement in care among adult patients receiving collaborative care. The main questions it aims to answer are: * Does using a clinical decision support system (which includes an enhanced pre-visit questionnaire and patient-level dashboard) improve patient engagement in the collaborative care model? * Does using a clinical decision support system improve patient and clinician satisfaction with care? Researchers will compare the enhanced collaborative care with traditional collaborative care. Patient participants will complete pre-visit questionnaires before their collaborative care appointments. Responses will be viewed by the clinician and/or patient in a visual dashboard inside the electronic health record.
This study will test a model of providing treatment to Latinx/Hispanic youth, who experience suicidal thoughts and behavior, and their caregivers. An affirmative and culturally relevant treatment will be provided to all youth and half of the families will be assigned to the additional support of a community health worker (CHW). Youth symptoms and family engagement to treatment will be followed for nine months. The potential benefit of adding the CHW intervention will be assessed.
A randomized controlled trial (RCT) will be conducted to evaluate both the short-term and long-term efficacy of innovative, incentive-free parent-based interventions (PBIs) designed to reduce underage drinking on college campuses. Although the current NIAAA-recommended Parent Handbook has shown modest effects, our preliminary work suggests that combining personalized normative feedback (PNF) delivered through a social media-inspired app with psychoeducational content can effectively decrease alcohol-related risk. In this large, multi-site trial with 2,040 first-year students, we will examine the short- and long-term effects of the experimental app-based PNF program (PNF+ PBI) compared to an email-based social norms marketing campaign (SNMC+ PBI), the Parent Handbook (PH+ PBI), and an assessment-only control on alcohol use and consequences (primary outcomes). Parent alcohol approval and communication will also be assessed as potential mediators of intervention effects (secondary outcomes). The researchers hypothesize that students whose parents receive PNF+ and SNMC+ PBIs will report lower levels of alcohol use and fewer alcohol-related consequences compared to those whose parents receive PH+ PBI or no intervention. It is also expected that parental approval will be lower and alcohol-related communication will be higher in these two experimental conditions, relative to PH+ PBI and no intervention.
The goal of this study is to learn if Pain Self-Management (PSM) can improve chronic pain care in individuals with opioid misuse or opioid use disorder (OUD) The main questions it aims to answer are: * Does PSM help participants manage their chronic pain more effectively? * Does PSM help participants engage in treatment for opioid use? Researchers will compare PSM to standard care to see if PSM is effective in managing chronic pain and engagement in treatment. Participants will: * Take part in the PSM program or receive standard care for 12 weeks after enrolling in the study * Complete surveys every 3 months for 9 months (total of 4 visits) Participants will receive compensation for participating in the study. There are risks associated with participating in the study, including breach of confidentiality and psychological distress caused by discussing difficult topics.
HIV testing and service uptake are infrequent among people who use drugs (PWUD) in the United States. In partnership with a community-based syringe service program (SSP), this project will develop the SSP-based "Prevention Ambassadors" (PA) intervention to promote HIV testing and service uptake among PWUD via the secondary distribution (i.e., peer delivery) of HIV self-testing (HIVST) kits with local HIV service information and referrals to HIV service navigation in the social networks of SSP clients (i.e., PWUD). The PA intervention will then be piloted to assess its preliminary effects, acceptability, and feasibility among PWUD in the Ending the HIV Epidemic priority jurisdiction of Riverside County, California.
The goal of this study is to learn if behavioral activation can improve daily quality of life for patients with advanced cancer. The main questions it aims to answer are: * Can behavioral activation be adapted to help patients living with advanced cancer optimize their daily quality of life? * Can behavioral activation be delivered primarily via smartphone? Participants will: * Complete a demographic questionnaire at the beginning of the study and quality-of-life and activity questionnaires at the beginning, midpoint, and end of study. Complete nightly surveys about daily quality of life, mood, activities, and experiences. * Wear a Fitbit activity tracker for 8 weeks. * After the first four weeks, they will complete a session with a member of our team about their day-to-day activities, behaviors, and experiences. They will select at least 4 activities/behaviors to increase over the next portion of the study. * Incorporate personalized meaningful activities into daily life * At the end of approximately eight weeks, (four weeks after the session with a study team member), they will complete a semi-structured interview.
The goal of this clinical trial is to learn if having a 4-week heartfulness meditation program in a healthcare organization would 1. decrease burnout 2. improve sleep and work engagement. Researchers will compare : intervention group : participating in 4 weeks of Heartfulness Meditation with control group: receiving no intervention Responses to the Utrecht Work Engagement Scale (UWES), Bergen Insomnia Scale (BIS) and two burnout questions will be compared between the study groups at the beginning and end of the intervention period.
The ENGAGE-HF mobile application tracks three key features over time: (1) heart failure health status, (2) vital signs (e.g., blood pressure, heart rate) and weight, and (3) the quality of heart failure medication therapy. Helping patients understand how these characteristics interact and change over time may improve their ability to understand and manage heart failure. In this study, the investigators aim to evaluate whether the ENGAGE-HF mobile application, by facilitating the behavior change strategies of self-monitoring and feedback, and a clinician-facing dashboard, improves the optimization of heart failure guideline-directed medical therapies (GDMT) and quality of life. An optional sub-study of cognitive function will invite all eligible participants enrolled in the main study to participate.
Compared to non-Veterans, Veterans demonstrate an increased risk for obesity and multimorbidity. Thus, interventions to improve overall health are warranted in this population. Healthy diets that include fruits and vegetables are linked to a reduced risk of chronic disease including mobility disability, and are associated with higher muscle mass, strength and physical performance potentially slowing further disability progression later in life. The investigators will determine if a three-month virtual group nutrition intervention paired with produce delivery and virtual teaching kitchen cooking demonstrations tailored for older Veterans with impaired mobility will improve diet, health-related quality of life and muscle strength.
The proposed research seeks to determine whether virtual coaching and social support focusing on key social cognitive factors will be an effective strategy for maintaining physical activity (PA) after completing cardiac rehabilitation (CR). Despite the well-documented benefits of CR, only 15-50% of individuals continue to exercise 6 months after completing CR.4-6 Thus, after 36 sessions (typically 12 weeks), many patients are left without the support necessary to sustain physical activity (PA) and prevent adverse secondary cardiac events. Though previous research has explored interventions to sustain PA after CR, many studies have been lacking in a theoretical basis, objective measurement of PA, measurement, and analysis of psychosocial and social cognitive factors, and long-term impact on clinical outcomes. Low-cost, pragmatic approaches to maintaining PA after CR is urgently needed for older adults, and virtual technologies offer promising solutions to promote adherence to PA. The three specific aims of the project are to: 1) determine the effect of virtual coaching and social support on adherence to PA (measured by objective step counts) in the intervention vs. control groups; secondary measures will be amount of sedentary time, functional fitness, and self-reported exercise; 2) determine the effect of virtual coaching and social support on psychosocial and social cognitive factors in the intervention vs. control groups; 2a) evaluate the extent to which psychosocial and social cognitive factors mediate the effect of the intervention on PA adherence; 3) examine differences in cardiovascular (CVD) risk factors (blood pressure, lipids, HbA1c, BMI) between groups.
The goal of this clinical trial is to evaluate the effectiveness of different outreach strategies in closing HEDIS gaps for Well-Child Visits (WCV) in children aged 0-21 years. The main questions it aims to answer are: Does automated SMS outreach improve the rate of completed Well-Child Visits compared to traditional passive outreach? Does the combination of automated SMS and appointment scheduling assistance lead to higher completion rates than automated SMS alone? Researchers will compare three groups to see if the different outreach strategies have varying effects on WCV completion rates: Control Group: Participants will receive traditional passive outreach (current standard practice). Automated SMS Group: Participants will receive standardized SMS messages to remind them of their Well-Child Visits. Automated SMS + Scheduling Assistance Group: Participants will receive SMS messages along with proactive assistance in scheduling their appointments. Participants will: Be randomized into one of the three study groups. Receive outreach according to their group assignment. Have their appointment scheduling and attendance tracked. Contribute data that will help evaluate the effectiveness of each outreach strategy in closing HEDIS gaps for Well-Child Visits. This study aims to optimize outreach methods to improve healthcare delivery and preventive care adherence for pediatric populations.
The goal of this pilot study is to evaluate the feasibility and acceptability of implementing a peer recovery support program to support patient engagement in medication treatment for opioid use disorder (MOUD). The program, entitled "Promoting Enhanced Engagement through Recovery Support" (PEERS) was developed in collaboration with community and clinical partners for the MOUD outpatient setting. Information gathered during this pilot study will inform refinements to the program and study components for a future clinical trial that will evaluate the effectiveness of the peer recovery support program in increasing patient retention in MOUD. The investigators will recruit 12 participants to the pilot study, all of whom will receive the PEERS program. The study will take place in Geisinger outpatient addiction treatment clinics in northeast Pennsylvania. Patients initiating MOUD treatment at one of the clinics will be eligible for participation, and will be recruited via email, patient portal messages, and phone. Each participant will receive the PEERS program, entailing regular sessions with a Certified Recovery Specialist (CRS) for 6 months. Participants will also be asked to complete assessments at baseline and 12 weeks and will be invited to provide qualitative feedback on their experience with the program through an interview conducted between 8-12 weeks. As the focus of the pilot pertains to the feasibility and acceptability of the program and the study components, study outcomes focus on participant engagement in and acceptance of the program, CRS fidelity to the program, barriers to implementation, and feasibility of data collection.
The goal of this clinical trial is to learn whether a companion software application can improve program engagement in the National Diabetes Prevention Program in adults with prediabetes. The main question\[s\] it aims to answer \[is/are\]: Do participants using the software application (the intervention group) have better engagement with the Diabetes Prevention Program than those who do not use the companion software application (the control group)? Are participants using the software application (the intervention group) more likely to stay in the Diabetes Prevention Program longer than those who do not use the companion software application (the control group)? Participants are those who have signed up for their local Diabetes Prevention Program and agree to be in the study.