Malden

Researchers are evaluating the effects of vicadrostat combined with empagliflozin in adults who have type 2 diabetes, high blood pressure, and cardiovascular disease but no history of heart failure. The study aims to assess whether this combination can help reduce cardiovascular risks compared to a placebo with empagliflozin. This Phase III trial involves adults with these conditions who are already receiving treatment for them. Participants are randomly assigned to one of two groups. One group takes vicadrostat and empagliflozin tablets daily, while the other group takes placebo tablets that look like vicadrostat but have no active medicine, alongside empagliflozin. Treatment lasts from two and a half years up to four years and three months. All participants continue their usual medications for diabetes, blood pressure, and heart disease during the study. Throughout the study, lasting up to four years and three months, participants visit the study site regularly for health checks and blood samples. Doctors monitor cardiovascular events and any side effects experienced. The main outcome measured is the time until the first cardiovascular death or heart failure event. Other health indicators like blood pressure and kidney function are also tracked to understand the effects of the treatment combination.

This research aims to evaluate the acceptability and feasibility of a brief mindfulness intervention combined with Respiratory-gated Auricular Vagal Afferent Nerve Stimulation RAVANS to help young adults who are heavy drinkers reduce their alcohol consumption. The study focuses on young adults aged 21 to 29 who consume high amounts of alcohol. Researchers will assess how these interventions affect autonomic nervous system regulation, alcohol use, and other clinical outcomes using heart rate variability and self-report surveys. Participants will first complete a one-week mindfulness practice involving daily 10-minute audio meditations. They will then attend two in-person lab visits spaced one week apart. During these visits, participants will be randomly assigned to receive either active or inactive sham RAVANS device stimulation. Lab visits include surveys, heart rate variability measurements, exposure to alcohol-related visual cues, and sessions involving the RAVANS device alongside mindful breathing exercises. The active RAVANS delivers nerve stimulation linked to breathing, while the inactive version looks identical but does not provide electrical pulses. Throughout the study, participants will complete surveys online at baseline, during lab visits, and in a final virtual follow-up one week after the second lab visit. Heart rate variability will be monitored using wearable ECG sensors during resting periods and cue exposure tasks. Researchers will evaluate responses to alcohol-related stimuli and the impact of mindfulness and nerve stimulation on autonomic function. The total involvement spans approximately three weeks, including remote and in-person visits, with ongoing safety and acceptability assessments.

Researchers are investigating a web-based program to help adults with chronic musculoskeletal pain better manage their pain and improve related outcomes. This study compares the effects of an interactive mindfulness platform combined with weekly online group sessions against a control group receiving a lower dose of the same mindfulness content without group interaction. Participants will engage with the Our Whole Lives OWL program on the GEMINI platform for 9 weeks. One group will receive a full OWL curriculum with nine self-paced mindfulness sessions plus weekly 1.5 to 2-hour live online group meetings. The control group will access a low-dose version of the mindfulness program without group meetings, focusing on static content. During the study, participants will complete surveys before starting and at 10, 16, and 24 weeks to track pain impact and self-management. Optional interviews or focus groups about their experience with the OWL website are also offered. The main outcome measured is reduced pain impact using the PROMIS 29 tool up to 24 weeks, alongside other assessments of pain self-efficacy and behavior.

Researchers are evaluating the effectiveness of two types of four-week mindful self-compassion programs for adolescents aged 14 to 19 years. The study aims to find out whether these formal and informal mindfulness programs can improve adolescents coping skills, mental health outcomes like stress, anxiety, and depression, as well as academic engagement. The trial also assesses how much adolescents like each program. Participants will be randomly assigned to one of three groups a formal mindful self-compassion program MSC-F focusing on guided meditation practices, an informal mindful self-compassion program MSC-I focusing on everyday mindful experiences, or a waitlist control group that does not participate during the initial four weeks but may complete a program after the study. Both programs involve weekly live online group sessions led by trained researchers, including psychoeducation, mindfulness practice, and group discussions, with assigned home practice and supporting materials. During the nine-week study, participants will complete surveys on coping, mental health, and academics at the start, one week after the programs end, and one month later. Those in the program groups will also complete weekly home practice surveys during the intervention. All procedures are conducted virtually through phone, video calls, and secure online surveys. The main outcome measured is the Coping Index score one week after the intervention to assess improvements in coping skills.