Malden

Researchers are investigating whether the medicine vicadrostat, when taken together with empagliflozin, can lower the risk of heart-related problems in adults who have type 2 diabetes, high blood pressure, and cardiovascular disease but no history of heart failure. This study is a Phase III trial that compares the effects of vicadrostat plus empagliflozin to a placebo plus empagliflozin in people with these conditions. Participants are randomly assigned to one of two groups: one group takes vicadrostat and empagliflozin tablets, and the other group takes placebo tablets that look like vicadrostat along with empagliflozin. All participants take one tablet daily for a period ranging from two and a half years up to four years and three months. Throughout the study, participants continue their usual medications for diabetes, high blood pressure, and cardiovascular disease. During up to 51 months of participation, participants visit the study site regularly where doctors collect health information and blood samples. Researchers track when participants experience cardiovascular events such as heart-related deaths or heart failure events. The study also monitors participants’ overall health and any side effects they may experience to assess the safety and effects of the treatments.

Researchers are evaluating a brief intervention aimed at helping young adults who drink heavily reduce their alcohol use. The study focuses on the combined effects of a short mindfulness training and respiratory-gated auricular vagal afferent nerve stimulation (RAVANS), a device that stimulates specific nerve fibers during exhalation. This approach may influence brain areas related to problematic drinking and autonomic nervous system regulation. The study also collects heart rate variability data and self-reported surveys to understand the impact on alcohol consumption and related clinical measures. Participants will first complete an online baseline survey and then attend two in-person lab visits scheduled about one week apart. During these visits, participants will be randomly assigned to receive either active or inactive RAVANS while engaging in mindfulness practices and exposure to alcohol-related visual cues. The RAVANS device uses ear electrodes and a breathing sensor to deliver stimulation linked to the breathing cycle. Between visits, participants will be asked to practice mindfulness meditation daily using a 10-minute audio guide. After the second lab visit, participants will complete a 30-minute virtual follow-up session with surveys. Throughout the lab visits, participants will complete survey batteries, wear a heart rate monitor to record heart rate variability during rest and cue exposure, and participate in tasks involving alcohol-related images and videos. The study measures how RAVANS and mindfulness affect heart rate variability and responses to alcohol cues. Safety and adherence are monitored closely, and the total participation lasts about three weeks including the follow-up. The study aims to assess the feasibility and acceptability of this combined intervention for reducing alcohol consumption in young adults.

Researchers are evaluating a culturally grounded mental health training program called First Face for Mental Health in Tribal communities. This study aims to determine whether the training improves mental health knowledge, the ability and confidence to respond to mental health crises, reduces stigmatizing attitudes, and increases cultural identity among participants. The research is conducted using a waitlist control design within seven Tribal Nations in the Northwestern United States. The First Face training is a community-based program designed for laypersons and others living or working in Tribal communities to help them assist individuals experiencing mental health crises. The course takes approximately 8 hours to complete. Participants are divided into two groups: one receives training immediately, and the other after a 6-month waitlist period. Multiple training sessions of 15–30 people occur separately within each tribe. Assessments are done before and after training, with follow-up surveys conducted up to 24 months after initial training. Participants complete surveys at several time points: before training, immediately after, and at 6, 12, 18, and 24 months post-training. The surveys evaluate mental health knowledge, perceived competence, ability to respond using situational judgment tasks, and actual responsive actions. Researchers compare outcomes between the initial training group and the waitlist control group during the first six months and monitor sustained effects in both groups over two years. Recruitment is community-based, and participant numbers are proportional to the size of each tribe.

Researchers are evaluating a web-based platform called Our Whole Lives (OWL) designed to help adults with chronic musculoskeletal pain manage their symptoms. The study aims to see if using this non-prescription, online mindfulness program combined with weekly virtual group visits improves pain outcomes and reduces pain's impact compared to a control group with low-dose online content. The study is a Phase II trial focusing on adults experiencing chronic pain lasting at least three months with moderate intensity. Participants will be divided into two groups. One group will engage in a nine-week OWL mindfulness program featuring self-paced sessions and weekly 1.5 to 2-hour online group meetings via Zoom or Google Meets. The other group will receive a low-dose version of the OWL program through static online content without group meetings. Both programs focus on mindfulness, mind-body practices, education about chronic pain therapies, stress reduction, sleep, and nutrition. Participants will complete baseline surveys and follow-up assessments at weeks 10, 16, and 24 to measure changes in pain impact using the PROMIS 29 tool. Optional online focus groups or individual interviews will be offered. Throughout the study, researchers will monitor engagement with the OWL platform and evaluate changes in pain management outcomes. The total study duration for participants is approximately 24 weeks.

Researchers are evaluating whether two types of mindful self-compassion programs can help adolescents improve their coping skills. The study also aims to find out if these programs can enhance mental health aspects such as stress, anxiety, and depression, as well as academic engagement. The trial compares two four-week mindful self-compassion programs—formal and informal approaches—to a waitlist control group that does not participate during the initial study period. This hybrid effectiveness-implementation randomized clinical trial focuses on adolescents aged 14 to 19 years, addressing concerns about social pressures and unhealthy coping behaviors linked to increased smartphone and social media use. The interventions include two adaptations of the Mindful Self-Compassion - Teen program. Both the formal (MSC-F) and informal (MSC-I) programs consist of weekly hour-long virtual group sessions over four weeks led by trained researchers and clinicians. Each session covers psychoeducation on stress, mindfulness, self-compassion, and coping, along with mindfulness practice and group discussion. Participants complete weekly home practice with supporting materials. The waitlist control group does not engage in activities during this period but is offered a program after the study concludes. Participants will first complete a phone interview to confirm eligibility, followed by a baseline online survey about coping, mental health, and academic engagement. Those in the intervention groups will attend the four-week program and complete weekly home practice surveys. All participants will then complete follow-up online surveys one week and one month after the program ends. The total study period is nine weeks, and all procedures are conducted virtually through phone, videoconference, and secure online surveys. The study's main outcome measure is the Coping Index, assessed from baseline to one week after the intervention.