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Found 3 Actively Recruiting clinical trials
Actively Recruiting
Researchers are evaluating surgical and minimally invasive treatments for lumbar spinal stenosis (LSS) by comparing Medicare patients who received the MILD procedure against those who had interspinous process decompression (IPD). The study focuses on outcomes such as the rate of harms related to the initial procedure and the frequency of additional surgical or minimally invasive interventions within 24 months after treatment. Enrollment includes patients treated from January 1, 2017, onward, with continuation until the sponsor decides to stop. The MILD procedure involves percutaneous image-guided lumbar decompression, performed under fluoroscopy through a dorsal approach to partially remove tissue and bone at the affected spinal level. The control group receives the IPD procedure for LSS. Both groups are monitored for a 24-month period post-index procedure using Medicare claims data to track reoperations and any harms. Participants contribute data through Medicare claims without needing prior enrollment or consent, as the study is exempt from IRB oversight. Researchers collect and analyze information on procedure-related harms and subsequent interventions over two years. This approach allows evaluation of long-term safety and effectiveness outcomes for patients treated with either MILD or IPD.
Actively Recruiting
Mental health conditions during pregnancy and up to one year after birth affect one in five individuals in the United States, making them a leading cause of death in this period. This research compares two approaches to improving care for mood and anxiety disorders during this time: a health system-focused model and a healthcare-community partnership model. The study includes 32 perinatal care settings across the country and aims to help states and healthcare systems decide which approach better increases access to mental health care for pregnant and postpartum individuals, especially addressing disparities in care for racial and ethnic groups. The study tests two main interventions: the Program in Support of Moms (PRISM), which helps obstetric practices integrate mental health screening, assessment, and treatment with training and support; and the Postpartum Support International (PSI) Peer Support, which pairs individuals with trained volunteer mentors who provide support, education, and tools to manage parenting and mental health symptoms. Half of the care settings will implement the health system-focused approach (PRISM alone), while the other half will use the healthcare-community partnership approach (PRISM plus PSI Peer Support). Participants will receive mental health screening and treatment integrated into their prenatal and postpartum care. Researchers will review patient records to assess treatment and support received and measure changes in depression symptoms up to 13 months after birth. The study also evaluates how well care settings implement mental health care, including screening for social needs, and surveys providers and peer mentors about racial bias, discrimination, and burnout. The research will last throughout the perinatal period with ongoing engagement of patients, professionals, and peer mentors to identify barriers and ways to expand these care approaches.
Actively Recruiting
Researchers are evaluating DeafMET, a specially adapted version of Motivational Enhancement Therapy (MET), designed for Deaf adults who use American Sign Language (ASL) and have high-risk alcohol use. This pilot study addresses the unique challenges faced by the Deaf community, including lower English literacy and limited access to behavioral health care tailored to their needs. The study aims to test the feasibility, acceptability, and early effectiveness of DeafMET in supporting motivation to change alcohol use behaviors. Participants will receive the DeafMET intervention delivered by a Deaf therapist fluent in ASL, either in-person at UMass Chan's Shrewsbury campus or remotely via Zoom, depending on their preference and location. The intervention consists of six one-hour sessions held every two weeks, featuring Deaf-friendly materials, ASL educational content, and interactive visual strategies. The sessions include introductory rapport building, a values card sort activity, assessment interviews, review of a personalized feedback report, and motivational discussions to strengthen commitment to change. During the 13-week participation, individuals will complete assessments before, during, and after the intervention through REDCap links offering both ASL and written English versions. Researchers will monitor changes in participants' readiness to change their alcohol use and evaluate recruitment, retention, satisfaction, and adherence. Sessions will be recorded for quality review, and participants will be interviewed about their experience with DeafMET to guide future improvements and research planning.