West Hartford

Researchers are collecting Optical Coherence Tomography (OCT) data to better understand both healthy eyes and eyes affected by retinal disease, glaucoma, and corneal diseases. The study includes adults aged 22 years or older who meet specific eye health criteria and are able to consent to participate. The purpose is to gather detailed imaging data from various eye conditions to support further research and evaluation. Participants will undergo imaging using the A10900 OCT device, which captures detailed scans of the eyes. The study includes multiple groups: those with retinal disease, glaucoma, corneal diseases, and healthy eyes. Each participant will have their eyes scanned to collect OCT images, with the number of scans tracked over one year. The device imaging will be carefully performed to ensure acceptable image quality for research purposes. Throughout the study, participants will be assessed for their ability to tolerate imaging and comply with study procedures. Researchers will collect and analyze OCT scan data to evaluate eye health and disease characteristics. Safety and image quality will be monitored, and participants will be followed for one year to track the number of OCT scans obtained and any related observations.

Excessive anxiety is common among elementary school students and can seriously affect their academic, social, and behavioral functioning. This research evaluates the effectiveness of a brief nurse-delivered program called Child Anxiety Learning Modules (CALM) compared to a relaxation-only program (CALM-R) and a waitlist control. The study aims to reduce anxiety symptoms and improve educational outcomes immediately after the intervention and at a one-year follow-up, while also assessing the cost effectiveness of CALM and exploring factors that influence its impact on children. The study involves elementary school nurses delivering the interventions in rural, suburban, and urban schools across the United States. CALM includes five modules focusing on psychoeducation, relaxation, behavioral exposure, cognitive restructuring, and relapse prevention, delivered over 8 weeks. CALM-R also has five modules but focuses only on relaxation skills like deep breathing and muscle relaxation, also over 8 weeks. Both programs are designed for children aged 5 to 12 years. Participants will be assessed through evaluations by independent experts, questionnaires, and reports from parents and children. The main outcomes include the Clinical Global Impression - Impairment Scale measured 8 weeks after starting the intervention and again at 12 months. The study tracks changes in anxiety symptoms and educational progress. Nurses involved must be registered professionals working in school settings and fluent in English. The total study participation includes the 8-week intervention and follow-up assessments over one year.

This trial evaluates the effectiveness of Fathers for Change (F4C), a father-focused therapy, compared to the standard Batterer Intervention Program (BIP) in reducing family violence and improving child mental health. It focuses on fathers with a history of intimate partner violence (IPV) who have children aged 6 months to 12 years. The study addresses the need for interventions that target fathers' emotion regulation and reflective functioning, as current programs often fail to improve father-child relationships or reduce violence effectively. Participants are randomly assigned to receive either the Fathers for Change intervention or the Duluth Model BIP, each lasting 18 weeks. Fathers for Change involves individual therapy sessions aimed at enhancing emotion regulation, reflective functioning, and family communication. The Duluth BIP provides psychoeducation and cognitive behavioral therapy focused on IPV. Both interventions seek to reduce violence and improve family dynamics. Throughout the study, fathers and their children undergo assessments at baseline, 19 weeks, 43 weeks, and 70 weeks to measure changes in physical and verbal IPV and child maltreatment. Researchers monitor fathers' emotion regulation and reflective functioning through in-session observations and weekly self-ratings. The study also collects reports from mothers and evaluates child mental health outcomes, aiming to understand how these therapeutic mechanisms influence family violence and child well-being over time.

Researchers are evaluating a brief intervention called the Anxiety Action Plan (AxAP) to help pediatric primary care providers better support children and youth struggling with anxiety. Anxiety disorders are common and disabling in young people but often go untreated. This study aims to improve access to effective care by training primary care providers to identify and treat anxiety during regular clinic visits, especially in areas with few mental health specialists. The study compares the MAPP behavioral intervention, which is based on exposure therapy strategies and delivered by trained primary care providers in community clinics, to Enhanced Usual Care (EUC) that includes videos, handouts, and other anxiety reduction resources. Providers participating in MAPP receive training, coaching, and administer the intervention to youth over 1 to 4 brief sessions lasting 20 to 30 minutes each, which can be delivered virtually. Families receive either the MAPP intervention or EUC based on their group assignment. Participants will be assessed at 2 months post-intervention and again at 6 months to evaluate anxiety improvement using the Clinical Global Impression Improvement scale and reports from primary care providers. The study collects information through questionnaires and evaluations from families and providers to measure the feasibility and effect of the intervention. The goal is to refine the AxAP and support future wider use to improve anxiety care in primary care settings for children aged 6 to 17 years.

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.

High blood pressure, also known as hypertension, is a common condition that affects the arteries and increases the risk of serious health problems such as heart attack and stroke. This research aims to explore both the immediate and long-term effects of brief periods of exercise on blood pressure in adults with hypertension or pre-hypertension. The study focuses on short bouts of exercise lasting 5-10 minutes, as current evidence on their impact is limited. Participants will first complete a single session of resistance exercise using a leg press, with or without a blood flow restriction technique, to observe acute blood pressure changes before and after exercise. Following this, they will participate in a six to eight-week home-based exercise program involving two different wall-sit exercises: one where four sets of wall-squats are performed at four different times throughout the day, and another where four sets are done continuously. During the study, participants' 24-hour blood pressure will be monitored from enrollment to the end of the six-week period. Researchers will assess blood pressure changes and overall safety throughout the trial, which includes regular monitoring and evaluations of adherence to the exercise protocols. The total study participation lasts approximately six weeks, focusing on both short-term and sustained effects of brief exercise on blood pressure.

Chronic low back pain is a common and persistent health issue that often involves an increased pain response beyond the initial injury site. Traditional links between pain and structural changes in muscles or joints are weak, and many patients experience central sensitization, where the nervous system amplifies pain signals. This trial explores treatments that aim to reduce this heightened pain response and improve daily function by focusing on pain intensity and duration. The study uses a randomized crossover design to compare three treatments: active transcutaneous electrical nerve stimulation (TENS), placebo TENS, and no treatment control. TENS is a non-drug therapy that uses electrical current to reduce pain by activating the body's natural pain-inhibiting pathways. Participants will receive all three interventions in random order, and treatments are assessed for their effects on pain, function, and nervous system activity. Participants will undergo evaluations measuring pain at rest and with movement using a numeric rating scale, alongside tests for central nervous system excitability and physical function, including sit-to-stand and trunk flexion tests. These assessments help monitor changes in pain sensitivity and physical abilities. The study focuses on adults aged 18 to 60 with chronic low back pain, and measures are taken to ensure safety and monitor responses throughout the trial.