16 Clinical Trials for Various Conditions
This study aims to assess acceptability and preliminary efficacy of an intervention being administered clinically, a virtual reality (VR) mindfulness program. It is hypothesized that patients will find VR mindfulness an acceptable intervention and that it will reduce symptoms of anxiety.
Teenagers are invited to take part voluntarily in a research study of a study drug known as guanfacine extended release (Intuniv™) and a type of psychotherapy called Mindfulness Skills Training which teaches people how to focus on the present moment in a nonjudgmental manner to help them cope with their stresses and worries. Teenagers are being asked to take part in this study if they have had traumatic stress related over arousal symptoms. He/she may also have difficulties with worries, anxiety, temper, aggression, quick mood changes, behavior problems, and/or difficulties with symptoms of Attention Deficit Hyperactivity Disorder (ADHD) including inattention, hyperactivity, and impulsivity with or without Posttraumatic Stress Disorder (PTSD); and is not responding adequately to his/her current treatment. The primary purpose of the teenager's participation in this study is to help answer the following research question(s), and not to provide treatment for his or her condition: * To investigate if Intuniv™ helps for the symptoms of traumatic stress and emotional and behavioral overarousal in children with a history of traumatic developmental stress with and without PTSD. * To investigate if Intuniv™ helps your teenager engage with and benefit from Mindfulness Skills Training therapy * To better understand how Intuniv™ works in the brain. * To investigate how well your child tolerates Intuniv™ during the study.
In the U.S., rates of preterm birth and low birth weight have increased over the past 30 years. Poor birth outcomes are especially high among racial/ethnic minority populations. Maternal stress is an important factor that can lead to negative birth outcomes. Thus, programs that reduce stress during pregnancy could improve birth outcomes. Initial pilot work tested a mindfulness-based approach to stress reduction during pregnancy. Women in the pilot study had lower stress and improved coping after the program. For the current study, mindfulness is added to an existing prenatal healthcare program called CenteringPregnancy (CP). CP provides prenatal care through 10 group sessions. This study compares CP with a version of CP infused with mindfulness skills training. Effects of the two versions of CP on psychological stress and coping, stress hormones, and birth outcomes will be tested. Data will be collected from participants three times: twice during pregnancy and once after birth. Medical records will provide data on birth outcomes and other health factors. The study will provide initial information about a mind-body program to reduce stress and improve birth outcomes. Data from the study will inform the development of an R01 proposal for a larger study. The study will also help advance the long term goal of reducing health disparities.
The goal of this research is to develop a new breathing feature on the meditation app, Equa, to help young adults who are distressed, understand their physiological responses and mindfulness skill development during meditation. Our main aims are to build an algorithm that can use physiologic signals to: * Give feedback about how participant physiology is changing during guided lessons on the meditation app, Equa * Measure how much participant mindfulness skills are improving Participants will: * Complete a survey about demographics, their thoughts and feelings before and after the mindfulness meditation program * Complete 14 smartphone guided mindfulness meditation training units while physiological measures are being recorded * Complete a few brief questionnaires before and after mindfulness practices to understand potential changes in their mindfulness skills
An eight week mindfulness training for physicians in a community hospital setting, largely administered through web-casts, will decrease stress and burnout, increase job satisfaction, and develop lasting mindfulness skills in the participants.
The purpose of this study is to compare the efficacy of a mindfulness-based skills training (MBST) to a psychoeducational intervention at reducing dating violence in a sample of college students. The MBST focuses on improving college students' abilities to manage emotionally charged states during conflict with their romantic partners by teaching them mindfulness-based skills. The psychoeducational intervention uses the Love is Not Abuse curriculum. Treatment groups are randomly assigned and are compared using a two-armed parallel design. 88 college students currently in a dating relationship were recruited through Kent State University's subject pool. All participants completed a baseline assessment online where self-reported data was collected on demographics, dating violence (during the past month), emotion regulation, mindfulness skills, and other potential covariates. Participants were then randomized into either the MBST intervention or the psychoeducational intervention. All participants completed three 50-minute sessions over the course of three weeks with assigned homework between sessions. Daily diary data was collected, assessing knowledge and use of skills learned in the sessions. Follow-up data was collected online 11 weeks following baseline (dating violence (during the last month), emotion regulation, mindfulness skills). It was hypothesized that the MBST intervention would be more effective at reducing dating violence as compared to the psychoeducational intervention.
The goal of this study is to test the feasibility and acceptability of a positive affect intervention for suicide in a population of young adults. Skills to Enhance Positivity (STEP) has been demonstrated to be feasible and acceptable among adolescents when delivered individually. The current study aims to test feasibility and acceptability in a group setting of young adults. The specific aims of STEP also seek to establish whether participants who received STEP report a significant increase in attention towards positive affect compared to those receiving Treatment As Usual (TAU). They also seek to explore whether participants who received STEP will report a significant decrease in suicidal ideation and depression compared to those receiving TAU. The final aim is to explore whether an increase in attention to positive affect regardless of condition is a potential mechanism of change for reductions in suicidal ideation and depression. Participants will be randomized into STEP or TAU groups, they will complete baseline and follow-up assessments after a period of 3-months. Participants enrolled in STEP will receive in-person group sessions focusing on psychoeducation of positive affect as well as skills in mindfulness, gratitude and savoring designed to promote positive affect. After completing the group sessions they will also receive text messages for one month, where they will receive prompts to practice skills they learned in the group setting.
This project addresses the significant challenge of providing evidence-based non-pharmacologic pain management to rural-dwelling Veterans in the VA healthcare system who have chronic pain. For this preparatory phase (UG3) the investigators will conduct a pilot study of 40 rural VA patients with chronic pain to assess the feasibility of delivering RAMP (experimental intervention for the UH3 trial) in terms of recruitment and engagement, intervention fidelity and adherence, data collection, and other key metrics.
Lifetime risk for developing an alcohol use disorder increases with earlier onset of alcohol consumption. This risk may reflect a tendency for escalated alcohol intake among youth due to immature executive control, leading to more frequent binge drinking, which is associated with more alcohol-related problems. Binge drinking is associated with deficits in behavioral flexibility, which may suggest impaired control networks that contribute to automatic behavior. Individuals with an alcohol or substance use disorder (A/SUD) exhibit attentional bias toward drug- or alcohol-related stimuli that have attained salience through consistent use. Reward history increases attention towards non-drug stimuli, even among individuals with no lifetime A/SUD. Preliminary data (from Dr. Boettiger's lab) from a nationally representative US adult sample using data collected via Prolific found that a questionnaire measure of mindfulness moderates the relationship between alcohol misuse and attention to reward. Given evidence that heavy alcohol drinking impairs behavioral flexibility, which in turn promotes escalating intake, insight into the relationship between mindfulness and behavioral flexibility could inspire new strategies to prevent alcohol and substance use disorders in people at elevated risk.
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 novel, timely, and theory-driven Food-Body-Mind intervention addresses the national emergency of mental health crises in early childhood. By targeting Head Start racially/ethnically diverse preschoolers from low-income backgrounds in both urban and rural areas, this intervention is expected to contribute toward reducing health disparities and promoting health equity, a major priority of the NIH and Healthy People 2030. If effective, it can be scalable to Head Start programs across urban and rural settings nationally with long-term sustainability benefits.
This study will test how well a mindfulness-based intervention called CHIME improves the emotional well-being of educators in Early Head Start and Head Start (EHS/HS) settings. The study also will examine if there are any benefits to young children's social emotional health as a result of the CHIME program. Researchers will compare educators who participate in CHIME to educators who are asked to participate at a later time to see if there are benefits to their emotional health and teaching practices.
This study aims to investigate the feasibility and effectiveness of a cognitive behavioral coping skills program, Treatment and Education Approach for Childhood-onset Lupus (TEACH), for youth with cSLE when integrated into medical care. This TEACH program aims to teach participants skills in order to cope with fatigue, pain, and depressive symptoms--symptoms that commonly affect adolescents and young adults with lupus.
The E-TIPS trial will evaluate an evidence-based, telehealth pain self-management intervention compared to standard care (a waitlist) for chronic pain in adults with physical disabilities who are employed. Participants from anywhere in the US will be randomized to either E-TIPS, a cognitive-behavioral pain self-management intervention delivered by telephone, or a waitlist control. Outcomes, including pain interference, will be assessed at baseline, mid-treatment, post-treatment, and 6-month follow up.
Project UPLIFT, a home-based treatment for depression in people with epilepsy, was designed to be delivered to groups by telephone or Web. The Project UPLIFT intervention materials were demonstrated to be effective in treating depression among people with epilepsy in Georgia. This project will assess whether the materials are also effective for preventing depression among people with epilepsy, and will extend the project beyond Georgia to Michigan, Texas, and Washington.
The purpose of this study is to determine whether a mindfulness meditation-based stress reduction program is useful in relieving symptoms associated with rheumatoid arthritis (RA).