62 Clinical Trials for Various Conditions
Insomnia is major problem among Operation Enduring Freedom (OEF), Operation Iraqi Freedom (OIF), and Operation New Dawn (OND) Veterans. Insomnia impacts physical and mental health functioning and is associated with reduced quality of life. Cognitive Behavioral Therapy for Insomnia (CBT-I) is one of the most promising treatments for insomnia; however, access to CBT-I is severely limited by a lack of trained clinicians within the Veterans Health Administration (VHA) and Department of Defense (DoD). There is a critical need to offer innovative approaches to meet the demand and need for insomnia treatment. Leveraging technology to meet treatment demands is consistent with service delivery models based upon stepped care principles. This randomized controlled trial will determine whether a computerized, self-guided, web-based version of CBT-I is efficacious in reducing insomnia symptoms and improving functioning compared to a computerized program control.
Insomnia is a major problem among veteran populations. Insomnia impacts physical and mental health functioning and is associated with reduced quality of life. Cognitive Behavioral Therapy for Insomnia (CBT-I) is one of the most promising treatments for insomnia; however, access to CBT-I is severely limited by a lack of trained clinicians within the Veterans Health Administration (VHA). There is a critical need to offer innovative approaches to meet the demand and need for insomnia treatment. Leveraging technology to meet treatment demands is consistent with service delivery models based upon stepped care principles. This randomized controlled trial will determine whether a computerized, self-guided, web-based version of CBT-I is efficacious in reducing insomnia symptoms and improving functioning compared to a computerized program control.
There is evidence demonstrating that aerobic exercise improves many symptoms of Posttraumatic Stress Disorder (PTSD) including; anxiety, depression, insomnia, and cognition. With the goal of using exercise as a rehabilitation therapy for Veterans with PTSD, a team of scientists and doctors developed a 12-week exercise program, combining aerobic and strength training with concentration training and mindful breathing techniques. The initial pilot study suggested that Integrative Exercise may improve overall quality of life, sleep quality, cardiovascular fitness, and PTSD symptoms. This new study will help determine the effectiveness of Integrative Exercise compared to health education classes. The overall goal is to determine if integrative exercise is an effective rehabilitation intervention for combat Veterans with PTSD.
The Researchers are trying to evaluate efficacy of a psychotherapeutic approach that can be applied to those who are critically ill. The daily approach in the Intensive Care Unit (ICU) is designed to provide patients with psychological support, reassurance, and explanations of where they are and what is happening to them.
Specific Aim #1: Examining the impact of mental health disorders (PTSD and GAD) on peripheral vascular function and sympathetic nervous system activity in young individuals. Specific Aim #2: Examining the impact of mental health disorders (PTSD and GAD) on peripheral hemodynamics and metabolic byproducts during small muscle mass exercise in young individuals. Specific Aim #3: Examining the impact of mental health disorders (PTSD and GAD) on exercise tolerance, peripheral hemodynamics and metabolic byproducts during large muscle mass exercise in young individuals.
The present study will explore the effectiveness of a computer based neurobehavioral intervention in improving cognition and emotion regulation in a college freshmen population. It will increase understanding of emotion-regulation and cognition at a neural-circuit level and aid development of new interventions for emotion regulatory problems.
This project aims to follow up on a prior project examining the impact of training therapists in an executive functioning intervention Unstuck and On Target (UOT) adapted for community mental health settings. Study aims are to test the clinical and implementation effectiveness of training mental health therapists in Unstuck and On Target, an executive functioning intervention, relative to Unified Protocol for Children, a transdiagnostic intervention for emotional disorders. This includes examining the implementation of Unstuck and associated outcomes (e.g., effective delivery, expanded use of Unstuck beyond autism, the feasibility of Unstuck) and impact on changes in child executive functioning and behaviors.
The purpose of this project is to conduct a feasibility test of an ASD executive functioning intervention adapted for mental health settings, including examining the effectiveness and process of implementing this adapted intervention in community mental health programs.
The purpose of this study is to understand how different types of community-based mental health care affect thinking abilities, daily functioning, and brain activity in adults with schizophrenia and related conditions. The investigators are especially interested in learning whether the Clubhouse Model-a structured, supportive community for individuals with mental illness-has unique benefits compared to standard outpatient mental health services. If participants decide to join, they will be asked to complete a total of six study visits with the research team over the course of your participation. Three of these study visits are at the beginning (baseline) and the remaining three are six months later. Two of the three visits will includes interviews, questionnaires, and thinking and memory tasks (cognitive testing) and one session will be an MRI brain scan, which is a safe and non-invasive imaging procedure. The total time required for each visit will be approximately 90 minutes to two hours. Participants may take breaks as needed.
The purpose of this clinical trial is to explore the effects of a 4 week cold-water immersion (CWI) intervention on measures of immune function, sleep quality, mental health and well-being, and muscular strength. The main questions it aims to answer are: * Does a 4 week CWI intervention improve measures of immune function, sleep quality, mental health and well-being, and muscular strength? * Are there any differences in these measures when comparing cold tubs versus cold showers? Researchers will compare chronic use of cold tubs to cold showers to see if cold water immersion may improve overall immune health and well-being. Participants will: * Undergo 4 weeks of Cold Tub or Cold Shower interventions at a frequency of 3 times a week for 4 minutes, if placed in the CWI intervention groups * Undergo testing measures at the two pre- and post- intervention time points, if placed in the healthy control group or the CWI intervention groups
The goal of this clinical trial is to test an app-based just-in-time-adaptive intervention (JITAI). The intervention aims to improve child and family mental health. A JITAI provides in-the-moment feedback to coach families. The questions it tests are if the app will improve mental health and family functioning. Participants will download an app on their phone and complete JITAI sessions. Researchers will compare intervention and control groups to see if the app improves mental health.
This proposed study aims to evaluate whether integrating mindfulness into an undergraduate biology course (Mindful Physiology) influences student applied mindfulness and stress regulation. The primary questions are 1. Would completing the Mindful Physiology course increase applied mindfulness? 2. Would completing the course increase self-efficacy in stress regulation? 3. Would completing the course reduce perceived reactivity to acute stressors?
The goal of this study is to refine and test a strategy for engaging veterans with symptoms of depression and/or anxiety as volunteers to help English language learners (ELLs) improve their speaking skills via structured conversations using videoconferencing.
The goal of this study is to evaluate in an effectiveness-implementation type I hybrid trial, an enhanced version of eHealth Familias Unidas for reducing depressive, anxious symptoms and suicide behavior in Hispanic youth. The study will use a randomized rollout design with 18 pediatric primary care clinics in the South Florida area.
This efficacy trial will evaluate the impact of an enhanced version of the Interconnected Systems Framework (ISFE) on elementary school-based team functioning, including use of evidence-based practices, and student emotional, behavioral, and academic functioning. The original interconnected systems framework (ISF) model was designed to improve the depth and quality of mental health services delivered within multi-tiered systems of support by integrating Positive Behavioral Interventions and Supports (PBIS) and school mental health (SMH) efforts to provide a continuum of high-quality services for students. Preliminary findings from a prior efficacy study show that the ISF improved team functioning and increased identification and services for students in need, particularly among youth of color, when compared to the other two conditions. Moreover, the ISF led to improvements in student social, emotional, and behavioral functioning. The current study builds on these findings by testing an enhanced version of the ISF designed to advance the model by adding/modifying several core components intended to further increase the impacts for youth with significant emotional and behavioral problems and reduce inequities in discipline and student service delivery.
Recent Veterans of the Afghanistan and Iraq conflicts are presenting in VA care with high rates of posttraumatic stress disorder (PTSD), depression, anxiety, and substance use disorders. Difficulties with social relationships and community reintegration are common functional impairments with these disorders. VA is transforming to a Whole Health, patient-centered system of care that will address these issues as part of health care. In a previous study, Omnis Salutis (OS) was developed with Veteran and clinician input. OS is a three-session intervention in which Veterans learn about Whole Health and practice communicating their health mission to providers and social supports. OS was shown feasible to deliver, acceptable to Veterans, and preliminarily effective at improving physical, mental, and social functioning. This study will use a large, multisite randomized controlled trial to test the impact of OS on Veterans' social and physical functioning and Veteran engagement in mental health care. Results will support broad delivery of OS throughout the VA.
Children with neurofibromatosis are more likely to have difficulties related to their psychological and neurocognitive functioning (e.g., more likely to have depression, have social difficulties, be diagnosed with ADHD). The purpose of this randomized control study is to determine how effective and useful this study's single session intervention can be in improving psychological and neurocognitive functioning. Enrolled families will consist of one parent/guardian and child. Parents and patients will complete questionnaires and objective tests at baseline, 3 months, and 6 months. Families randomized to the intervention arm will be provided with one single session intervention at Month 1 to learn about their child's testing results and receive psychoeducation and recommendations related to psychological and neurocognitive functioning.
The purpose of this research study is to examine the effect of various forms of exercise training on blood vessel function in healthy individuals as well as individuals with mental health disorders (posttraumatic stress disorder (PTSD) and/or generalized anxiety disorder (GAD)).
The purpose of this research study is to examine the effect of various forms of exercise training on blood vessel function in healthy individuals as well as individuals with mental health disorders (posttraumatic stress disorder (PTSD) and/or generalized anxiety disorder (GAD)).
The purpose of this research study is to examine the role oxidants, substances produced in the blood that can damage blood vessel function, may play in blood vessel function in healthy individuals as well as individuals with mental health disorders (posttraumatic stress disorder (PTSD) and/or generalized anxiety disorder (GAD)).
The purpose of this study is to demonstrate whether Behavioral Activation for depression delivered via home based telehealth (BA-HT) is effective in improving social and role functioning in Veterans recently discharged from Cardiovascular disease (CVD-related) inpatient care. Eligible participants will receive either (1) twelve sessions of BA-HT or (2) standard best practices post CVD hospitalization care. Study participants will be 132 Veterans discharged from the Ralph H. Johnson VA Medical Center inpatient care facilities with CVD diagnoses corresponding to ICD 10 codes I20-I25 (120 unstable angina, stable angina; 121 NSTEMI, STEMI, initial encounter; 122 NSTEMI, STEMI, subsequent encounter; 124 acute coronary syndrome; 125 coronary arteriosclerosis with angina). They will be male or female, age 21 and above, and with approximately 40-50% minority representation. There will be assessment at baseline, 1 week post treatment, as well as 3 and 9-months post treatment. The investigators predict that BA-HT will more effectively increase social role and activity functioning, activity, mood and reduce 9-month re-hospitalization compared to current best-practices post-discharge care among patients scoring at least moderately depressed on the PROMIS Depression scale one week following hospital discharge for a CVD event.
The proposed study will employ a cross-cultural Community Based Participatory Research (CBPR) approach to build from prior needs assessments and mixed-methods research to evaluate the effectiveness of the Family Strengthening Intervention for Refugees (FSI-R), a preventative family home-based visiting intervention intended to mitigate mental health disparities among refugee children and families using a hybrid implementation-effectiveness design. Results of the investigator's trial will expand the evidence-base on community-based interventions for refugees and has the potential to be replicated to reduce mental health disparities affecting diverse groups of refugee children and families.
The goal of this study is to learn about changes in the brain that occur during Engage, a psychotherapy for depression in older adults, and how they may differ from changes that occur during supportive therapy. Older adults with depression will receive 9 weeks of either Engage or supportive therapy and will complete research assessments before the therapy begins and at weeks 3, 6, and 9 of treatment. Research assessments will include questionnaires, computer tasks, and recordings of electrical brain activity (also called electroencephalography or EEG).
The need for assisted-technology at home reflects some of the most serious health-related conditions faced by children with physical and developmental disabilities. 'Technology-dependent' is often used in the literature to describe children "who need both a medical device to compensate for the loss of a vital body function and substantial and ongoing nursing care to avert death or further disability". Parenting a child is stressful and challenging, and even under ideal circumstances the care of a child with complex needs requires greater than normal parenting skills. Studies have showed that parents of children whose illness require assisted-technology experience significant emotional stress, potential gaps in social support, and social isolation leading to lower quality of life, unhealthy family functioning, and negative psychological consequences. This study intends to assess the feasibility and efficacy of a tele-psychotherapy (Tele-P) intervention as a way to promote the emotional functioning of parents and to help increase the quality of life of children that are technology-dependent in the Greater Boston Area. It is hypothesized that parents who adhere to psychotherapy sessions via videoconferencing (Tele-P) will demonstrate significant reductions in symptoms of depression, anxiety and social isolation. Children of parents in the (Tele-P) condition will show significantly greater improvements in their quality of life including their physical health, mental health, family life, free time, and general life enjoyment. A randomized controlled trial is proposed in order to evaluate the feasibility and efficacy of a tele-psychotherapy intervention for parents of technology-dependent children at the Critical Care, Anesthesia and Perioperative Extension (CAPE) program in Boston Children's Hospital. This study will serve as model for social workers to perform an intervention for parent's raising technology-dependent children. This study proposes that tele-psychotherapy be a means of advocating for this underserved population.
Functional abdominal pain (FAP), a pediatric pain condition without significant organic pathology, is a precursor to chronic pain and high healthcare utilization in young adulthood. This project aims to identify child and family characteristics that predict differential responses to a Cognitive Behavior Therapy intervention administered online to patients with FAP and their parents. The goal is to acquire scientific knowledge to guide individualized treatment of patients with FAP.
RATIONALE: Gathering information from older patients with newly diagnosed cancer may help doctors learn more about the risks of functional decline. PURPOSE: This studying is looking at the physical and mental health of older patients with newly diagnosed cancer.
This study will determine the effect of medication for bipolar disorder on the reproductive function and whether mood changes occur during the menstrual cycle in women with bipolar disorder.
This Study aims to build a diverse and inclusive group of participants to help researchers advance our understanding of how signals and information collected from apps and devices relate to health and may be used to predict, detect, monitor, and manage changes in health. Participants will be asked to complete tasks and surveys, using their iPhone and Apple Research app which include: * Selecting the types of data they would like to share with the study such as health and sensor data * Complete tasks and surveys including areas such as personal demographic information, personal medical history, family history, and social determinants of health
Drama Therapy involves of the use of theatrical techniques (such as script development, acting exercises, improvisation, etc.) to help treat patients' mental illness and improve their functioning and overall sense of wellbeing. This study will evaluate the effectiveness of a specific version of drama therapy for the treatment of patients suffering from both mental illness (such as depression, bipolar disorder, schizophrenia, etc.) and one or more substance use disorders. The study will also assess participants feelings and thoughts about the drama therapy intervention (such as whether or not they enjoyed it and if/how they found it helpful). The drama therapy intervention will consist of one group drama therapy session per week, for a total of twelve weeks (i.e., total twelve sessions) followed by a single performance (with composition of the audience determined by unanimous agreement of the participants) of the dramatic work (script) produced by the participants during the course of the drama therapy intervention.
Researchers at Massachusetts General Hospital are interested in learning more about the neurobiology of well-being in new mothers and novel ways to support them during their transition to parenthood. This study aims to evaluate well-being in new mothers and their infant and the impact of a probiotic dietary supplement on the gut microbiome. This study hopes to help improve the existing knowledge of maternal postnatal health.