48 Clinical Trials for Various Conditions
This study will examine how brain activation changes as a result of behavioral treatment for posttraumatic stress disorder (PTSD) in adolescents. The investigators will conduct functional magnetic resonance imaging (fMRI) scans before and after the widely-used trauma-focused cognitive behavioral therapy to better understand how the brain recovers from illness. This study will provide much needed information about brain abnormalities in abused youth, and could lead to improvements in behavioral treatments for patients who do not respond to current treatments.
PROJECT SUMMARY: PTSD is a debilitating psychiatric condition precipitated by exposure to extreme, or life threatening, trauma with an estimated lifetime prevalence between 8% and 9% in U.S. adults. One core symptom of PTSD is intense psychological distress in the presence of stimuli that "resemble" one or more aspects of the trauma experience (DSM-IV). This phenomenon referred to as stimulus generalization has received surprisingly little empirical testing in the context of clinical anxiety in general, and PTSD more specifically. The current proposal represents the first effort to study the neurobiology and pharmacology of this PTSD-relevant learning phenomenon across those with and without PTSD. The objective of this particular proposal is to apply fMRI and pharmacologic methods to: 1) identify brain mechanisms associated with generalization of conditioned fear and 2) examine the pharmacologic modifiability of levels of generalization using a partial agonist at the NMDA receptor complex (D-cycloserine) shown to increase discrimination of CS+ (danger cue) and CS- (safety cue) in animal studies.
The present study will: Aim 1: Enroll 15 family members of CA patients to (a) pilot recruitment procedures, (b) estimate retention, and (c) assess acceptability of study procedures. Family members will be randomized to either complete an ICU diary or to a control condition, and will complete surveys in the ICU, at patient discharge, and 30 days post-discharge. Aim 2: Obtain an estimate of the association of intervention v. control with (i) family member fear (operationalized as cardiac anxiety about the patients' cardiac condition) at hospital discharge and (ii) family member PTSS 30 days post-discharge. Exploratory Aims: Obtain an estimate of the association of intervention v. control with family member aversive cognitions towards exercise at hospital discharge.
The purpose of this study is to assess the use of an audio recording containing positive suggestion as a means to provide needed psychological support to critically ill patients in a feasible and reliable manner.
Background: Current military involvement in Afghanistan (Operation Enduring Freedom - OEF) and Iraq (Operation Iraqi Freedom - OIF) has created unforeseen burdens on the mental health and well-being of US service women and men. Although OEF/OIF service members and veterans are at high risk of developing sub-threshold combat stress and depressive symptoms or full disorders in the post-deployment period, only a small fraction ever receive care. The VETS PREVAIL Intervention, which combines Cognitive-Behavioral-Therapy-based (CBT-based) coping skills training with peer-to-peer support and counseling, was specifically designed to offer the returning OEF/OIF service member or veteran an accessible and confidential first step to care. Evaluation Study: RISE Consulting, lead by Dr. Benjamin W. Van Voorhees, MD, MPH, was contracted to supervise a pilot study of potential benefit, feasibility and safety of the VETS PREVAIL Intervention. The study would consist of a single group pre/post comparison study of N=50 recent OEF/OIF veterans in the frame work of a phase 1 clinical trial (phase 1). Feasibility (adherence and satisfaction), evidence of clinical benefit would be evaluated through changes in the following clinical self-report measures: i) symptoms of depressed mood (Center for Epidemiologic Studies Depression Scale, CES-D), ii) post traumatic stress disorder (Post Traumatic Stress Disorder Checklist-Military, PCL-M), and iii) functional status (Short Form 12, SF-12), as well as changes in key attitudes toward mental health care seeking (intent to seek treatment, mental health self-efficacy and stigma).
A great many soldiers are returning from Iraq and Afghanistan with symptoms of Post Traumatic Stress Disorder (PTSD). Clinical experience with many people has shown the effectiveness of the techniques of Energy Psychology for rapidly alleviating PTSD symptoms. The study proposes to determine whether a very brief course of treatment (3 sessions) with a common form of Energy Psychology called Emotional Freedom Techniques (EFT) has an effect on the stress biochemistry of subjects, by measuring their levels of stress hormones (cortisol, DHEA) before and after treatment.
The goal of this randomized controlled trial is determine if education on common events in labor in nulliparous women can reduce the postpartum traumatic symptoms. The main question it aims to answer are: * Does prenatal education on labor events reduce post-traumatic symptoms, as measured by thePost Traumatic Stress Disorder Cecklist for Diagnostic and Statistical Manual for Mental Health Disorders (PCL-5) at 6 weeks postpartum? * Does prenatal education on labor affect labor outcomes? Participants will be given surveys: * At enrollment on mental health and previous traumatic experiences * After education on expectations on childbirth * After delivery on experience of childbirth * At 6 weeks and 6 months postpartum on traumatic symptoms and mental health outcomes. They will also have the option to participate in collection of discarded cerebrospinal fluid, blood and serum and physiologic sensitivity testing.
Distal radius fractures (DRF) are the most common type of fracture in the human body, and a large proportion of DRFs result in complications. Previously proposed preventive strategies have questionable efficacy and may impose additional risks on the patient. Because many complications secondary to distal radius fractures are associated with excessive swelling, a prophylactic means for edema reduction could dramatically reduce morbidity among this population. A compression glove is a non-invasive, non-pharmacological way to reduce edema. Previous studies have confirmed its utility in edema reduction after hand trauma and among patients with chronic inflammatory conditions, but none have sufficiently investigated the application to patients with distal radius fractures, a population in which this intervention could have a large impact. The investigators propose a randomized controlled trial to evaluate use of a compression glove during recovery among patients who have sustained an unstable distal radius fracture. The investigators hypothesize that patients who wear a compression glove after a distal radius fracture: * Will experience less edema * Will demonstrate greater functionality * Will recover more quickly * Will have lower incidence rates of carpal tunnel syndrome * Will have lower incidence rates of complex regional pain syndrome
This is a pilot trial to see if one or two 40 treatment courses of low pressure hyperbaric oxygen therapy can improve cognition and brain imaging in subjects with either chronic mild-moderate traumatic brain injury (TBI), also known as post-concussion syndrome (PCS) or chronic PCS with post-traumatic stress disorder (PTSD) secondary to blast injury.
Background: A traumatic brain injury (TBI) could mean a person is at high risk for other long-lasting problems. These problems could include post-traumatic stress disorder (PTSD), depression, and post-concussive syndrome (PCS). For example, about 700,000 Americans each year who have a TBI later go on to have PTSD also. Depression and PCS are also common in people who had a TBI. Some people will have these problems later. These problems can seriously interfere with a person s life. Some people will not have these problems at all. There are many reasons for this difference. Researchers think the main reason is that people have different genetic and environmental influences. Right now, we only have few kinds of treatments to prevent or treat these problems after a TBI. The few treatments we have often do not work well. It is important to understand what factors make a person at high risk for these problems after a TBI. This could allow researchers and doctors to help address these problems early. Addressing these problems earlier may help a person have better health in the long run. Objectives: * To study the biological changes that happen after mild to moderate TBI which could be linked to the onset of PTSD, depression, and post-concussive syndrome * To study brain mechanisms that could explain risks for getting a psychiatric disorder after mild to moderate TBI. This will be done using a test called functional MRI (fMRI). This test takes images of the brain while a person is doing a simple task. Eligibility: * Men and women who are 18 to 65 years old. * Had a mild to moderate TBI (including concussion) in the last month. Design: * 5 outpatient visits to the NIH Clinical Center over one year. * The first visit is a screening visit to see if you can join the study. This visit must happen within 30 days of the TBI. The visit includes lab work (blood and urine), a history and physical exam done by a physician or nurse practitioner, and a psychiatric interview with a behavioral health nurse. * Visits 2, 3, 4 and 5 happen at one, three, six and twelve months post-injury. At these visits participants may have some or all of the following tests: blood and saliva collection, urine collection, questionnaires and interviews to assess symptoms, a test to see your response to stress (called hydrocortisone challenge), and fMRI brain imaging. * This study does not provide treatment. * This study is not a substitute for seeing a primary care provider. * This study should not replace any therapies you may be taking.
A two site, 2-arm, Phase III randomized pragmatic clinical trial evaluating the effectiveness of quetiapine monotherapy in comparison to Treatment As Usual (TAU) medication management for symptoms experienced by veterans receiving rehabilitation therapy for mild traumatic brain injury (mTBI) and comorbid symptoms of posttraumatic stress disorder (PTSD).
This study evaluates the use of nebulized hypertonic saline (aerosolized salt water) as a preventive treatment for post-traumatic acute lung injury (ALI). Both animal and human research indicate that aerosolized salt water might help reduce harmful inflammation with minimal risks.
An open-label clinical outcomes study to determine the safety and efficacy of Sentra AM® and Sentra PM® for post-traumatic stress disorder (PTSD) and Gulf War fibromyalgia (GWF).
Freeman-Sheldon syndrome (FSS) is a rare human neuromusculoskeletal disorder present before birth, involving primarily limb and craniofacial deformities. The hypotheses in the present study of FSS and related conditions are: (1) FSS and related conditions are associated with higher rates of posttraumatic stress symptoms (PTSS), depression, and reduced quality of life than is observed in the general population; (2) persons close to an individual with FSS or related condition suffer similarly; and (3) current measures, which are single-disease specific (i.e., PTSS, depression, craniofacial deformities, or limb deformities), do not capture the unique picture of FSS and related conditions, which involve both limb and craniofacial deformities in an intellectually capable individual. There have been no studies looking at quality of life associated with FSS. Some authors have looked at quality of life in persons with facial differences; other authors have looked at bone and joint problems. Many other authors have looked at PTSS and depression caused by health problems and bad medical experiences. No authors have looked at these problems when they happen together, as they do in FSS. Because of the above, there may be differences in patients that have FSS versus patients in previous quality of life studies. The study will also develop and validate an outcomes-based quality of life survey for FSS and related conditions.
The association between the COMT haplotypes and the presence or absence of CPSP or CRPS will be assessed stratifying the patients based on the individual categories of trauma or elective surgery.
Moral Injury Syndrome (MIS) affects up to 35-60% of Veterans managing combat-related PTSD; it results from experiences that challenge deeply held values or spiritual beliefs. Symptoms of MIS may include hopelessness, helplessness, loss of spiritual beliefs, difficulty with forgiveness, loss of meaning or purpose, reduced trust in self or others, or intractable guilt, shame or anger. Veterans managing MIS have difficulty responding to mental health treatment, and are at increased risk for suicide ideation or attempts. To date evidence-based interventions for MIS are not widely available in VA. This study will implement an evidence-based intervention for MIS in four VA facilities, collect data on the effectiveness of the intervention, and develop an implementation toolkit. This data will inform national dissemination in collaboration with the Office of Mental Health and Suicide Prevention and the National Chaplain Service.
This pooled analysis will assess Cognitive, Mental Health, Functioning, and Quality of Life Assessments data from the Phase 3 registration studies INSPiRE-ICU 1 (NCT05312385) and INSPiRE-ICU 2 (NCT05327296) to explore potential differences in Long-Term Outcomes at 3 and 6 months after treatment between critically ill mechanically ventilated patients sedated with inhaled isoflurane compared to sedated with intravenous propofol. The analyses were pre-planned and agreed prior to completion of enrollment of either study.
The goal of this study is to investigate a new treatment for chronic symptoms after concussion or mild traumatic brain injury in people aged 18-65 years old. Chronic symptoms could include dizziness, headache, fatigue, brain fog, memory difficulty, sleep disruption, irritability, or anxiety that occurred or worsened after the injury. These symptoms can interfere with daily functioning, causing difficulty returning to physical activity, work, or school. Previous concussion therapies have not been personalized nor involved direct treatments to the brain itself. The treatment being tested in the present study is a noninvasive, personalized form of brain stimulation, called transcranial magnetic stimulation (TMS). The investigators intend to answer the questions: 1. Does personalized TMS improve brain connectivity after concussion? 2. Does personalized TMS improve avoidance behaviors and chronic concussive symptoms? 3. Do the improvements last up to 2 months post-treatment? 4. Are there predictors of treatment response, or who might respond the best? Participants will undergo 14 total visits to University of California Los Angeles (UCLA): 1. One for the baseline symptom assessments and magnetic resonance imaging (MRI) 2. Ten for TMS administration 3. Three for post-treatment symptom assessments and MRIs Participants will have a 66% chance of being assigned to an active TMS group and 33% chance of being assigned to a sham, or inactive, TMS group. The difference is that the active TMS is more likely to cause functional changes in the brain than the inactive TMS.
The goal of this randomized control trial (RCT) is to test the feasibility and acceptability of a lifestyle intervention with a focus on implementing a high dose Mediterranean Diet protocol with physical activity to reduce systemic inflammation and body weight among WTC first responders having overweight/obesity and PTSD. The findings of this study will demonstrate the suitability of the proposed approach to reduce comorbidities among similar populations exposed to traumatic events; the findings will also inform the World Trade Center Health Program's extensive research and clinical efforts with the potential to provide a preventive care model to reduce systemic inflammation and related chronic disease among WTC responders with PTSD.
This study plans to learn if creative arts programs that include visual, musical, written, or physical expression can reduce symptoms of burnout syndrome, Post Traumatic Stress Disorder (PTSD), depression, and anxiety in critical care healthcare professionals. This study also explores if creative arts can enhance the connection to the purpose of work, the development of adequate coping skills, while providing time to connect with peers.
This is a randomized, placebo-controlled, double-blinded trial in which subjects with a post concussive headache meeting inclusion criterion will be assigned to one of two treatment groups: placebo or nortriptyline. Each group will be evaluated at week 0 and again each week for the next 4 weeks of treatment with a concussion survey that rates their symptoms. At the end of 4 weeks the study will be unblinded. It is hypothesized that the addition of nortriptyline to the standard headache treatments will result in more rapid decrease of symptom score than with placebo.
The purpose of this study is to determine whether a behavioral sleep treatment improves functioning and sleep in Veterans with posttraumatic stress disorder (PTSD).
The investigator's aim is to evaluate the efficacy of two types of neurofeedback treatments for PTSD symptoms reduction. Half of the participants will receive the current standard for PTSD neurofeedback care undergoing alpha/theta neurofeedback regulation. The other half will receive the newly developed limbic modulation index neurofeedback.
The purpose of this study is to compare a 4-week, moderately intensive, lab and home-based aerobic exercise program versus exercise plus cognitive training. Participants will include individuals who experience lingering symptoms of a head injury or concussion.
Developed over 10 years ago, Mindfulness Based Cognitive Therapy (MBCT) synergistically combines mindfulness training and cognitive behavioral therapy and can increase resiliency. In this study, the investigators proposed two aims: Aim #1: To adapt and optimize a MBCT resiliency program specifically for ICU nurses. For this aim, the investigators will engage multiple stakeholder groups to assist the protocol adaptation. Aim # 2: To conduct a pilot clinical trial to determine acceptability of the MBCT resiliency program and the control intervention. In this aim, the investigators will also identify the most feasible randomization level to minimize contamination between the control and intervention groups. Collectively, this proposal will pave the way for a properly designed large multi-center trial of a MBCT resiliency program (MBCT-ICU) to determine its ability to decrease BOS symptoms; and allow nurses to more effectively care for patients in the challenging ICU environment.
The purpose of this study is to determine if prazosin is more effective than placebo in decreasing frequency, severity, disability, and other negative effects of headaches related to mild traumatic brain injury in Service Members and Veterans.
The investigators propose a prospective single arm pilot cohort study of 100 youth (ages 15-25) to evaluate the feasibility of this project. A convenience sample of subjects will be enrolled on a voluntary basis from those who come to the day care center located in Nyanza, a district of the Southern province, in Rwanda.
This research project is a follow-up to the prior VA-funded study that found that chronic fatigue reported by many Gulf War veterans may be a symptom of dysfunctional cardiovascular stress response regulation. Specifically, ill veterans had diminished autonomic responses during demanding psychosocial tasks involving high level cognitive processing and emotional stress. There was a close relationship between clinical status of ill veterans and their inability to mount an appropriate physiological response under stress. The main objective of the present investigation is to determine the specific mechanism through which this abnormality may contribute to Gulf War-related chronic fatigue. We also observed that Gulf veterans with posttraumatic stress disorder (PTSD) had the most dampened autonomic activation to stressors involving higher brain activities. The second major focus of this study is to explore the role of a psychiatric disorder, specifically PTSD, as a factor in abnormalities in stress response regulation. This aspect of the study may also provide pertinent information as to the role of stress of military deployment as a contributing factor in post-Gulf War illnesses.
The purpose of the feasibility study is prevention of Post Intensive Care Syndrome in Family (PICS-F), specifically in spouses of critically ill, mechanically ventilated patients, using a nonpharmacological intervention called Sensation Awareness Focused Training (SĀF-T). This will be accomplished using a prospective, randomized, experimental design to achieve robust and unbiased results.
Background: - The autonomic nervous system helps control things that happen automatically in the body, like blood pressure, heart rate, and digestion. When it doesn t work properly, it s called dysautonomia. Researchers want to learn more about dysautonomias and train doctors to learn how to better diagnose them. Objectives: * To allow people with autonomic disorders to be evaluated. * To help fellows in the NIH Autonomic Disorders fellowship program see a variety of diseases in their training. Eligibility: * People age 18 and older with dysautonomia; children over age 2 if they might benefit * Healthy adult volunteers Design: * Participants will have different procedures depending on their symptoms. They will have one or more visits. They will have some but not all of the tests below. * Participants will have a medical history and physical exam. They may be tested for problems thinking. They may complete a symptom questionnaire. They may have their temperature and blood pressure taken. * Participants may have an intravenous line placed. A needle will guide a thin plastic tube into an arm vein. * Participants may have blood drawn several times. They may give a urine sample. * Participants may have an electrocardiogram. * How much blood a participant s heart is pumping and/or how much blood is flowing through their arm may be measured. The total amount of blood in their bloodstream may be measured. * Participants may have their ability to sweat and/or sense of smell tested. * Breathing, bowel sounds, and/or body functions may be monitored. * Pupil size, response to environmental temperature changes, and/or breathing may be measured. * Participants may have a bladder ultrasound. * Small pieces of skin may be taken for study.