26 Clinical Trials for Various Conditions
This study has two components, an observational and a trial component. The observational part is being done to screen for postpartum posttraumatic stress disorder by collecting mental health assessments in women who are immediately postpartum for up to 6 weeks. Additionally, the project has a small number of subjects that will participate in a clinical trial in which they would self-select to receive one dose of hydrocortisone intravenously while they are in the hospital. This pilot of up to 20 participants in the trial arm is designed to create a first indication of whether this could become an effective early intervention to prevent PTSD if given while trauma memories are first being formed. This registration will list the observational part (number of participants =100) as well as the clinical trial (number of participants =20).
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.
Hospitalized patients are often moved from their rooms to other hospital locations, particularly imaging facilities. For patients with traumatic brain injury, such movements may raise the risk of secondary brain injuries. The purpose of this study is to monitor brain injured patients during transport and to measure the resulting changes in intracranial pressure. This will allow for documentation of the frequency of secondary injury and help in understanding their causes.
The overall purpose of this research study is to investigate the safety of pharmacological therapies that may potentially improve pediatric outcomes after traumatic brain injury. Traumatic brain injuries are the leading cause of death and disability among children and young adults. Hypothesis: Combinational therapy with a membrane transporter and antioxidant are safe after TBI and can overcome barriers to the brain and synergistically improve bioavailability and efficacy the antioxidant content of the body and CNS after TBI.
The objective of the proposed study is to conduct a systematic comparison of post traumatic stress disorder (PTSD) outcomes for veterans receiving exposure therapy via telemedicine versus in-person care. The primary aim is to determine feasibility: whether telemedicine can be used as a tool to extend effective, specialized mental health services, such as Prolonged Exposure therapy (PE; a therapy designed to help clients face fears related to a traumatic event), to veterans with limited access to care. A secondary aim is to determine if therapy delivered by telemedicine affects the quality of care in terms of clinical outcomes and the quality of patient-therapist interaction. A tertiary aim is to examine whether results from neuropsychological testing predict treatment outcomes.
Posttraumatic stress disorder (PTSD) among military service members and veterans is as high as 32% and is the third most service-connected disability, resulting in over $1.5 billion in direct costs over a five-year period. According to Clinical Practice Guidelines, strong evidence exists for psychotherapies, such as prolonged exposure (PE) for PTSD. However, psychotherapies are often met with high drop-out rates, treatment non-compliance, and emotional stress due to trauma recall. A successful approach to reduce drop-out rates and maintain efficacy is to compress psychotherapy into daily, day-long PE sessions. Yet another deficit exists regarding the feasibility of this approach outside of residential treatment facilities, which are typically reserved for the most extreme cases. The newest study from the our team aimed to augment PE residential treatment with a neuromodulatory treatment: image-guided, robot-navigated transcranial magnetic stimulation (IR-TMS). Along with the PE-focused intensive inpatient program (IIP-PE), participants received IR-TMS targeting the right dorsolateral prefrontal cortex (DLPFC) daily for 20 consecutive days. Results demonstrated superiority of the combined IIP-PE/IR-TMS approach, compared to IIP-PE and a sham condition. However, it is not yet established whether a standalone IR-TMS approach will achieve similar results. Our goal is to implement an open-label trial of IR-TMS for PTSD, in which veterans and active-duty service members with PTSD will receive accelerated IR-TMS throughout a 2-week timeframe. Results will be used as a foundation for future extramural funding to scale-up the stand alone IR-TMS intervention for PTSD treatments.
Posttraumatic stress disorder (PTSD) is prevalent among Veterans and effective evidence-based psychotherapies (EBPs) for PTSD have been implemented within the Veterans Health Administration (VHA). However, retention in PTSD EBPs is poor. Premature dropout is associated with worse clinical outcomes and greater healthcare utilization. Delivery of PTSD EBPs in a massed format, typically three or more days per week delivered within a month, have shown promise for increasing retention. The present study is a pilot feasibility and acceptability study comparing massed PTSD treatment to treatment as usual (e.g., typically weekly treatment).
The purpose of this randomized controlled trial is to evaluate whether the InMotion intervention, delivered via telehealth (using a HIPAA-compliant video platform or phone), which uses evidence-based behavioral and motivational counseling to increase daily physical activity, is an effective treatment for Major Depressive Disorder (MDD) for people who are at least one year out from sustaining a traumatic brain injury (TBI). The first aim is to compare the efficacy of the InMotion intervention to the waitlist control (WLC) condition on measures of depression severity and associated conditions in under-active adults with TBI and MDD. For the second aim the investigators plan to identify possible moderators of exercise treatment effects. The third aim will examine possible mediators of treatment outcome. In addition, the weekly dose of exercise, the extent to which exercise generates positive affect, and engagement in enjoyable or meaningful aspects of life will be explored.
The goal of this clinical trial is to extend the accessibility of the Diabetes Prevention Program Group Lifestyle Balance (DPP-GLB) modified for people with TBI (GLB-TBI) to reduce health inequities and reach a broad and diverse sample. To increase the accessibility and reach of the GLB-TBI we will conduct a randomized control trial (RCT) to assess intervention efficacy of telehealth delivery of the GLB-TBI (tGLB-TBI). Results will provide a scalable telehealth weight-loss program that clinicians and community workers across the country can use to help people with TBI lose weight and improve health.
This is an open-label study of the use of MDMA Assisted Therapy for postpartum people with co-occurring Post Traumatic Stress Disorder (PTSD) and Opioid Use Disorder (OUD). The study protocol has been adapted from the Phase 3 studies sponsored by the Multidisciplinary Association for Psychedelic Studies (MAPS) for PTSD. Due to the high rate of concurrence of PTSD and OUD, people with OUD may experience great benefit from the treatment of their PTSD with MDMA-assisted therapy based on the phase 2 and 3 studies for PTSD. Use of MDMA-assisted therapy in this population has the potential to be of benefit for their OUD and maternal- infant attachment. This study will serve to explore the feasibility and safety of offering MDMA-assisted therapy for treatment of PTSD in postpartum people with opioid use disorder. The CAPs 5 (PTSD) is the primary outcome, the Timeline Follow-Back (TLFB) for opioid use is the secondary outcome and other assessments of opioid use disorder, effects on maternal-infant attachment, social connectedness and other mental health outcomes are exploratory. The study will be conducted at the University of New Mexico Health Sciences Center located in Albuquerque New Mexico. In addition to northern New Mexico being an epicenter of the current opioid use disorder epidemic in the United States there is a long-standing history of multigenerational use of illicit opioids in many communities of northern New Mexico. There are high rates of opioid use disorder on pregnancy and accompanying Neonatal Opioid Use Withdrawal Syndrome (NOWS) in Albuquerque, Santa Fe, and surrounding communities.
Comparing the efficacy of Intracthecal Baclofen dose between the Prometra II and Medtronic SynchroMed II for patients with spasticity and with current a current SyncroMed II pump needing replacement.
Traumatic brain injury (TBI) is highly prevalent and frequently comorbid among Veterans and Service Members. Many of these individuals sustain more than one TBI over the course of their military careers, often with little recovery time between exposures placing them at increased risk for persistent cognitive, psychological, and psychosocial difficulties that impact daily functioning and life satisfaction. The short-term objective of this study is to examine the efficacy of the manualized, 10-week, telephone delivery of Tele-CABA for improving cognitive and adaptive functioning. The long-term objective of this study is to develop an accessible and acceptable intervention that can be broadly disseminated to address the complex rehabilitation needs of Veterans and Service Members. The overall goal of the Tele-CABA intervention is to reduce negative cognitive and psychiatric health outcomes for Veterans and Service Members with a history of TBI, promote personal resilience, and to design an intervention that is accessible and acceptable to patients struggling to recover from TBI.
Background: Patients with mild blunt traumatic brain injury (TBI) are frequently transferred to Level 1 trauma centers (L1TC) if they have any positive finding of any acute intracranial injury identified on a CT scan of the head. The hypothesis for the study is that patients with such injuries and minor changes on the Head CT scan can be safely managed at community hospitals (CH). Methods: Patients with blunt, mild TBI (defined as a GCS 13-15 at presentation) presenting to CH, L1TC, and transferred from CH to L1TC between March, 2012 and February, 2014 were included. Minor changes on head CT were defined as: 1) epidural hematoma\<2mm; 2) subarachnoid hemorrhage\<2mm; 3) subdural hematoma\<4mm; 4) intraparenchymal hemorrhage\<5mm; 5) minor pneumocephalus; or 6) linear or minimally depressed skull fracture. TBI-specific interventions were defined as intracranial pressure monitor placement, administration of hyperosmolar therapy, or neurosurgical operation. Three groups of patients were compared: 1) those receiving treatment at CH, 2) those transferred from CH to L1TC, and 3) those presenting directly to L1TC. The primary endpoint was the need for TBI-specific intervention and secondary outcome was death of any patient.
This study will use technology to deliver effective treatment for cognitive problems associated with TBI to Veterans at home, which may result in improved daily functioning and increased access to health care for the growing population of aging Veterans with history of TBI. The successful completion of this project may also increase older Veterans' ability to participate in research through increased understanding of the effect of in-home research opportunities on recruitment and retention. Additionally, the evidence gathered from this study may be used in future research studying home-based cognitive rehabilitation treatments for Veterans using telehealth technology.
The purpose of this study is to evaluate potential risk factors for developing postpartum depression or posttraumatic stress disorder during the first year postpartum in patients who have no preexisting history of PTSD or PPD.
Mounting amounts of evidence suggests that non-invasive stimulation of the dorsolateral prefrontal cortex (DLPFC) using repetitive transcranial magnetic stimulation (rTMS) maybe a safe and effective treatment modality for Post-Traumatic Stress Disorder (PTSD). However the large variability in the magnitude of clinical outcomes reported is likely related to the current lack of knowledge of ideal side of stimulation (left vs right) and the limited precision in the targeting of brain circuits needed to obtain an optimal treatment response. In this protocol the investigators will: 1) generate individualized treatment plans based on an individual's functional Magnetic Resonance Imaging (fMRI) and meta-analytical based connectivity analysis to guide the delivery of adjunct, imaging-based \& robotically delivered rTMS to active duty military (ADM) subjects with PTSD participating in an intensive program providing integrated evidence-based psychotherapy and pharmacological management (Treatment as Usual (TAU)). 2) To use clinician ratings and self-report PTSD symptom scales, as well as other indicators of clinical change, to determine whether compared with TAU, addition of adjunct rTMS improves clinical outcomes. 3) To conduct neuroimaging-based assessments aimed to measure rTMS effects on network connectivity in ADM receiving treatment for PTSD and the potential correlation of connectivity changes with clinical outcomes.
The purpose of this study is to determine whether a scientifically validated treatment for Posttraumatic Stress Disorder (PTSD) called Prolonged Exposure (PE) can be delivered effectively to Veterans with Military Sexual Trauma (MST) related PTSD using videoconferencing technology, which allows a therapist and patient who are not in the same room as one another to communicate. The investigators are interested in learning if this form of mental health service delivery is an acceptable alternative to traditional face-to-face therapy delivered with the therapist in the same room as the patient. This study is being conducted at the Charleston VA Medical Center and surrounding Community-Based Outpatient Clinics (CBOCs), and will involve approximately 100 female participants.
The purpose of this study is to determine if 1 gram of prehospital tranexamic acid given during emergency medical transport to a level 1 trauma center in patients at risk of hemorrhage is associated with lower 30 day mortality.
Patient-Centered Trauma Treatment, i.e., treatment delivered by peers with lived-experience, has the potential to increase access to trauma treatment in underserved communities. This could positively impact the lives of millions of people as 70% of adults in the U.S have experienced a traumatic event and the consequences of trauma are devastating and far reaching, including chronic and comorbid physical and mental health problems. The most known consequences of trauma include post-traumatic stress disorder (PTSD) and substance use disorders (SUDs). Seeking Safety (SS) is the most effective evidenced-based treatment for co-occurring trauma, PTSD and SUDs. While no specific degree or experience level is required to conduct SS, all the evidence comes from studies using trained clinicians to implement the treatment, including social workers, psychologists, and psychiatrists. However, these research findings do not generalize to underserved communities that lack mental health professionals. Innovative approaches to treatment, such as peer-delivered services, are required to meet the demand for care in underserved areas. While the benefits of peer-delivered services have been well-documented in many areas, the value of peers in the provision of trauma-treatment is unknown. A theoretical basis supports the potential for peer-delivered trauma-treatment to be effective in addition to the strong therapist-patient bond, (i.e. therapeutic alliance (TA), which is an important predictor of treatment outcome and a typical result of peer-patient relationships. Our research question is whether there is a difference between peer-led SS (PL-SS) groups and clinician-led SS (CL-SS) groups in improving the lives of people with trauma, PTSD and SUDs? The investigators have three specific aims: 1. Determine the effectiveness of PL-SS groups compared to CL-SS groups in decreasing substance use and PTSD symptoms and improving coping skills, overall mental health and physical health. Hypothesis: PL-SS compared to CL-SS groups will be as effective in improving outcomes. 2. Compare levels of TA among PL-SS and CL-SS groups and examine the impact of TA on outcomes.Hypotheses: Levels of TA will be higher and will play more of a role in impacting outcomes in the PL-SS compared to CL-SS groups. 3. Determine if the standard Seeking Safety Instructor Training (SS-IT) is adequate for peers. Hypothesis: Peers will identify topics that will enhance the SS-IT.
The purpose of this study is to record signatures from the fluid surrounding the spinal cord from people who have an implanted drug infusion system.
The present proposal is to study whether Prolonged Exposure (PE) delivered via Telemedicine is as effective as PE delivered In Person for Operation Iraqi Freedom (OIF), Operation Enduring Freedom (OEF) Veterans and Veterans of all theatres, particularly Vietnam era with Post-Traumatic Stress Disorder (PTSD). ).
The objective of this study is to evaluate whether use of TRMDU in addition to medication review leads to improved outcomes and reduced health care costs for patients when compared with medication review alone. The study will be conducted in patients assigned to Department of Defense (DOD) Warrior Transition Units (WTU's), similar DOD units, and VA polytrauma centers.
The purpose of this study is to evaluate the equivalence of CPT treatment delivered remotely via telemental health (TMH) over videoconferencing or via traditional face-to face (FTF) treatment to veterans who have Post-traumatic Stress Disorder (PTSD) from a military-related stressor (i.e., combat, sexual assault, non-combat physical assault). The secondary objective is to determine if patients' ratings of PTSD symptoms, affect, social adjustment, therapy alliance, treatment satisfaction and therapist satisfaction, are equivalent between service-delivery conditions (TMH vs. FTF). A final objective is to develop web-based practice assignments to assist participants in the TMH condition with treatment adherence (completion of the between- session practice assignments).
The major goal of this project is to test the feasibility and acceptability of using videoconferencing to provide support groups led by trained facilitators to rural women with breast cancer in northern California.
This is a randomized controlled trial of a dyad-centered, doula support and healthcare coordination model of care in a large urban neonatal intensive care unit (NICU), which serves a high-risk, low-income, majority Black population. In addition to doula support and coordination of care in the NICU, there will be a warm handoff to a community doula to continue the support once infants leave the Hospital of the University of Pennsylvania (HUP) NICU.
Injuries to the genitalia are of concern to the military with emphasis placed on the surgical reconstruction and psychological health of these Wounded Warriors. However, despite significant surgical advances in microvascular surgery and autologous free tissue transfer, conventional reconstructions cannot truly replace the complicated structures and functions of the penis including the urethra, erogenous sensation, and erectile corporal bodies. Conventional reconstruction poses several challenges: patients may not have sufficient donor tissue due to other injuries or previous surgery; multiple operations are often needed to restore the neophallus; the final reconstruction only approximates the penis' native form; recreating the urethra is challenging and the new urethra is prone to stricture and fistula formation; the erectile function necessary for sexual intercourse is often lacking; and insufficient protective sensation can lead to penile implant extrusion, infection, subsequent explantation or loss of the reconstruction. The investigators propose this clinical trial to determine functional outcomes and quality of life for Wounded Warriors and civilians who choose to undergo penile allotransplantation. The investigators will combine extensive experience performing total penile reconstruction in a large population affected by congenital, traumatic, and therapeutically extirpated Genitourinary deformities and expertise in reconstructive transplantation using an immunomodulatory protocol to for this study. The investigators anticipate penile transplantation can potentially replace "like with like," restoring the appearance, anatomy, and function of the recipient in a manner far superior to autologous reconstruction. This project will establish the ability to perform penile allotransplantation using an immunomodulatory protocol and will compare outcomes with conventional phalloplasty patient results. Study Design: This is a non-randomized subject self-controlled clinical trial to implement a cell-based immunomodulatory protocol for penile allotransplantation. An intermediate deliverable is achieving allograft survival and functional return with reduced dosing/frequency of maintenance immunosuppression on steroid-free monotherapy (tacrolimus) immunosuppression. The long-term deliverable and goal is to demonstrate superior outcomes when compared to satisfaction and QOL in conventional phalloplasty patients 12-60 months post-transplant.