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Showing 1-20 of 692 trials
NCT06386003
This is an open-label trial evaluating feasibility, tolerability, safety and efficacy of psilocybin assisted cognitive processing therapy for chronic Posttraumatic Stress Disorder (PTSD).
NCT07670702
This study is evaluating the long-term safety and efficacy of TSND-201 in adults with PTSD. Participants that have completed a double-blind clinical trial with TNSD-201 for PTSD will be invited to participate in this open-label extension trial. Each participant will be able to receive up to three Treatment Courses over the duration of the study (up to 48 weeks). Each Treatment Course includes 4 dosing sessions, spaced one week apart.
NCT07175025
The NEXT Study is a randomized controlled pilot examining the feasibility and acceptability of a revised perinatal PTSD protocol. This study will randomize perinatal participants with PTSD to receive NET (n=45); treatment group) and will be compared to perinatal women randomized to usual care (n=45; comparator group). The overall objective of this project is to determine the most feasible and acceptable protocol for a brief virtual perinatal PTSD intervention.
NCT07082218
Following adolescent concussion, poor sleep health is common and relates to the development of persisting post-concussion symptoms, and uninjured adolescents (independent of concussion) also commonly experience sleep insufficiency. Given the sparse guidance that exists for clinicians to provide evidence-based sleep health recommendations for adolescents with a concussion, the primary objectives of this prospective randomized clinical trial of adolescents with a recent concussion are to discover if a multidimensional and prescriptive sleep health intervention leads to: 1) faster symptom resolution time, better sleep quality, or longer sleep duration; and 2) improved sleep habits, mental health, or academic engagement, relative to standard-of-care post-concussion sleep health guidance. Findings from this research will provide the basis for more precise sleep health recommendations for adolescents who experience a concussion.
NCT00178659
The specific aim of this research is to determine if the blood from brain-injured patients contains reproducible protein markers that appear prior to elevations in intracranial pressure (ICP).
NCT05692271
This study evaluates the therapeutic tolerability of the use of Cognitive Processing Therapy (CPT) with propranolol in participants with Posttraumatic Stress Disorder (PTSD) and Alcohol Use Disorder (AUD). The investigators are planning to perform an initial proof -of- concept randomized, placebo- controlled trial evaluating propranolol in participants with PTSD and AUD starting CPT for 12 weeks with three post-treatment follow ups at week-16, week-20, and week-24. Participants with current diagnosis of PTSD and AUD seeking treatment will be randomized to either a propranolol group (n=24) or placebo group (n=24) after enrollment. All participants will receive CPT for 12 weeks after randomization. Primary outcomes will be measured in both groups at the end of the study (week 12).
NCT05929911
People living with HIV (PLWH) have a higher rate of post-traumatic stress disorder (PTSD) diagnosis than the general population. Comorbid PTSD is also associated with negative HIV-related health outcomes. Unfortunately, little outcome research has examined the usefulness of PTSD treatments for PTSD. This pilot study adapts for PLWH a non-exposure based psychotherapy for PTSD focused on reflecting on one's emotions and relationships and understanding and working through how trauma may have disrupted them. The study team is interested in better understanding the needs of PLWH with PTSD, learning whether PLWH with PTSD find this treatment acceptable and helpful, and beginning to understand the relationship between HIV-related health factors (e.g., inflammation and stress biology) and PTSD, and how these health factors may improve during treatment.
NCT05446597
Given the rising rates of concussion in youth ages 10-19 and the significant proportion of young people who remain symptomatic for months following concussion, research evaluating the efficacy of multifaceted treatment options following concussion is imperative. Studies examining the efficacy of treatment strategies following concussion in children and adults are surprisingly limited, and most focus on one treatment approach, have small sample sizes, are not randomized controlled trials, and focus on individuals with prolonged recovery (months). There is a need for a multifaceted treatment trial to examine the early implementation of treatment approaches that may reduce prolonged recovery while considering the heterogeneous presentation of symptoms and patient preferences in the sub-acute stage following concussion. Randomized controlled trials that consider a multifaceted transdisciplinary approach to treatment in the early period following concussion are needed to raise the bar regarding evidence-informed management following concussion
NCT07643181
This study aims to examine the effect of a Mindfulness-Based Self-Compassion Program on self-compassion levels, secondary traumatic stress, and professional quality of life in midwives and nurses working in obstetrics. Healthcare professionals in this field are frequently exposed to traumatic experiences such as complicated deliveries, perinatal loss, and obstetric emergencies, which may lead to secondary traumatic stress and reduced professional quality of life over time. This study is designed as a pre-test/post-test randomized controlled trial. A total of 80 participants (40 intervention, 40 control) will be recruited from Gaziantep Cengiz Gökçek Obstetrics and Pediatrics Hospital. The intervention group will receive an 8-week Mindfulness-Based Self-Compassion Program (one session per week, 60-90 minutes each). The control group will receive no intervention. Outcomes will be measured before and after the program using validated scales for self-compassion, secondary traumatic stress, and professional quality of life.
NCT07090473
The goal of this study is to test whether electrical stimulation from the skin surface starting 3 days after spinal cord injury (SCI) is safe and may help patients recover their movement. The main questions it aims to answer are: * is starting electrical stimulation 3 days post SCI safe? * can starting electrical stimulation 3 days post SCI help patients recover movement? This study will be done in two phases. Both phases will be done during the patient's stay in the hospital/intensive care unit (ICU). In the first phase, participants' will undergo several tests before and after a single treatment. Assessments will be repeated before the patient will go home at around 7 days post injury. * assessment of the ability to move arms/legs and feel touch or pin prick * blood and cerebral spinal fluid draws * assessment of their spinal cord function using electrical stimulation * receive a single 60-minute continuous electrical stimulation treatment * patient's safety will be monitored throughout the intervention with the existing standard of care methods in the ICU settings. In the second phase, researchers will compare active electrical stimulation to sham stimulation to see if active stimulation safely leads to improvement in person's movement ability. In this second phase, participants' will undergo tests before and after electrical stimulation treatment which will be delivered 5 days in the row. Assessments will be repeated before the patient will go home at around 7 days post injury. * assessment of the ability to move arms/legs (every day) and feel touch or pin prick (before and after 5 days of treatment) * blood and cerebral spinal fluid draws (before the first treatment session and before going home) * assessment of their spinal cord function using electrical stimulation (before the first treatment session and before going home) * receive daily 60-minute continuous electrical stimulation treatment for 5 days while in ICU * patient's safety will be monitored throughout the intervention with the existing standard of care methods in the ICU settings.
NCT06635486
This project aims to improve mental health support for Venezuelan migrants living in Lima, Peru, who often face challenges like anxiety, depression, and post-traumatic stress disorder (PTSD). Since 2015, millions of Venezuelans have fled their country due to a severe humanitarian crisis, including extreme inflation, food shortages, and political unrest. Many of these individuals now live in Peru, where they struggle to access mental health services. A new type of intervention that is both evidence-based and culturally adapted to meet the specific needs of Venezuelan migrants is the focus of this research. The intervention is designed to be delivered by trained lay providers-people from the community who have received special training but are not professional mental health workers. The intervention consists of 6 to 12 weekly online sessions, each lasting about an hour. These sessions will cover various therapeutic techniques, including cognitive restructuring (changing negative thought patterns), behavioral activation (encouraging positive activities), and emotional regulation (managing feelings). The sessions will be conducted remotely, allowing participants to join from the comfort of their homes.This approach is intended to make mental health care more accessible and relatable for migrants, who may feel more comfortable receiving help from someone who understands their cultural background and experiences.
NCT07590778
This study examines a trauma-focused treatment for very young children who were born prematurely and developed post-traumatic stress related symptoms after medical care. Preterm infants often experience stressful events in the hospital, which can affect their emotional and behavioral development. In this study, an adapted form (storytelling) of Eye Movement Desensitization and Reprocessing (EMDR) therapy was used with preterm born children aged 0 to 2 years. The treatment was delivered in a small group of participants, and changes in post- traumatic stress symptoms, sleep, emotional functioning, parental PTSD symptoms and perceived bonding and parent-infant interaction were monitored over time using parent reports. The aim of the study is to evaluate whether this early intervention (EMDR, storytelling) is feasible, well accepted by families, and potentially effective in reducing post-traumatic stress related symptoms in this vulnerable population.
NCT06938932
This is a randomized controlled human exposure crossover study. Investigators aims to assess the acute effects of high temperature exposure and the underlying mechanisms.
NCT07583277
The investigators will investigate the selective dorsal rhizotomy in post traumatic brain and spinal cord injury induced spasticity to evaluate the efficacy of this procedure in reducing the tone of the spastic muscle groups. Selective dorsal rhizotomy is well established effective procedure in participants with cerebral palsy associated spasticity. As low and middle income countries, intrathecal baclofen pump is expensive for patients.
NCT03400345
Upper extremity allotransplantation is a new procedure which is becoming more common in the United States. Ongoing data collection for research purposes is vital to the long-term assessment as to the safety of the procedure and accompanying immunosuppression protocol, as well as quantifying patient outcomes and changes in quality of life. For these reasons, The Johns Hopkins Hand/Arm Transplantation Team is interested in enrolling transplanted patients in a follow-up protocol to continue collecting informative data to further the field of vascularized composite allotransplantation.
NCT03819608
This study will determine (i) the magnitude of immediate and sustained effects of a current clinical standard interactive computer attention processing training (APT) when combined with intermittent theta burst stimulation (iTBS), a type of repetitive transcranial magnetic stimulation and (ii) determine how APT + iTBS changes the neurocognitive system of attention in individuals with persistent attention deficits related to mTBI +/- PTSD.
NCT06096740
The purpose of this study is to identify how trauma-focused psychotherapy changes the function of brain circuitry in posttraumatic stress disorder (PTSD) and how this mediates improvements in the diminished ability to experience positive emotions following a traumatic or extremely stressful life event. In this instance, the investigators will be using cognitive processing therapy (CPT), a widely-utilized and evidence-based treatment for PTSD.
NCT03992404
The purpose of this study is to determine whether a single treatment with administration of 400 Units NT 201 (botulinum toxin) is superior to placebo (no medicine) for the treatment of lower limb spasticity caused by stroke or traumatic brain injury (Main Period). Participants will be assigned to the treatment groups by chance and neither the participants nor the research staff who interact with them will know the allocation. The following 4 to 5 treatment cycles will investigate the safety and tolerability of treatment with NT 201 (botulinum toxin) when administered in doses between 400 and 800 Units (Open Label Extension Period). All participants will receive the treatment and the dose will depend on whether only lower limb spasticity or combined upper and lower limb spasticity are treated.
NCT07299136
Pregnant women participating in our study will receive the intervention (hugging, praying, and hugging + praying) from the researcher or a relative as often as they wish during labor and contractions. These sessions will be administered during each stage of labor, taking into account when the pregnant woman is ready to begin the intervention.
NCT06693778
Six primary care practices within a large Philadelphia pediatric care network will use an electronic Clinical Decision Support (eCDS) tool as standard care for concussion evaluation. The eCDS tool will include a prediction rule for children aged 5-18 assessed for mild traumatic brain injury (mTBI). The eCDS tool predicts risk for persistent symptoms and prompts referral to specialty care for those deemed high risk. This research proposes to analyze the clinical and process outcomes in these six practices relative to the rest of the care network, specifically, whether the eCDS tool reduces time to symptom resolution.