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Stress Disorders, Post-Traumatic clinical trials

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NCT ID: NCT04554537 Completed - Clinical trials for Traumatic Brain Injury

Strategic Memory and Reasoning Training for Cognitive Problems

SMART
Start date: May 2016
Phase: N/A
Study type: Interventional

The focus of this study is to test a treatment program (Strategic Memory Advanced Reasoning Training; SMART) that was developed to address specific brain functions found to be crucial for the recovery following traumatic brain injury (TBI). New research has shown that when these very specific brain functions are targeted, such as ability to focus on a task while ignoring irrelevant information, brain changes are more significant. SMART emphasizes top-down processing by targeting focused attention, assimilation of information, and mental flexibility and innovation, all higher-order cognitive functions driven by the frontal lobes. Evidence from other top-down cognitive training programs demonstrates their effectiveness in improving cognitive and daily functioning in individuals reporting a TBI. In addition to improving frontal lobe capacity, SMART has also been shown to increase brain blood flow critical for complex thinking and strengthen white matter integrity. The effectiveness of SMART has been extensively tested with a variety of populations, including healthy adults and adolescents, adolescents with brain injuries, healthy seniors and those at risk for Alzheimers, and veterans and civilians with lingering impairment following TBIs. This will be the first study to test its effectiveness with individuals with mild TBI (MTBI) and posttraumatic stress disorder (PTSD). The SMART program has previously been tested with patients with TBI using an 18-hour training format. When compared to the Brain Health Workshop (BHW), an education-based active learning module, participants in the SMART group (n = 31) demonstrated improvements in gist reasoning, executive function, and memory, generalization of improvement to daily functioning activities and continuation of these gains 6 months posttraining. The training consisted of 15 hours of training conducted over 10 group sessions in the first 5 weeks and a final 3 hours of training at spaced intervals over the next 3 weeks. SMART training has not been tested with patients with PTSD-related neuropsychological impairments. The purpose of the current study is to investigate the efficacy of a shortened training program (9 hours) in improving neurocognitive function in patients with mTBI and/or PTSD.

NCT ID: NCT04532996 Completed - Clinical trials for Post-traumatic Stress Disorder

Trauma-focused Psychodynamic Psychotherapy for LGBT Patients With Post-traumatic Stress Disorder

Start date: August 12, 2020
Phase: N/A
Study type: Interventional

This is a pilot, open trial of trauma-focused psychodynamic psychotherapy for LGBT-identifying individuals who meet for DSM-5 defined post-traumatic stress disorder and are interested in receiving a research psychotherapy intervention. A sample of at least 15 therapy completers will be collected.

NCT ID: NCT04525469 Completed - Clinical trials for Post Traumatic Stress Disorder

Feasibility Trial of Narrative Exposure Therapy (NET) for Posttraumatic Stress Disorder (PTSD) During Pregnancy

NET
Start date: February 27, 2019
Phase: N/A
Study type: Interventional

Posttraumatic stress disorder (PTSD) affects up to 35% of pregnant trauma survivors. Moreover, prenatal PTSD rates are up to 4 times higher among communities of color compared to white populations. PTSD during pregnancy has been linked to an increased risk of adverse perinatal and infant health outcomes and may even contribute to racial disparities in adverse perinatal outcomes. Although front-line treatments exist for PTSD, treatment research that specifically focus on pregnancy are extremely limited. Clinical studies examining the safety, acceptability, feasibility, and efficacy of treatments for PTSD during pregnancy are virtually non-existent. Thus, pregnant individuals with PTSD, particularly within low-income communities of color, are a vulnerable and underserved group in need of effective treatment approaches for their distress. Investigators propose to conduct a feasibility and acceptability study of a PTSD treatment, Narrative Exposure Therapy (NET), in a sample of pregnant individuals with PTSD in which low-income people of color are highly represented. Aim 1: The purpose of Aim 1 will be to examine feasibility. Investigators will evaluate the recruitment and assessment procedures. Aim 2: The purpose of Aim 2 will be to examine acceptability. Investigators will evaluate participant feedback of the NET intervention. Aim 3: The purpose of Aim 3 will be to examine the proportion of participants demonstrating clinically meaningful reduction in PTSD and perinatal depression symptoms from pre- to post-treatment. Investigators will aim to enroll up to 30 participants; participation will last up to ten months. Data sources will include questionnaires, electronic medical records, and qualitative feedback interviews. With this study, investigators aim to fill a critical gap in knowledge of how to safely and effectively treat PTSD among a vulnerable and underserved population (i.e., perinatal individuals of color).

NCT ID: NCT04518007 Completed - Clinical trials for Post Traumatic Stress Disorder

Hyperbaric Oxygen Therapy for Post Traumatic Stress Disorder

HBOT
Start date: February 25, 2020
Phase: N/A
Study type: Interventional

The study evaluates the effect of hyperbaric oxygen therapy on veterans with combat-associated PTSD in an double blind sham control study.

NCT ID: NCT04508166 Completed - Clinical trials for Inflammatory Response

Towards a Post-exposition Pharmacological Prophylaxis for Post-traumatic Stress Disorder

TRAUMA-PRO
Start date: October 1, 2021
Phase: N/A
Study type: Interventional

In this study, we investigate the role that deep sleep plays in the prevention of posttraumatic stress disorder after someone has been exposed to a trauma by boosting deep sleep with two drug conditions compared to placebo condition. Each volunteer in the study goes through all three conditions. The quantity of intrusive memories of the trauma will be compared between the three conditions.

NCT ID: NCT04506294 Completed - Pain Clinical Trials

Evaluating an eHealth Solution for Screening in Pediatric Care

Start date: January 29, 2021
Phase: N/A
Study type: Interventional

This study will evaluate the predictive validity of a game-based screening system based on child self-report measures. The core study hypotheses are that (1) in-game assessments will predict problematic recovery (child pain and posttraumatic stress symptoms [PTSS]) and (2) parents in the intervention group will report greater confidence in managing child recovery.

NCT ID: NCT04504877 Completed - Covid19 Clinical Trials

Burnout and Distress preventiOn With caNnabidiol in Front-line Health Care workerS deAling wIth COVID-19

BONSAI
Start date: June 16, 2020
Phase: Phase 2/Phase 3
Study type: Interventional

The objective of this work is to monitor the level of stress and overload of a group of front-line health workers (physicians, nurses and physiotherapists) who will participate in the care of patients with COVID-19 at Hospital das Clínicas in Ribeirão Preto and its Emergency Unit (HCRP), for four weeks, and evaluate the cannabidiol - CBD's effectiveness in reducing stress for those who wish to use it.

NCT ID: NCT04501445 Completed - Clinical trials for Post Traumatic Stress Disorder

Psychological Symptoms and Families of COVID-19 Patients

Start date: September 14, 2020
Phase: N/A
Study type: Interventional

Families of patients in Intensive Care Units (ICUs) are at increased risk for developing psychological symptoms that can last for months after the patient is discharged. These symptoms can have significant impact on both the patient and family member's quality of life. The investigators have found that families of patients admitted to the Rush University Medical Center ICU during to the COVID-19 pandemic were more likely to develop clinically significant psychological symptoms than families of patients admitted prior to the COVID-19 pandemic. The investigators suspect that this finding is due in part to the hospital-wide no visitation policy that altered our standard communication practices and may have prevented families from being active participants in the patient's medical care. The goals of this project are 1) to determine the prevalence of psychological disorders among families of COVID-19 patients after ICU discharge 2) to determine the characteristics of ICU care that were associated with the development of psychological disorders among family members and 3) to pilot a program in which families with psychological disorders after ICU discharge receive therapy from mental health professionals.

NCT ID: NCT04479670 Completed - Clinical trials for Psychological Trauma

Psychometric and Patholinguistic Assessment of Psychotrauma Related to Natural Hazards in the Commune of "Le Prêcheur"

EP3LAN
Start date: March 26, 2021
Phase:
Study type: Observational

The project is to study the evolution of mental health in a little town of the French Martinique (Le Prêcheur) by using an innovative method of analysis that combines patholinguistic and psychometric indications for patients who risk of developing psychotrauma due to a natural hazard. Investigators will gather precise and factual data concerning the psychic and mental state of the population, by collecting patients' feelings and sentiments through individual interviews and audio recordings that will be then transcribed, and analyzed, and repeated, according to a quantitative, qualitative, and prospective methodology. This research is launched in order to meet the needs expressed both by the French authorities and the population towards an optimization of crisis management.

NCT ID: NCT04476914 Completed - Depression Clinical Trials

Stress Related Disorders in Family Members of COVID-19 Patients Admitted to the ICU

Start date: June 29, 2020
Phase:
Study type: Observational

Coronavirus disease 2019 (COVID-19) is a novel infectious disease caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). This syndrome has been associated with high mortality, estimated to be about 1.7% of all infected in the US, though in those who develop acute respiratory distress syndrome (ARDS) in the context of the infection, mortality rates appear to be much higher, perhaps up to 70%. To avoid transmission of the virus, patient isolation has become the standard of care, with many hospitals eliminating visitors of any type, and particularly eliminating visitation to patients infected with COVID-19. These necessary, but restrictive, measures add stress to the ICU and particularly to the family members who are not only left with fear, but also many unanswered questions. In contrast to the Society of Critical Care Guidelines (SCCM) which recommend family engagement in the ICU and recent data from this study team which suggests engaging families in end-of-life situations reduces symptoms of Post-Traumatic Stress Disorder (PTSD) in family members, family members are now unable to say good-bye and unable to provide support to their loved-one throughout the process of the patients' ICU stay. The study hypothesizes is that these restrictive visiting regulations will increase rates of Post-intensive care syndrome- family (PICS-F) which includes symptoms of PTSD, depression, and anxiety and aim to evaluate for factors that either exacerbate these symptoms or protect from them.