View clinical trials related to PTSD.
Filter by:Our research team has designed a chaplain delivered intervention focused on surrogate decision makers for hospitalized adults in the ICU. In this study, surrogates will complete an enrollment interview with research staff, including the completion of anxiety screening (GAD-7). Based on their score the surrogate will be put into one of two groups, and then randomized to either the control or intervention group. Control group members will receive usual care, while intervention group members will meet with our study chaplain, who will provide the SCAI (Spiritual Care Assessment and Intervention) framework.
Post-traumatic stress disorder (PTSD), a chronic, debilitating condition, is a growing public health concern as the Canadian population has the highest PTSD prevalence worldwide (9.2%; 3.7 million people). PTSD is linked with other comorbid mental health disorders (e.g., depression) and increased risk of chronic disease (e.g., cardiovascular disease, obesity) which presents challenges as far as selection of the appropriate treatment approach. Adjunctive treatment approaches for PTSD that include somatic-sensory body awareness (e.g., mindfulness, yoga) have been shown to be viable treatment options to reduce stress-related symptoms and enhance emotion regulation. Online treatment delivery for mental health disorders demonstrate similar reductions in self-reported symptoms as face-to-face methods and emphasize accessibility, reduced costs, and enhanced appeal to certain demographic groups. A target population at risk of untreated PTSD symptoms that may benefit from an online treatment is young adults, 18-34 yrs., who have experienced childhood trauma. No known clinical trial (CT) has addressed the effectiveness of a brief (8-week) online trauma-informed yoga intervention using both self-report and objective psychophysiology measures. The purpose of this study is to evaluate changes in self-reported PTSD symptoms and objectively measured biomarkers of autonomic regulation via pupil dilation and heart-rate-variability (HRV) following an 8-week single-arm experimental design. It is hypothesized that clinically significant reductions of: 1) PTSD total symptom severity by 10% and 2) significant reductions in pupil dilation at post-intervention and; 3) significant increases in HRV at post-intervention. This is the first study to examine objective markers of autonomic regulation among an at-risk population using multiple novel technologies (e.g., Eye Tracking Glasses, HRV) and comparing two theoretically-linked measures (e.g., HRV, Pupillometry). Comparisons of psychophysiology data with a cross-sectional convenience sample with no history of clinical PTSD or mental health conditions were made.
Early Check provides voluntary screening of newborns for a selected panel of conditions. The study has three main objectives: 1) develop and implement an approach to identify affected infants, 2) address the impact on infants and families who screen positive, and 3) evaluate the Early Check program. The Early Check screening will lead to earlier identification of newborns with rare health conditions in addition to providing important data on the implementation of this model program. Early diagnosis may result in health and development benefits for the newborns. Infants who have newborn screening in North Carolina will be eligible to participate, equating to over 120,000 eligible infants a year. Over 95% of participants are expected to screen negative. Newborns who screen positive and their parents are invited to additional research activities and services. Parents can enroll eligible newborns on the Early Check electronic Research Portal. Screening tests are conducted on residual blood from existing newborn screening dried blood spots. Confirmatory testing is provided free-of-charge for infants who screen positive, and carrier testing is provided to mothers of infants with fragile X. Affected newborns have a physical and developmental evaluation. Their parents have genetic counseling and are invited to participate in surveys and interviews. Ongoing evaluation of the program includes additional parent interviews.
The primary purpose of this study is to examine physical fitness, PTSD, and satisfaction with a Tai Chi intervention for older (aged 60 and older), sedentary, trauma-exposed veterans, in comparison to a wellness education attention control. Secondary outcomes include physical activity, depression, well-being, late-onset stress, functional status, cognition, and exercise self-efficacy. Outcomes will be examined pre- to post-intervention and in comparison to the control condition.
Research by the investigators' team and others demonstrates that posttraumatic stress disorder (PTSD), depression, alcohol use disorders (AUD), traumatic brain injury (TBI), and chronic pain frequently co-occur among post-9/11 war Veterans and are associated with functional impairment and suicide risk; however, no treatment currently exists that has been specifically designed to promote functional recovery among Veterans experiencing any combination of these most common mental and physical wounds of war. The investigative team has: (A) identified multiple modifiable psychosocial factors (emotion regulation, psychological flexibility, self-compassion) that prospectively predict impairment and suicidal ideation in Veterans; (B) characterized long-term trajectories of resilience and functional disability in Veterans; (C) determined that high utilization of VA mental health services appears to have little, if any, impact on the functional recovery of Veterans on the moderate and severely impaired trajectories; (D) identified psychological flexibility (i.e., the ability to remain present in the moment despite emotional distress and to persist in changing behavior in the pursuit of one's values and goals) as a unique, prospective predictor of membership in the severely impaired functional trajectory and of suicidal ideation, even after accounting for the effects of co-morbidity; and (E) demonstrated that Acceptance and Commitment Therapy (ACT)-a trans-diagnostic, mindfulness-based behavior therapy that seeks to improve functioning by targeting psychological flexibility -can lead to recovery, including sustained improvements in functional disability, quality of life (QoL), suicidal ideation, PTSD, and AUD symptoms among severely impaired Veterans with co-occurring PTSD-AUD. This study is Phase 3 of Project SERVE (Study Evaluating Returning Veterans' Experiences). Through two prior RR&D MERIT awards, SERVE has followed a cohort of post-9/11 Veterans since 2010 and has identified numerous risk and protective factors. SERVE's overall objective is to understand and improve the long-term functional outcomes of post-9/11 Veterans. Consistent with the investigators' conceptual model, the central hypothesis is that psychological flexibility and other trans-diagnostic treatment targets mediate the effects of the most common mental and physical wounds of war on long-term functioning and self-directed violence (i.e., suicide risk). Thus, integrated interventions specifically designed to improve functioning associated with these conditions are most likely to promote long-term recovery among the most impaired Veterans. The investigators will test the central hypothesis and accomplish the overall objective by pursuing the following specific aims: Aim 1: Identify treatment targets that prospectively predict functional disability, family functioning and self-directed violence (SDV) in post-9/11 Veterans with PTSD, depression, chronic pain, TBI, and/or AUD. To achieve this aim, the investigators will follow 500 Veterans for 2 years in order to prospectively evaluate the impact of several novel, treatment-relevant factors on functional disability and SDV over time. H1: Novel factors (mindfulness, perceived burdensomeness, thwarted belongingness, and moral injury) along with established treatment targets (psychological flexibility, self-compassion, and emotion regulation) will prospectively predict functional disability and SDV after accounting for covariates.
The overall purpose of this project is to determine the feasibility of conducting a randomized clinical trial that compares written exposure therapy with usual care among patients at risk for cardiovascular event-induced PTSD. Patients hospitalized with acute cardiovascular events, including strokes, heart attacks, and cardiac arrest are at risk of developing post-traumatic stress disorder (PTSD) due to the trauma of the acute medical event. The goal of this study is to test the feasibility of conducting a randomized trial involving a psychological intervention to prevent the development of PTSD symptoms in patients at risk for PTSD. Patients who are admitted with these acute cardiovascular events will first be screened for PTSD risk factors while in-hospital after the index event. These risk factors will include elevated threat perceptions at the time of presentation to the hospital or early symptoms of PTSD due to the cardiovascular event. Patients at elevated risk for PTSD will then be randomized to the intervention group or usual care. Those assigned to the intervention will participate in 5 sessions of written exposure therapy in which they are asked to write about the experience of their cardiovascular event with guidance from a trained study clinician. At 1 month after discharge, all patients will be contacted by phone to complete a questionnaire that assesses PTSD symptoms related to the cardiovascular event. Descriptive statistics will be used to understand the feasibility of testing the written exposure therapy intervention as part of a larger, fully powered clinical trial.
This project is responsive to RR&D's current special areas of interest for non-pharmacological activity-based interventions for chronic pain impacting pain reduction, function and quality of life. This project aligns with the VA mandate for complementary and integrative health (CIH) care for Veterans and their families. CIH complements traditional care for Veterans managing chronic conditions, such as chronic pain and PTSD. Mission Reconnect (MR) is a user-driven, dyadic, CIH self-care management program delivered remotely that teaches techniques the Veteran/partner dyad can use to reduce pain, anxiety and stress, promote well-being and improve relationship quality. The research goal is to evaluate MR as an approach to manage chronic pain and PTSD symptoms, for potential subsequent implementation. This study will possibly provide a model for establishing remote access and sustainable implementation of CIH within VA.
The purpose of this study is to optimize, culturally adapt, implement, and pilot test a trauma-informed collaborative care intervention for low-income African Americans who receive care in Federally Qualified Health Centers (FQHCs) in New Orleans, Louisiana. We will randomize 40 patients to either a Posttraumatic Stress Disorder (PTSD) collaborative care intervention or to an enhanced usual care control and will evaluate the effectiveness of the intervention (including whether outcome expectancy, coping efficacy, and trust mediate the impact of the intervention) as well as its feasibility, tolerability, and acceptability.
This study evaluates two readily implementable approaches to the delivery of transitional care for injured patients treated emergently in US trauma care systems. The two approaches to be compared are a multidisciplinary team collaborative care intervention that integrates front-line trauma center staff with peer interventionists to trauma surgical team notification of patient emotional distress with recommended mental health consultation. The collaborative care intervention will be supported by a novel Emergency Department (ED) health information exchange technology platform.
It is common for Veterans with injuries, illnesses, or physical disabilities to experience depression, post-traumatic stress disorder (PTSD), chronic pain, and other concerns. They may also have goals like becoming happier or better able to cope with challenges that life brings. The purpose of this research study is to learn whether Veterans like and benefit from a 5-week, group-based positive psychology program aimed at improving mental health, resilience, well-being, and quality of life. Participants will be asked to complete several assessments (surveys/interviews) over the course of the study that are not considered part of standard care. Additionally, participants will be asked to participate in a focus group at the end of the study to provide feedback about their experiences in the group.