PTSD Clinical Trials

Heart disease and diabetes are leading causes of death and disability in the US, especially among Veterans. Posttraumatic stress disorder (PTSD) is a disabling condition that also affects many Veterans. New research suggests that PTSD further increases the risk of developing heart disease and diabetes. What causes this increased risk is unknown. However, individuals with PTSD are often less physically active and make more unhealthy dietary choices than individuals without PTSD. Maintaining a physically active lifestyle, staying physically fit, and eating a healthy diet may be important for reducing the PTSD related risk for heart disease, diabetes and disability. The proposed research seeks to assess how important these lifestyle factors are for reducing the risk of heart disease, diabetes and disability in Veterans with and without PTSD. A better understanding of these lifestyle factors and cardiometabolic health in Veterans will help to clarify how lifestyle interventions can best be applied to the prevention and treatment of long-term disability in Veterans. Aim 1: To examine physical activity participation as a mechanism linking PTSD to cardiometabolic health and functioning in post-9/11 Veterans. This study will longitudinally assess associations between PTSD diagnosis, physical activity, cardiometabolic health, and functioning over time in 250 TRACTS participants. H1-1: Total self-report physical activity will mediate the effects of PTSD on cardiometabolic health and functioning over time, such that lower physical activity will increase the detrimental effect of PTSD on cardiometabolic health and functioning. H1-2: physical activity intensity will moderate the effect physical activity has on cardiometabolic health and functioning. Aim 2: To examine diet quality as a mechanism linking PTSD to cardiometabolic health and functioning in post-9/11 Veterans. This study will longitudinally assess associations between PTSD diagnosis, diet quality, cardiometabolic health, and functioning over time in 200 TRACTS participants. H2: Self-report dietary intake will mediate the effects of PTSD on cardiometabolic health and functioning over time, such that a poor diet will increase the detrimental effect of PTSD on cardiometabolic health and functioning. Supplemental Aim: To validate the use of a self-report clinical measure of physical activity against objective measure obtained via accelerometry. Objective measurement of physical activity is not often accessible or feasible for VA providers (e.g., time constraints). It is essential that quick self-report physical activity measures accurately reflect the physical activity of Veterans. This study will compare data from a self-report clinical physical activity measure to objectively measured physical activity/sedentary time (i.e., accelerometry), cardiorespiratory fitness, cardiometabolic health, functioning, and PTSD symptom severity in 100 post-9/11 Veterans. H1A-1: Self-report and objective measurement of physical activity will be significantly correlated. H1A-2: Both self-report and objectively measured physical activity/sedentary time will be associated with cardiorespiratory fitness, cardiometabolic health, functioning, and PTSD symptom severity. Read Less

The goal of this observational study is to learn how the brain's information processing changes during and following administration of serotonergic psychedelics (psilocybin, N,N-Dimethyltryptamine/DMT, Lystergic Acid Diethylamide/LSD, etc.) for people with and without mental illness receiving serotonergic psychedelics through any clinical trial at Yale University. The main questions it aims to answer are: 1. Do serotonergic psychedelics cause the brain to rely on new information more than previously learned information while under the influence? What about 1 day, 5-14 days, and 4-6 weeks after use? 2. Do serotonergic psychedelics cause long-lasting side-effects in how people perceive (see, hear, feel, etc.) the world and how easily people change their beliefs? 3. How does the brain's electrical activity change after using serotonergic psychedelics? How does the balance between excitation and inhibition change while under their effect? 4. Can changes in how the brain uses information predict who will benefit from a psychedelic and who will have side effects from psychedelics? Researchers will compare with people given placebos to see what changes in brain processing are unique to serotonergic psychedelics. Participants will have the opportunity to do some combination of the following: 1. Online computer assessments consisting of games and questionnaires that probe how participants think. 2. Magnetoencephalography (MEG) or electroencephalography (EEG) with eyes closed and with repeated clicks, images, or sensations delivered. 3. A magnetic resonance imaging (MRI) scan. 4. Semi-structured qualitative interviews about their experience after taking a serotonergic psychedelic recorded via Zoom. Read Less

The purpose of this study is to test the safety and efficacy of repeated doses of ketamine as compared to placebo to reduce symptoms of Posttraumatic Stress Disorder (PTSD) among Veteran receiving Prolonged Exposure Therapy. Read Less

The U.S. Deaf community - a group of more than one million Americans who communicate using American Sign Language (ASL) - experiences nearly triple the rate of lifetime problem drinking and twice the rate of trauma exposure compared to the general population. Although there are several treatments for alcohol use disorder (AUD) and posttraumatic stress disorder (PTSD) in hearing populations, none have been developed for or tested with Deaf clients. To address these barriers, the study team developed Signs of Safety, a Deaf-accessible therapy toolkit for treating AUD and PTSD. Their aims are to conduct a nationwide, virtual clinical trial to compare (1) Signs of Safety with (2) treatment as usual and (3) a no treatment control, to collect data on clinical outcomes, and to explore potential mediators and moderators of outcome. Read Less

The purpose of this study is to assess the efficacy of the combined interventions, Skills Training in Affective and Interpersonal Regulation (STAIR) and Parent-Child Interaction Therapy (PCIT) or P-STAIR, for treating maternal PTSD and reducing maltreatment recidivism. Read Less

Posttraumatic stress disorder (PTSD) is a disabling psychiatric disorder that affects 20%-30% of U.S. Veterans. PTSD is strongly associated with increased risk for substance abuse comorbidity, including cannabis use disorder. Multiple states now include PTSD as a condition for which patients can be legally prescribed medical marijuana, despite the fact that there has not been a single large-scale randomized clinical trial demonstrating the efficacy of cannabis to treat PTSD to date. The overall objective of the current proposal is to study the impact of reduced cannabis use on functioning among Veterans with PTSD. The investigators will evaluate the relationship between cannabis use and daily functioning among cannabis users and heavy cannabis users. The central hypothesis is that reductions in cannabis use will lead to positive changes in the functional outcomes of Veterans. The rationale for this research is that it will provide the first and only real-time data concerning the impact of reduced cannabis use on daily functioning among Veterans with PTSD. Read Less

Veterans with mild traumatic brain injury (mTBI) and post-traumatic stress disorder (PTSD) commonly experience cognitive impairments including attention and executive function deficits that interfere with their ability to engage in productive personal and social activities. Of the limited interventions available to address cognition, none rigorously train attention beyond strategy management. This study will evaluate an innovatively combined strategy training known as Goal Management Training plus computerized attention training in Veterans with mTBI/PTSD. Preliminary testing suggests an effectiveness in improving problem solving, attention and functional tasks in a small number of Veterans. Considering these promising results, cost effectiveness, and the demand for access to care from Veterans living in rural areas, a Randomized Controlled Trial will determine and compare the effects of this treatment, administered either in-person or via telehealth, on executive function, attention, other aspects of cognition and real life functional tasks. Read Less

This is a randomized controlled trial of Trauma-Focused Psychodynamic Psychotherapy (TFPP) in comparison with TAU (at the VA) in a 2:1 ratio in 75 Veterans with PTSD who have not responded to standard treatment at the VA. Read Less

To evaluate if intranasal insulin is effective in reducing PTSD symptoms. Read Less

Although most people recover from acute pain (such as pain caused by injury, surgery, repetitive motion, or unknown causes), many people do not fully recover and will experience chronic pain. Untreated posttraumatic stress disorder (PTSD) appears to be a key risk factor for the transition from acute pain to chronic pain. However, few published studies have addressed the issue of preventing the transition from acute to chronic pain via PTSD reduction. This project will aim to test whether trauma-related PTSD symptoms can be reduced using either Stellate Ganglion Block (SGB) treatment or Cognitive Processing Therapy (CPT), and whether reducing PTSD symptoms can prevent the transition from non-injury based acute pain to chronic pain. Read Less

The proposed study will test whether a working memory training (WMT) program improves fear extinction learning and its underlying neural circuitry in Veterans with posttraumatic stress disorder (PTSD). WMT is designed to improves the ability to maintain task-relevant information in mind. The project will further validate the relationship between working memory and fear extinction using novel computational and multivariate analyses that link to specific PTSD symptoms. If WMT can enhance fear extinction learning, then WMT may be a powerful adjunctive treatment that can enhance exposure therapy outcomes or be leveraged as a stand-alone treatment. This project supports the Department of Veteran Affairs mission of developing viable targets of treatment for Veterans with PTSD. Read Less

The trial will include a randomized control trial to evaluate the efficacy of using Cannabidiol (CBD), a non-intoxicating cannabinoid, as an adjunctive to Prolonged Exposure therapy (PE). The trial will compare PE + CBD to PE + placebo in a sample of 136 military Veterans with PTSD at the VA San Diego Medical Center. The study represents the logical and innovative next step for augmenting existing treatments and developing novel pharmacotherapy for PTSD. Findings from the proposed RCT will inform clinical practice and policy by investigating whether administration of CBD in the context of PE therapy will improve treatment outcomes for military Veterans with PTSD. Read Less