788 Clinical Trials for Various Conditions
The purpose of this study is to assess the safety and effectiveness of co-administered MDMA and psilocybin in military Veterans with a diagnosis of Posttraumatic Stress Disorder (PTSD).
This study examines clinical and process outcomes following variable length prolonged exposure (PE) for posttraumatic stress disorder (PTSD) delivered by one of three treatment modalities: home-based telehealth (HBT), office-based telehealth (OBT), or in-home-in-person (IHIP).
The purpose of this study is to study new ways to treat post-traumatic stress disorder (PTSD). Current treatments for PTSD do not work for everyone and it can take time to determine whether a person responds to a chosen treatment. The purpose of this study is to see whether ketamine, when given repeatedly intravenously can produce a quick and persistent improvement in PTSD symptoms. At higher doses, ketamine has been used for many years as an anesthetic for medical procedures, and at lower doses may be an effective treatment in patients with major depression and PTSD. Ketamine given for PTSD is investigational, which means that the FDA has not yet approved the drug for treating this condition. In this study, the effects of ketamine will be compared to those of midazolam. Midazolam has similar acute anesthetic effects compared to ketamine but has not been shown to treat or alleviate any symptoms of PTSD. This makes midazolam an appropriate substance to gauge whether ketamine can treat or alleviate PTSD symptoms thereby acting as what we call an active control.
This study is designed to investigate the safety of intranasal administration of NPY using a dose escalation, randomized, double-blinded, placebo-controlled crossover design in a medication-free, symptomatic PTSD group.
The purpose of this study is to examine the relationship between trauma and startle. The investigators are also looking at the effect of menstrual phase on this relationship.
This study is being conducted to understand whether training in tasks that require perceiving and thinking about things, or cognition, can improve memory in veterans who have been exposed to a blast explosion and have TBI and PTSD. A primary goal of the study is to determine whether it is feasible for veterans who don't live close to a VA to perform this cognitive training at home.
The purpose of this study is to examine the efficacy of exercise in comparison to wellness education to determine if they can improve the effects of prolonged exposure therapy (PE) in reducing symptoms of anxiety associated with Post-traumatic Stress Disorder (PTSD). In addition, the two strategies (i.e., exercise and wellness education) will be compared in terms of improvements in sleep as well as levels of brain-derived neurotrophic factor (BDNF). BDNF is a protein that helps to support the survival of existing neurons and stimulate the growth new neurons and synapses. BDNF is important to learning and memory in general and therefore may be associated with the learning and memory as it relates to PE and corresponding symptom PTSD improvement.
Posttraumatic stress disorder (PTSD) is a condition that involves intense memories of a traumatic event and intense, persistent feelings of anxiety. There are several effective therapies for PTSD, but they are often time consuming. The investigators want to see if the investigators can shorten treatment time while keeping therapy effective by adding a medication called methylene blue, USP, taken orally as a pill, to the therapy. The specific aims are: 1) To see whether medication plus psychotherapy improves PTSD symptoms more than placebo plus psychotherapy or a waitlist; 2) To examine the long-term outcome of those receiving medication plus psychotherapy 1 and 3 months after treatment has ended; 3) To examine whether medication plus psychotherapy helps with depression, trauma-related cognitions, and functioning.
Eligible veterans, National Guardsmen \& Reservists with post-traumatic stress disorder (PTSD) and problems with addiction will be randomly assigned to one of two treatment conditions. All participants will undergo exposure therapy, a gold standard behavioral treatment for PTSD for 10 weeks. In addition to exposure therapy, some participants will be randomly assigned to receive (1) virtual reality (VR)-based exposure to cues for marijuana, cocaine, heroin, cigarette, and/or alcohol use, and (2) cellular phone-based reminders of learning (extinction reminders, or, ERs) to VR exposure (available 24 hours per day/7 days per week) to high-risk contexts for drug use. The main hypothesis is that those participants who receive exposure therapy + VR/ERs will demonstrate less substance use and lower PTSD symptoms during treatment, at post-treatment, and at follow-up than those participants who only receive exposure therapy. At study completion, a total of 123 subjects signed consent.
The purpose of this study is 1) to evaluate whether massing 10 PE sessions in 2 weeks (massed trials; M-PE) is more efficacious than Minimal Contact control (MCC); 2) whether the massed sessions format retains the efficacy of treatment compared to 10 PE sessions spaced over 8 weeks (spaced trials; S-PE), and 3) to evaluate for the first time the efficacy of the 10 PE sessions delivered in 8 weeks in an active duty population by comparing it to an active comparison condition, Present-Centered Therapy (PCT).
The purpose of this study is to determine whether prazosin will: * reduce the incidence of nightmares and sleep disturbance * increase functioning and sense of well being in combat-trauma exposed Operation Iraqi Freedom/Operation Enduring Freedom (OIF/OEF) Veterans.
The purpose of this study is to test the effectiveness of group psychotherapy designed specifically for male veterans and active-duty personnel with Post-traumatic Stress Disorder (PTSD), Major Depressive Disorder (MDD) and with disturbances in their sleep or daily routine.
The goal of this study is to improve the effectiveness of tobacco cessation treatment for veterans with Post Traumatic Stress Disorder (PTSD) through ongoing, integrated care management approach using telehealth and motivational interviewing counseling. Both tobacco dependence and PTSD represent enormous challenges to the Veterans Affairs (VA) healthcare system.
In this study, the investigators are looking at how PTSD affects things such as memory, attention, reaction to sounds, eye movements, and heart rate. The investigators are also studying whether a medication called prazosin has an effect on these things.
Many service members returning from Iraq and Afghanistan have difficulties adjusting back to civilian life. Research shows that symptoms of posttraumatic stress disorder (PTSD) are particularly high in returning Operation Enduring Freedom (OEF)/Operation Iraqi Freedom (OIF) veterans, and that combat-related nightmares and sleep disturbances are common in veterans with PTSD. This is of concern because people with these problems will often use unhealthy ways of coping. Although combat-related nightmares and difficulty sleeping are highly distressing, there are helpful treatments that do not involve taking medication. One of these treatments teaches specific skills to help people improve their sleep habits and to change their nightmares so that they are less upsetting. This treatment can be very helpful and research shows that people experience decreases in the frequency and severity of their nightmares, decreased symptoms of depression and PTSD, and improved sleep quality and quantity after completing treatment. However, because this treatment has only been studied with civilians, it is not clear how well this treatment works for returning veterans. This study tests how well this treatment works in treating combat nightmares in veterans who also have PTSD from experiencing a traumatic event.
The overall objective of this project is to develop the first longitudinal registry of combat-exposed men and women with PTSD. This registry will provide essential data on the natural history, including progression and remission, and outcomes associated with PTSD in military service men and women who have utilized the Department of Veterans Affairs (VA) health care system. Additional goals of this project are to determine risk factors for PTSD among combat-exposed service men and women (by incorporating a combat-exposed non-PTSD group of veterans into analyses), and to assess the joint effects of combat exposure and PTSD on a broad range of outcome measures (by incorporating a non-combat-exposed group of veterans into analyses). Thus, the registry will allow an evaluation of current theoretical models of symptom development and progression in a large sample of service men and women who utilize the VA medical system. In addition to the PTSD registry, we will collect information on two comparison groups of OIF/OEF-era veterans to conduct nested case control studies within the general VA health care utilization database. First, a comparison group of combat veterans who are high utilizers of VA medical care, but who have not received a diagnosis of PTSD will be identified. This group will be used in analyses to identify risk factors for PTSD. Additionally, the rate of PTSD symptoms will be evaluated in this comparison group to estimate the prevalence of missed PTSD diagnoses among combat veterans with high rates of service utilization, and the resulting impact on utilization and outcomes. A second comparison group will consist of veterans with similar service record and demographic backgrounds, who were not deployed to the OIF/OEF war zones. Thus, the proposed project will create a PTSD registry from the VA database to assess the natural history and progression of PTSD in combat veterans from OIF/OEF and also to conduct case-control studies nested within the VA database. The case-control comparisons will be used to evaluate key hypotheses related to the specific aims of the overall project.
An increasing literature shows that omega-3 fatty acids provide numerous health benefits, including a variety of psychiatric symptoms and disorders including stress, anxiety, cognitive impairment, mood disorders (major depression and bipolar disorder) and schizophrenia. Omega-3 fatty acids may additionally represent a promising treatment strategy in patients with PTSD. Moreover, given its beneficial cardiovascular effects, adjunctive omega-3 fatty acids may also benefit the general health status of these veterans, who frequently present with a variety of comorbid medical disorders.
A great many soldiers are returning from Iraq and Afghanistan with symptoms of Post Traumatic Stress Disorder (PTSD). Clinical experience with many people has shown the effectiveness of the techniques of Energy Psychology for rapidly alleviating PTSD symptoms. The study proposes to determine whether a very brief course of treatment (3 sessions) with a common form of Energy Psychology called Emotional Freedom Techniques (EFT) has an effect on the stress biochemistry of subjects, by measuring their levels of stress hormones (cortisol, DHEA) before and after treatment.
The purpose of the study is to determine if quetiapine is effective in the treatment of PTSD.
To study the potential therapeutic effects of topiramate (Topamax) in the treatment of PTSD.
Combat-related post traumatic stress disorder (PTSD) has become an increasingly pressing public health problem in the United States following the overseas wars of the last decade. Rates of PTSD have skyrocketed in the military and among veterans, leading to increased rates of suicide, impairment on the job and off, and behavioral changes that negatively affect not just the veteran, but also his or her family. Although effective medication and psychotherapy treatments exist for combat-related PTSD, many individuals suffering with PTSD do not adequately respond to currently available treatment options, highlighting the need to develop and test new interventions for the disorder. To address this pressing clinical issue, the investigators will conduct a pilot study to determine if Whole Body Hyperthermia (WBH) reduces symptoms in adults suffering from combat-related PTSD. The investigators plan to recruit a sample of 10 medically healthy individuals with combat-related PTSD who will receive a single session of WBH to determine if this single session improves PTSD symptoms and, if so, whether this improvement will last at least 2 weeks. To do this, the study will include basic clinical and psychiatric assessments immediately before and one and four weeks after WBH. Because sleep is so often impaired in PTSD, the investigators will measure at-home sleep patterns for a week prior to and a week following the WBH session using sleep diaries and a wristwatch actigraphy device. Given scientific evidence from our research group that WBH may improve depression, the investigators anticipate that it may also be of benefit or adults suffering from combat-related PTSD.
The purpose of this study is to determine the effectiveness of acupuncture as a treatment for Posttraumatic Stress Disorder (PTSD) among military personnel.
This study aims to improve treatment for Veterans Health Administration (VHA) patients who experience intimate partner violence (IPV). This study will evaluate two brief counseling interventions for VHA patients who have experienced IPV in the past 12 months: Recovering from IPV through Strength and Empowerment (RISE) and advocacy-based Enhanced Care as Usual (ECAU). The RISE intervention includes up to 8 sessions and includes specific topic areas (e.g., social support, health effects, resources). The other intervention, ECAU, includes a single session that includes supportive education about IPV and health effects, discussion of ways to increase safety, and information about resources. This study will test which approach is better for improving self-efficacy and other aspects of health. Participants will answer surveys about their self-efficacy and other health and safety indicators (e.g., mental health symptoms) right before receiving treatment, approximately 12 weeks later, and then every three months after that for one year. Participation in this research will last about 15 months.
This study addresses PTSD symptoms in First Responders and Healthcare workers. Specifically, it tests whether a brief PTSD treatment (talk therapy) effectively treats PTSD when provided to First Responders and Healthcare workers by counselors in Employee Assistance Programs (EAPs). The central hypothesis is that the PTSD treatment, Prolonged Exposure for Primary Care (PE-PC), will reduce PTSD symptoms and improve functioning, compared to EAP Treatment as Usual (TAU).
Posttraumatic Stress Disorder (PTSD) and Substance Use Disorder (SUD) are highly comorbid, and comorbidity increases risk for poor functional outcomes. Risks for poor quality of life and suicide increase further for those with co-occurring PTSD and SUD diagnoses as compared to either condition alone, with suicide attempt rates three times higher for Veterans with alcohol use disorder and PTSD (Norman, Haller, Hamblen, Southwick \& Pietrzak, 2018). For patients with PTSD-SUD, there is evidence of greater PTSD symptom severity and poorer SUD treatment outcomes (e.g., Back et al., 2000), as well as higher rates of homelessness and disability (Bowe \& Rosenheck, 2015). PTSD-SUD treatments have shown promising reductions in PTSD and SUD symptoms (Flanagan, Korte, Killeen \& Back,2016). Yet, there are still major challenges in widely implementing concurrent or single-target gold-standard treatments for this population, especially with rural veterans where care access may be limited (e.g., Flanagan et al., 2016). Written Exposure Therapy (WET) is a front-line, brief and effective treatment for PTSD that addresses some of the challenges posed by other gold-standard treatments. This project is designed to examine the feasibility and acceptability of Written Exposure Therapy (WET) delivered to Veterans with comorbid PTSD-SUD while they are completing a 28 day-residential SUD program (DOM SUD). The preliminary effects of the treatment during the program, and at one month and 3-month follow-up periods will also be examined, with particular attention to rates of substance use, homelessness, treatment attendance, treatment completion, quality of life, suicidality, and PTSD and depression symptoms. Veterans enrolled in the residential substance use disorder clinic will be recruited for screening into the study. Those that meet criteria for PTSD will be randomized into one of two treatment arms: Treatment as Usual (TAU: DOM SUD) and Written Exposure Therapy in a residential SUD program (resWET). Those in the TAU control group will participate in the DOM SUD treatment program, while those in the resWET group will also have five individual treatment sessions of WET. Participants will complete weekly measures of symptoms, in addition to rating cravings for substance use. Treatment completion rates will also be compiled for both DOM SUD and resWET. Participants will complete pre-treatment, post-treatment, 1 month, and 3 month follow-up measures to look for important trends regarding symptom responses to treatment (e.g., PTSD, depression), as well as suicide attempts, homelessness, treatment attendance, treatment completion, substance use, and quality of life. This preliminary data will be used to inform future studies. Additionally, providers will provide feedback to provide essential information about implementation barriers that need to be addressed for the broader uptake of the treatment approach and to enhance accessibility of the treatment. All Veterans will also provide feedback about their treatment. Findings will be used to improve the treatment and assessment approach and to prepare for a larger study to evaluate resWET.
This study will evaluate the efficacy and safety of 10 mg of oral administration balovaptan once a day (QD) compared with matching placebo in adults with PTSD.
The purpose of this study is to assess the effectiveness of the Sana Device when added to Treatment as Usual in participants with a diagnosis of post-traumatic stress disorder (PTSD)
The purpose of this study is to assess the effects of BNC210 compared to placebo on Post-Traumatic Stress Disorder (PTSD) symptom severity as measured by the Clinician Administered PTSD scale for The Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) (CAPS-5) Total Symptom Severity Scores.
The purpose of this study is to investigate the effect of Lu AG06466 after multiple doses of 30 milligrams (mg) in participants with PTSD.
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).