Active clinical trials for "Stress Disorders, Post-Traumatic"

Patient-Centered Trauma Treatment, i.e., treatment delivered by peers with lived-experience, has the potential to increase access to trauma treatment in underserved communities. This could positively impact the lives of millions of people as 70% of adults in the U.S have experienced a traumatic event and the consequences of trauma are devastating and far reaching, including chronic and comorbid physical and mental health problems. The most known consequences of trauma include post-traumatic stress disorder (PTSD) and substance use disorders (SUDs). Seeking Safety (SS) is the most effective evidenced-based treatment for co-occurring trauma, PTSD and SUDs. While no specific degree or experience level is required to conduct SS, all the evidence comes from studies using trained clinicians to implement the treatment, including social workers, psychologists, and psychiatrists. However, these research findings do not generalize to underserved communities that lack mental health professionals. Innovative approaches to treatment, such as peer-delivered services, are required to meet the demand for care in underserved areas. While the benefits of peer-delivered services have been well-documented in many areas, the value of peers in the provision of trauma-treatment is unknown. A theoretical basis supports the potential for peer-delivered trauma-treatment to be effective in addition to the strong therapist-patient bond, (i.e. therapeutic alliance (TA), which is an important predictor of treatment outcome and a typical result of peer-patient relationships. Our research question is whether there is a difference between peer-led SS (PL-SS) groups and clinician-led SS (CL-SS) groups in improving the lives of people with trauma, PTSD and SUDs? The investigators have three specific aims: Determine the effectiveness of PL-SS groups compared to CL-SS groups in decreasing substance use and PTSD symptoms and improving coping skills, overall mental health and physical health. Hypothesis: PL-SS compared to CL-SS groups will be as effective in improving outcomes. Compare levels of TA among PL-SS and CL-SS groups and examine the impact of TA on outcomes.Hypotheses: Levels of TA will be higher and will play more of a role in impacting outcomes in the PL-SS compared to CL-SS groups. Determine if the standard Seeking Safety Instructor Training (SS-IT) is adequate for peers. Hypothesis: Peers will identify topics that will enhance the SS-IT.

Posttraumatic stress disorder (PTSD) robustly predicts anger and aggression, and U.S. Iraq/Afghanistan-era combat Veterans report that treatment for anger and aggression is among their top priorities. PTSD-related anger and aggression are associated with profound functional impairments, yet to date there are no empirically-supported treatments for Veterans with PTSD and aggression. Effective group treatment programs could improve functioning and facilitate community reintegration for these Veterans. Given that anger impedes progress in treatment of PTSD symptoms, group anger treatment could also improve Veterans' capacity to benefit from individually-administered empirically-supported therapy for PTSD such as prolonged exposure or cognitive processing therapy.

The purpose of this study is to evaluate whether the combination of prazosin and naltrexone will decrease alcohol cravings and drinking in individuals who have problems with alcohol and have used alcohol at risky levels compare to naltrexone and placebo (Nal/Pl), prazosin and placebo (Praz/Pl), and double-placebo (Pl/Pl). We hypothesize that those assigned to both prazosin and naltrexone would report significantly greater decreases in percent drinking days and heavy drinking days as well as significantly greater reduction in craving from pre to post-treatment than those assigned to either single medication or double-placebo. Prazosin is a medication that is approved by the U.S. Food and Drug Administration (FDA) to treat people with high blood pressure. Some studies have shown that prazosin may also decrease nightmares and improve sleep in Veterans suffering from Posttraumatic Stress Disorder (PTSD). Animal studies have consistently found that prazosin is associated with decreased alcohol consumption and that the combination of prazosin and naltrexone outperforms either medication alone. The current study is evaluating an "off-label" use of prazosin to determine whether it is helpful in decreasing alcohol cravings and consumption among people with alcohol problems. "Off-label" means that the FDA has not approved the use of prazosin for alcohol problems. Naltrexone is a medication that is FDA approved for treating alcohol problems. This study is sponsored by the Department of Defense and the Congressionally Directed Medical Research Program (DoD/CDMRP). We expect approximately 120 participants in this study, which will run over approximately 4 years. Study participants will be involved in the study for 7 weeks, or until they complete the Final Assessment.

This project will examine the impact of PE therapy for the treatment of PTSD with a sample of Latinos. The need to provide effective treatment to Spanish-speaking Latinos with PTSD is critical given the high prevalence of PTSD among Latinos. Furthermore, PTSD remains an under detected and under treated condition. Untreated PTSD has a substantial impact on health, functioning and quality of life. PE is one of the most empirically supported psychological interventions for PTSD. However, most studies that evidence the efficacy of PE have been conducted mainly with English-speaking Caucasian populations. This study has the potential to contribute to improvements in the well-being of Spanish-speaking Latinos with PTSD.

The purpose of this study was to assess the effects of the medication paroxetine on symptoms of posttraumatic stress disorder (PTSD) and the brain in women with a history of PTSD related to childhood abuse. The hypothesis is that paroxetine will result in an improvement in PTSD symptoms accompanied by changes in brain functional response to reminders of childhood trauma.

Individuals with serious mental illness have greater morbidity from physical illness and mortality than the general population, but tend not to initiate or sustain engagement in health promotion interventions. Although promising weight management and wellness interventions have been developed for this population, they are very intensive and tend to have low enrollment, high attrition, and low reach. This pilot study will investigate a novel low-demand intervention that may be initially more acceptable, the Get Moving and Get Well! (GMGW) program. The primary objectives of the proposed study are to investigate the effects of participation in the GMGW program on measures of behavioral activation, self-efficacy, physical activity, general physical and mental health, mood, participants' intent to engage in more intensive physical health interventions, and actual engagement in those programs. Results of this pilot study will inform a future full-scale study of GMGW.

One of the most pressing concerns within the VA currently is the provision of interventions that address the cognitive as well as emotional problems faced by Veterans with concurrent mild TBI and PTSD. One purpose of this study is to learn more about how PTSD and mild brain injury influences how people think, act, and feel. This may include how people pay attention, keep information in memory, organize plans for achieving important goals, and manage stress. Another purpose of this research is to learn more about the effects of cognitive training on the thinking, behavior, and emotions of individuals with PTSD and mild brain injury - both in the short- and long-term. With this research, the investigators hope to better understand and treat cognitive and emotional difficulties that can occur due to PTSD and mild brain injury.

Accumulating evidence suggests a key role of the N-methyl-D-aspartate (NMDA) receptor in the pathophysiology of post-traumatic stress disorder (PTSD). Recent studies suggest that the NMDA receptor antagonist ifenprodil tartrate may be a potential therapeutic drug for PTSD. The purpose of this study is to confirm whether ifenprodil tartrate is effective in the treatment of adolescents PTSD patients. If ifenprodil tartrate is effective in these patients, this study contributes to the development of novel therapeutic drugs for PTSD.

VA Cooperative Study CSP #591 is designed to compare the effectiveness of two types of psychotherapy, Prolonged Exposure (PE) and Cognitive Processing Therapy (CPT), for treating posttraumatic stress disorder (PTSD) in male and female Veterans. Despite solid evidence that both treatments are effective in Veterans and non-Veterans, there is a lack of evidence about the effectiveness of these treatments compared with one another. The sample will include 900 male and female Veterans with PTSD due to any traumatic military event. Veterans who are eligible and agree to participate in the study will be randomly assigned (by chance) to receive Prolonged Exposure or Cognitive Processing Therapy. The standard "dose" of treatment is 12 weekly sessions but Veterans who improve more rapidly may finish in fewer sessions and Veterans who improve more slowly may have additional sessions. The primary outcome is improvement in PTSD symptoms after treatment. The outcome will be measured at regular follow-up visits that will occur at the middle and at the end of treatment and then 3 and 6 months later. The investigators will measure other outcomes, including additional mental health problems, functioning, quality of life, and use of treatments for mental and physical problems. The investigators also will measure Veterans' treatment preference and examine whether Veterans who get the treatment they prefer do better than Veterans who get the less-preferred treatment. As a large multi-site trial with men and women, CSP #591 is designed to provide conclusive information about whether one treatment is better than the other, overall and for different types of patients-for example, men vs. women, combat Veterans vs. Veterans who experienced military sexual trauma, and older vs. younger Veterans. Regardless of the outcome, patients will have more information to help them make an informed decisions about which treatment to choose and VA will have stronger evidence to help make care Veteran-centered.

The purpose of this study is to explore the functional and physiological effects associated with the use of High-resolution, relational, resonance-based, electroencephalic mirroring (HIRREM), as supplemental care, for symptoms of neurological, cardiovascular, and neuropsychological disorders. This is a non-randomized, open label, and unblinded before-and-after trial, evaluating the effect of HIRREM on an objective, physiological common denominator (heart rate variability, HRV), across a variety of relevant conditions, as well as changes in clinical symptoms inventories, to generate hypotheses and pilot data for investigation in future proposals.