Preventing Risky Drinking and PTSD After Sexual Assault: A Web-Based Intervention
Sexual assault victimization is a common and particularly harmful form of trauma that is associated with increased risk for high-risk drinking and other conditions of public health concern, such as PTSD. Given evidence that sexual assault survivors who have low social support or receive negative social reactions to sexual assault disclosure are more likely to experience PTSD and drinking problems, improving social support is a novel target for intervention. The proposed study will attempt to prevent the onset of high-risk drinking and PTSD in sexual assault survivors by developing and testing a web-based early intervention aimed at increasing contact with social supporters and mitigating the harm of negative social reactions; ultimately, results will contribute to advancing the field's understanding of the potential for social support to mitigate the harm of trauma.
NCT03703258 — Post Traumatic Stress Disorder
Status: Completed
http://inclinicaltrials.com/post-traumatic-stress-disorder/NCT03703258/
Network Dysregulation Among Individuals With Comorbid Tinnitus and PTSD
Evaluation of the overlap between tinnitus-related distress and symptoms of Post Traumatic Stress Disorder (PTSD), to identify functional covariance among resting-state networks among individuals with tinnitus and PTSD
NCT03702166 — Stress Disorders, Post-Traumatic
Status: Completed
http://inclinicaltrials.com/stress-disorders-post-traumatic/NCT03702166/
Assessment and Treatment of Cognitive Functioning Deficits in Veterans With PTSD
Approximately half a million Veterans receiving services at the VA have Posttraumatic Stress Disorder (PTSD). PTSD is strongly associated with cognitive functioning deficits in areas of concentration, attention, memory, learning, verbal abilities, processing speed, and multitasking. Compensatory Cognitive Training (CCT) is an evidence-based intervention for cognitive problems that is effective in other Veteran populations such as those with a history of traumatic brain injury (TBI), but CCT has not yet been tested in Veterans with PTSD who don't have a history of TBI. The investigators will conduct a pilot randomized controlled trial (RCT) of CCT in Veterans who have been treated for PTSD but continue to have cognitive functioning deficits. The investigators will examine feasibility, acceptability, participant characteristics, and effect size estimates in preparation for a fully-powered RCT of CCT for PTSD-related cognitive functioning deficits.
NCT03696225 — Posttraumatic Stress Disorder
Status: Recruiting
http://inclinicaltrials.com/posttraumatic-stress-disorder/NCT03696225/
CSP #2016 - National Adaptive Trial for PTSD Related Insomnia
Many Veterans with posttraumatic stress disorder (PTSD) have trouble sleeping or have frequent nightmares. So far, no medication has been approved for treatment of insomnia in PTSD. The purpose of this research study is to find out if taking medications called trazodone or eszopiclone can help decrease symptoms of insomnia in patients with PTSD. PTSD is a form of intense anxiety which sometimes results from severe trauma. Symptoms may include nightmares, flashbacks, troublesome memories, difficulty sleeping, poor concentration, irritability, anger, and emotional withdrawal. Insomnia is a disorder that can make it hard to fall sleep, stay asleep or cause a person to wake up too early and not be able to fall back to sleep.
NCT03668041 — Insomnia
Status: Recruiting
http://inclinicaltrials.com/insomnia/NCT03668041/
Leveraging Biomarkers for Personalized Treatment of Alcohol Use Disorder Comorbid With Post Traumatic Stress Disorder
This is a double-blind, 2-group randomized controlled trial evaluating the effects of topiramate versus placebo in patients with comorbid PTSD and moderate-to-severe AUD. This trial will provide one of the first rigorous tests of whether the effects of topiramate in AUD generalize to patients with co-occurring PTSD, and one of the first rigorous tests of whether topiramate has beneficial effects on PTSD symptoms in this population. It will be the first study to test whether the rs2832407 genotype predicts clinical response to topiramate for AUD and PTSD in patients with both disorders. Further, it will contribute to the understanding of topiramate's mechanisms of action in the co-morbid AUD/PTSD population, and to the discovery of predictors of treatment response.
NCT03667846 — Alcohol Use Disorder
Status: Recruiting
http://inclinicaltrials.com/alcohol-use-disorder/NCT03667846/
Propranolol Reactivation Mismatch (PRM) Treatment for PTSD: A Pilot Study
The aim of the proposed work is to gather pilot data from an attempt to enhance the ability of propranolol reactivation (PR) to improve PTSD symptoms by incorporating into the design a mismatch (PRM) between what is expected and what occurs while a subject reads a narrative of the traumatic event that caused their PTSD under the influence of the ß-adrenergic blocking drug propranolol. It is hypothesized that a series of PRM treatments will produce superior symptomatic decreases compared to what the investigators have found in prior, published studies using PR without mismatch. Under certain circumstances, retrieval (reactivation) of a traumatic memory returns it to a deconsolidated state from which it must be reconsolidated if it is to persist. Concomitant administration of the ß-adrenergic blocker weakens a deconsolidated traumatic memory and reduces PTSD symptoms, presumably through blockade of reconsolidation. It has recently been discovered that in order for deconsolidation to occur, there must be a mismatch between what is expected and what actually occurs. Altering the context in which a traumatic memory is retrieved putatively represents a deconsolidation-promoting mismatch. Experimentally increasing mismatch by manipulating context may make propranolol more effective in the treatment of PTSD. The design is a single-blind, placebo-controlled, randomized PRM clinical trial by Partners researchers in 11 convenience pilot subjects between ages 18 and 65 with active PTSD, using a 10:1 propranolol:placebo randomization schedule. This two-month study will have the following components: Pre-treatment psychometric evaluation; Treatment consisting of six weekly PRM sessions with propranolol, or placebo; Post-treatment psychometric evaluation; Six-month follow-up psychometric evaluation. The Clinician-Administered PTSD Scale (CAPS) and PTSD Checklist (PCL) will be administered at pre- and post-treatment and at follow-up. The Structured Clinical Interview for the Diagnostic and Statistical Manual of Mental Disorders-fifth edition (DSM-5) will also be administered at the pre-treatment evaluation. The PCL will also be administered prior to each weekly treatment session. Pilot data analysis will consist of calculation of percent improvements and effect sizes in CAPS-5 and PCL-5 scores; observational comparisons with results obtained without mismatch in prior published studies; informal statistical comparisons via t-tests; and calculation of effect sizes for power analysis for a subsequent definitive study, if indicated.
NCT03652922 — Stress Disorders, Post-Traumatic
Status: Not yet recruiting
http://inclinicaltrials.com/stress-disorders-post-traumatic/NCT03652922/
Neurobiological Mediators of Self-Regulatory and Reward-Based Motivational Predictors of Exercise Maintenance in Chronic Pain and PTSD
The primary purpose of the R21 is using an experimental medicine research approach to study whether a chronic, progressive-based exercise program will help Veterans suffering from chronic low back pain (cLBP) and PTSD achieve exercise maintenance, and shared symptom reduction, through neuropeptide Y mediated improvements in putative factors (self-regulation and reward sensitivity) known to improve exercise related self-efficacy and motivation.
NCT03644927 — Posttraumatic Stress Disorder
Status: Terminated
http://inclinicaltrials.com/posttraumatic-stress-disorder/NCT03644927/
Cognition and Psychotherapy in PTSD: Mechanisms and Functional Outcomes
Posttraumatic stress disorder (PTSD) is prevalent among combat Veterans and is a substantial public health burden. Several psychotherapies, including cognitive processing therapy (CPT) and prolonged exposure therapy, have been recommended as efficacious for the treatment of PTSD and are being disseminated nationally in the VA Healthcare System. Yet many individuals show limited benefit from such treatments. Accumulating evidence indicates that episodic memory deficits may be one factor limiting psychotherapy treatment efficacy in PTSD. The proposed study will determine whether verbal memory is a specific predictor of CPT outcomes in PTSD, including both symptom reductions and functional outcomes. The study will also determine the pathways by which memory functioning affects treatment outcomes by examining relationships between memory functioning, treatment engagement, recall of treatment content, and illness course. More specifically, analyses will examine whether memory for treatment content affects the relationship between memory functioning and treatment outcomes.
NCT03641924 — Posttraumatic Stress Disorder (PTSD)
Status: Completed
http://inclinicaltrials.com/posttraumatic-stress-disorder-ptsd/NCT03641924/
Identification of Biopsychosocial Factors Predictive of the Post-traumatic Stress Disorder Occurrence in Patients Admitted to the Emergencies After Trauma
After trauma or stress factor like death exposition, serious injuries or sexual violence, some patients may develop stress reaction characterized by the presence of various symptoms among different categories (reviviscence, negative humor, dissociates symptoms, occasion, hypervigilance). In the month following trauma, the investigators speak of acute stress reaction (ASR) when symptoms are present during at least three days. If symptoms are present one month after trauma, then it is a post-traumatic stress disorder (PTSD). Among patients visiting emergency after latest trauma, quite a few is in acute stress reaction. However, this reaction is often incorrectly identified by healthcare team, due to lack of oriented medical examination, patients visiting about other complaints (pain, insomnia) and not expressing clearly the trauma context. Yet, it is know that acute stress reaction occurrence and existence of dissociate symptoms after trauma confrontation is considerably predictive of the eventual post-traumatic stress disorder occurrence. The identification of risk population of post-traumatic stress disorder is not the subject of any particular structured procedure in emergency services while early care of these patients may allow limiting post-traumatic stress disorder occurrence and associate consequences. Previous works on the subject having exclusively targeted some trauma subgroups or some predictive factors subtypes, investigators propose here biopsychosocial global approach that can weight the impact of each parameters. In this study, investigators aim at determining predictive biopsychosocial factors of the post-traumatic stress disorder occurrence at 3 months in patients visiting emergency after latest trauma (less than one month old) and identified as "high-risk" to develop post-traumatic stress disorder (moderate or high).
NCT03615014 — Post Traumatic Stress Disorder
Status: Completed
http://inclinicaltrials.com/post-traumatic-stress-disorder/NCT03615014/
Written Exposure Therapy to Prevent PTSD in Survivors of Acute Cardiovascular Events: A Pilot Randomized Clinical Trial
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.
NCT03605693 — Stroke
Status: Terminated
http://inclinicaltrials.com/stroke/NCT03605693/