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Stress Disorders, Post-Traumatic clinical trials

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NCT ID: NCT04185155 Terminated - Clinical trials for Post Traumatic Stress Disorder

Simple Cognitive Task After Trauma EKUT RCT

Start date: December 10, 2019
Phase: N/A
Study type: Interventional

This research study is designed to investigate the effects of a simple cognitive task (a memory cue following by playing the computer game "Tetris") on intrusive memories ("flashbacks") and other symptoms after a traumatic event. Patients presenting to a hospital emergency department soon after a traumatic event will be randomly allocated to either the simple cognitive task intervention or control. Participants will be followed up at one week and one month, and where possible 3 and 6 months. It is predicted that participants given the simple cognitive task intervention will develop fewer intrusive memories and less severe related clinical symptoms than those who are not. This will inform the future development of a simple technique to prevent distressing psychological symptoms after a traumatic event. Implementation and training aspects in a hospital context will also be explored. Patients use their smartphone for part of the intervention in the study.

NCT ID: NCT04183205 Recruiting - Clinical trials for Major Depressive Disorder

Predicting SSRI Efficacy in Veterans With PTSD

SSRI
Start date: September 11, 2019
Phase: Phase 4
Study type: Interventional

This is a research study to examine the effectiveness of a brief screening method that may predict which people with posttraumatic stress disorder (PTSD) or depression are most likely to show a positive response to selective serotonin reuptake inhibitor (SSRI) medications. Participants will be recruited over approximately 5.25 years, until at least 94 participants complete the 17 week study.

NCT ID: NCT04180930 Recruiting - Clinical trials for Stress Disorders, Post-Traumatic

An Evaluation of Two PTSD Assessments in an Active Duty and Military Veteran Sample

Start date: April 15, 2019
Phase:
Study type: Observational

Given the high prevalence of post-traumatic stress disorder (PTSD) in veterans and active duty military, the focus of this research study is to test the reliability of two new PTSD assessments, the Clinician Administered PTSD Scale for DSM-5 (CAPS-5) and the PTSD Symptom Scale Interview for DSM-5 (PSSI-5) and compare the results between the two new assessments and the previous "gold standard", the Clinician Administered PTSD Scale for DSM-IV (CAPS-IV). Biomarkers believed to be related to PTSD (e.g., biofluid biomarkers, cognitive and physiological markers, and neural activity as measured by EEG) will be collected to inform targeted interventions in specific groups of patients and other large-scale biomarker discovery efforts in the field. Participants will be 950 male and female active duty military and veterans ages 18 or older who have been exposed to at least one traumatic event.

NCT ID: NCT04174170 Completed - Clinical trials for Post Traumatic Stress Disorder

Brexpiprazole as Combination Therapy With Sertraline in the Treatment of Adults With Post-traumatic Stress Disorder

Start date: October 30, 2019
Phase: Phase 3
Study type: Interventional

This will be a 12-week, multicenter, randomized, double-blind trial evaluating the efficacy, safety, and tolerability of fixed-dose brexpiprazole + sertraline combination treatment in adult subjects with post-traumatic stress disorder.

NCT ID: NCT04163341 Completed - Depression Clinical Trials

Tailored Response to Psychiatric Comorbidity to Improve HIV Care Engagement in the United States

TRACE
Start date: October 23, 2020
Phase: N/A
Study type: Interventional

This pilot randomized clinical trial will randomize 60 participants 1:1 to either enhanced usual care or to adapted CETA, a counseling intervention for HIV care engagement plus depression, anxiety, PTSD, and/or substance use.

NCT ID: NCT04160273 Not yet recruiting - Delivery Clinical Trials

Evaluation of Postpartum Posttraumatic Stress Disorder at Angers University Hospital (ESPT-PP)

ESPT-PP
Start date: November 2019
Phase: N/A
Study type: Interventional

The purpose of this study is to estimate the prevalence of post-traumatic stress disorder (PTSD) at one month in women who have given birth at the University Hospital of Angers over a period of 1 year.

NCT ID: NCT04152993 Recruiting - Clinical trials for Post-Traumatic Stress Disorder

Responsive Neurostimulation for Post-Traumatic Stress Disorder

Start date: March 22, 2021
Phase: Early Phase 1
Study type: Interventional

Post-traumatic stress disorder (PTSD) refractory to treatment is marked by failure of fear extinction and its biological substrate, amygdala reactivity to trauma reminders. Decades of research have clarified the neuronal mechanisms coordinating fear extinction and consolidation. Fear cells and extinction cells in the basolateral amygdala (BLA) alter their firing rate based on the nature of the stimulus and the influence from the medial prefrontal cortex (mPFC) and the ventral hippocampus (vHPC). Together, the BLA, mPFC, and the vHPC form an anxiety-processing network where the BLA links stimulus to emotion, the vHPC provides memory context, and the mPFC coordinates extinction or consolidation. Local field potential (LFP) recordings from the BLA have revealed specific signals that correspond to an enhanced fear state. Previous studies have shown that neuromodulation of the BLA can promote extinction in a rodent model and in a treatment-refractory PTSD patient. This action is likely carried by disrupting fear signals within the BLA; however, continuous neurostimulation may also disrupt normal function of the amygdala. The present application proposes to investigate the use of Responsive Neurostimulation (RNS, Neuropace) in six (6) veterans suffering from severe treatment-resistant PTSD. This dual-activity device will allow us to chronically record LFPs from the BLA under specific conditions such as fear conditioning, exposure to trauma reminders, and emotional memory encoding and retrieval. In addition, the neural activity will be captured during real-life symptoms of flashback and nightmares. These recordings will provide the specific electrophysiological biomarkers of hypervigilance and re-experiencing. The device will then be programmed to detect and treat these biomarkers with a pre-determined electrical pulse. The patients will be followed prospectively using psychological scales but also with functional neuroimaging and electroencephalograms. These modalities will be used to determine the extent of circuit engagement as a result of the therapy. By approaching PTSD from a fear processing mechanism perspective, our project will serve as a proof of concept for other circuit-based therapies in psychiatry. This proposal is a multi-departmental effort involving 11 investigators across 7 departments and requires a close collaboration between clinical and basic scientists. As a result, the findings underlying chronic recordings will bridge the basic science results from fear conditioning research to clinical neural processes in PTSD patients.

NCT ID: NCT04152772 Completed - PTSD Clinical Trials

Effect of tDCS Timing on Safety Memory in PTSD

Start date: November 22, 2019
Phase: N/A
Study type: Interventional

The primary purpose of this study is to investigate the effects of tDCS timing on safety memory in PTSD. A total of 90 participants will be randomized equally across one of three groups: 1. One group receiving active stimulation during extinction and sham during consolidation 2. One group receiving sham stimulation during extinction and active during consolidation 3. One group receiving sham stimulation both during extinction and consolidation This study will also include an online sub-study focused on contextual processing along the PTSD spectrum. A maximum of 500 participants will be recruited using an online, panel-based platform.

NCT ID: NCT04150380 Recruiting - Inflammation Clinical Trials

Probiotic (LGG) for Veterans With PTSD

Start date: August 24, 2020
Phase: Phase 2
Study type: Interventional

Exaggerated inflammation in the body and brain is thought to play a role in the vulnerability to and aggravation and perpetuation of adverse consequences among those with posttraumatic stress disorder (PTSD). The proposed study begins the process of investigating the use of a natural immunoregulatory/anti-inflammatory probiotic, Lactobacillus rhamnosus GG (LGG; ATCC53103), to treat chronic symptoms associated with PTSD among Veterans. By looking at the impact of probiotic supplementation on biological signatures of increased inflammation, as reflected by biomarkers of inflammation, gut microbiota composition, intestinal permeability, stress response, decision making, and PTSD symptoms, this study may identify a novel intervention for the treatment of symptoms associated with this frequently occurring condition.

NCT ID: NCT04143243 Active, not recruiting - Depression Clinical Trials

One-day Life Skills Workshop for Veterans With TBI, Pain, and Psychopathology: Evaluating Efficacy and Mechanism of Change

Start date: July 1, 2020
Phase: N/A
Study type: Interventional

Mild traumatic brain injury (mTBI) is the signature wound of Veterans returning from the operations in Iraq and Afghanistan (i.e., OIF/OEF/OND), with up to 20 percent experiencing persistent post-concussive symptoms. Among Veterans with mTBI, the majority also experience stress-based psychopathology (e.g., depression, post-traumatic stress disorder, and/or generalized anxiety disorder) and chronic pain. To cope with distress, pain, and other difficulties, Veterans often turn to maladaptive avoidant coping strategies which offer short term relief but exacerbate/maintain mental health problems and have detrimental long-term effects on social, occupational, and community reintegration. Unfortunately, Veterans face important barriers to seeking mental health treatment, including stigma and logistical issues. This proposal aims to examine 1) the impact of a Veteran-centered, non-stigmatizing, 1-day "life skills group workshop" on overall distress and reintegration; and 2) the mechanisms by which this treatment might work as well as possible influences on treatment efficacy.