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Stress Disorders, Post-Traumatic clinical trials

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NCT ID: NCT04262895 Withdrawn - Clinical trials for Posttraumatic Stress Disorder

TTI-0102 for Veterans With TBI

Start date: October 1, 2021
Phase: Phase 1/Phase 2
Study type: Interventional

Traumatic brain injury (TBI) is a signature wound of the recent wars. How chronic TBI symptoms develop after a mild brain injury is not fully understood, but it is now thought that injury results in damage that reduces brain energy production, increases inflammation, and results in a leaky blood-brain barrier. Difficulties in daily function may persist in areas such as thinking (e.g., attention, learning, memory, planning, and problem-solving), pain (e.g., headache) and behavior (e.g., sleep, posttraumatic stress disorder, depression). No medications for TBI have been developed, so evidence-based cognitive rehabilitation interventions such as Compensatory Cognitive Training (CCT) are the mainstay of treatment. The investigators are proposing to study a medication, TTI-0102, that shows anti-inflammatory activity, as a potential adjunct treatment with CCT for Veterans with TBI-related symptoms. The investigators plan to first determine the best dose of TTI-0102 to use, and then to conduct a pilot study to test the feasibility and acceptability of combining TTI-0102 with CCT in Veterans with mild to moderate TBI and PTSD.

NCT ID: NCT03874845 Withdrawn - Clinical trials for Post Traumatic Stress Disorder

Neural Mechanisms of Mindfulness-based Cognitive Therapy (MBCT) for Posttraumatic Stress Disorder (PTSD)_VA Only

Start date: January 29, 2022
Phase: N/A
Study type: Interventional

This study will examine the effects of psychotherapy as treatment for PTSD. This research will see how brain activity and brain connectivity is affected by Mindfulness Based Cognitive Therapy (MBCT) and Muscle Relaxation Therapy (MRT). Participants that qualify to be in this study will receive 8 weeks of group therapy in MBCT or MRT. Prior to receiving therapy participants will: complete baseline assessments related to their PTSD; fill out surveys; have an functional magnetic resonance imaging (fMRI); and provide a saliva sample. These assessments will be repeated after the therapy is over. Overall study participation should last approximately 10-12 weeks.

NCT ID: NCT03752918 Withdrawn - Clinical trials for Post Traumatic Stress Disorder

The Effects of MDMA on Prefrontal and Amygdala Activation in PTSD.

Start date: May 2024
Phase: Phase 1
Study type: Interventional

This study aims to investigate the effects of MDMA on prefrontal and amygdala activation, and to explore the relationship between these MDMA-induced neural changes and the acute behavioral effects of the drug in patients with PTSD.

NCT ID: NCT03722745 Withdrawn - Clinical trials for Stress Disorders, Post-Traumatic

Examine the Preliminary Effect of an Evidence-Based Practice (EBP) Consultation Model on Staff Fidelity to EBP

Start date: July 17, 2019
Phase: N/A
Study type: Interventional

Youth involved in the juvenile justice system report high rates of exposure to traumatic events (>90%) and posttraumatic stress disorder (PTSD; 20-50%). Although youth offenders are routinely assessed and referred for mental health services, few receive evidence-based interventions for PTSD. The current study evaluates an innovative approach to overcoming this problem: train front-line juvenile justice staff to deliver PTSD treatment groups. To determine the preliminary effectiveness and safety of PTSD groups delivered by juvenile justice staff, investigators will compare outcomes for youth offenders randomly assigned to receive evidence-based PTSD group treatment or treatment as usual (i.e., referral to community mental health clinic). Investigators hypothesize that PTSD groups led by justice staff will lead to significantly better youth outcomes (mental health symptoms, re-arrest) compared to treatment as usual.

NCT ID: NCT03641768 Withdrawn - Clinical trials for Traumatic Brain Injury

Risk Prediction for Alzheimer Dementia With Brain Imaging and Genetics

Start date: January 1, 2019
Phase: N/A
Study type: Interventional

The purpose of this study is to learn about how trauma, posttraumatic stress disorder (PTSD), and mild traumatic brain injury that can occur during deployment affect the brain. The investigators also want to learn how PTSD and mild traumatic brain injury can affect the chance of developing Alzheimer disease later in life. The investigators will study this by using magnetic resonance imaging and positron emission tomography scans to obtain pictures of the brain.

NCT ID: NCT03496714 Withdrawn - Clinical trials for Psychoeducation on Safety Behaviors and How to Fade Them

Online Psychoeducation for the Prevention of PTSD

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

Research on decreasing safety behaviors in therapy has been restricted to treatments for other anxiety disorders and has not included PTSD. In order to address this gap and to develop a widely accessible, cost-effective prevention, an internet-based, three-arm randomized secondary PTSD prevention trial is proposed. Self-help psychoeducation on common reactions to trauma and eliminating safety behaviors will be employed for participants who have recently experienced a traumatic event. Participants will be randomized to receive (a) psychoeducation on trauma symptoms only, (b) combined psychoeducation on trauma symptoms and eliminating safety behaviors, or (c) monitoring only control. All participants will monitor safety behaviors and trauma symptoms weekly for eight weeks. Psychoeducation materials will be handouts and videos administered online via REDCap. It is hypothesized that participants in both psychoeducation conditions will have a lower incidence of PTSD, threat appraisal, and safety behaviors than participants in the monitoring-only control. It is also hypothesized that participants who receive combined psychoeducation on trauma symptoms and fading safety behaviors will have a lower incidence of PTSD, threat appraisal, and safety behaviors at Weeks 4 and 8 than will participants who receive psychoeducation on trauma symptoms only or participants in the monitoring-only control. It is further hypothesized that the effects of combined psychoeducation on preventing PTSD and threat appraisal will be mediated by decreased use of safety behaviors. Finally, it is hypothesized that combined psychoeducation on trauma symptoms and fading safety behaviors will be more effective in preventing PTSD for participants with higher levels of safety behaviors or threat appraisal at baseline. If effective, this secondary prevention program could be distributed widely to people who have recently experienced a trauma to prevent their development of PTSD.

NCT ID: NCT03376139 Withdrawn - Clinical trials for Alcohol Use Disorder

Zonisamide Outpatient Study

Start date: March 1, 2019
Phase: Phase 2
Study type: Interventional

The objective of this study is to determine if, compared to placebo, zonisamide (400mg/day) is a safe and efficacious treatment for post-traumatic stress disorder (PTSD) and alcohol use disorder (AUD) in Veterans with PTSD and co-occurring AUD.

NCT ID: NCT02699138 Withdrawn - Clinical trials for Sleep Apnea, Obstructive; Post-Traumatic Stress Disorders

Obstructive Sleep Apnea and Arousal Threshold in Patients With Post-traumatic Stress Disorder

Start date: October 2021
Phase: Early Phase 1
Study type: Interventional

Obstructive sleep apnea (OSA) has traditionally been attributed only to a collapsible upper airway. However, it is increasingly recognized that multiple additional non-anatomical mechanisms contribute to the disease. Higher rates of OSA in patients with post-traumatic stress disorder (PTSD) than in those without PTSD have been reported however the mechanism behind this increased prevalence has not been investigated. Our hypothesis is that patients with PTSD have a predisposition to OSA due to a lower respiratory arousal threshold (wake up too easily) than patients without PTSD. The goal of this project will be to study and compare the ArTH in patients with PTSD and those without. In addition, we plan to see whether medications can be used to increase the arousal threshold and treat OSA in patients with PTSD.

NCT ID: NCT02565563 Withdrawn - Clinical trials for Post Traumatic Stress Disorder

Recording Heart Rate Variability During Eye Movement Desensitisation Reprocessing With or Without Eye Movement

EMDR;PTSD
Start date: October 2015
Phase: N/A
Study type: Interventional

The purpose of the study is to gain greater insight into Eye Movement Desensitisation Reprocessing (EMDR). EMDR is an NHS recommended treatment, which can significantly reduce trauma symptoms. There is some debate regarding how it actually works, however there is evidence to suggest that the eye movements component helps reduce anxiety and increase relaxation levels. To measure these arousal levels during EMDR previous research has used electrocardiography (ECG) to measure heart rate, which offers insight into the effectiveness of eye movements (EM). All studies to date have used ECG to measure arousal levels which requires technical knowledge to administer and interpret. Furthermore, applying electrodes to a patient experiencing PTSD may heighten anxiety. The present study will use new technology which is a small device that would be gently attached to the end of the patient's index finger. This device is very similar to one that measures oxygen levels in the blood and therefore is a very simple piece of equipment and should cause no discomfort to the patient. The study also requires patient's faces to be video recorded throughout and it will only be their face that is recorded. This is to match the stages of treatment (i.e. when EM starts and stops) to their corresponding arousal level outcome. The new technology will digitally measure the patient's anxious and relaxed arousal levels during EM and no EM treatment sessions. 10 NHS patients would be recruited to receive two treatment sessions; one with EM and one without and then continue with treatment as usual without any of the recording devices. EM and no EM phases occur at least three times within a treatment session and therefore several measurements can be taken and analysed.

NCT ID: NCT02553252 Withdrawn - Clinical trials for Post Traumatic Stress Disorder

SKY Versus WLC in PTSD

Start date: November 2015
Phase: N/A
Study type: Interventional

Patients with post traumatic stress disorder (PTSD) will be randomized to a 12-week intervention of Sudarshan Kriya Yoga Trauma Relief Program (SKY) or a wait list control (WLC) to assess the effects of this intervention on symptoms of PTSD, depression, anxiety, quality of life, autonomic symptoms, and blood inflammatory markers.