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Stress Disorders, Traumatic clinical trials

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NCT ID: NCT05169190 Recruiting - Clinical trials for Post-traumatic Stress Disorder

Stellate Ganglion Block for PTSD

SGB-PTSD
Start date: November 17, 2022
Phase: N/A
Study type: Interventional

Posttraumatic Stress Disorder (PTSD) is a debilitating condition that affects about 15% of Veterans. Current treatments for Veterans with PTSD include medications and psychological therapies that help to process and desensitize to traumatic events. While effective for many, these treatments do not work for all patients, and many may refuse them. Stellate Ganglion Block (SGB), established to treat pain and other conditions, has shown promise for PTSD: early small studies show it may work fast and greatly reduce symptoms. However, data from larger studies are not clear about SGBs effects. A definitive trial is needed, especially for the Veteran population. This large, well-powered, randomized, sham-controlled trial of SGB for PTSD will assess the short-term efficacy of this intervention, the durability of the effects and the safety of the treatment. Additionally, this study will provide critically important information about biological effects of SGB and potential mechanisms of action. This timely study is critical to help VA clinicians better decide about the merits of SGB for PTSD.

NCT ID: NCT05163496 Active, not recruiting - Depression Clinical Trials

Frontline Clinician Psilocybin Study

Start date: March 3, 2022
Phase: Phase 3
Study type: Interventional

This study aims to investigate the effects of a single dose of psilocybin, delivered in the contextof pre- and post-dose psychotherapy, on symptoms of depression and burnout suffered by healthcare clinicians as a result of frontline work in the COVID pandemic.

NCT ID: NCT05157035 Not yet recruiting - Clinical trials for Posttraumatic Stress Disorder

Testing a Mindfulness/Acceptance-Based Smartphone App for Nurses Impacted by the COVID-19 Pandemic

Start date: January 1, 2022
Phase: Early Phase 1
Study type: Interventional

The purpose of the study is to test the feasibility and acceptability of a mindfulness- and acceptance-based smartphone app (MABSA) intervention for frontline nurses emotionally and psychologically impacted by the COVID-19 pandemic. The study will use a randomized controlled trial design of two groups: an intervention group of about 30 participants with posttraumatic stress symptoms and a wait-list control group of about 30 participants. The duration of the MABSA intervention is 6 weeks. The following are the outcomes to be measured: resilience, PTSD, mindfulness, experiential avoidance, and rumination.

NCT ID: NCT05156112 Recruiting - Clinical trials for Obstructive Sleep Apnea

OSA PAP Treatment for Veterans With SUD and PTSD on Residential Treatment Unit

Start date: January 2, 2023
Phase: N/A
Study type: Interventional

Substance use disorder (SUD) and posttraumatic stress disorder (PTSD) frequently co-occur and having both disorders is associated with greater psychological and functional impairment than having either disorder alone. This is especially true in residential settings where both disorders are more severe than outpatient settings. Obstructive sleep apnea (OSA) is highly comorbid with both disorders and untreated OSA is associated with worse functional impairment across multiple domains, worse quality of life, worse PTSD, higher suicidal ideation, and higher substance use and relapse rates. Treating OSA with evidence-based positive airway pressure (PAP) in Veterans with SUD/PTSD on a residential unit is a logical way to maximize treatment adherence and treatment outcomes. This study compares OSA treatment while on a SUD/PTSD residential unit to a waitlist control group. The investigators hypothesize that treating OSA on the residential unit, compared to the waitlist control, will have better functional, SUD, and PTSD outcomes.

NCT ID: NCT05149534 Recruiting - Clinical trials for Post Traumatic Stress Disorder

rTMS-augmented Written Exposure Therapy for PTSD

Start date: January 3, 2022
Phase: N/A
Study type: Interventional

Post-traumatic stress disorder (PTSD) is prevalent and represents a high healthcare burden among Veterans. Repetitive transcranial magnetic stimulation (rTMS) is a brain-based therapy that may be effective for treating PTSD. The theorized mechanism of rTMS is enhancement of emotional flexibility via the dorsolateral prefrontal cortex node of the brain's cognitive control network. Given this mechanism of action, adding rTMS to an evidence-based psychotherapy (EBP) for PTSD may enhance treatment effects. Written exposure therapy (WET) is a brief EBP for PTSD found to reduce attrition compared to lengthier first line treatments. In this study, the investigators will determine if active rTMS added to WET compared with sham rTMS added to WET results in improved PTSD outcomes. The investigators will also determine if emotional flexibility is a mechanism of symptom improvement. This work will improve upon PTSD intervention and inform the mechanism of treatment effectiveness for Veterans suffering from PTSD.

NCT ID: NCT05138198 Active, not recruiting - Metabolic Syndrome Clinical Trials

Lifestyle Intervention to Reduce Body Weight and Systemic Inflammation Among World Trade Center Responders

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

The goal of this randomized control trial (RCT) is to test the feasibility and acceptability of a lifestyle intervention with a focus on implementing a high dose Mediterranean Diet protocol with physical activity to reduce systemic inflammation and body weight among WTC first responders having overweight/obesity and PTSD. The findings of this study will demonstrate the suitability of the proposed approach to reduce comorbidities among similar populations exposed to traumatic events; the findings will also inform the World Trade Center Health Program's extensive research and clinical efforts with the potential to provide a preventive care model to reduce systemic inflammation and related chronic disease among WTC responders with PTSD.

NCT ID: NCT05137769 Completed - Clinical trials for Post Traumatic Stress Disorder

Women's Responses to a Mindfulness-Based Body Scan: A Pilot Study

Start date: April 15, 2022
Phase: N/A
Study type: Interventional

PTSD develops after trauma and is marked by intrusive memories, avoidance of reminders, negative changes in mood and cognitive processes, and dysregulated physical and emotional stress reactivity. PTSD disparately affects twice as many women as men (8.0% vs. 4.1%), and finding effective treatments for these women is critical to reduce poor health outcomes associated with PTSD. Mind-body therapies (MBT), using the mind in combination with the body to facilitate healing hold promise to enhance PTSD treatment by improving stress regulation. While MBT reduce PTSD symptoms long-term, women with PTSD may initially experience distress, leading to treatment avoidance. This pilot study will explore women's initial responses to MBT, the prevalence of adverse responses, and which women are at risk for adverse responses in a sample of participants with a history of trauma and varying levels of PTSD symptoms. Study participants will attend one virtual study visit via one-on-one videoconference with the PI, where they will complete self-report measures of stress and affect before and after one session of a MBT exercise. A subset of the sample will complete a semi-structured individual videoconference interview with the PI within two weeks following completion of the MBT exercise and quantitative measures.

NCT ID: NCT05133804 Recruiting - Clinical trials for Posttraumatic Stress Disorder

Efficacy of Reboxetine and Methylphenidate Treatment on Attentional, Sensory and Emotional Dysregulation in Adults With PTSD

Start date: June 1, 2022
Phase: Phase 2
Study type: Interventional

Up-to-date, no studies have examined the attentional, sensory and emotional processing (difficulties) among patients diagnosed with Posttraumatic Stress Disorder (PTSD). In addition, the efficiency of drug treatments that focus on the noradrenergic and dopaminergic, and thus influence attention processing and PTSD symptoms through these pathways, have only briefly been investigated. There is well-established and long-standing evidence for the involvement of dopamine and noradrenaline in attentional function. This previously led to an investigation by the investigator's research lab in which the investigators hypothesized the involvement of an attentional disorder would influence PTSD symptoms in a rat model. Based on these results, the current study aims to characterize attentional deficits in patients with PTSD, as well as the correlation between attention, emotional regulation and sensory processing. The investigators do this partially by conducting a case-control study and through a subsequent double-blind RCT (with only the cases). The patients will be either treated with reboxetine + methylphenidate or placebo.

NCT ID: NCT05132699 Completed - Clinical trials for Posttraumatic Stress Disorder

Enhancing Prolonged Exposure With Cannabidiol to Treat Posttraumatic Stress Disorder

Start date: April 4, 2022
Phase: Phase 1/Phase 2
Study type: Interventional

The primary goal of this pilot project is to demonstrate the safety and feasibility of using Cannabidiol (CBD) in combination with standard of care prolonged exposure (PE) psychotherapy to reduce PTSD symptoms.

NCT ID: NCT05123690 Recruiting - Clinical trials for Post-traumatic Stress Disorder

Neurofeedback for Post-Traumatic Stress Disorder

ViN-PTSD
Start date: January 1, 2023
Phase: N/A
Study type: Interventional

A two-arm randomized pilot of standard neurofeedback and a waiting list for patients with treatment resistent PTSD.