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Stress Disorders, Post-Traumatic clinical trials

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NCT ID: NCT06403449 Recruiting - PTSD Clinical Trials

The Effectiveness of Group-Delivered Guided Written Exposure Therapy for PTSD and Subclinical PTSD Among Chinese Adolescents : A Pilot Study

Start date: May 1, 2024
Phase: N/A
Study type: Interventional

The study aims to examine the effectiveness of the group-delivered guided written exposure therapy (G-WET) for post-traumatic stress disorder (PTSD) and subclinical PTSD among Chinese adolescents with a randomized controlled trial. The study will recruit 40 participants, with 20 randomized to the G-WET group and 20 randomized to the waiting list (WL) group. The G-WET intervention consists of 5-8 group sessions. The primary outcome CPSS-5-I (Child PTSD Symptom Scale-Interview Version for DSM-5) and PCL-5 ( PTSD Checklist-5) will be administered on baseline, post-treatment, 1-month follow-up, 3-month follow-up, and 6-month follow-up assessments.

NCT ID: NCT06394284 Recruiting - Moral Injury Clinical Trials

Examining 3,4-methylenedioxymethamphetamine (MDMA) Effects on Psychological, Relational and Hyperarousal-Related Neural Reactivity Mechanisms in Veterans With PTSD and Moral Injury

Start date: February 18, 2024
Phase: Phase 3
Study type: Interventional

Despite being exposed to a high level of potentially traumatic experiences due to exposure to combat, military veterans have poor response rates to traditional PTSD treatments, in some reports, just 1/3 of veterans recover using traditional treatments. In recent years 3,4-methylenedioxymethamphetamine (MDMA), a psychedelic drug has demonstrated a significant treatment potential for severe and treatment resistant PTSD though not specifically in a veteran population. Additionally, even in groups where participants receive a placebo, the effect of the psychedelic treatment formulation, intensive, focused and respectful structure, appears to have promising effects. Indeed, in the current psychedelic literature, the setting and mind with which participant approach psychedelic therapy, significantly contributes to the treatment effect. The current study proposes to address the major gaps in the theoretical literature by examining the proposed mechanisms by which MDMA enhances the "window of tolerance" for PTSD therapy, specifically in those with comorbid symptoms of moral injury; namely by reducing hyperarousal and enhancing connection (to self and others) and whether MDMA assisted therapy is more successful in reducing PTSD in veterans compared to a matched somatic experiential PTSD treatment, Somatic Experiental Acceptance Intensive Trauma-based therapy, (SEA-IT) which builds upon the promising placebo results, enhancing them with somatic and acceptance based treatment protocols.

NCT ID: NCT06390293 Recruiting - PTSD Clinical Trials

The Effectiveness of Group-Delivered Revised Guided Written Exposure Therapy for PTSD and Subclinical PTSD Among Chinese Adolescents

Start date: May 1, 2024
Phase: N/A
Study type: Interventional

The study aims to examine the effectiveness of the group-delivered revised written exposure therapy (WET-R) for post-traumatic stress disorder (PTSD) and subclinical PTSD among Chinese adolescents with a randomized controlled trial. The study will recruit 70 participants, with 35 randomized to the WET-R group and 35 randomized to the waiting list (WL) group. The WET-R intervention consists of 5-8 group sessions. The primary outcome CPSS-5-I (Child PTSD Symptom Scale-Interview Version for DSM-5) and PCL-5 ( PTSD Checklist-5) will be administered on baseline, post-treatment, 1-month follow-up, 3-month follow-up, and 6-month follow-up assessments.

NCT ID: NCT06372639 Recruiting - Clinical trials for Post Traumatic Stress Disorder

Characterization and Modulation of Traumatic Memories in PTSD Patients Using TMS

Start date: February 23, 2022
Phase: N/A
Study type: Interventional

Characterization and modulation of traumatic memories in PTSD patients using TMS.

NCT ID: NCT06363968 Recruiting - PTSD Clinical Trials

Biomarkers in the Retina for Prognosticating Mental Health Treatments

BRIGHT
Start date: February 12, 2024
Phase: N/A
Study type: Interventional

Title: ERG as a potential biomarker of SSRI-responsive PTSD: A pilot study Posttraumatic stress disorder (PTSD) affects many individuals who experience a traumatic event. Previous studies suggest that there is a connection between the brain and the retina, and that the electroretinogram (ERG) may be a valuable biomarker to tell us more about signals in the brain that are related to mental health disorders like PTSD. The goal of this observational study is to examine the ERG waveform in veterans with PTSD before and after a single dose of the selective serotonin reuptake inhibitor (SSRI), sertraline. Sertraline is one of two FDA-approved medications for the treatment of PTSD. The main questions this pilot study aims to answer are: 1. How does sertraline, an SSRI, influence the ERG waveform in veterans with PTSD? 2. Is there a significant correlation between baseline ERG signals and the change in ERG following SSRI treatment? Participants will be asked to: - Undergo ERG recordings before and after a single dose of sertraline. - Provide relevant clinical information related to PTSD symptoms and treatment history. Following the initial study visits, participants will enter an optional open label phase of the study in which qualifying participants who initiate antidepressant treatment through routine clinical care will be invited back for a follow-up ERG recording.

NCT ID: NCT06348472 Recruiting - Clinical trials for Posttraumatic Stress Disorder

The Predictive Role of Immune-inflammatory Biomarkers and Their Interaction With the Oxytocin System in Trauma-related Psychotherapy Responsiveness

Start date: March 14, 2024
Phase:
Study type: Observational

Despite a range of treatments for posttraumatic stress disorder (PTSD), only a small proportion of patients reach full symptomatic remission. Recent developments in the field of neuroscience have been providing compelling evidence to suggest that neurobiological determinants might influence not only the emergence of PTSD, but also its resistance to treatment. Immune-inflammation regulatory processes were found to be active during recovery from PTSD, potentially through interactive relationship with the oxytocin secretion system. This innovative longitudinal study aims to examine the role of inflammatory biomarkers and their interactive effect with the oxytocin (OT) system on the development of PTSD and on treatment response among patients with PTSD symptoms undergoing psychotherapy treatment. Patients (N = 100) suffering from trauma-related distress will be recruited from the trauma clinic in Shalvata Mental Health Center. Participants will be followed for 12 weeks of once-a-week psychotherapy sessions. They will be measured for endogenous OT level and cytokines levels in saliva before and after sessions 1, 6, and 12, and will complete psychotherapy outcome self-report questionnaires following each of these sessions.

NCT ID: NCT06345053 Recruiting - Clinical trials for Post Traumatic Stress Disorder

Presence of PTSD and Emotion Dysregulation Among Inpatients With Substance Use Disorder

Start date: May 1, 2021
Phase: N/A
Study type: Interventional

There are high rates of co-occurring posttraumatic stress disorder (PTSD) among patients receiving treatment for substance use disorder (SUD). PTSD and SUD should be treated simultaneously, but adults in SUD treatment are often not assessed for PTSD nor offered PTSD-based interventions. One of the reasons for reluctance in offering trauma focused treatment is increased risk of drop out. PTSD and related emotion dysregulation are related to elevated psychological burden, higher dropout rates and increased risk of relapse. this is a feasibility study, where the plan is to integrate a combination of Dialectical Behaviour Therapy for Substance Use Disorder (DBT-SUD skills) a therapy targeting difficulties in emotion regulation and Narrative Exposure Therapy (NET) a trauma focused therapy, for patients with co-occurring PTSD symptoms into standard SUD treatment . The plan is to assess its potential benefits by assessing whether adding this combination to standard SUD treatment is relevant, feasible, acceptable, and safe. Treatment outcomes are 1) Prevalence of PTSD, suicidal behaviour, and self-harm, as well as the severity of difficulties in emotion regulation and emotional avoidance among patients (N approx. = 100) in inpatient treatment for SUD. 2) Change post-treatment and at 3 and 12 months follow up, from baseline in PTSD symptom severity, depressive symptoms, emotion regulation, emotion avoidance, and experience of shame. 3) Rates of dropout and relapse compared to previous rates. This project can increase knowledge about psychological mechanisms in co-occurring PTSD and SUD and improve the quality of treatment for this vulnerable patient population.

NCT ID: NCT06324383 Recruiting - Depression Clinical Trials

Enhancing Purpose and Well-Being Through a Volunteering Experience Connecting Veterans With English Language Learners

Start date: April 15, 2024
Phase: N/A
Study type: Interventional

The goal of this study is to refine and test a strategy for engaging Veterans with symptoms of depression, anxiety, and/or PTSD (Post Traumatic Stress Disorder) as volunteers to help English language learners (ELLs) improve their speaking skills via structured conversations using videoconferencing.

NCT ID: NCT06310109 Recruiting - Depression Clinical Trials

Effect of Pediatric Intensive Care Unit Diaries on PICS-p

PICS-p
Start date: July 14, 2021
Phase: N/A
Study type: Interventional

When children become very sick and need to stay in a Pediatric Intensive Care Unit (PICU), it can have a big impact on their recovery and their family's well-being. Sometimes kids and their families feel worried or sad even after they leave the hospital. This can have an impact on the quality of their life after hospital discharge. To help understand and improve these experiences, the investigators want to study the "PICU diaries." These are journals that families and hospital staff can write in during the child's time in the hospital. Parents, other visitors and healthcare professionals can share thoughts, experiences, and even drawings or photos related to the child's admission. The content is a narrative account of what happens during the child's hospital stay, for the family to take home at PICU discharge. The investigators believe that writing in these diaries might help children and their families feel better after leaving the hospital. It might help kids feel less worried or sad, and it might also help their parents or caregivers feel better too. The study will include children who have been in the PICU and their families. Some families will receive these special diaries to use during their time in the hospital, while others won't. We'll then see how everyone feels after they leave the hospital and compare the two groups to see if the diaries make a difference. The investigators hope that by understanding how these diaries can help, healthcare professionals can make hospital experiences better for everyone involved.

NCT ID: NCT06303648 Recruiting - Clinical trials for Post Traumatic Stress Disorder

A Single, Ascending Dose Evaluation of the Safety, Pharmacokinetics of Methylone in Healthy Subjects

Start date: March 20, 2024
Phase: Phase 1
Study type: Interventional

This is an open-label, single, ascending dose study evaluating the PK and safety of methylone in healthy subjects.