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Stress Disorders, Post-Traumatic clinical trials

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NCT ID: NCT06399874 Recruiting - Clinical trials for Nightmares Associated With Chronic Post-Traumatic Stress Disorder

Pilot Trial Comparing Nightmare Deconstruction and Reprocessing vs. NightWare Wristband

NDR/NW
Start date: June 11, 2024
Phase: Phase 2
Study type: Interventional

The overall goal of this Phase IIa randomized controlled pilot trial is to assess the potential efficacy of two emerging treatments for post-trauma nightmares and to test the feasibility of study design and methods. Symptom change will be assessed in two treatment arms: (1) Nightmare Deconstruction and Reprocessing (NDR), an exposure-based psychotherapy; and (2) NightWare (NW), a non-exposure approach using a wristband device. We will also assess the feasibility of circadian-dependent blood sampling and use of another wristband to collect physiologic data. Toward this goal, we will pursue the following specific aims: (1) Compare evidence of how well participants tolerate and comply with the different treatments and to test feasibility of methods and procedures; (2) Collect additional evidence of the potential efficacy of two contrasting non-pharmacologic approaches to treating posttraumatic nightmares; (3) Explore the operational stress index (OSI) as a reliable, objective measure of sleep disturbance and nightmare events.

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: NCT06390618 Not yet recruiting - Clinical trials for Post-Traumatic Stress Disorder

Biopsychosocial Effectiveness of Exercise Trainings in Earthquake Survivors With Post-Traumatic Stress Disorder

Start date: June 25, 2024
Phase: N/A
Study type: Interventional

In study, the investigators aim to demonstrate the effectiveness of biopsychosocial-based exercise approach in post-traumatic stress disorder of physiotherapists in post-earthquake disaster management.

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: NCT06388876 Completed - Clinical trials for Stress Disorders, Post-Traumatic

The Effect of Exercise on Post-traumatic Stress Disorder and Sleep Quality in Individuals Affected by the 2023 Kahramanmaraş Earthquakes

Start date: April 1, 2023
Phase: N/A
Study type: Interventional

Natural disasters can have adverse impacts on both physical and mental health. Post-traumatic stress disorder (PTSD) and sleep disorders are among the most common problems seen after natural disasters. Exercise may represent a safe, cost-effective, accessible, non-pharmacological method for treating PTSD and sleep problems. The aim of this study was to investigate the effect of exercise interventions on PTSD and sleep quality in young individuals affected by the 2023 Kahramanmaraş earthquakes in Türkiye.

NCT ID: NCT06386003 Not yet recruiting - PTSD Clinical Trials

Psilocybin-Assisted Cognitive Processing Therapy for Chronic PTSD

Start date: August 2024
Phase: Phase 2
Study type: Interventional

This is an open-label trial evaluating feasibility, tolerability, safety and efficacy of psilocybin assisted cognitive processing therapy for chronic Posttraumatic Stress Disorder (PTSD).

NCT ID: NCT06381180 Not yet recruiting - Clinical trials for Post Traumatic Stress Disorder

Warrior CARE: Cannabis Behavioral Health

CBH
Start date: May 1, 2024
Phase: Phase 1/Phase 2
Study type: Interventional

This study is a randomized, controlled clinical trial to examine the therapeutic potential of cannabinoids for treating veterans with PTSD and suicidal ideation.

NCT ID: NCT06378528 Not yet recruiting - Clinical trials for Posttraumatic Stress Disorder

Ketamine-assisted Psychotherapy for Adolescent PTSD (KAP)

Start date: August 2024
Phase: Early Phase 1
Study type: Interventional

The objectives of this study are to investigate the feasibility, tolerability, and efficacy of repeated ketamine-assisted psychotherapy sessions in adolescents with severe posttraumatic stress disorder. The study will enroll adolescents with a current diagnosis of posttraumatic stress disorder (PTSD) to complete three intravenous ketamine administrations immediately prior to a psychotherapy session over the span of six weeks. All participants will complete an initial set of preparatory sessions, and each dosing session will be followed by three integration sessions. Finally, participants will complete 7 nights of at-home sleep recordings. The investigators hypothesize that this protocol will be well-tolerated by adolescents and that patients will experience decreases in PTSD symptom severity at follow-up.

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: NCT06371404 Not yet recruiting - Clinical trials for Alcohol Use Disorder

Imaging Traumatic Stress and Alcohol Use Disorder With [18F]Bavarostat

Start date: June 1, 2024
Phase:
Study type: Observational

The overall objective of this study it to use Positron Emission Tomography (PET) brain imaging and a radiotracer that measures the epigenetic marker Histone Deacetylase 6 (HDAC6) to examine HDAC6 expression in people with Post-Traumatic Stress Disorder (PTSD), Alcohol Use Disorder (AUD), or concurrent PTSD and AUD with control groups. While there are a large number of studies conducted in preclinical stress and addiction models, these findings have not been translated to people living with these disorders. We will examine relationships between HDAC6 and clinical variables of interest. Findings could direct treatment development.