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Stress Disorders, Traumatic clinical trials

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NCT ID: NCT06419959 Not yet recruiting - Clinical trials for Cardiovascular Diseases

NightWare and Cardiovascular Health in Veterans With PTSD

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

The purpose of this study is to learn more about the effectiveness of a prescription wrist-wearable device called NightWare (NW) on improving sleep in Veterans with nightmares related to posttraumatic stress disorder (PTSD). The investigators also want to learn whether it improves cardiovascular health among this population.

NCT ID: NCT06418178 Not yet recruiting - Clinical trials for Posttraumatic Stress Disorder

Dose Optimization of MDMA-Assisted Therapy for PTSD

DosOp
Start date: October 2024
Phase: Phase 2
Study type: Interventional

This open label, within-subjects dose optimization trial will investigate the optimal number of MDMA-Assisted Therapy treatment cycles (i.e., one MDMA session and three integration sessions) in a sample of U.S. veterans with PTSD. Participants will complete from one to five cycles of MDMA-AT.

NCT ID: NCT06412757 Not yet recruiting - Clinical trials for Post Traumatic Stress Disorder

Silexan in the Treatment Of Posttraumatic Stress Disorder Trial

STOP
Start date: June 1, 2024
Phase: Phase 3
Study type: Interventional

Posttraumatic stress disorder (PTSD) is a common and debilitating mental illness. Current treatments for PTSD include psychotherapy and antidepressant medications. Many patients are unable to tolerate psychotherapy for PTSD and drop out of it. In addition, its effectiveness is limited. Up to 50 percent of patients who receive psychotherapy do not benefit from it. Antidepressant medications have only small benefits in PTSD. They also have unpleasant side effects that can make patients unwilling to take them. There is an urgent need to develop new treatments for PTSD that work and are well-tolerated. Silexan has the potential to provide an important alternative treatment for PTSD. Silexan is derived from lavender oil. It is taken orally in the form of capsules. It is currently available over-the-counter in 14 countries, including Australia and the United States. Previous research has shown that it is an effective treatment for anxiety disorders, including Generalized Anxiety Disorder. It is also well-tolerated by patients. The only side effects that have been identified so far are mild gastrointestinal symptoms (including burping and breath odour) and these are uncommon. The results of a small pilot study suggest that Silexan may also be effective and well-tolerated in PTSD. The STOP trial is a clinical trial that aims to investigate whether adding Silexan to treatment-as-usual improves PTSD symptoms in adults with PTSD. The trial will recruit 224 participants. Participants will be randomly assigned to take Silexan or a placebo (look-alike dummy pills) daily in addition to their usual medications for 12 weeks. The severity of their PTSD symptoms will be assessed prior to and at the end of this 12-week period. The STOP trial has the potential to obtain definitive evidence regarding whether Silexan helps treat symptoms of PTSD. If Silexan is found to be an effective treatment for PTSD, the pool of patients who could potentially benefit from this treatment includes any adults with PTSD. Silexan is already available over-the-counter at a relatively low cost so there will be few barriers to accessing this treatment.

NCT ID: NCT06407635 Not yet recruiting - Clinical trials for Post Traumatic Stress Disorder

A Study of Psilocybin for PTSD

PSI-3PO
Start date: May 2024
Phase: Phase 1
Study type: Interventional

The proposed open-label, controlled study at the Johns Hopkins Center for Psychedelic and Consciousness Research (CPCR) will test the following primary hypotheses in adult patients with chronic PTSD who are currently taking a serotonin reuptake inhibitor: psilocybin therapy will be feasible and safe for participants, significantly remediate PTSD symptoms, and enhance wellbeing and quality of life. In addition, the study will examine whether elements of evidence-based trauma-focused psychotherapy enhance treatment response when paired with psilocybin.

NCT ID: NCT06403514 Not yet recruiting - Clinical trials for Post Traumatic Stress Disorder

The Effects of a Psychoeducational Intervention on Health and Performance-based Outcomes of Veterans Diagnosed With PTSD

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

Nova Southeastern University and the Veterans trust through this line of research will strengthen community engagement and awareness for the need to recognize and provide treatment models for veterans diagnosed with PTSD. The goal is to improve self-regulatory mechanisms within the racecar simulated-environment with the hope it translates to real-life scenarios. The design is a single-case approach with the application of range-bound changing criterion design. It will include elements of stress-inoculation therapy, cognitive processing therapy, optimal zones of functioning, biofeedback and psychological skills training. This particular design will allow for the collection and identification of the idiosyncratic differences between each participant which will guide how the data are collected and the tailoring of the intervention.

NCT ID: NCT06399874 Not yet 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: May 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: 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: April 25, 2024
Phase: N/A
Study type: Interventional

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

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.