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Stress Disorders, Post-Traumatic clinical trials

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

A Pilot 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.

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.

NCT ID: NCT06367764 Not yet recruiting - PTSD Clinical Trials

A Comparative Effectiveness Study of PTSD Treatments Among Sexual and Gender Minority Populations

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

The goal of this clinical trial is see if Cognitive Processing Therapy and STAIR Narrative Therapy work to treat posttraumatic stress disorder (PTSD) among lesbian, gay, bisexual, transgender, queer/questioning, intersex, asexual/aromantic, and all other sexual or gender minority (LGBTQIA+) adults. The main questions it aims to answer are: - Do these treatments reduce PTSD symptoms in LGBTQIA+ patients? - Do these treatments help improve quality of life and reduce depression in LGBTQIA+ patients? - Do stress from stigma and discrimination and drug/alcohol use change the impact of the treatment on PTSD symptoms? - Are LGBTQIA+ patients satisfied with these treatments? Do these treatments work differently among different groups within the LGBTQIA+ community? - Do LGBTQIA+ patients complete these treatments? Study participants will receive one of these two PTSD treatments. Participants will complete assessments before and after receiving treatment.

NCT ID: NCT06355284 Not yet recruiting - Clinical trials for Stress Disorders, Post-Traumatic

Overcontrol and Suicide in PTSD

OSP
Start date: July 1, 2024
Phase:
Study type: Observational

High standards and self-discipline are prized in military culture, but drawbacks of overcontrol are often ignored. Overcontrol is characterized by over-regulated behavior and cognitive rigidity, driven by an intense need for perfection and control. It is frequently observed in people with obsessive-compulsive (OC) spectrum disorders, especially OC Personality Disorder (OCPD). Their inclination to set high expectations for others can strain social bonds. When grappling with mental health challenges, overcontrolled individuals often do so with limited social support, and as a result, tend to be at greater risk of developing more severe mental health symptoms, or suicidal thoughts and behaviors, over time. New treatments are needed to improve social functioning in these vulnerable Veterans. Adding brain stimulation to psychotherapy is one method that might speed learning of social skills discussed in therapy. However, before this technology can be developed and tested more broadly, the investigators must make sure that the methods used to measure social functioning and related brain circuits are acceptable to most potential patients and can be used consistently. In this pilot project, the investigators aim to recruit trauma-exposed Veterans with overcontrolled traits and study the feasibility and acceptability of: 1. Our recruitment strategy and social functioning and mental health symptom assessments 2. A three-session, weekly fMRI protocol. 3. A three-week online protocol for remote monitoring of social and emotional functioning.