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Stress Disorders, Post-Traumatic clinical trials

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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.

NCT ID: NCT06354361 Not yet recruiting - Clinical trials for Post-Traumatic Stress Disorder

Trauma-Informed Goal Management Training for Public Safety Personnel (PSP) With Post-traumatic Stress Disorder (PTSD)

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

Goal Management Training (GMT) is a program designed to help improve cognitive functioning. For this study, researchers have worked closely with the developers of this program to create a modified version called Trauma-Informed Goal Management Training (TI-GMT), that is more sensitive to the needs of public safety personnel (PSP) diagnosed with Post-Traumatic Stress Disorder (PTSD). The goal of this clinical trial is to find out how effective this modified, Trauma-Informed Goal Management Training program is for public safety personnel diagnosed with Post-Traumatic Stress Disorder, in comparison to the standard Goal Management Training program. The main questions it aims to answer are: 1. Does Trauma-Informed Goal Management Training result in better neuropsychological functioning and greater reductions in the severity of PTSD symptoms when compared to standard Goal Management Training? 2. Does Trauma-Informed Goal Management Training result in self-reported improvements in cognitive functioning and the overall ability to function (including intent to return to work, and/or intent to stay at work, reductions in disability status, etc.) when compared to standard Goal Management Training? 3. Does Trauma-Informed Goal Management Training continue to benefit individuals three months after treatment? Participants will: - complete three separate assessments before starting the treatment - a clinical interview to evaluate symptoms, a cognitive assessment, and completing a set of questionnaires - participate in a nine-week group treatment program (one day a week for two hours) - complete three separate assessments after completing the treatment - a clinical interview to evaluate symptoms, a cognitive assessment, and completing a set of questionnaires - complete three separate assessments three months after completing the treatment - a clinical interview to evaluate symptoms, a cognitive assessment, and completing a set of questionnaires

NCT ID: NCT06353282 Not yet recruiting - Adolescents Clinical Trials

MDMA-Assisted Psychotherapy for Treatment Resistant PTSD in Adolescents

Start date: July 1, 2025
Phase: Phase 2
Study type: Interventional

The primary objective of this study is to determine the safety and feasibility of 3,4-methylenedioxymethamphetamine (MDMA) -assisted psychotherapy to treat resistant post-traumatic stress disorder (PTSD). The secondary objectives are the exploration of effectiveness for treatment-resistant PTSD, symptoms of depression, and anxiety symptoms.

NCT ID: NCT06341413 Not yet recruiting - Clinical trials for Post Traumatic Stress Disorder

Sleep and Emotion Processing in Adolescent Post-traumatic Stress Disorder

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

The goal of this clinical trial is to characterize the role of sleep, emotion processing, and daily affect in post-traumatic stress disorder (PTSD) and whether improving sleep quality using slow wave activity enhancement will impact next-day affect in youth. Participants will attend 4 study visits: - A clinical and trauma assessment visit - A testing day that may include cognitive testing, surveys, and an MRI. - An overnight sleep study following one week of at-home sleep recordings with the device in the sham condition - An overnight sleep study following one week of at-home sleep recordings with the device in the sleep enhancement condition

NCT ID: NCT06335589 Not yet recruiting - Clinical trials for Stress Disorders, Post-Traumatic

Adapting Treatment Delivery to Improve Retention in Evidence-Based PTSD Treatment

Start date: June 17, 2024
Phase: N/A
Study type: Interventional

Posttraumatic stress disorder (PTSD) is prevalent among Veterans and effective evidence-based psychotherapies (EBPs) for PTSD have been implemented within the Veterans Health Administration (VHA). However, retention in PTSD EBPs is poor. Premature dropout is associated with worse clinical outcomes and greater healthcare utilization. Delivery of PTSD EBPs in a massed format, typically three or more days per week delivered within a month, have shown promise for increasing retention. The present study is a pilot feasibility and acceptability study comparing massed PTSD treatment to treatment as usual (e.g., typically weekly treatment).

NCT ID: NCT06335407 Not yet recruiting - Clinical trials for Alcohol Use Disorder (AUD)

Effect of Sublingual Formulation of Dexmedetomidine Hydrochloride (HCl) (BXCL501) - Outpatient Study

Start date: April 29, 2024
Phase: Phase 1
Study type: Interventional

The overall objective of the proposed study is to determine if Dexmedetomidine HCl (BXCL501) is safe for treatment of alcohol use disorder (AUD) with comorbid posttraumatic stress disorder (PTSD) in an outpatient setting and also shows potential signals of efficacy thereby supporting the conduct of later phase clinical trials.

NCT ID: NCT06332209 Not yet recruiting - Clinical trials for Post-Traumatic Stress Disorder

Randomized Trial of Tele Vs. Clinic TF-CBT in Puerto Rico

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

The current study will evaluate TF-CBT delivered via tele-health for youth presenting with trauma symptoms via a randomized controlled trial. Goals of the current study are to examine the effectiveness of Tele-TF-CBT delivered by community providers in Puerto Rico in improving youth trauma outcomes. Goals are also to support the feasibility, acceptability, and engagement outcomes of Tele-health delivery.

NCT ID: NCT06318195 Not yet recruiting - Clinical trials for Post Traumatic Stress Disorder

Condensed Digital Prolonged Exposure for Individuals Treated Within Somatic Trauma Care.

CiPE
Start date: March 2024
Phase: N/A
Study type: Interventional

The purpose of the study is to investigate the feasibility of implementation aspects, treatment effects and change processes regarding a brief trauma-focused Internet-based CBT treatment, for patients who have been treated in trauma care at Karolinska University Hospital and who exhibit symptoms of psychological consequences of the traumatic event. Another aim is to explore factors (predictors, moderators and mediators) that influence the effect of the treatment, in order to better understand who responds to the treatment.

NCT ID: NCT06307340 Not yet recruiting - Clinical trials for Posttraumatic Stress Disorder

Adaption of the STAIR-NT Trauma Intervention for Polysubstance Populations

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

During this 36-month R34 trial, eight study phases are proposed to adapt an evidence-based post traumatic stress disorder (PTSD) intervention (STAIR-NT) and layer it into a methadone maintenance treatment (MMT) program (START Treatment and Recovery centers) in New York City for use among individuals engaged in stimulant-opioid polysubstance use. The study aims to adapt STAIR-NT to a massed treatment schedule. Once an adapted protocol is complete, it will be tested for feasibility, acceptability, and short-term polysubstance and PTSD symptomology outcomes in a pilot randomized control trial (RCT) of 80 participants. Participants who screen eligible and consent will be randomized 1:1 to the adapted STAIR-NT intervention or treatment as usual (TAU) using randomization blocks of two and two and four via a computer-generated randomization sequence. Participants assigned to the intervention will receive the adapted massed delivery of STAIR-NT by trained counselors.

NCT ID: NCT06298279 Not yet recruiting - Depression Clinical Trials

Assessing Social Learning and Course Delivery Timing in Internet-delivered Cognitive Behaviour Therapy for Public Safety Personnel

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

This study is a randomized factorial trial designed to evaluate unguided (i.e., purely self-help), transdiagnostic internet delivered cognitive behaviour therapy tailored for public safety personnel with tunneled of personalized course delivery and with or without the incorporation of social learning resources.