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Stress Disorders, Post-Traumatic clinical trials

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NCT ID: NCT06467916 Recruiting - Clinical trials for Post Traumatic Stress Disorder

The Development of PATH, a Program to Support NICU Parent Mental Health Through the Transition From Hospital to Home

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

The objective of this study is to develop and pilot test a telehealth-based mental health screening and engagement program that supports parents as they transition from the NICU to home. The program will use a stepped-care approach to screen parents for depression, anxiety, and PTSD; provide a brief behavioral intervention to those who screen as having at least a low risk of these conditions; and provide a warm hand-off to community mental health services for those at medium to high risk.

NCT ID: NCT06464432 Recruiting - Clinical trials for Complex Post-Traumatic Stress Disorder

Complex-Posttraumatic Stress Disorder in Urban Egypt: Pilot Testing of a Culturally-adapted Evidence-Based Treatment Manual and Development of a Culture-specific Diagnostic

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

Background: The CPTSD diagnosis presented in the ICD-11 is supposed to provide core and culturally invariant symptoms, which is supported by recent research. Yet, evidence also shows the necessity of integrating culture-specific symptoms in intervention and diagnostic tools to enhance the validity and efficacy of such diagnoses and therapeutic interventions. Along with cultural aspects, there are relevant structural aspects e.g., economic, and social inequalities, which impact mental health. These aspects remain understudied in low middle income countries like Egypt, where there are considerable rates of violence. Aims: The project aims to i) culturally adapt and pilot test the therapeutic manual ESTAIR/MPE in urban Egypt, and ii) to pilot test a cultural and structural module for the diagnostic assessment of CPTSD among the same target population. The objective is to assess the feasibility, acceptability, and initial impact on clinical outcomes of both the manual and diagnostic modules. Methods: In earlier phases, the project gathered qualitative data from key informants on the cultural and structural dimensions of CPTSD in urban Egypt. Using the collected data, investigators culturally adapted this intervention and developed a diagnostic cultural module. Subsequently, the investigators will pilot-test it in four groups of five participants each, 20 participants in total. The project intends to collect both quantitative and qualitative measures to explore determined outcomes and analyze them accordingly.

NCT ID: NCT06435052 Recruiting - Clinical trials for Post Traumatic Stress Disorder

Efficacy of Eye Movement Desensitization & Reprocessing vs Cognitive Behavioral Therapy in Post-Traumatic Stress and Comorbid Disorders in Pakistan

Start date: August 15, 2022
Phase: N/A
Study type: Interventional

This Randomized Controlled Trial will check the efficacy of Eye Movement Desensitization & Reprocessing vs Cognitive Behavioral Therapy in Post-Traumatic Stress and Comorbid Disorders in Pakistan

NCT ID: NCT06429293 Recruiting - Clinical trials for Posttraumatic Stress Disorder

Impact of Cognitive Behavioral Therapy on PTSD-CVD Link

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

This is a pilot randomized controlled trial to assess the impact of a first-line treatment for posttraumatic stress disorder (PTSD) (Cognitive Processing Therapy; CPT) versus waitlist control on mechanisms of cardiovascular disease (CVD) risk. Further, this study will test the hypothesis that CPT reduces CVD risk through its effects on inflammation and autonomic function and that these changes are driven by changes in stress-related neural activity (SNA)

NCT ID: NCT06407635 Recruiting - Clinical trials for Post Traumatic Stress Disorder

A Study of Psilocybin for PTSD

Start date: June 7, 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: 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: 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: 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.