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Stress Disorders, Traumatic clinical trials

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NCT ID: NCT06296030 Withdrawn - Anxiety Clinical Trials

Culturally Tailored ACT for Black Trauma

Start date: September 1, 2021
Phase: N/A
Study type: Interventional

Blacks in America more frequently meet the criteria for posttraumatic stress disorder (PTSD) than any other US race or ethnicity. Yet, blacks are among the groups least likely to use mental health services for trauma. Thus, a large number of traumatized blacks suffer silently and remain untreated. Acceptance and Commitment Therapy (ACT) is an empirically-based psychological intervention that uses acceptance and mindfulness strategies, with commitment and behavior change strategies, to increase psychological flexibility and decrease anxiety outcomes. While culturally tailored mental health interventions have been shown useful for racial and ethnic minorities, there have been few efforts to tailor ACT for blacks. This NIH R21 would compare an ACT model specifically culturally tailored for blacks (POOF) to the classic ACT model in a randomized trial, where clinicians will conduct 12-session telehealth synchronous virtual groups. Eighty black participants who self-identify as suffering from stress or anxiety will be confidentially recruited. Two specific aims are proposed: Aim 1) It is expected that POOF participants will report higher levels of acceptability of treatment than classic ACT participants and that POOF participants will have better adherence to treatment regimens than traditional ACT participants. Aim 2) Given that race-based stress may mediate anxiety symptoms in U.S. based blacks, it is expected that POOF will decrease race-based stress, thereby mattering the most for improving anxiety outcomes for blacks. The proposed R21 pilot study will be the first randomized controlled trial to evaluate an ACT intervention tailored explicitly for black racial trauma. This study will provide critical data needed to plan and design a future R01 controlled longitudinal effectiveness study. The long-term objective is to significantly reduce the prevalence of stress and anxiety-related symptoms due to traumatic events for Blacks by increasing treatment acceptability for this population. Since blacks have the highest rates of trauma prevalence and chronicity, yet they are still underrepresented in mental health treatment, this tailored intervention can have a significant public health impact.

NCT ID: NCT05562973 Withdrawn - Clinical trials for Post-Traumatic Stress Disorder

Safety and Tolerability of Psilocybin in Post-Traumatic Stress Disorder

Start date: January 2025
Phase: Phase 1
Study type: Interventional

The purpose of this study is to evaluate the safety, tolerability, and potential efficacy of psilocybin-assisted psychotherapy to reduce post-traumatic stress disorder (PTSD) severity in a sample of individuals with PTSD.

NCT ID: NCT05386862 Withdrawn - Clinical trials for Post Traumatic Stress Disorder

Warrior CARE: Naturalistic Observation and Harm Reduction

NOC
Start date: July 13, 2022
Phase: N/A
Study type: Interventional

This study is looking at therapeutic potential of reducing Tetrahydrocannabinol (THC) levels in regular cannabis smokers using contingency management (CM) intervention in a U.S. veteran population with post-traumatic stress disorder (PTSD).

NCT ID: NCT05187156 Withdrawn - Clinical trials for Posttraumatic Stress Disorder

Assessing and Enhancing Social Support

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

Posttraumatic stress disorder (PTSD) is a common and impairing problem among Veterans, many of whom first seek treatment in primary care settings. PTSD is linked to reduced quality of life and increased rates of suicide. Additionally, social support, defined as the availability of others to provide emotional or practical support when needed, is frequently poor for Veterans with PTSD. For Veterans with PTSD, poor social support negatively impacts PTSD treatment engagement and outcomes, interfering with PTSD recovery. There is a need for additional brief, primary care-based treatments for PTSD that also work to improve social support in traumatized Veterans. The proposed research seeks to evaluate and refine such an intervention and establish a protocol for routinely measuring social support to inform treatment. This intervention and measurement protocol will likely improve Veterans' mental health and social relationships.

NCT ID: NCT04968938 Withdrawn - Clinical trials for Posttraumatic Stress Disorder

Study of Safety and Effects of MDMA-assisted Therapy for Treatment of PTSD

NUMCAP1
Start date: August 2022
Phase: Phase 2
Study type: Interventional

This Phase 2, Open Label study will provide supportive data on the safety and effectiveness of MDMA-assisted therapy in participants with posttraumatic stress disorder (PTSD). This study will be conducted at a single study site in Vancouver, BC. There will be at least 2 co-therapy pairs. The study will enroll up to 20 participants The Preparatory Period will consist of three 90-minute non-drug Preparatory Sessions. A flexible divided dose of MDMA, will be administered during the Treatment Period with manualized therapy in up to two open-label Study Drug Sessions. During the Treatment Period, each Study Drug Session is followed by three 90-minute Integrative Sessions of non-drug therapy. The Study Drug Sessions are scheduled roughly 3 to 5 weeks apart.

NCT ID: NCT04875221 Withdrawn - PTSD Clinical Trials

Network-based Neurofeedback in PTSD

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

This project will examine the use of real-time fMRI (rt-fMRI) neurofeedback in the regulation of neural networks underlying symptoms experienced by individuals with posttraumatic stress disorder (PTSD). Investigators will use rt-fMRI neurofeedback in order to facilitate emotion regulation during symptom induction, and examine individual differences that influence regulation capacities.

NCT ID: NCT04809116 Withdrawn - Clinical trials for Posttraumatic Stress Disorder

Pimavanserin for Insomnia in Veterans With Posttraumatic Stress Disorder: Proof of Concept

Start date: December 15, 2022
Phase: Phase 4
Study type: Interventional

This is a proof-of-concept, open-label trial of pimavanserin 34mg at bedtime for 6 weeks in Veterans with insomnia and Posttraumatic Stress Disorder.

NCT ID: NCT04664907 Withdrawn - Clinical trials for Post Traumatic Stress Disorder

Videomusic and Psychic Trauma

VIMUTRAU
Start date: January 2021
Phase: N/A
Study type: Interventional

This project is interested in the flow of consciousness and its modalizations during psychological trauma (post-traumatic stress disorder) and its resolution. It is based on the premise that in PTSD, consciousness becomes more rigid, less fluid, due to the memory always imposing itself on the consciousness. The resolution of the trauma and the subsequent reduction of anxiety might improve the fluidity of consciousness and thus lead to an overall improvement in the psychological state of PTSD patients. In cases of PTSD, music has been shown to reduce anxiety from the very first session and has a very positive effect on all PTSD symptoms. In this project the following elements will be evaluated : on one hand, the changes in consciousness and its fluidity and, on the other hand, the evolution of anxiety following the listening of a new kind of work, videomusic (which associates a video scenario with music) exemplifying (metaphorizing) the trauma and its resolution.

NCT ID: NCT04654130 Withdrawn - PTSD Clinical Trials

Neurofeedback Effectiveness Trial in PTSD

Start date: February 1, 2022
Phase: N/A
Study type: Interventional

This study is an effectiveness trial investigating neurofeedback (NFB) in adults with PTSD (Post-Traumatic Stress Disorder). Participants will be randomly assigned to one of two treatment conditions - i) NFB, or ii) wait list. Due to the coronavirus pandemic, our study will, primarily, take place online (i.e., online assessment and treatment, with option of in-person fMRI, or functional magnetic resonance imaging, scans). NFB sessions will be conducted from home, with videoconferenced supervision by research staff. After study completion, individuals in the wait list condition will be offered the same NFB treatment.

NCT ID: NCT04592159 Withdrawn - Clinical trials for Post-Traumatic Stress Disorder

Study of the Safety and Efficacy of Nabiximols Oromucosal Spray Versus Placebo in Patients With Post-traumatic Stress Disorder

Start date: February 1, 2021
Phase: Phase 2/Phase 3
Study type: Interventional

This study will be conducted to evaluate the efficacy of nabiximols for the treatment of symptoms of post-traumatic stress disorder (PTSD) in participants receiving selective serotonin reuptake inhibitor (SSRI) or serotonin-norepinephrine reuptake inhibitor (SNRI) pharmacotherapy.