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Stress Disorders, Traumatic clinical trials

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NCT ID: NCT06280170 Enrolling by invitation - Anxiety Disorders Clinical Trials

AI to Support Mental Health Case Management Providers

Start date: February 19, 2024
Phase: N/A
Study type: Interventional

The goal of this clinical trial is to assess the effectiveness of an artificial intelligence (AI) platform for case managers in a nonprofit health system specializing in mental health and substance use disorder. The main questions it aims to answer are: 1. Is the AI platform acceptable and feasible for case managers? 2. Does the AI platform improve providers' productivity and reported interventions? Participants will be approximately 30 case managers and their 250 adult clients receiving case management services. Researchers will compare the provider productivity and work satisfaction prior to the implementation of the AI platform to following its implementation.

NCT ID: NCT06237426 Enrolling by invitation - Clinical trials for Post Traumatic Stress Disorder

An Evaluation of the Long-term Efficacy and Safety of Methylone for the Treatment of PTSD

IMPACT-EXT
Start date: March 6, 2024
Phase: Phase 2
Study type: Interventional

This is an extension study of participants who previously completed a Transcend-sponsored clinical trial with methylone as a treatment for PTSD (IMPACT-1 or IMPACT-2). Participants will be followed for up to 52 weeks. During the 52 week period, PTSD symptoms and safety will be assessed monthly. Participants' PTSD symptoms will be assessed at each observational visit and if criteria for Relapse has been met, participants may be eligible to receive a course of methylone treatment. After a course of methylone treatment, participants resume observational study visits until Week 52.

NCT ID: NCT05900479 Enrolling by invitation - Clinical trials for Stress Disorders, Post-Traumatic

Multi-site, Longitudinal Trial Evaluating the Efficacy, Mechanisms, and Moderators of Service Dogs for Military Veterans With PTSD

Start date: September 15, 2023
Phase: N/A
Study type: Interventional

Posttraumatic stress disorder (PTSD) among military Veterans is a critical public health concern. Veteran suicide rates exceed those of the general population, with the disorder creating a mental health challenge that is costly and debilitating. The majority of Veterans with PTSD also have comorbid mental health diagnoses, such as generalized anxiety disorder, substance abuse disorder, and major depression. The treatment of Veteran PTSD and comorbid disorders represents an important therapeutic and rehabilitation problem. The disorder is complex and difficult to treat, with high treatment dropout and nonresponse rates spurring some Veterans to seek complementary integrative health strategies. One promising complementary strategy is the provision of a trained service dog. Initial evidence across multiple research groups highlights service dogs as a promising complement to evidence-based practices that can offer short-term improvements. However, the long-term effectiveness, mechanisms of action, and moderators of efficacy remain largely unknown. Thus, the overarching objective of this proposal is to understand how, why, and for whom PTSD service dogs are most effective. To address this objective, the present project will assess the longitudinal efficacy and dose-response curve of service dogs for Veteran PTSD symptomology and psychosocial functioning. The research design will consist of a two-arm, randomized clinical trial (RCT) with longitudinal assessments at 0, 3, 9, and 15 months. Results are expected to elucidate the clinical impact of service dogs for military Veterans with PTSD, as well as the biobehavioral mechanisms of action and characteristics that moderate efficacy. These outcomes will support the long-term goal of accelerating complementary and integrative health interventions, through optimized and evidence-based service dog interventions. As such, this project will further advance the scientific understanding of human-animal interactions for psychosocial health.

NCT ID: NCT05899322 Enrolling by invitation - Clinical trials for Post Traumatic Stress Disorder

Adaptation of the PCIP for Spanish Speaking Adolescents and Families

Start date: June 12, 2023
Phase: N/A
Study type: Interventional

This study will implement a brief Post-traumatic Stress Disorder (PTSD) intervention for children, the Primary Care Intervention for PTSD (PCIP) delivered through telehealth (computer or smart phone delivery), to 10 Spanish speaking youth and their families. Mixed methods (qualitative and quantitative) randomized pilot feasibility trial (n=10 to treatment and 10 to waitlist control) to refine the intervention, study procedures, and explore effectiveness. Following RE-AIM guidelines, the investigators will assess: Reach: patient participation in intervention delivery (out of all those asked to participate) and retention rate (out of all those who consented to participate and completed at least two intervention sessions) Adoption: patients and their parents/guardians will complete screening and intervention satisfaction ratings. To understand patient experiences with the intervention and to identify and explain positive or negative treatment mechanisms or effects, the investigators will conduct post-intervention semi-structured interviews with the participating patients, their parents/guardians, and with providers. This treatment ranges from 1-3 sessions which last 30-50 minutes per session. The first session will cover psychoeducation about PTSD symptoms in children that can be delivered to the parent or both the parent and child. The first session will also teach the parent and child a breathing technique to combat the physiological impact of PTSD in children. The subsequent sessions will be tailored to meet the needs of the child's most distressing PTSD symptom cluster including hyper arousal, negative changes in cognition and mood, avoidance, re-experiencing. Each session contains coping skills that the parent and child can learn together. There is also material for parents to address behavior problems in youth. This treatment will be delivered via telehealth. All treatment materials have been developed in both Spanish and English.

NCT ID: NCT05816421 Enrolling by invitation - Clinical trials for Post Traumatic Stress Disorder

Adaptation and Evaluation of the KEEP Model

Start date: May 16, 2022
Phase: N/A
Study type: Interventional

This study capitalizes on an opportunity to formally evaluate local adaptations of "Keeping Foster and Kinship Parents Supported and Trained" (KEEP), an evidence-based foster parent intervention, to reduce mental health disparities among child welfare-involved youth and improve care quality and long-term outcomes for Native, Hispanic/Latino, Black/African American, and sexual and gender minority youth. The knowledge gained from the study will impact all current and future large-scale implementations of KEEP and will bolster our scientific understanding the impact of KEEP on youth mental health outcomes.

NCT ID: NCT05797441 Enrolling by invitation - PTSD Clinical Trials

Testing the Effectiveness of a Therapist-Assisted Self-Management Program for Veterans Who Finished PTSD Therapy

EMPOWER
Start date: October 16, 2023
Phase: N/A
Study type: Interventional

Patients who complete prolonged exposure and cognitive processing therapy, the treatments for posttraumatic stress disorder (PTSD) with the most empirical support, continue to express a need for mental health treatment. A therapist-assisted self-management program for patients who have completed one of these two treatments and achieved symptom improvement has the potential to meet patients' stated treatment needs, maintain or build upon their PTSD symptom reductions, increase their confidence in managing their symptoms, and reduce the number of mental health appointments that they need to attend. Further, reducing the number if mental health sessions attended by completers of these time and resource intensive psychotherapies will increase the likelihood that their implementation in regular-practice clinics will be maintained.

NCT ID: NCT05600868 Enrolling by invitation - Clinical trials for Trauma, Psychological

The Effect of Dual Attention in an EMDR Intervention

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

Research to date indicates that trauma-focused treatments are safe and effective for PTSD, even when higher-risk comorbidities (e.g., psychosis or substance use) are present. In particular, there are data pointing to the efficacy of prolonged exposure therapy and eye movement desensitization and reprocessing (EMDR) therapy. Clinical practice guidelines specifically recommend trauma-focused treatment with exposure and/or cognitive restructuring components. Regarding EMDR interventions, there are increasing results supporting its efficacy. Some interesting clinical advantages presented by EMDR as opposed to cognitive-behavioral therapies are 1) the efficacy found despite less exposure to the traumatic memory, 2) the exclusion of homework, 3) as well as the rapid reduction in subjective disturbance produced even after a single session of EMDR therapy. However, the mechanisms producing the improvement and, in particular, the effect of bilateral stimulation are not precisely known. More research is needed in this regard since bilateral stimulation is the most controversial part and with less evidence found. In addition to this, there are very few studies that have analyzed the differential efficacy of the presence or absence of bilateral stimulation or of the different types of stimulation possible. As for the comparison between types of stimulation (bilateral with eye movements, or focusing on a fixed point), greater treatment effects have been found for EMDR with fixation on an immobile hand compared to eye movements. The aim of this study is to examine the effectiveness of a comprehensive intervention protocol for people who have experienced traumatic events and present post-traumatic symptomatology. In addition, this study will compare the efficacy of traumatic memory processing with and without dual attention.

NCT ID: NCT05565352 Enrolling by invitation - Clinical trials for Major Depressive Disorder

Observation of Ketamine Treatment Safety and Tolerability in Adult Psychiatry Clinic Medical University of Gdańsk Inpatients

KetGD
Start date: September 1, 2022
Phase:
Study type: Observational

Adult Psychiatry Clinic Medical University of Gdańsk (MUG) is a healthcare facility that provides ketamine treatment to adult patients suffering from mental health conditions. The Clinic especially treats individuals suffering from treatment-resistant disorders, like - mood disorders, anxiety disorders, obsessive-compulsive and related disorders, trauma and stressor-related disorders, somatic symptom and related disorders, and dissociative disorders. Herein, this naturalistic observation aims to look at the safety and tolerability of ketamine treatment to further develop the understanding of ketamine in the use of psychiatry.

NCT ID: NCT05553249 Enrolling by invitation - Clinical trials for Post Traumatic Stress Disorder

Written Exposure Therapy for PTSD in a Virtual, Group-based Format

Start date: November 14, 2022
Phase:
Study type: Observational

The purpose of this study is to examine whether Written Exposure Therapy (WET) can be effectively delivered virtually and in a group format for the treatment of Post-Traumatic Stress Disorder in a military and police population. The objective of this study is to assess treatment feasibility and acceptability, drop out rates, changes in severity of trauma-related symptoms and symptoms of depression, quality of life, and the need for further trauma-focused treatment (TFT) for the the delivery of WET as a virtual, group based intervention.

NCT ID: NCT04775524 Enrolling by invitation - Stress Clinical Trials

AWARENESS Trial (AWARENESS) of Storytelling Through Music in Healthcare Workers

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

This research study is examining the feasibility and effectiveness of an online version of the Storytelling Through Music (STM) program with oncology nurses who have worked during the COVID-19 pandemic.