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Stress Disorders, Post-Traumatic clinical trials

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NCT ID: NCT05517304 Recruiting - Clinical trials for Stress Disorders, Post-Traumatic

Transcutaneous Vagal Nerve Stimulation in Veterans With Posttraumatic Stress Disorder

VNS in PTSD
Start date: October 1, 2022
Phase: N/A
Study type: Interventional

This study effects the effects of transcutaneous cervical vagal nerve stimulation (tcVNS) or a sham control on brain, physiology, and PTSD symptoms in Veterans with posttraumatic stress disorder (PTSD). Veterans undergo brain imaging and physiological measures in conjunction with traumatic scripts before and after three months of twice daily treatment with tcVNS or sham stimulation at home.

NCT ID: NCT05516862 Recruiting - PTSD Clinical Trials

Determining the Right Acupuncture for Good Recovery Over Neuropsychiatric Trauma

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

This study seeks to verify that a specific acupuncture treatment is effective at reducing symptoms of neuropsychiatric trauma found in those diagnosed with Post-Traumatic Stress Disorder (PTSD).

NCT ID: NCT05516368 Completed - Clinical trials for Major Depressive Disorder

TF-CBT for Long-term PTSD, Major Depressive Disorder and Anxiety Disorders in Victims of Terrorism

Start date: March 2012
Phase: N/A
Study type: Interventional

The objective of this study is to test the efficacy of a Trauma-Focused Cognitive-Behavioural Therapy (TF-CBT) adapted for use with victims of terrorism in Spain who are diagnosed with posttraumatic stress disorder (PTSD), major depressive disorder and/or anxiety disorders subsequent to direct or indirect exposure to a series of terrorist attacks that occurred 20 years prior to treatment on average. Spanish victims who meet the criteria for long-term posttraumatic stress disorder, major depressive disorder, and/or anxiety disorders related to direct or indirect exposure to terrorist attacks that occurred 20 years ago, on average, will be randomly assigned to 16 weekly sessions of TF-CBT (experimental group) or waiting list control (control group) conditions. Between groups comparisons related to diagnostic rates and posttraumatic, depressive and anxiety symptoms will be made immediately after the intervention. Pre- follow-up comparisons related to diagnostic rates and posttraumatic, depressive, and anxiety symptoms will be carried out for the experimental group. It is hypothesised that participants receiving TF-CBT will have significantly lower diagnostic rates and mean levels of posttraumatic, depressive and anxiety symptoms than the control group immediately after the intervention, and that they will experience significant pre-treatment to 6-month follow-up decreases in diagnostic rates and in posttraumatic, depressive and anxiety symptoms.

NCT ID: NCT05516277 Recruiting - Clinical trials for Cardiovascular Diseases

Insomnia Treatment and Cardiometabolic Health in Older Adults With Posttraumatic Stress Disorder

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

This pilot randomized controlled trial will address a gap in knowledge related to addressing modifiable risk factors for cardiometabolic disease through treating residual insomnia, sleep difficulties that remain after successful treatment of another condition, in the context of PTSD in understudied older adults. This study provides a non-medication treatment for PTSD called Cognitive Processing Therapy (CPT) followed by one of two non-medication sleep education and treatment programs for sleep problems that remain after completing PTSD treatment in older adults with PTSD. The aims of this project are to evaluate 1) the added benefits of treating residual insomnia on sleep and PTSD symptoms; 2) the added benefits of treating residual insomnia following CPT on cardiometabolic risk biomarkers and quality of life; and 3) the durability of the sleep, PTSD, cardiometabolic and quality of life benefits of treating residual insomnia following CPT at 6-month follow-up in older adults with PTSD.

NCT ID: NCT05514093 Active, not recruiting - Clinical trials for Post-traumatic Stress Disorder

Beyond Silence: Advancing E-mental Health Solutions to Support Canadian Healthcare Workers

Start date: November 1, 2022
Phase:
Study type: Observational

The purpose of this project is to scale implementation and evaluation of an m-health app designed to promote early intervention and mental health support for frontline healthcare workers to reduce their risk of post-traumatic stress disorder (PTSD) and/or the mental health impact of the COVID-19 pandemic. Beyond Silence has received an additional year of funding to scale implementation across 4-6 additional healthcare organizations.

NCT ID: NCT05512143 Not yet recruiting - Hypertension Clinical Trials

TMS for PTSD and Blood Pressure

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

In this randomized clinical trial, we will test the short and longer term effects of repetitive transcranial magnetic stimulation (TMS) on blood pressure among reproductive aged female participants with elevated symptoms of post-traumatic stress disorder and hypertension.

NCT ID: NCT05497115 Recruiting - Depression Clinical Trials

Testing a Scalable Model of Care to Improve Patients Access to Mental Health Services After Traumatic Injury

Start date: November 4, 2022
Phase: N/A
Study type: Interventional

The purpose of this study to learn about patients' experience with the Trauma Resilience and Recovery program (TRRP) and/or the enhanced care group.

NCT ID: NCT05491538 Recruiting - Schizophrenia Clinical Trials

Acceptability and Feasibility of Work-Oriented Social-Cognitive Skills Training for Veterans With Serious Mental Illness

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

Many individuals with serious mental illness have difficulty accurately interpreting interpersonal cues and effectively engaging in social exchanges. Difficulties related to the interpersonal aspects of work can lead to isolation, poor productivity, and job loss. The goals of this study are to: 1) adapt an evidence-based social cognitive skills intervention for work settings and use with Veterans, 2) examine the acceptability of the work focused skills training intervention, 3) assess the feasibility of combining the social cognitive skills training program with supported employment, and 4) examine change on functional outcomes. The current study will use feedback from veteran and employment specialist stakeholders to adapt an evidence-based social cognitive skills training program, Social Cognition and Interaction Training (SCIT). The intervention will be modified to tailor it to work relationships and to address any unique relationship concerns among Veterans that are identified by stakeholders. SCIT-Work Edition (SCIT-WE) will add: 1) education about work-related social norms; 2) examples of work-related social interactions that require perspective taking and problem- solving; 3) individual sessions with the study therapist to enhance learning and relevance to each participant's goals; 4) structured interactions with the participant's employment specialist to practice skills outside of group; and 5) skill application sessions with the participant's employment specialist that prompt use of skills after training is completed. SCIT-WE will be developed and piloted in an open trial with 20 Veterans enrolled in the supported employment program at the Minneapolis VA who have a qualifying serious mental illness diagnosis. SCIT-WE will be offered for 2 hours weekly over 13 weeks, when most participants are in the job development and job search phases of supported employment. While participating in the group skills training, participants will have weekly, individual homework review sessions with the group facilitator to promote understanding of the skills and to discuss relevance of the skills to personal goals. Participants also will practice skills weekly with their employment specialist for 10-15 minutes to promote use of skills outside of group sessions. In the 3-months following skills training completion, participants will complete 10 15-minute skills review sessions with their employment specialist to encourage continued skill application in a work setting. Participants will complete assessments at baseline, before receiving the intervention; 3-months post-enrollment, after participating in a weekly skills training group; and 6-months post-enrollment, after receiving 10 additional individual skills review sessions with their employment specialist. Accessibility will be measured with rate of treatment uptake, rate of treatment completion, and participant attitudes toward the intervention. Feasibility of the intervention will be assessed by examining retention in supported employment and the study at 3- and 6-months post-enrollment. Impact of the intervention will be examined with measures of quality of life, social adjustment, self-efficacy, and work relationship quality. It is hypothesized that the intervention will be acceptable to Veterans. The investigators predict a 50% treatment uptake rate, a 70% intervention completion rate, and positive ratings on measures of satisfaction, interest, and value. The investigators hypothesize that it will be feasible to complete this intervention in combination with supported employment activities. The investigators predict that retention in both skills training and supported employment will be 75% at 3-months post-enrollment and 60% 6-months post enrollment. The investigators hypothesize that positive change will be seen at 3-months post-enrollment and sustained at 6-months post-enrollment on measures of quality of life and social adjustment. The investigators predicted that self-efficacy regarding return to work will be improved at 3-months post-enrollment. The investigators predict that Veterans will report being productive and having positive work relationships 6-months post-enrollment. The findings will inform the development of a novel intervention targeting the social and functional impairments associated with serious mental illness. The knowledge gained from this study will guide the development of the next generation of interventions. Given that employment is a critical part of recovery, advancement in therapeutic interventions that support Veterans in this process will be of significance.

NCT ID: NCT05489133 Recruiting - Clinical trials for Post Traumatic Stress Disorder

Early Psychological Intervention After Rape

EIR
Start date: June 14, 2022
Phase: N/A
Study type: Interventional

Rape is a common cause of post-traumatic stress disorder (PTSD) among women, as around 30-50% will develop PTSD in the aftermath of rape. A modified protocol based on Prolonged Exposure Therapy (mPE), has been developed, consisting of three to five once or twice weekly 60 minutes sessions, and studies indicate that if implemented early after rape, mPE may prevent the development of PTSD. The aim of the study is to conduct a multi-site (4 Sexual assault care centers in Norway) randomized control trial (RCT) in which patients are recruited early after rape, and randomized to intervention (mPE) or treatment as usual (TAU).

NCT ID: NCT05488418 Not yet recruiting - Clinical trials for Depressive Disorder, Major

Clinical Study of Biomarkers of Stress Resilience: Role of ELK1 and GPR56

GeBra-clin
Start date: September 1, 2022
Phase: N/A
Study type: Interventional

70% of Europeans will be exposed to a potentially traumatic event (PTE). Following this experience, people are likely to develop various psychiatric disorders such as post-traumatic stress disorder (PTSD) or a major depressive episode (MDE). However, not all subjects have the same risk to develop a pathology, and resilience capacities, which depend on multiple factors are difficult to predict. Currently, there are no objective tools to stratify exposed subjects according to their risk of developing pathological responses to stress, which leads to difficulties in allocating means of prevention and treatment. Recently, new biological hypotheses explaining vulnerability/resilience to stress and depression, implicating the GPR56 and ELK1 genes, have been described. Previous studies have shown that evaluation of the vulnerability risk can be obtained from clinical, cognitive, biological or brain imaging variables, but no study has integrated these different approaches. Therefore, the project presented here aims at integrating behavioral, biological and neuroimaging data to predict the development of psychiatric disease. In this study, a prospective cohort of 255 violent trauma victims will be set up in 3 French cities for a period of 2 years. Eligible subjects will be included in the month following PTE and will be followed longitudinally for 12 months. Evaluations at 1, 3, 6 and 12 months will be performed, during which the subject will complete various clinical and cognitive tests. A blood sample will be collected at each visit to study biological processes including the regulation of genetic and epigenetic expression, in particular the expression of the GPR56 and ELK1 genes in the blood. For eligible subjects a brain MRI will be proposed at the first visit. We hypothesize that the genetic expression of ELK1 and GPR56 is predictive of the development of psychiatric pathologies at 6 and 12 months post-PTE. The ambition of this project is also to highlight the importance of a multimodal approach integrating a triad of markers (behavioral, biological and neuroimaging) to test this hypothesis.