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Stress Disorders, Post-Traumatic clinical trials

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NCT ID: NCT05344092 Recruiting - Depression Clinical Trials

Designing a Mobile App to Support Academic Success for Student Veterans

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

Compared to civilian students in higher education, student Veterans have high rates of mental health disorders (PTSD: 40% vs. 9% and Depression: 24% vs 12.1%). As a result, Veterans with mental health disorders can be more likely to experience academic issues, such as lower enrollment rates and slower degree attainment on average. In addition, student Veterans with mental health disorders can experience substantial challenges with the already-difficult transition to the student role, with difficulties related to education planning, academic skills, and mental health management. Though many student Veterans could benefit from programming embedded in supported education interventions, current in-person VA supported education treatments are often difficult to access - or not available locally - for these Veterans. In addition, there is no widely available, VA-specific online or mobile-app based resource for students, which is a substantial gap in resources for student Veterans. The goal of this project is to develop and evaluate a comprehensive mobile app for student Veterans with mental health disorders. This intervention will use the principles of Veteran supported education research and manualized treatments to develop a personalized academic success app, VetEd, to address a variety of academic and psychiatric symptom-related educational barriers for student Veterans. Specifically, VetEd will provide a resource to (1) orient student Veterans with mental health disorders to successfully transition to the role of student as defined by their self-created educational roadmap, which will include helping students acquire (2) academic skills, (3) mental health management skills, and (4) up-to-date information on psychiatric, academic, and financial resources to help them successfully meet higher-education expectations. This overall study will involve three aims: 1) Developing a Veteran-centered educational support app to help student Veterans with mental health disorders to identify their perceived academic needs, app preferences, and evaluate Veteran-centered content; 2) Testing and iteratively revising the VetEd app (n =15) by assessing app software, content, human-computer interface, usability, satisfaction data, and preliminary exploration of changes in educational functioning (course activity completion, academic self-efficacy, and retention; and 3) Completing final revisions of the VetEd app for a future grant application of a larger RCT. This pilot project is significant and innovative in three key respects: (1) it extends services based in previous, effective supported education research to address both psychiatric and academic concerns for Veterans with mental health disorders; (2) is potentially cost-effective and easy to disseminate nationally; and (3) focuses on improving Veterans' academic functioning and quality of life is substantially different than current VA mobile app offerings. Results from this pilot project will inform the development of a Merit Review application for a larger, randomized clinical trial of VetEd with student Veterans.

NCT ID: NCT05342480 Recruiting - Clinical trials for Post Traumatic Stress Disorder

Intensiv Inpatient Trauma Treatment. A Pilotstudy.

ITBD
Start date: April 8, 2022
Phase: N/A
Study type: Interventional

Aim of the study: Post traumatic stress disorder (PTSD) is a psychiatric illness that can develop after having experienced traumatic, often life treathening, events. The symptoms often leads to significant subjective suffering, and may limit vocational and social functioning. Intensive trauma treatment with Eye Movement Desensitization and Reprocessing (EMDR) and Prolonged Exposure (PE) of patients with PTSD has not previously been conducted in an inpatient setting in Norway. In this study we foremost seek to examine if this combined intervention, given at a five day inpatient unit, is suitable to a norwegian PTSD population and clinical setting. We will do this by systematically gathering information about how many drop out of the treatment program, and if so, at what stage of the program. We will also ask the patients to complete a short questionnaire about how they viewed the treatment program overall, and the separate parts of the program. We also wish to examine how the patients experienced the intervention, and in what way it contributet to their possible improvemen,t through a qualitative interview. We will also use well established clinical self report questionnaires to investigate if the patients who participate in the treatment program will experience an improvement of their PTSD symptoms and improved functioning, and examine if this possible improvement lasts two and six months post treament. Method: This is a pilotstudy where a total of twelve patients with PTSD will be recruited from the Nydalen outpatient department, Oslo University Hospital. The patients have to satisfy the studies inclusion criteria, including having experienced at least two traumatic experiences, and had at least one previous psyhotherapeutic treament. The patients will be examined with validated self report questionnaires before and after the intervention, as well as after two and six months post treatment. Six patients will be invited to participate in a qualitative interview focusing on their experience of the intervention. The Intervention: Treatment program monday to friday with daily PE and EMDR sessions, physical activity between sessions, in vivo exposure treament and psychoeducational groups. Daily rotation of both EMDR and PE therapists. Multidisiplinary team attached to each patient. Significance of the study: Intensive inpatient trauma treatment with EMDR and PE have not previously been done in Norway. It has neither, as far as we know, been conducted any qualitative studies of this intensive combined treatment method internationally.The project wish to contribute to change trauma treatment in our hospital from a stabilisation focus to a focus on active trauma processing and treatment, to increase our staffs and therapists competency in trauma treatment, and to further the national and international body of knowledge about how patients with PTSD best can experience functional and symptomatic improvement.

NCT ID: NCT05341882 Completed - Mindfulness Clinical Trials

Adaptation of Mindfulness Training to Treat Moral Injury in Veterans

Start date: June 1, 2021
Phase: Phase 3
Study type: Interventional

This project is highly innovative as it will be the first to develop a mindfulness-based treatment as a first-line intervention tailored to target moral injury among combat-wounded veterans. In Study 1, the investigators recruited a small group of veterans to give feedback on the project. In Studies 2 and 3, the investigators will compare the newly developed mindfulness training to an equally intensive Educational Support condition. Further, if successful, this application may have the ability to adapted and extended to address common to other professions that experience moral injury.

NCT ID: NCT05331534 Not yet recruiting - Clinical trials for Post Traumatic Stress Disorder

Effect of Attentional Therapy on Post-traumatic Stress Disorder

BATRAUMA
Start date: September 2022
Phase: N/A
Study type: Interventional

Post-traumatic stress disorder (PTSD) is associated with an attentional bias towards negative stimuli, which is supposed to contribute to the development and the maintenance of the disorder. We recently showed using eye-tracking evidenced two types of AB towards negative stimuli: a "physiological AB" found both in healthy and individual with PTSD, characterized by a stronger initial attentional engagement towards negative stimuli compared to neutral stimuli, as revealed by longer first fixation duration dwell time on negative pictures than on neutral pictures; a "pathological bias" observed only in individuals with PTSD and characterized by an heightened sustained attention towards negative stimuli once detected, which further increases with prolonged exposure. The present study aimed at assessing the effectiveness of an eye-tracking assisted attentional bias reduction therapy, targeting specifically the pathological bias on the reduction of PTSD symptoms

NCT ID: NCT05327504 Recruiting - Clinical trials for Posttraumatic Stress Disorder

Written Exposure Therapy for Veterans With SUD and PTSD

WET
Start date: September 26, 2022
Phase: N/A
Study type: Interventional

The proposed project will evaluate the efficacy of written exposure therapy (WET) among Veterans engaged in substance use disorder (SUD) treatment, who present with co-occurring posttraumatic stress disorder (PTSD). While SUD treatment programs traditionally do not address PTSD, effective trauma treatments have been used successfully among those with substance use comorbidities. WET is a brief trauma-focused intervention shown to effectively treat PTSD. In a recent acceptability and feasibility pilot study among Veterans with co-occurring SUD and PTSD, results showed a decrease in PTSD symptoms among participants receiving WET. The goal of the present study is to improve outcomes for Veterans who present for SUD treatment with comorbid SUD/PTSD.

NCT ID: NCT05323318 Recruiting - COVID-19 Clinical Trials

Neuropsychological Sequelae and Long COVID-19 Fatigue

PostCoV2Psy
Start date: April 1, 2022
Phase:
Study type: Observational

An association of fatigue with post-viral neuropsychological disturbs has been reported. Among patients hospitalized with COVID-19 there is an increased incidence of anxiety and depression symptoms. In addition, a quarter of patients experience at least mild symptoms of acute post traumatic stress disorder. (Mazza, M. G. et al 2020). The prevalence of chronic fatigue syndrome had a correlation with post-traumatic stress disorder (PTSD) in a study conducted after the outbreak of the COVID-19 in Iran (Silmani et al, 2021), that showed 5.8% of subjects suffering from PTSD after 6 months of SARS-CoV-2 infection onset. In this Study we propose to use a tool to quantify the degree of physical and psychological fatigue in post-COVID-19 patients, and assess the correlation of fatigue with the neuropsychiatric sequelae in hospitalized and non hospitalized patients.

NCT ID: NCT05319665 Completed - Clinical trials for Post Traumatic Stress Disorder

"Connected Caesarean Section": Creating a Virtual Link Between Mothers and Their Infants to Improve Maternal Childbirth Experience: A Pilot Trial

e-motion-pilot
Start date: April 8, 2022
Phase: N/A
Study type: Interventional

One third of mothers rate their childbirth as traumatic. The prevalence of childbirth-related posttraumatic stress disorder (CB-PTSD) is of 4.7% and the prevalence of childbirth-related posttraumatic stress symptoms (CB-PTSS) of 12.3%. Skin-to-skin contact is a protective factor against CB-PTSD. However, during a caesarean section (CS), skin-to-skin contact is not always feasible and mothers and infants are often separated. In those cases, there is no validated and available solution to substitute this unique protective factor. Based on the results observed in studies using virtual reality (VR) and head-mounted displays (HMDs) and studies on childbirth experience, we hypothesize that enabling the mother to have a visual and auditory contact with her baby could improve her childbirth experience whilst she and her baby are separated. To facilitate this connection, we will use a 2D 360° camera filming the baby linked securely to a head-mounted device (HMD) that the mother can wear during the end of the surgery.

NCT ID: NCT05319405 Completed - Clinical trials for Post Traumatic Stress Disorder

Effectiveness of Sana Treatment in Post-Traumatic Stress Disorder (PTSD)

Start date: April 19, 2023
Phase: N/A
Study type: Interventional

The purpose of this study is to assess the effectiveness of the Sana Device when added to Treatment as Usual in participants with a diagnosis of post-traumatic stress disorder (PTSD)

NCT ID: NCT05314829 Recruiting - Clinical trials for Post Traumatic Stress Disorder

Trauma Treatment in Norwegian Child Advocacy Centers

Start date: August 1, 2020
Phase:
Study type: Observational

Norwegian child and advocacy centers´ core activities include both forensic services (e.g., forensic interviews) and follow-up services (e.g., treatment), aiming to coordinate the different services involved in each case to prevent additional burdens for youth in already vulnerable situations. However, a recent study indicates that very few receive follow-up after the forensic interview and that the follow-up in most cases includes one-time or occasional support and only in rare cases treatment. In the same study, youth receiving follow-up in the CAC in Oslo revealed significantly higher levels of common mental health problems than a comparable community sample, yet lower than clinical samples, indicating that many youths in CACs may be falling between different services within the health care system, not necessarily receiving the help they need elsewhere. The current project will investigate four issues related to these knowledge needs; 1. How do children and parents experience receiving trauma treatment at child advocacy centers? 2. What predicts treatment effects? 3. What is the prevalence of symptoms of burnout and secondary traumatic stress among employees working in child advocacy centers, and can training in evidence-based treatment prevent burnout and secondary traumatic stress?

NCT ID: NCT05313334 Recruiting - Clinical trials for Posttraumatic Stress Disorder

GAMBIT Task With PTSD and Healthy Control Participants

GAMBIT
Start date: November 18, 2022
Phase: N/A
Study type: Interventional

This is a pilot study of a digital training task called GAMBIT. This study will be the first to examine potential relationships between GAMBIT task completion and brain circuit flexibility, behavior, and symptoms in participants with PTSD.