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Stress Disorders, Traumatic clinical trials

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NCT ID: NCT04985344 Recruiting - PTSD Clinical Trials

Treatment of Pediatric Post-traumatic Stress Disorder With Memory Reactivation Under the Influence of Propranolol

PPP
Start date: February 1, 2023
Phase: Phase 3
Study type: Interventional

By age 18, roughly 8% of traumatized youth have met criteria for a diagnosis of PTSD, with numbers rising up to 40% in cases of sexual abuse and assault. To date there is no empirical support for the use of psychopharmacological interventions as treatment of pediatric PTSD. Trauma-focused psychotherapeutic/TFP approaches should be favored in childhood PTSD. However, when compared to active control conditions, TFP produced a mean effect size on child and adolescents population (g=0.83). Moreover, in therapies with a substantial exposure component, the intense and lengthy reexperiencing of the traumatic event results in a substantial proportion of participants dropping out. The reactivation of a previously consolidated memory can make it labile, subsequently requiring a re-stabilization of it called reconsolidation of the memory. Acting on these reconsolidation processes makes possible to interfere with the subsequent storage of this memory.

NCT ID: NCT04959695 Recruiting - Clinical trials for Posttraumatic Stress Disorder

Evaluation of the PE Coach Mobile Application Among Veterans With PTSD

Start date: July 29, 2022
Phase: N/A
Study type: Interventional

Thousands of mental health mobile applications (apps) are available but limited research has been conducted on their effectiveness. VA has been a leader in mental health mobile app development and must research whether these apps work, and if so, how? PE Coach is a well-designed treatment companion app to one of the most researched, efficacious psychotherapies for PTSD (prolonged exposure), a treatment that has been broadly disseminated throughout VA mental health clinics. Research suggests that VA therapists find the app helpful in supporting patients. Preliminary results suggest that Veteran patients prefer to receive therapy withPE Coach and Veterans complete more recovery-oriented homework when they do. This study will randomize 124 Veterans with PTSD to treatment with or without PE Coach. The project will evaluate the effect of the app on PTSD-related functioning, quality of life, and PTSD symptoms. The investigators will test whether the app improves functioning and symptoms, increases homework, and reduces drop out.

NCT ID: NCT04953273 Recruiting - Clinical trials for Post-Traumatic Stress Disorder

A Case Management Algorithm for Women Victims of Violence

VIGITRAUMA
Start date: July 6, 2021
Phase: N/A
Study type: Interventional

A considerable body of research has demonstrated that women who are victims of interpersonal violence are at substantially elevated risk for the development of post-traumatic stress disorder (PTSD). In France, victims can request a medico-legal examination in a clinical forensic medicine unit. Although these units are also a place for initial psychological examination, women often don't attend future scheduled appointments. Decision-making algorithm using phone contact are effective in suicide prevention. Our aim is to assess the effectiveness of case management algorithm using early phone contact compared to a control group treated as usual on clinical outcome after consultation requested in a clinical forensic medicine unit by female victims of violence. Method: Prospective, multicenter, open-label, randomized controlled clinical trial, for women victims of violence. Victims randomized in VIGITRAUMA group will be contacted by phone at 3 weeks after the consultation in a clinical forensic medicine unit, and a second phone call can be done. If the subject is not contacted after the second phone call, he will receive a postcard. Control group will benefit from usual follow-up. All the subjects included will be then evaluated at 3 months, 6 months and 1 year during a phone call.

NCT ID: NCT04950426 Recruiting - Clinical trials for Posttraumatic Stress Disorder

Impact of Post-Traumatic Stress Disorder Treatment by Reconsolidation Therapy on Fibromyalgia Syndrome

PTSD-FMS
Start date: August 13, 2021
Phase: Phase 2
Study type: Interventional

The aim of the study is to demonstrate a significant improvement in quality of life specific to patients with fibromyalgia syndrome in patients with fibromyalgia syndrome with comorbid posttraumatic stress disorder, treated with reconsolidation blockade. Patients receive a treatment with propranolol associated with reconsolidation blockade of traumatic story once a week during 6 weeks, with evaluation at inclusion and at 3 months.

NCT ID: NCT04934202 Recruiting - Clinical trials for Post-traumatic Stress Disorder

Cohort Follow-up of Survivors of Hospitalization for COVID-19 During the 2nd Wave of the Epidemic in France

COMEBAC 2
Start date: May 5, 2021
Phase:
Study type: Observational

From July to September 2020, in a first uncontrolled cohort study, 478 patients who were hospitalized at Bicêtre hospital for COVID-19 and who survived were evaluated at 4 months (publication accepted at JAMA). The current project aims to bring together the means to continue this work during the 2nd epidemic wave.

NCT ID: NCT04916938 Recruiting - Clinical trials for Post-traumatic Stress Disorder (PTSD)

Post-natal Post-traumatic Stress: Impact of an Early Dyadic Intervention Though Interaction Guidance Therapy on Maternal Sensitivity and Reduction of Maternal Stress

EVAGIT
Start date: December 29, 2021
Phase: N/A
Study type: Interventional

The aim of this study is to assess if an early therapeutic management focused on the mother-baby interaction using Interaction Guidance Therapy (IGT) with video feedback, brings an improvement of the maternal sensitivity in the interaction but also a decrease of the post-traumatic maternal symptoms. Post Natal Post traumatic stress is known as a disorder that impaired maternal mental health but also development of motherhood and the construction of the bond to the baby through interactive disturbances. The investigators will screen, among women who had a traumatic perception of an event related to the pregnancy or the childbirth, those who still present posttraumatic stress symptoms at 4 weeks post-partum. Four weeks from the traumatic event is the minimum delay to qualify a PTSD. After randomization IGT versus Treatment As Usual (TAU), the investigators planned an early therapeutic intervention, 3 sessions at 8, 10 and 12 weeks of post-partum. The investigators will assess the effect of the IGT on Maternal sensitivity and on the intensity of post-traumatic stress symptoms at 3 month post-partum and 1year.

NCT ID: NCT04911010 Recruiting - Schizophrenia Clinical Trials

Effectiveness of Trauma Therapy in Patients With PTSD and Comorbid Psychotic Disorder

PEPSY
Start date: January 20, 2021
Phase: N/A
Study type: Interventional

Effectiveness of trauma therapy using prolonged exposure for the treatment of post-traumatic stress disorder (PTSD) in patients with comorbid psychotic disorder

NCT ID: NCT04908410 Recruiting - Chronic Pain Clinical Trials

The Norwegian Addiction, Pain and Trauma Study

NOR-APT
Start date: March 23, 2021
Phase:
Study type: Observational

THIS STUDY DOES NOT OFFER ANY FORM OF TREATMENT FOR PTSD, PAIN OR SUBSTANCE DEPENDENCE. In populations with substance use disorders (SUD), there is a high prevalence of chronic pain with various underlying causes. Chronic pain can complicate the treatment of SUD and lead to poorer treatment outcomes. There is a need for a better understanding of the connections and interactions between chronic pain and substance use and dependence. Further, there is a high prevalence of chronic pain among patients with post-traumatic stress disorder (PTSD). As there is an overlap between populations with SUD and PTSD, taking potentially traumatizing life-experiences and post-traumatic stress symptoms into account can provide a better understanding of chronic pain in populations with SUD. The Nor-APT study is a cross-sectional study, where the goal is to recruit 1 500 patients from outpatient and inpatient substance use treatment centres connected to Akershus University Hospital and Oslo University Hospital in Norway. Participants are invited to complete a questionnaire about substance/medication use, pain and how pain affect function, stressful life events and post-traumatic stress symptoms. The questionnaire has been developed in collaboration with clinicians at the various substance dependence treatment units and the Norwegian Centre for Violence and Traumatic Stress Studies (NKVTS). The purpose of the Nor-APT study is to contribute to a better understanding and treatment of chronic pain among people with substance use disorders (SUD), and to contribute to the understanding of co-occurring substance use, chronic pain and post-traumatic stress symptoms. The four over-arching research aims are to: I. Describe the prevalence and characteristics of pain for people in need of treatment for substance/medication use/dependence. II. Describe how the pain affects physical and emotional functioning, and subjective quality of life. III. Explore any connections between substance/medication use and pain, both what came first and any ways substance/medication use and pain affect each other. IV. Explore the connection between chronic pain, potentially traumatizing life events and post-traumatic stress symptoms. In addition, the investigators will explore whether participants' experiences can be categorized into typical trajectories for how substance use, chronic pain and stressful life events occur and develop over the life span.

NCT ID: NCT04888169 Recruiting - Clinical trials for Post Traumatic Stress Disorder

Studying the Modification of Attention Bias Remotely After Trauma

SMART
Start date: April 20, 2023
Phase: N/A
Study type: Interventional

The investigators will complete an entirely remote randomized controlled trial (RCT) comparing 14 sessions of attention bias modification (ABM), attention control training (ACT), placebo neutral attention training, and a final control condition with daily questions in 1,897 individuals with clinically significant Post-traumatic Stress Symptoms (PTSS) (defined as PCL-5 score ≥ 33). To assess effects of the training and control conditions, the investigators will administer tests of threat-related attention bias and variability, and self-report assessments of PTSS, depression, anxiety, and perceived stress at baseline, after one and two weeks of training, and at eight-week follow up. The investigators plan to screen and confirm interest from over 3,000 eligible participants over a period of 24 months to enroll and randomize 1,897 participants with the end goal of 1,232 completers (176 per condition).

NCT ID: NCT04871100 Recruiting - Clinical trials for Posttraumatic Stress Disorder

Integrated CBT to Improve Functioning in Veterans With Anxiety and Substance Use

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

Individual with anxiety and post-traumatic stress disorder often use alcohol in ways that could cause them harm. Treating both mental health concerns and alcohol use at the same time can help reduce difficulties engaging in multiple treatments. The investigators are evaluating how a cognitive behavioral therapy program that helps Veterans with anxiety, posttraumatic stress disorder, and alcohol use at the same time can help improve the participants lives.