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Stress Disorders, Traumatic clinical trials

View clinical trials related to Stress Disorders, Traumatic.

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NCT ID: NCT04678232 Completed - Clinical trials for Major Depressive Disorder

Positive Processes and Transition to Health

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

The R61 will be an open trial to determine if Positive Processes and Transition to Health (PATH) engages the proposed targets: unproductive processing, avoidance, and reward deficits in a sample of 45 adults who have experienced a destabilizing life event involving profound loss or threat, report persistent stressor-related symptoms of PTSD and/or depression, and are elevated on symptoms related to 2 of the 3 therapeutic targets. Additionally, will examine whether patients perceive PATH as helpful and complete/adhere to treatment, and therapist fidelity. Patients will receive 6 sessions of PATH (with 2 boosters, if partial responders). Primary targets will be assessed at pre-treatment, week 4, post-treatment, and at 1- and 3-month follow-up; secondary targets at pre-treatment, weekly during treatment, post-treatment, and at 1- and 3-month follow-ups.

NCT ID: NCT04658810 Completed - Pregnancy Related Clinical Trials

Assessment of Post-traumatic Stress Disorder (PTSD) in Patients Monitored for Cytomegalovirus (CMV) Seroconversion During Pregnancy,

PTSD CMV
Start date: May 2, 2021
Phase:
Study type: Observational

Reports of maternal seroconversion to CMV during pregnancy can be extremely stressful. This virus is little known to the general public and searching for information on the Internet quickly leads to a consultation of a site mentioning the risk of severe psychomotor retardation in the event of prenatal cytomegalovirus infection. The psychological repercussions in the event of prenatal CMV infection with criteria of severity, leading or not to a request for IMG, is undeniable, but no study has investigated the consequences of seroconversion to CMV without transmission of the virus to the patient fetus, or in the case of transmission without criteria of seriousness, on the patient's experience during and after her pregnancy. Such a study would, if necessary, improve the care and support of these future mothers

NCT ID: NCT04648605 Completed - Clinical trials for Post-traumatic Stress

Post-traumatic Stress Disorder After Pediatric Intensive Care Unit Hospitalization

POETIC
Start date: January 26, 2021
Phase: N/A
Study type: Interventional

The elements that promote the development of post-traumatic stress in parents following hospitalization in pediatric resuscitation and thus the options for improving initial care at the time of hospitalization are unknown. It is therefore important to describe the prevalence of post-traumatic stress disorder with current pediatric resuscitation management data, but also to possibly describe the factors associated with it in order to optimize initial management.

NCT ID: NCT04617769 Completed - Clinical trials for Post Traumatic Stress Disorder

Effects of Antagonistic Actions in Response to Trauma Exposure

Start date: March 22, 2021
Phase: N/A
Study type: Interventional

The overarching objective of this study is to investigate the use of antagonistic actions as a treatment augmentation strategy for enhancing emotional processing during exposure to trauma-relevant stimuli. To accomplish this, participants (N = 84) reporting exposure to a combat, sexual assault, physical assault, or motor vehicle accident Criterion A trauma will be randomized to one of three experimental conditions: (a) Psychoeducation alone (PSYED); (b) Psychoeducation followed by repeated exposure to trauma-videoclips (PSYED + EXP); or (c) Psychoeducation followed by repeated exposure to trauma-videoclips while engaging in antagonistic actions (PSYED + EXP + AA). Antagonistic action strategies during exposure to the trauma-videoclips will include (a) adopting an open posture; (b) eating a palatable snack; (c) smiling; and (d) wishing on high levels of emotional distress. The investigators expect that (a) those randomized to receive psychoeducation alone will show less improvement relative to the two groups that receive psychoeducation plus repeated exposure to trauma-videoclips; (b) those receiving psychoeducation in combination with repeated exposure to trauma-videoclips while performing antagonistic actions will show significantly enhanced treatment outcome at the one-month follow-up relative to the other two treatment arms; (c) participants with greater PTSD symptom severity are likely to have a poorer treatment outcome to PSYED alone; (d) changes in trauma-related threat appraisals, coping self-efficacy, and safety behaviors will each independently mediate the effects of treatment; and (e) participants displaying reductions in their emotional reactivity are more likely to have a reduction in PTSD symptoms.

NCT ID: NCT04615195 Completed - Clinical trials for Post Traumatic Stress Disorder

Effect of COVID-19 Related COntainment in ChildreN

E-COCCON
Start date: June 10, 2020
Phase:
Study type: Observational

The current pandemic situation (SRAS COV2) is an unprecedented event and a source of stress potentially aggravated by containment. The Child Revised Impact Event Scale (CRIES-13) was evaluated in children 8 years or older in survivors of traumatic events, flood, stay in intensive care, or war (Bosnia). In this study CRIES-13 will be used to determine the prevalence of precursor signs of post-traumatic stress in children aged 8 to 15 confined between March 17, 2020 and May 2020

NCT ID: NCT04604574 Completed - Clinical trials for Substance Use Disorders

Evaluating the Integration of Indigenous Healing With Principals of Seeking Safety for Treatment of Indigenous Patients With a History of Trauma and Active Substance Use Disorder.

Start date: January 1, 2018
Phase: N/A
Study type: Interventional

Background: The negative health outcomes experienced by Indigenous peoples may be understood as direct consequences of colonization. One of the key consequences of the colonial influence on Canada's Indigenous peoples has been intergenerational trauma (IGT). Indigenous communities in Canada face significant challenges with IGT, which often manifest in substance use disorders (SUD). Indigenous communities have identified SUD as one of their greatest health challenges(Maté 2009), with some Northern Ontario First Nations communities experiencing SUD rates of 70% (Calveson 2010). Most Elders, traditional healers, and Indigenous scholars agree that connecting treatment to culture, land, community, and spiritual practices is a pathway to healing trauma and SUD for Indigenous peoples. Recent work by Dr. Teresa Naseba Marsh has demonstrated that Indigenous Healing and Seeking Safety (IHSS) model for trauma therapy can be effectively combined for the treatment of Indigenous patients with a history of trauma and SUD. Seeking Safety incorporates the inclusion of the mind, body, spirit, and self-awareness during treatment, and the perspective of Seeking Safety is convergent with traditional Indigenous healing methods. Benbowopka Treatment Centre is a residential treatment site operated by Mamaweswen, located in the North Shore Tribal Council in Blind River, Ontario. Benbowopka's mandate is to provide treatment for Indigenous clients with trauma and SUD. They are also implementing a culturally sensitive program grounded in IHSS methodology for the treatment of Indigenous patients' trauma and SUD. Through our current collaboration with Benbowopka and Mamaweswen the applicants have collected baseline data from client files to establish historical outcomes going back three years. In 2016, we began the collaborative implementation of the Indigenous Healing and Seeking Safety (IHSS) model for trauma therapy for clients at Benbowopka. Objective: The purpose of this proposal is to evaluate the effectiveness of the IHSS intervention which blends Indigenous Healing Practices and a mainstream treatment model, Seeking Safety for the treatment of Indigenous patients with a history of trauma and SUD. Methodology: In collaboration with the North Shore Tribal Council and the Benbowopka Treatment Center, we propose a prospective evaluation of IHSS treatment for Indigenous patients with a history of trauma and SUD. Benbowopka treats approximately 90 patients per year in a residential treatment program, and the program has high quality retrospective data on their programming and outcomes. We propose to benchmark anonymized historical program outcomes by evaluating program outcomes and the impact of program completion on health systems usage. Impact of treatment on health system usage will be determined by linking anonymized patient records with records at the Institute for Clinical and Evaluative Sciences (ICES). ICES linkage will provide further insight into hospitalizations, interaction with emergency, mental health, and primary care usage before and following the implementation of the IHSS intervention. We will respect the Tricouncil Policy Statement, Chapter 9, which highlights the importance of engaging with First Nations throughout all phases of the research process. In addition, we will honour Indigenous knowledge by engaging with Elders and the North Shore Tribal council. Through the data governance protocols established at ICES, we will respect the First Nations principles of ownership, control, access and possession of data (OCAP™). Dr. Jennifer Walker Canada Research Chair in Indigenous Health at the Center for Rural and Northern Health Research and ICES Scientist will oversee the process of data sharing and linking de-identified Benbowopka treatment data to anonymized health system data at ICES. Benbowopka and the North Shore Tribal council will maintain complete ownership over the study data and its subsequent dissemination. Anticipated Outcome: We expect that patients who are treated in the IHSS treatment model will have improved outcomes as compared to previous patients of Benbowopka treated under the abstinence based model of therapy. Objectives measures will include treatment completion, substance use at program completion, substance use at follow-up, ED visits, hospitalization, and death. Patient satisfaction will be tracked using surveys administered at treatment completion and is expected to improve with implementation of IHSS. Impact: We expect to demonstrate that the IHSS is a culturally sensitive and effective treatment model for Indigenous patients who are affected by trauma and substance use disorder.

NCT ID: NCT04598100 Completed - Depression Clinical Trials

Promoting Resiliency in Veteran Families With Young Children

FOCUS-EC
Start date: April 3, 2014
Phase: N/A
Study type: Interventional

Family-centered prevention services for civilian dwelling military (CDM) families & children are rarely available in civilian communities or often framed around mental disorders and family deficits. As of June 2010, over 1 million military service members from various military conflicts have become veterans. Wartime deployments can adversely impact the psychological health of children as well as marital relationships, parent-child relationships & overall family functioning. Although young children in CDM families may never have to cope with another parental deployment, their families may continue to struggle with the lasting effects of wartime deployment that cannot be ameliorated by singularly treating the service member. There is a need for family-centered preventive interventions that effectively build resilience and mitigate war deployment-related family difficulties, especially given the potential adverse emotional & developmental impact of deployment separations and reintegration stress on young children and their parents. To address this need, this study proposes to test the efficacy of FOCUS-EC (Families OverComing Under Stress for Early Childhood), an established strength-based, family-centered preventive intervention that is culturally sensitive and socially accepted by active duty military communities & has promising program evaluation data. A randomized control trial will be conducted with 200 CDM families with young children, ages 3 to 5 years, recruited from Los Angeles & surrounding counties (200 veterans, 150 spouses, and 300 children). CDM families will be randomized to the FOCUS-EC intervention condition (n=100 families; 100 veterans, 75 spouses, 150 children) or web-based educational materials condition (n=100 families; 100 veterans, 75 spouses, and 150 children) and assessed at baseline, 3, 6, & 12 months. It is hypothesized that in the FOCUS-EC condition: 1) children will exhibit more positive social-emotional & behavioral outcomes & developmental competencies than children in the comparison condition, 2) families will exhibit more positive family environment, improved parenting, enhanced parent-child relationships, & fewer parent psychological health problems than families in the comparison condition. The investigators also aim to explore potential moderating effects of child health/development risk, military & deployment/separation history, exposure to combat/trauma during deployment, and veteran & spouse/partner background factors.

NCT ID: NCT04595123 Completed - Depression Clinical Trials

Impact of COVID-19 Pandemic in Perinatal Mental Health (RISEUP-PPD-COVID-19)

Start date: June 15, 2020
Phase:
Study type: Observational

Introduction: Coronavirus disease 2019 (COVID-19) is a new pathology, declared a public health emergency by the World Health Organization, which can have negative consequences for pregnant women and their newborns. It is estimated that 1 in 5 women will develop a mental illness in the perinatal period. COVID-19 pandemic has been associated with anxiety and depression in the population. The current pandemic is a unique stressor with potentially wide-ranging consequences in the perinatal period, but little is known about the impact of COVID-19 on perinatal mental health. Thus, the objective of this study is to explore the experiences of pregnant and new mothers during the current pandemic, particularly its impact on perinatal mental health (including depression, anxiety, PTSD and psychological distress). Methods: The study design is a prospective observational study, with a baseline assessment and three follow-ups: one month; three months; and six months post baseline. This international study will be carried out in 11 European countries (Albania, Bulgaria, Cyprus, France, Greece, Israel, Malta, Portugal, Spain, Turkey, United Kingdom) Chile and Brazil. The study population will comprise pregnant women and new mothers with an infant under six months of age, covering a broad range of women across the perinatal period. Ethics and dissemination: The study and handling of the data will follow all national required data protection standards. Each researcher (or team of researchers) involved will submit the project to their local ethical committee before starting the project. Results from the project will be disseminated in peer reviewed journals and international conferences.

NCT ID: NCT04594434 Completed - Clinical trials for Complex Post-Traumatic Stress Disorder

Eye Movement Desensitization and Reprocessing (EMDR) in Complex Psychotrauma

Start date: December 12, 2020
Phase: N/A
Study type: Interventional

This study wants to demonstrate the effectiveness of combining a positive memory with "recommended" therapy based on EMDR in reducing the disturbance that patients with complex psychotrauma may experience. The positive memory will be called "benevolent memory" (SB) or "less worse memory" (SMP).

NCT ID: NCT04592770 Completed - Clinical trials for Post Traumatic Stress Disorder

Effect of Exercise on Post-traumatic Growth Among Health Care Providers With Post-traumatic Stress

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

The purpose of designing this randomized control trial is to observe the effect of nature-based walk on post-traumatic growth and Psychophysiological alterations associated with it, in traumatic stress among health care providers of Karachi Pakistan. This study is planned to investigate the recreational exposure to the natural environment for the promotion of PTG, in the traumatic stress subjects and to determine whether PTG is associated with psychophysiological alterations, i.e. C-Reactive Protein, Brain Derived Neurotropic Factor, Interleukin-6, Cortisol, and Heart Rate Variability. Subjects who had experienced any traumatic event in the last 12 months will be recruited, and at baseline, the participant will be assessed with Trauma Symptom Checklist 40 to evaluate trauma intensity. Moreover, subjects who had developed PTG or did not have any trauma intensity will be excluded from the study. Blinded treatment will be provided to subjects meeting eligibility criteria and will be randomized into two groups sequentially as they agree to participate. The nature-based walk will be used as intervention vs the control (relax in nature). The study outcomes will be monitored in subjects of both groups at different intervals, i.e. at baseline and 3-month follow-up (post-interventional).