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Stress Disorders, Traumatic clinical trials

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NCT ID: NCT04626050 Recruiting - Clinical trials for Post-traumatic Stress Disorder

General Psychological Distress, PTSD, and Co-Morbidities in Healthcare Workers Consequent to COVID-19

Start date: January 20, 2022
Phase: N/A
Study type: Interventional

It is expected that large numbers of healthcare workers will experience a broad range of psychological reactions and symptoms including anxiety, depression, moral distress, and trauma symptoms that will cause both significant suffering as well as occupational and social impairment. The purpose of this study is to find interventions which are helpful in treating psychological distress in healthcare workers caring for COVID-19 patients. There are two phases of the study. All participants will take part in Phase I, which consists of 4 sessions over a two-week period of either a narrative writing intervention or a medical music intervention. Participants will be randomly assigned to the narrative writing intervention or medical music intervention. After Phase I, participants will be re-assessed. Healthcare workers who meet criteria for PTSD will be given the option to participate in Phase II of the study, in which they will be offered a choice between one of two evidence-based treatments for PTSD: Interpersonal Therapy (IPT) or Exposure Therapy (ET). Both treatments are comprised of ten 75-minute sessions scheduled twice weekly. Participants will be allowed to choose a preferred treatment in Phase II. After Phase II participants will complete a final assessment concluding the study. All interventions will be offered using distance technology.

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).

NCT ID: NCT04592159 Withdrawn - Clinical trials for Post-Traumatic Stress Disorder

Study of the Safety and Efficacy of Nabiximols Oromucosal Spray Versus Placebo in Patients With Post-traumatic Stress Disorder

Start date: February 1, 2021
Phase: Phase 2/Phase 3
Study type: Interventional

This study will be conducted to evaluate the efficacy of nabiximols for the treatment of symptoms of post-traumatic stress disorder (PTSD) in participants receiving selective serotonin reuptake inhibitor (SSRI) or serotonin-norepinephrine reuptake inhibitor (SNRI) pharmacotherapy.

NCT ID: NCT04585685 Recruiting - Clinical trials for Stress Disorders, Post-Traumatic

Healthy Recovery After Trauma Study

HRT
Start date: September 10, 2020
Phase: N/A
Study type: Interventional

Mental contamination-an internal experience of dirtiness evoked in the absence of physical contact with an external source-has been linked to the development and maintenance of posttraumatic stress disorder (PTSD) following exposure to sexual abuse or assault (Adams et al., 2014; Badour et al., 2013; Brake et al., 2017). Mental contamination has been associated with greater PTSD severity (Rachman et al., 2015) and higher elevations in specific PTSD symptom clusters (particularly those of intrusive reexperiencing, negative cognitions/mood, and arousal/reactivity; Brake et al., 2019; Fergus & Bardeen, 2016). Additionally, trauma-related mental contamination has been linked to a number of negative posttraumatic emotions such as shame, guilt, disgust, and anger (Fairbrother & Rachman, 2004; Radomsky & Elliott, 2009) Despite clear and consistent links between mental contamination and problematic posttraumatic outcomes following sexual trauma, there is a dearth of research investigating how existing or promising new interventions for PTSD impact mental contamination. Cognitive Processing Therapy (CPT) is an efficacious and effective 12-session manualized cognitive-behavioral intervention for PTSD that is considered a gold-standard empirically-supported treatment for PTSD that is recommended by the American Psychological Association (APA, 2017). In addition to PTSD symptom improvement, CPT has also demonstrated benefit for improving feelings of shame and guilt, which are often seen among individuals with trauma-related mental contamination (Nishith et al., 2005; Resick et al., 2002, 2008). Cognitive reappraisal, a primary technique employed in CPT, involves challenging one's view of an emotionally-eliciting situation to alter its emotional impact (Gross & John, 2003). However, some investigators have suggested that cognitive reappraisal may be less effective in targeting moral emotions such as shame, guilt, and self-disgust that are based on an individual's standards and virtues (Finlay, 2015). Self-compassion (SC; i.e., self-directed care and kindness; forgiveness; and feelings of common humanity; Neff, 2003) has been proposed as an alternative method for addressing trauma-related shame and preliminary evidence suggests a 6-session self-compassion intervention may have benefit for reducing both PTSD symptoms and trauma-related shame (Au et al., 2017). Given the centrality of shame, guilt, and self-disgust to the experience of mental contamination, and the fact that mental contamination often arises in response to experiences involving moral violation or betrayal (Millar et al., 2016; Rachman, 2010), a SC intervention for PTSD may also offer promise as a standalone or adjunctive intervention for reducing trauma-related mental contamination. A test of these interventions for their impact on reducing trauma-related mental contamination is needed. The current study will use Single Case Experimental Design to isolate and evaluate the effects of CPT and SC in reducing both PTSD symptoms and trauma-related mental contamination among individuals with PTSD resulting from sexual trauma. Aims: 1) explore whether participants demonstrate reductions in mental contamination and PTSD symptoms in response to 12-sessions of CPT or 6-sessions of a SC intervention; 2) evaluate whether presentation of either treatment first yields differences in symptom reduction for PTSD and/or mental contamination symptoms; 3) evaluate whether the addition of the alternative module will enhance reductions in PTSD symptoms and mental contamination; 4) evaluate if such reductions are maintained during follow-up. Visual inspection analysis and statistical methods will be used to draw conclusions regarding the effects of the interventions on PTSD symptoms and mental contamination.