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Trauma, Psychological clinical trials

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NCT ID: NCT06014970 Completed - Clinical trials for Stress, Psychological

The Health and Wellness Curriculum Assessment

Start date: September 2014
Phase: N/A
Study type: Interventional

The overarching goal of the study is to examine the effects of a new Health and Wellness Curriculum (Pure Power) being implemented in the Ravenswood City School District in East Palo Alto. The Pure Power Curriculum, which the Sonima Foundation (Now Pure Edge Inc.,)developed, includes exercise based on yoga, common exercise regimes, relaxation techniques, mindfulness practices, and nutrition education, and was introduced in 2014 to the Ravenswood City Schools, independent of the research. The new curriculum was expected to yield dramatic positive effects on students' socio-emotional development, which the investigators aimed to examine through this study. This research evaluation measures the impact of the Pure Power Curriculum on the socioemotional, behavioral, cognitive, academic, and physiological functioning of students in a low-socioeconomic status (SES) school community over time by evaluating student development at three time points: baseline (i.e., prior to implementation of the curriculum), one-year follow-up, and two-year follow-up. Only third and fifth-grade students were eligible for enrollment at baseline. All data collection procedures were replicated with the control group.

NCT ID: NCT05627206 Completed - Anxiety Clinical Trials

The Impact of PM+For Moms Intervention on Improving Mother's Mental Health in Zambia (PM+FM)

PM+FM
Start date: November 15, 2022
Phase: N/A
Study type: Interventional

CMHD are particularly prevalent among women, posing a major threat to their own and their children's wellbeing. Despite the high prevalence of CMHD and the existence of effective treatments, interventions supporting women living in low-resourced settings remain limited. This study builds on a parent study (Zamcharts NCT03991182), which identified a high prevalence of women with anxiety and/or depression. We propose to design, test, and validate a community-based intervention nested within the public primary health system in Zambia, to identify and treat women with mild-to-severe CMHDs.

NCT ID: NCT05137769 Completed - Clinical trials for Post Traumatic Stress Disorder

Women's Responses to a Mindfulness-Based Body Scan: A Pilot Study

Start date: April 15, 2022
Phase: N/A
Study type: Interventional

PTSD develops after trauma and is marked by intrusive memories, avoidance of reminders, negative changes in mood and cognitive processes, and dysregulated physical and emotional stress reactivity. PTSD disparately affects twice as many women as men (8.0% vs. 4.1%), and finding effective treatments for these women is critical to reduce poor health outcomes associated with PTSD. Mind-body therapies (MBT), using the mind in combination with the body to facilitate healing hold promise to enhance PTSD treatment by improving stress regulation. While MBT reduce PTSD symptoms long-term, women with PTSD may initially experience distress, leading to treatment avoidance. This pilot study will explore women's initial responses to MBT, the prevalence of adverse responses, and which women are at risk for adverse responses in a sample of participants with a history of trauma and varying levels of PTSD symptoms. Study participants will attend one virtual study visit via one-on-one videoconference with the PI, where they will complete self-report measures of stress and affect before and after one session of a MBT exercise. A subset of the sample will complete a semi-structured individual videoconference interview with the PI within two weeks following completion of the MBT exercise and quantitative measures.

NCT ID: NCT05090046 Completed - Clinical trials for Trauma, Psychological

Understanding Neurocognitive Impairment After Trauma Exposure

UNITE
Start date: February 10, 2022
Phase:
Study type: Observational

Individuals living in Canterbury (New Zealand) have experienced significant stress related to the Canterbury earthquake sequence. Previous research conducted at the Department of Psychological Medicine (Christchurch, New Zealand) has shown significant cognitive difficulties in a group of Cantabrians exposed to high levels of earthquake trauma. A high proportion (30%) perceive themselves to have significant cognitive difficulties, even seven years post-earthquake. People who perceive that they have cognitive difficulties find this distressing and tend to function less well in work and parenting. Understanding pathways underlying cognitive difficulties in the population is vital for developing appropriate treatments and strategies to help with this. This will be the first study to investigate rates of, and factors contributing to, perceived cognitive difficulties in a large population exposed to multiple stressors and is important for the population of Canterbury, and populations affected by natural and man-made disasters worldwide. Four hundred and sixty people who were exposed to the Canterbury earthquake sequence will be recruited from the Christchurch Health and Development Study (CHDS). Psychological, cognitive, functional and biological factors will be compared between those with the greatest levels of perceived cognitive difficulty and those with the lowest levels of difficulty. This will determine what factors relate most strongly to perceived cognitive difficulties, which will in turn be used to develop treatments for this population.

NCT ID: NCT05048758 Completed - Clinical trials for Alcohol Use Disorder

Adverse Childhood Experiences in Alcohol Use Disorder

Start date: November 22, 2021
Phase:
Study type: Observational

Adverse childhood experiences (ACE) and their relation to the development of an alcohol use disorder (AUD) will be measured with functional magnetic resonance imaging (fMRI).

NCT ID: NCT04866511 Completed - Domestic Violence Clinical Trials

Video NET With CYP Who Witnessed Domestic Violence

Start date: April 13, 2021
Phase: N/A
Study type: Interventional

Research suggests that children and young people (CYP) who witness domestic violence are susceptible to develop Post-traumatic stress (PTS). As their traumatic experiences are often repeated and prolonged, these CYP are likely to present with 'complex trauma' presentations, which also include other difficulties such as depressive symptoms and problems in functioning. This study aims to investigate whether Narrative Exposure Therapy (NET) delivered via videoconferencing can be effective, feasible, and acceptable for CYP who witnessed domestic violence. NET is a brief, evidence-based intervention for complex trauma which has been adapted for CYP. The study will use a 'single case study series' design and look at whether NET can impact on PTS, psychological distress, and functioning. It will also look at the processes of change within NET and participants' experience of the therapy. Young people aged 12-17 who are experiencing PTS after exposure to domestic violence will be recruited from the waiting lists of Child and Adolescent Mental Health Services in Lincolnshire Partnership NHS Foundation Trust and Nottinghamshire Healthcare NHS Foundation Trust. Up to six participants will receive six to ten weekly video sessions and the changes in the outcomes will be explored before, during and after NET. Finally, participants will be interviewed about their experiences. The study is part of a Doctorate in Clinical Psychology programme and funded by Health Education England. Potential benefits include investigating NET with a new group, contributing to the research on complex trauma interventions for CYP, and providing insights on the effectiveness and acceptability of therapies via video.

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: NCT04587752 Completed - Clinical trials for Trauma, Psychological

Cognitive-Behavioral Therapy for Weight-related Bullying (Online Treatment)

Start date: October 5, 2020
Phase: N/A
Study type: Interventional

This study will perform a clinical trial with adolescent girls to pilot a new cognitive-behavioral treatment (CBT) for weight-related bullying testing (1) feasibility, (2) acceptability, and (3) initial efficacy. The treatment will be conducted via audio/video telehealth.

NCT ID: NCT04466163 Completed - Clinical trials for Trauma, Psychological

Strengthening the Healthy Adult Mode: a Case Experimental Study Exploring the Effects of a New Schema Therapy Protocol in an Adult Outpatient Population.

ST-HA
Start date: September 1, 2020
Phase: N/A
Study type: Interventional

Background: Strengthening the Healthy Adult schema mode is the ultimate goal in Schema Therapy, working as an assumed mechanism of long-term change through improved positive mental health. Evidence-based interventions to directly strengthen this Healthy Adult mode are sparse. Objective: To study the feasibility, acceptability and effectiveness of the treatment protocol 'Schema Therapy and the Healthy Adult' (ST-HA) during the final stage of schema therapy in adult outpatients with personality- or chronic psychopathology. Method: In this study a single case experimental design (n = 8) with multiple measures will be used, to determine the effects of the ST-HA protocol on self-compassion, well-being, positive affect and Healthy Adult functioning. For each participant a no-treatment randomized baseline period (2-5 weeks) will be compared with treatment (ST-HA, 10 weekly sessions) and post-treatment follow-up (at 1- and 3-months). Assessments include brief diaries regarding self-compassion and Healthy Adult functioning (daily from baseline to end of intervention, and 7-days at 1- and 3-months follow-up) and standardized questionnaires for measuring weekly changes in self-compassion, well-being and adaptive schema modes. During phase changes additional measures of trait self-compassion, positive affect, adaptive schema modes and symptomatic distress will be administered.

NCT ID: NCT04180293 Completed - Clinical trials for Trauma, Psychological

Family Psychoeducation for Military Veterans: A Pilot Study

Start date: January 18, 2021
Phase: N/A
Study type: Interventional

Operational Stress Injuries (OSIs), including post traumatic stress disorder (PTSD), are prevalent among veterans deployed in recent combat missions, the effects of which are experienced within their families. The development of evidence-based programs for veterans with OSIs and their families is critical because family functioning both affects and is affected by OSIs. Few programs have been implemented, however, particularly in Canada, and those that have are not evaluated. Research suggests that brief, systems-focused family psychoeducation programs are useful in the treatment of OSIs, specifically PTSD, leading to increases in targeted PTSD knowledge and skills and enhancing resilience. The purpose of this pilot study is to: (1) develop a systems-focused, virtual psychoeducational program designed to enhance resilience in veterans with OSIs receiving clinical care at an OSI clinic in Atlantic Canada and their families; (2) to implement the virtual program with veterans and their families at the OSI clinic; (3) to evaluate the efficacy of the program; and (4) to compare resilience-building family psychoeducation to the standard information-providing services currently available to families at the OSI clinic. Results will be shared within the network of OSI clinics in Canada and will inform the development of a proposal for a mixed-method study.