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Trauma, Psychological clinical trials

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NCT ID: NCT06397105 Not yet recruiting - PTSD Clinical Trials

Boosting Refugee Integration Through Psychological Intervention: a Pilot Randomised Controlled Trial

BRIGHT
Start date: May 13, 2024
Phase: N/A
Study type: Interventional

Refugees and asylum seekers (RAS) face numerous stressors and adversities which put them at risk for developing mental health problems. However, access to adequate mental health care in host countries is limited. To address this problem, the World Health Organization (WHO) introduced Problem Management Plus (PM+), a short, low-intensity psychological intervention administered by non-professionals, aiming to alleviate common mental disorders among crisis-affected communities. The objective of this pilot RCT is to assess the feasibility and acceptability of an adapted version of PM+ for refugees and asylum-seekers. This will inform the design of a definitive RCT and implementation study.

NCT ID: NCT06378476 Not yet recruiting - Clinical trials for Chronic Kidney Diseases

Supportive Understanding and Patient-centered Partnership for Optimizing Renal Treatment

SUPPORT
Start date: June 2024
Phase: N/A
Study type: Interventional

Black and Hispanic people face higher risks of chronic kidney disease (CKD) but have unequal access to the highest-quality kidney care. Black adults with CKD face 1.5 times higher hospitalization risks than non-Black adults with CKD. Once reaching end stage kidney disease (ESKD), Black patients are half as likely to receive a transplant and are often excluded from home dialysis. Structural racism creates complex barriers to optimal CKD care, providing an explanation for these findings. The Penn Medicine IMPaCT Community Health Worker (CHW) program is a rigorously tested approach to employ people from local communities to dismantle structural racism within health care systems and improve outcomes for marginalized patients. This trial will innovate by training CHWs to focus specifically on CKD care for minoritized people. The investigators will also train primary care clinicians caring for CKD patients on how to provide trauma-informed care (TIC). The first aim is to determine the feasibility, acceptability, and reach of a clinic-level TIC training to address the needs and concerns of Black and other minoritized patients. The second aim will be to conduct a three arm trial comparing individuals in usual care to individuals randomized to either our tailored CHW intervention in conjunction with clinic-level TIC training or to clinic-level TIC intervention only. The investigators will examine whether patients in the intervention arms have greater improvements in quality of life (primary). The investigators will also explore the impact of the interventions on patient activation, hospitalizations, and ESKD treatment preferences.

NCT ID: NCT06290180 Recruiting - Addiction Clinical Trials

Healing Lodge First Face Training Evaluation Study

Start date: April 4, 2024
Phase: N/A
Study type: Interventional

The purpose of this study is to evaluate a culturally grounded training program, xaʔtus (meaning First Face) for Mental Health. This program will train community members in how to recognize and respond to youth and adults experiencing mental health crises and ways to serve as a bridge between these individuals and the help they need. All Healing Lodge staff are being asked to complete First Face training. To evaluate First Face, the investigators will ask all trainees to complete surveys before and after training, and again 3 months later. These surveys will measure knowledge about mental health and addiction, as well as the ability and confidence to respond appropriately to mental health crises. The study will help the investigators understand whether the First Face training program influences mental health and attitudes, as well as responses to mental health crisis situations.

NCT ID: NCT06285708 Recruiting - PTSD Clinical Trials

Enhancing the Effectiveness of Prolonged Exposure Among Suicidal Individuals With PTSD

Start date: February 2024
Phase: N/A
Study type: Interventional

The long-term goal of this study is to reduce suicidal thoughts and behaviors among treatment-seeking individuals who also have posttraumatic stress disorder (PTSD). Prolonged exposure (PE) and crisis response plan (CRP) have demonstrated empirical support for reducing suicide attempts as compared to treatment as usual. However, no studies to date have assessed their effectiveness when used in combination. In light of this knowledge gap, the primary objective of this study will be to test the effectiveness of PE augmented with CRP as compared to PE with care as usual (self-guided treatment plan), an active comparator, for the reduction of suicide ideations and attempts for individuals with comorbid PTSD.

NCT ID: NCT06284382 Not yet recruiting - Clinical trials for Trauma, Psychological

Interaction Between Early Trauma and Odor-induced Dopamine Release

T-ODOR
Start date: June 1, 2024
Phase: N/A
Study type: Interventional

This prospective, double-blind, parallel-group controlled trial aims to investigate the consequence of early trauma on dopamine release evoked by positive valence odors.

NCT ID: NCT06237439 Recruiting - Depressive Symptoms Clinical Trials

Sharing HaRT in New Expanses

SHiNE
Start date: August 21, 2023
Phase: N/A
Study type: Interventional

The goal of this parallel cluster randomized control (CRT) trial is to evaluate a group-based mind-body intervention (Move with HaRT) in survivors of human trafficking. The main study aims are: 1. Determine effectiveness of the Move with HaRT intervention on PTSD, depression, and anxiety symptoms among survivors of human trafficking in Uganda 2. Explore participant characteristics (e.g., age, trafficking history, food security) that may moderate the intervention effectiveness. 3. Understand potential barriers and facilitators to future implementation and scale-up. Participants will complete: - Complete three surveys (baseline, endline, and 3 month follow-up) - Participate in either Services as Usual or Move with HaRT groups - Qualitative in-depth interviews Researchers will compare Move with HaRT with Services as Usual to see effects on mental health symptoms.

NCT ID: NCT06175104 Not yet recruiting - Clinical trials for Neurodevelopmental Disorders

HeartGPS: A Study Exploring the Effects of a Psychological Intervention for Parents and Their Babies After Prenatal Cardiac Diagnosis

HeartGPS
Start date: January 2024
Phase: N/A
Study type: Interventional

Babies with single ventricle congenital heart disease (SVCHD) are often diagnosed during pregnancy. While prenatal diagnosis has important clinical benefits, it is often stressful and overwhelming for parents, and many express a need for psychological support. HeartGPS is a psychological intervention for parents who receive their baby's diagnosis of SVCHD during pregnancy. It includes 8 sessions with a psychologist, coupled with tailored educational resources, and a personalized care plan. The intervention focuses on fostering parent psychological adjustment and wellbeing, and supporting parents to bond with their baby in ways that feel right for them. Through this study, the investigators will learn if HeartGPS is useful and effective for parents and their babies when it is offered in addition to usual fetal cardiac care. The investigators will examine the effects of the HeartGPS intervention on parental anxiety, depression, and traumatic stress; fetal and infant brain development; parent-infant bonding; and infant neurobehavioral and neurodevelopmental outcomes. The investigators will also explore mechanisms associated with stress biology during pregnancy, infant brain development and neurodevelopmental outcomes, and parent and infant intervention effects.

NCT ID: NCT06027658 Recruiting - Quality of Life Clinical Trials

Validation of a Dance as Therapy Program in Co-facilitation

VaDDanC
Start date: November 1, 2021
Phase:
Study type: Observational

The objective is to validate a psychotherapeutic group protocol of dance as therapy created by LOBA association with a comparative non-randomized study.

NCT ID: NCT06020339 Recruiting - Pregnancy Related Clinical Trials

The Effect of the Continuous Midwifery Care Model on Birth Outcomes

Start date: December 2023
Phase: N/A
Study type: Interventional

It is the right of both the mother and her baby to receive the best care and give birth in the best way possible for every pregnant woman. World Health Organization midwife; It defines a person trained to provide necessary care and counseling during pregnancy, at birth and after birth, to have normal births under his own responsibility, to care for the newborn and to provide family planning counseling. According to the Ministry of Health, the midwife provides these services as well as immunization, protection from infectious and social diseases, etc. He is a healthcare professional who fulfills his roles. However, in our country, pregnancy, birth and postpartum care services are primarily carried out under the control of a physician, and most of them include medical follow-up. The routine care given by midwives to pregnant women during pregnancy is unfortunately limited to performing the procedures and cannot adequately meet the needs of the woman. As a result, cesarean section rates in our country have risen well above the acceptable level by WHO. Studies have shown that the rate of cesarean section increases with the number of pregnant women who apply to the doctor for pregnancy control. Turkey is the country with the highest cesarean section rates among OECD countries. According to the 2018 results of the Turkey Demographic and Health Survey (TNSA), the rate of cesarean section in our country is 52%. The World Health Organization (WHO) recommended 10-15% cesarean section rate in terms of maternal and infant health in 1985, and re-evaluated this recommendation in 2015. Women who have had a cesarean delivery have greater risks compared to women who have had a vaginal delivery. One of the most common complications after cesarean section is sepsis, and maternal mortality rates increase due to complications such as bleeding and infection after cesarean section. In addition, the choice of cesarean section, which negatively affects many variables such as epigenetically transmitted fear of birth and traumatic birth perception, breastfeeding and microbiota of the baby, is an important factor that will affect future generations. Cesarean section rates, which also cause high maternal and neonatal complication rates, have become a problem that increases health expenditures economically all over the world. However, cesarean section rates are decreasing in countries where midwives play an active role in pregnancy follow-up. In the midwife-led continuous care model (MLCC), which is carried out by midwives, especially in countries with high normal birth rates, care is completely woman-centered. The model advocates vaginal delivery, which is the most superior form of delivery for maternal and infant health. Studies show that midwife-led continuous care increases vaginal birth rates, women experience a more positive birth, and reduces many unnecessary medical interventions. Within the scope of this care model, midwives train pregnant women from the beginning of pregnancy to the postpartum period and minimize their fear of childbirth based on the fear of the unknown. Another advantage of MLCC is that care will be given by the same midwife or midwife group. This ensures a good bond and uninterrupted communication between the woman and her midwife. This maintenance model is not yet used in our country. The study to be carried out with this training process planned within the scope of MLCC is unique in that it will be carried out for the first time at the national level. The aim of the study is to evaluate the effect of training to be given with MLCC in reducing cesarean section preferences.

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.