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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: 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: 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: NCT05952427 Not yet recruiting - Health Behavior Clinical Trials

Adverse Childhood Experiences and Infertility : ACESI

ACESI
Start date: August 1, 2023
Phase:
Study type: Observational

Adverse childhood experiences can have powerful effects on health and quality of life in adulthood. Thus, having a history of childhood trauma, before the age of 18 (physical aggression, sexual abuse, death of a close person, etc.) significantly increases the risk of having cancer, cardiovascular disease, psychological damage , or earlier mortality. Validated scores allow the evaluation of the importance of adverse childhood experiences, in particular the ACE score (adverse childhood experiences) published by Felitti. Studies on the subject show a dose-response relationship between exposure to adverse childhood experiences and negative outcomes in terms of health and well-being. The physiopathological tracks to explain the occurrence of somatic pathologies in adulthood include the observation of a state of hyper-activation of the HPA axis that persists in adulthood; modulations of immunity, but also epigenetic modifications. Some data are available on the associations between childhood trauma and obstetric risks, with a significant increase in the risk of preterm delivery and fetal death in utero. Primary objective : 1a) To study the prevalence of adverse childhood experiences (ACE) in women consulting for the first time in an PMA service for the desire to become pregnant, and 1b) To study the association between adverse childhood experiences and infertility in adulthood, by comparing infertile women with nulliparous control women in the general population consulting for their classic gynecological follow-up.

NCT ID: NCT05453864 Not yet recruiting - Suicidal Ideation Clinical Trials

CMAP Plus Trauma-focused Cognitive Behavior Therapy for Suicidal Ideation Among Burn Survivors

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

The study aims to determine whether CMAP Plus TFBCT is feasible and acceptable for burn survivors with suicidal ideations. To identify any barriers to the recruitment of participants. To determine initial data for the primary outcome measure to perform a sample size calculation for a larger trial.

NCT ID: NCT05397483 Not yet recruiting - Clinical trials for Trauma, Psychological

Legal-Education Plus Trauma-informed Therapy to Improve Community Acceptance and Reintegration of Repentant Terrorists in Nigeria

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

Terrorism is an issue of global concern, and reintegrating repentant terrorists, including their families, has often proved challenging considering the damages done by the terrorist group. Despite Boko Haram atrocities in Nigeria, the focus seems directed toward the repentant terrorists with limited attention to the communities, the trauma they suffered, and their involvement in the design of reintegration programmes. There is also limited community awareness of legal support channels to foster positive reintegration (Ike et al., 2021). The implication is that it risks undermining the social context that informs successful reintegration, improves acceptance, and reduces reoffending. However, there appears to be limited research on this important policy problem in Nigeria. Our study proposes to fill this gap by contributing to the research initiative through a novel cross-disciplinary intervention drawing on law and psychology entitled Legal Education plus Trauma-informed Therapy (LETiT) to improve community acceptance and reintegration of repentant terrorists in Nigeria.

NCT ID: NCT05363878 Not yet recruiting - Alcohol Drinking Clinical Trials

Development of a Culturally Grounded, Trauma-Informed Alcohol Intervention With a Reserve-Dwelling First Nation Group

NativeHEALTH
Start date: June 1, 2024
Phase: N/A
Study type: Interventional

The objective of this project is to develop and obtain preliminary data on a culturally grounded, trauma-informed alcohol intervention. The specific aims are to (1) use Community-Based Participatory Research methods to deepen partnerships with First Nation through capacity-building and knowledge sharing; (2) collect and apply qualitative data to develop a culturally grounded, trauma-informed alcohol intervention that is focused on historical trauma for use with a First Nation sample; and (3) conduct a pilot RCT study to examine acceptability, sustainability, and initial efficacy data of the intervention compared to waitlist control. This work is important, timely, and innovative. Addressing alcohol use has important implications for the health of Indigenous populations.

NCT ID: NCT05039853 Not yet recruiting - Clinical trials for Post-traumatic Stress Disorder

Improving Mental Health Following Early PREgnancy Loss Using a Brief Cognitive Task

IMPREL
Start date: October 2021
Phase: N/A
Study type: Interventional

This is a randomised controlled trial designed to investigate the impact of a brief-cognitive task based intervention on intrusive memories, mental health symptoms and daily functioning, in women following an early pregnancy loss.

NCT ID: NCT04303143 Not yet recruiting - Multiple Sclerosis Clinical Trials

Hypnosis and Direct Autonomic Experience Influence on Chronic Symptoms

HDAX1
Start date: March 2021
Phase:
Study type: Observational [Patient Registry]

Study will look at a limited number of participants with various chronic symptoms. Investigating a new and novel form of hypnosis application called "Direct Autonomic Experience (DAX)" which is using combination of visualization, metaphor, post-hypnotic suggestion and anchoring. Purpose is to confirm that DAX generally appears to impact SUDS value and subjects report observed level of effect on short and longer term measurements. Most significantly, testing that DAX technique/action is reusable later if the measured SUDS value returns or increases.