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Trauma, Psychological clinical trials

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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: 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: 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: NCT05799339 Recruiting - HIV Infections Clinical Trials

Optimizing CAB-LA as PrEP for Women Who Inject Drugs

Start date: January 13, 2022
Phase:
Study type: Observational

The goal of this study is to elicit information crucial for designing strategies to support engagement in cabotegravir, a long-acting injectable form of pre-exposure prophylaxis (PrEP) to reduce HIV risk among women who inject drugs (WWID), a population with high unmet need that has been understudied in all phases of PrEP research. The main questions this study aims to answer are: 1. How do WWID perceive long-acting injectable cabotegravir (CAB-LA) as a HIV prevention tool? 2. If and how their decisions to initiate CAB-LA as PrEP are informed by their experiences with other long-acting medications, experience with daily oral medications, and their personal circumstance (e.g., like housing or addition severity)? 3. Do PrEP outcomes (e.g., adherence) and engagement in care over time differ between WWID prescribed CAB-LA versus daily oral PrEP? The sample for this study will be derived from and ongoing prospective trial of "TIARAS," a multi-component behavioral intervention designed to reduce HIV acquisition risk among women who inject drugs (see NCT05192434).

NCT ID: NCT05419934 Recruiting - Anxiety Disorders Clinical Trials

EMDR Therapy in Young Children, a Double-blinded Randomized Controlled Trial

EMDRJEER
Start date: September 27, 2022
Phase: N/A
Study type: Interventional

This project aims to answer to the question of EMDR effectiveness in young children and to determine whether or not the therapy effectiveness is related to the level of cognitive functioning in young children. The study requires a total of 60 children, girls and boys, aged 3 to 6 years and presenting disorders related to stressors, anxiety and/or trauma. Participants will be randomly distributed in two groups: "EMDR therapy" (N=30) group or "routine care" (N=30) group. The study will take place in four stages: 1/ Pre-treatment phase : An evaluation of child's various cognitive and executive functions, child's symptomatology and parental distress is planned in a pre-treatment phase. 2/ Treatment phase : An EMDR therapy or a routine care is administered to the child between 6 to 10 weeks. 3/ Post-treatment phase : A reassessment of child's and parent's symptoms is planned at the end of treatment. 4/ Continuation of treatment: Children who have received routine treatment and without symptomatic improvement will be proposed EMDR treatment. These children will receive the same symptomatic assessments at the end of EMDR treatment. A significant reduction in disorders related to trauma or stress and anxiety factors and their symptomatology, as well as comorbid disorders and their symptomatology, is expected in children who received EMDR therapy compared to the group who received a routine care. These results are expected to be robust over a period of at least 3 months. The positive effects of EMDR on child symptomatology are also expected to be more pronounced in children showing higher levels of cognitive functioning

NCT ID: NCT05192434 Recruiting - HIV Infections Clinical Trials

Trauma Intervention to Optimize PrEP Among Women Who Inject Drugs

TIARAS
Start date: June 17, 2022
Phase: N/A
Study type: Interventional

The goal of this randomized controlled trial is to test the effectiveness of "TIARAS," a trauma intervention designed to reduce HIV acquisition risk among women who inject drugs (WWID). To be eligible for this study, participants must have been prescribed pre-exposure prophylaxis (PrEP), a medication taken to prevent HIV for Prevention Point Philadelphia, a large harm reduction agency located in Philadelphia (PA, USA). Enrollment in this study lasts for 12-months so that we can see if TIARAS reduces HIV risk immediately after the intervention ends and whether these effects last over time. During the first 3 months, participants engage in contingency management (CM), an evidenced-based intervention to reduce drug use and HIV risk. We will use CM to encourage engagement in PrEP care as well as stimulant/opioid abstinence. Also during the first 3-months, participants are randomly assigned to complete expressive writing exercises to address a previously undisclosed trauma or neutral writing exercises. Half of the participants will be assigned to the trauma writing group and the other half will be assigned to the neutral writing group. To understand the impact of TIARAS on HIV risk, we will collect and analyze data from surveys, interviews, and biological specimen during the 12-month study period. Our main questions are: - Does participation in TIARAS reduce HIV risk among WWID? - If observed, how long do beneficial effects last? - How and why do WWID experience benefits from TIARAS?

NCT ID: NCT05107752 Recruiting - PTSD Clinical Trials

Stellate Ganglion Block to Augment Trauma-focused Therapy Among Veterans With PTSD

Start date: January 3, 2022
Phase: Phase 2
Study type: Interventional

Our long-term goal is to improve clinical outcomes among patients receiving psychological treatment for posttraumatic stress disorder (PTSD). The primary objective of this project is to examine if stellate ganglion block (SGB) improves outcomes among military personnel and veterans receiving cognitive processing therapy (CPT), an empirically-supported psychological treatment for PTSD. To accomplish this objective, we will enroll adult military personnel and veterans with a current diagnosis of PTSD and/or subthreshold PTSD, provide CPT sessions over two weeks, administer SGB during or after CPT, and repeatedly assess key outcomes during follow-up.

NCT ID: NCT05090046 Recruiting - 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: NCT04713722 Recruiting - Depression Clinical Trials

Early Life Stress and Depression: Molecular and Functional Imaging

ELS
Start date: February 1, 2021
Phase:
Study type: Observational

Severe childhood adversity accounts for a large portion of psychiatric illness, and an increased risk for major depressive disorder (MDD). For some individuals, childhood adversity has negative psychological and medical consequences; others preserve mental and physical health despite such experiences (they are resilient). In spite of this, little is known about the neurobiological mechanisms related to childhood adversity, especially oxidative stress abnormalities in the brain. To fill this gap, this study combines functional, structural, and molecular imaging approaches to examine the role of oxidative stress abnormalities related to childhood adversity.