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Trauma, Psychological clinical trials

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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: NCT05627206 Active, not recruiting - 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: NCT05619822 Enrolling by invitation - Psychosis Clinical Trials

A Comprehensive Third-generation Intervention for People With Psychosis and Post-traumatic Stress Symptoms

IITG-PPT
Start date: May 27, 2022
Phase: N/A
Study type: Interventional

Existing data suggest that both trauma and Post-Traumatic Stress Disorder (PTSD) are very common among individuals with psychosis. The presence of PTSD symptoms in psychosis is associated with worse clinical outcomes and poorer social functioning. However, PTSD is a poorly attended and poorly studied condition among this population. Research to date indicates that trauma-focused treatments are safe and effective for PTSD, even when psychotic comorbidity is present. Recent systematic reviews of psychological interventions for trauma in psychosis found that are effective in reducing trauma symptoms, suggesting that they should be implemented in front-line services. Nonetheless, larger confirmative trials are required to form robust conclusions.The aim of this project is to examine the efficacy of comprehensive third-generation protocol for people with comorbid trauma and psychosis.

NCT ID: NCT05600868 Enrolling by invitation - Clinical trials for Trauma, Psychological

The Effect of Dual Attention in an EMDR Intervention

DA_EMDR
Start date: September 1, 2022
Phase: N/A
Study type: Interventional

Research to date indicates that trauma-focused treatments are safe and effective for PTSD, even when higher-risk comorbidities (e.g., psychosis or substance use) are present. In particular, there are data pointing to the efficacy of prolonged exposure therapy and eye movement desensitization and reprocessing (EMDR) therapy. Clinical practice guidelines specifically recommend trauma-focused treatment with exposure and/or cognitive restructuring components. Regarding EMDR interventions, there are increasing results supporting its efficacy. Some interesting clinical advantages presented by EMDR as opposed to cognitive-behavioral therapies are 1) the efficacy found despite less exposure to the traumatic memory, 2) the exclusion of homework, 3) as well as the rapid reduction in subjective disturbance produced even after a single session of EMDR therapy. However, the mechanisms producing the improvement and, in particular, the effect of bilateral stimulation are not precisely known. More research is needed in this regard since bilateral stimulation is the most controversial part and with less evidence found. In addition to this, there are very few studies that have analyzed the differential efficacy of the presence or absence of bilateral stimulation or of the different types of stimulation possible. As for the comparison between types of stimulation (bilateral with eye movements, or focusing on a fixed point), greater treatment effects have been found for EMDR with fixation on an immobile hand compared to eye movements. The aim of this study is to examine the effectiveness of a comprehensive intervention protocol for people who have experienced traumatic events and present post-traumatic symptomatology. In addition, this study will compare the efficacy of traumatic memory processing with and without dual attention.

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: October 1, 2023
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: NCT05425381 Enrolling by invitation - Depression, Anxiety Clinical Trials

Improving Social, Emotional, Behavioral, and Academic Functioning

Start date: February 1, 2022
Phase: N/A
Study type: Interventional

This efficacy trial will evaluate the impact of an enhanced version of the Interconnected Systems Framework (ISFE) on elementary school-based team functioning, including use of evidence-based practices, and student emotional, behavioral, and academic functioning. The original interconnected systems framework (ISF) model was designed to improve the depth and quality of mental health services delivered within multi-tiered systems of support by integrating Positive Behavioral Interventions and Supports (PBIS) and school mental health (SMH) efforts to provide a continuum of high-quality services for students. Preliminary findings from a prior efficacy study show that the ISF improved team functioning and increased identification and services for students in need, particularly among youth of color, when compared to the other two conditions. Moreover, the ISF led to improvements in student social, emotional, and behavioral functioning. The current study builds on these findings by testing an enhanced version of the ISF designed to advance the model by adding/modifying several core components intended to further increase the impacts for youth with significant emotional and behavioral problems and reduce inequities in discipline and student service delivery.

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: 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

Native HEALTH
Start date: December 1, 2022
Phase: Early Phase 1
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: NCT05264415 Active, not recruiting - Depression Clinical Trials

Intergenerational Transmission of Traumatic Stress

Start date: October 6, 2021
Phase: N/A
Study type: Interventional

Millions of U.S. parents have experienced trauma, putting them at risk for maladaptive parenting practices, which then confer vulnerabilities to their children. This study aims to enhance understanding of how parental emotional dysregulation associated with traumatic stress impedes effective parenting. The study employs neurophysiological methods (electroencephalogram; EEG) to address some of the challenges inherent in the study of emotion (particularly in trauma-exposed individuals) and to identify potential biomarkers of traumatic stress and response to intervention.