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Stress Disorders, Post-Traumatic clinical trials

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NCT ID: NCT05624931 Recruiting - Depression Clinical Trials

Reducing Psychological Barriers to PrEP Persistence Among Pregnant and Postpartum Women in Cape Town, South Africa

Start date: July 1, 2023
Phase: N/A
Study type: Interventional

Pregnant women in South Africa (SA) are at high risk of HIV acquisition. Pre-exposure prophylaxis (PrEP) use during pregnancy is both safe and effective in preventing HIV. However, posttraumatic stress (associated with intimate partner violence and/or other traumas) and depression negatively impact PrEP adherence among women in SA. Addressing posttraumatic stress and depression will likely improve PrEP adherence and persistence (i.e., sustained PrEP adherence over time) during pregnancy and breastfeeding, which are periods of dramatically increased HIV risk. The overarching goal of this proposal is to develop and test the feasibility and acceptability of a cognitive behavioral intervention that targets common underlying factors of posttraumatic stress and depression to improve PrEP adherence and persistence during pregnancy and the postpartum transition. The specific aims of the project are to (1) explore the mechanisms by which posttraumatic stress and depression impact PrEP adherence and persistence during pregnancy via qualitative interviews; (2) develop a brief PrEP adherence and persistence intervention (~4 sessions) that reduces the negative impact of psychological mechanisms common to posttraumatic stress and depression on PrEP use, and builds behavioral skills to improve self-care; and (3) evaluate the feasibility, acceptability, and signals of preliminary efficacy of the intervention, which will be integrated into antenatal care, in a pilot randomized controlled trial. All data will be collected in the Midwife Obstetrics Unit (MOU) in Gugulethu, a peri-urban settlement and former township community outside of Cape Town, SA.

NCT ID: NCT05620381 Recruiting - Clinical trials for Stress Disorders, Post-Traumatic

Health and Sleep Assessment After the Strasbourg Attacks of December 11, 2018

ELSSAS
Start date: September 9, 2020
Phase:
Study type: Observational

Evaluation of the prevalence of post-traumatic stress disorder (PTSD), associated risk factors, health care consumption, and sleep disorders in a civilian population exposed to the December 11, 2018, attacks in Strasbourg. Terrorist attacks have unfortunately become all too frequent on our territory in recent years. A better knowledge of the psychological and psychiatric repercussions on exposed populations is essential in order to better prevent and treat disorders that can have a major functional impact on the lives of exposed individuals and to adapt care during future similar events

NCT ID: NCT05618652 Recruiting - Clinical trials for Post Traumatic Stress Disorder

Pilot Testing of an Equity Focused and Trauma-informed Communication Intervention During Family-centered Rounds

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

Development and pilot testing of a clinician coaching communication intervention to improve communication between medical teams and caregivers (parents, family members) of children in the hospital. Our team is specifically focused on improving partnership, respect, and collaboration with Black and Latinx caregivers of children in the hospital by incorporating elements from trauma-informed care and racial equity into a communication intervention. The investigators will explore the impact of this intervention on child and caregiver mental health both in the hospital and 90 days after discharge.

NCT ID: NCT05616286 Recruiting - Clinical trials for Stress Disorders, Post-Traumatic

Mindfulness-SOS for Refugees

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

Worldwide, refugees and asylum seekers suffer at high rates from trauma and stress-related mental health problems. The research group therefore developed, and initially piloted in a single-site open trial, a novel mindfulness- and compassion-based digital intervention program - Mindfulness-SOS for refugees (Mindfulness-SOS). The pilot study had promising preliminary findings of utilization, feasibility and related dose-response effects of intervention program engagement with mental health outcomes. The digital intervention program was developed based on randomized control trial data of a group-based mindfulness- and compassion-based program for forcibly displaced people. To address common limitations of mobile health interventions such as attrition, engagement and adherence, the investigators will implement a personalized stepped-care adaptation and augmentation of Mindfulness-SOS, that entails providing intensified (remote) guidance for FDPs that do not respond to the intervention, to optimize capacity to therapeutically benefit from Mindfulness-SOS. To do so, the investigators propose to carry out a randomized controlled Sequential Multiple Assignment Randomized Trial (SMART) study to test and optimize the therapeutic outcomes of Mindfulness-SOS, using an adaptive intervention sequence of guidance format intensities among N ≅ 170 (50% female) adult trauma-affected Eritrean asylum-seekers residing in Israel.

NCT ID: NCT05606172 Recruiting - Clinical trials for Post-traumatic Stress Disorder

Adaptation of the PCIP for Children Aged 6 to 11

Start date: May 1, 2023
Phase: N/A
Study type: Interventional

This study will implement a brief Post-traumatic Stress Disorder (PTSD) intervention for children, the Primary Care Intervention for PTSD (PCIP) delivered through telehealth (computer or smartphone delivery), to 10 youth age 6-11 and their caregivers. Mixed methods (qualitative and quantitative) randomized pilot feasibility trial (n=10 to treatment and 10 to waitlist control) to refine the intervention, study procedures, and explore effectiveness. Following RE-AIM guidelines, the investigators will assess: 1. Reach: patient participation in intervention delivery (out of all those asked to participate) and retention rate (out of all those who consented to participate and completed at least two intervention sessions) 2. Adoption: patients and their parents/guardians will complete screening and intervention satisfaction ratings. To understand patient experiences with the intervention and to identify and explain positive or negative treatment mechanisms or effects, the investigators will conduct post-intervention semi-structured interviews with the participating patients, their parents/guardians, and with providers. This treatment ranges from 1-4 sessions which last 50 minutes per session. The first session will cover psychoeducation about PTSD symptoms in children that can be delivered to the parent or both the parent and child. The first session will also teach the parent and child a breathing technique to combat the physiological impact of PTSD in children. The subsequent sessions will be tailored to meet the needs of the child's most distressing PTSD symptom cluster including hyper arousal, negative changes in cognition and mood, avoidance, re-experiencing. Each session contains coping skills that the parent and child can learn together. There is also material for parents to address behavior problems in youth. This treatment will be delivered via telehealth.

NCT ID: NCT05598099 Recruiting - PTSD Clinical Trials

Concentrated Exposure Therapy for Post-traumatic Stress Disorder - a Cohort Study

Start date: November 1, 2022
Phase:
Study type: Observational

Post-traumatic stress disorder (PTSD) is a prevalent and disabling condition. Trauma-focused psychotherapy, including cognitive behavioural therapy (CBT), are among the recommended first-line treatment alternatives. However, a substantial proportion of patients decline, drop-out or do not respond to current psychotherapies. Previous research suggests that intensive or concentrated formats of trauma-focused psychotherapy can lead to faster recover and lower attrition, but there are currently few studies of these approaches. The current study will investigate the acceptability. treatment satisfaction and preliminary changes in symptoms after four consecutive days of concentrated CBT for PTSD.

NCT ID: NCT05592652 Recruiting - Clinical trials for Post Traumatic Stress Disorder

Identification of the Clinical Specificities of Complex Posttraumatic Stress Disorder

IDPLEX
Start date: January 25, 2023
Phase: N/A
Study type: Interventional

Identification of the clinical specificities of complex post-traumatic stress disorder post-traumatic stress disorder

NCT ID: NCT05591625 Recruiting - Critical Illness Clinical Trials

Eye Movement Desensitisation and Reprocessing (EMDR) to Improve Mental Health Following Intensive Care Admission

EMERALD
Start date: February 20, 2023
Phase: N/A
Study type: Interventional

The goal of this multi-centre, randomised, pilot feasibility study is to assess the feasibility of recruiting intensive care survivors, with symptoms of traumatic stress, to a study evaluating the use of eye movement desensitisation and reprocessing (EMDR). The main purpose is to determine whether it is feasible and acceptable to patients, clinicians and researchers. In addition, this study aims to identify design criteria that may be of use in a subsequent randomised controlled trial of clinical effectiveness. Participants will: - be recruited at hospital discharge - undergo a psychological assessment at 2-3 months post-hospital discharge - Those exhibiting symptoms of post-traumatic stress disorder (PTSD), will be randomised (1:1) to receive either usual care or usual care plus EMDR - Participants who do not exhibit PTSD symptoms at the 2-3 month assessment will enter a light-touch observation arm. - All participants will repeat the psychological assessment 12-months after hospital discharge. Feasibility parameters; recruitment, adherence, retention and safety data. Primary clinical outcomes; change in PTSD symptoms between 2-3 months and 12-months. The investigators will undertake a qualitative process evaluation using clinical ethnography and reported according to the Theoretical Framework of Acceptability.

NCT ID: NCT05579717 Recruiting - Clinical trials for Posttraumatic Stress Disorder

Examining EAL for PTSD

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

This RCT will evaluate the efficacy of Equine Assisted Learning for reducing PTSD symptoms in public safety personnel (e.g., fire fighters, police, nurses, etc.).

NCT ID: NCT05569915 Recruiting - Clinical trials for Stress Disorders, Post-Traumatic

Project QueST 2023: Queer Survivors of Trauma

QueST2023
Start date: June 1, 2023
Phase: N/A
Study type: Interventional

This study aims to test the initial efficacy of tailored online writing interventions specifically designed for sexual minority women, transgender individuals, and/or nonbinary people to target the primary outcomes: posttraumatic stress disorder (PTSD) symptom severity and hazardous drinking.