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Stress Disorders, Traumatic clinical trials

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NCT ID: NCT04468360 Recruiting - Clinical trials for Post Traumatic Stress Disorder

Facilitation of Extinction Retention and Reconsolidation Blockade in PTSD

Start date: March 4, 2022
Phase: Phase 2
Study type: Interventional

Purpose: About 6.4% of the U.S. population suffers from posttraumatic stress disorder (PTSD). Trauma-focused psychotherapies are generally effective in PTSD, but responses vary greatly across individuals and PTSD subpopulations. Neurobiological factors impacted by life experiences, stress, and genetics can affect treatment responses. These factors can alter brain capacities needed to reprocess traumatic memories prevent them from triggering intensely distressing, disruptive, out-of-place responses. For example, during psychotherapy for PTSD, trauma memory activation engages two competing brain processes that affect recovery: "extinction" versus "reconsolidation" of trauma-related emotional, physiological, and behavioral responses. This study tests whether a single intravenous (IV) dose of allopregnanolone (Allo) compared to placebo (which is non-active): 1. promotes consolidation of extinction learning (sub-study 1) or 2. blocks reconsolidation physiological responses triggered by aversive memories (sub-study 2). The study also tests whether Allo compared to placebo affects retention of non-aversive memories.

NCT ID: NCT04467320 Recruiting - Clinical trials for Posttraumatic Stress Disorder

Recovery Learning for Adolescents After Traumatic Experiences

RELATE
Start date: August 1, 2020
Phase: N/A
Study type: Interventional

Most children who have been removed from their family home and placed under the care of a Local Authority have been exposed to many frightening experiences, including witnessing violence, not being fed or cared for, or being abused. These experiences can lead to significant emotional difficulties. One such difficulty is posttraumatic stress disorder (PTSD), which can involve symptoms like having constant "flashbacks" of scary experiences, and a constant feeling of being in danger. This can have a big effect on children's lives. Yet, it is still not clear how to help young people in care who are experiencing high PTSD symptoms. One idea the researchers have is to use a group-based online programme which has successfully helped other young people who have been exposed to different kinds of stressful experiences (for example, war). To test whether this programme could help children in care too, the researchers first need to see whether social workers have the time to check in with a child about PTSD symptoms; whether young people and their carers are willing to be involved in a research project which will test out the treatment programme; and whether mental health workers might face any problems when delivering the programme. This project aims to answer these questions. The researchers will train social workers to complete an 8-question interview with 10-17 year olds in care, which will measure symptoms of PTSD. If the young person is experiencing high symptoms, they will be invited to take part in a research project. If they would like to join the project, children will be randomly selected to take part in the online group programme, or be given care-as-usual. The group programme involves the young person taking part in five weekly meetings held online, where they will learn skills to reduce their distress, and be supported to work through their difficult memories. Their carers will also take part in two online meetings which will teach them how to support their young person.

NCT ID: NCT04464148 Withdrawn - Clinical trials for Alcohol Use Disorder

Feasibility Trial of Pregnenolone for Posttraumatic Stress Disorder and Alcohol Use Disorder

Start date: December 2021
Phase: Phase 1
Study type: Interventional

Pregnenolone is a neurosteroid and an over-the-counter supplement that has shown promise in clinical studies of stress-related disorders, such as anxiety, depression and posttraumatic stress disorder (PTSD). Epidemiological studies suggest that patients with PTSD are at higher risk of developing addiction, including alcohol use disorder (AUD).The following hypothesis will be tested in this trial: pregnenolone is associated with a reduction in both PTSD symptoms and the number of standard drinks per week in outpatients with PTSD and AUD.

NCT ID: NCT04460014 Completed - Clinical trials for Post Traumatic Stress Disorder

Simple Cognitive Task Intervention After Trauma During COVID-19 In Hospital Staff EKUT-P RCT

Start date: September 30, 2020
Phase: N/A
Study type: Interventional

This research study is designed to investigate the effects of a remotely delivered simple cognitive task (a memory cue followed by playing the computer game "Tetris" with mental rotation instructions) on intrusive memories ("flashbacks") and other symptoms after a traumatic event(s). Hospital staff who experienced a work-related traumatic event(s) during the COVID-19 pandemic will be randomly allocated to either the simple cognitive task intervention or control. Randomization to assigned intervention occurs on Day 1, after completion of baseline measures (note: baseline measures are not used in randomization process). Baseline measures include questionnaires on Day 1 and an intrusive memory diary during the previous week (Week 0). Participants will be followed up at one week and one month, and where possible 3 and 6 months. It is predicted that participants given the simple cognitive task intervention will develop fewer intrusive memories, less severe related clinical symptoms, and will show higher functioning (e.g. at work) than those who are not. This will inform the future development of a simple technique to prevent distressing psychological symptoms after a traumatic event(s). Implementation and training aspects regarding remote recruitment and intervention delivery in a hospital context will also be explored. Participants use e.g. their smartphone for part of the intervention in the study.

NCT ID: NCT04457271 Withdrawn - Clinical trials for Cognitive Impairment

Goal Management Training in Individuals With PTSD

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

This study will evaluate the effect of a manualized treatment (Goal Management Training, or GMT) on the cognitive impairments associated with PTSD (Post-Traumatic Stress Disorder), as well as any impact on PTSD symptems themselves. Participants will be randomized to either GMT group treatment, or a wait list condition.

NCT ID: NCT04455360 Completed - Depression Clinical Trials

Early EMDR Following Covid-19 Critical Illness: A Feasibility Trial

Cov-EMERALD
Start date: October 1, 2020
Phase: N/A
Study type: Interventional

Primary objective is to evaluate the feasibility of delivering an online early Eye Movement Desensitisation Reprocessing (EMDR) Recent Traumatic Events Protocol (R-TEP) to patients who have survived Covid-19 related critical illness, within the context of a randomised controlled trial (RCT). This will inform the design of a future RCT investigating the effectiveness of EMDR R-TEP in reducing psychological symptoms, for adult survivors of intensive care.

NCT ID: NCT04452500 Recruiting - PTSD Clinical Trials

Phase IIa Trial of a Selective Glucocorticoid Receptor Antagonist in the Treatment of Veterans With Posttraumatic Stress Disorder (PTSD) (Seven Study)

SEVEN
Start date: October 15, 2022
Phase: Phase 2
Study type: Interventional

The purpose of this study is to test the drug CORT108297, which blocks the hormone cortisol, for treatment of PTSD in Veterans, and establish a safety profile that will inform the design of future studies.

NCT ID: NCT04449627 Not yet recruiting - Covid19 Clinical Trials

Psychological Impact of Admission With Covid-19 During the SARS-CoV-2 Pandemic: Naturalistic Cohort Study With a Digital Intervention

FeelGood
Start date: August 31, 2020
Phase:
Study type: Observational

Studies have shown that admission to hospital during a coronavirus epidemic is associated with increased levels of anxiety, depression and panic disorder. During the SARS-CoV-2 pandemic in North London the Royal Free Hospital admitted over 500 patients with Covid-19. As part of the standard of care, these patients are screened at 8 weeks post discharge for signs of anxiety and depression. The Feeling Good app is a NHS approved digital application which utilises applied relaxation, mindfulness based cognitive therapy and positive visualisation through audio tracks for the treatment of anxiety and depression. This is a naturalistic cohort study aimed to track the post illness psychological symptoms of those who have been admitted with Covid-19 to the Royal Free hospital up to 5-7 months after discharge. The study population is those who are exhibiting anxiety or depressive symptoms as measure by the PHQ-2 or TSQ questionnaires. All those with symptoms will be offered free access to a NHS approved app for anxiety and depression, and followed up for 3 months after recruitment to track changes to their symptoms.

NCT ID: NCT04448808 Recruiting - Clinical trials for Posttraumatic Stress Disorder

Treating Nightmares in Posttraumatic Stress Disorder With Dronabinol

Start date: October 1, 2020
Phase: Phase 2
Study type: Interventional

This randomized controlled exploratory phase II trial will test the hypothesis that oral dronabinol improves nightmares (primary outcome) and other PTSD symptoms (secondary outcomes) to a greater extent than placebo over a ten week intervention phase in a parallel group design.

NCT ID: NCT04442243 Not yet recruiting - Depression Clinical Trials

PTSD Symptoms Among Health Workers and Public Service Providers After the COVID-19 Outbreak: A 3 Month Follow up

Start date: June 22, 2020
Phase:
Study type: Observational

The aim of this study is to investigate the levels of trauma and mental symptoms (i.e., depression and anxiety) among health workers and public service providers 3 months after (T2) the strict social distancing government initiated non-pharmacological interventions (NPIs) related to the COVID-19 pandemic (T1), in a period of lifted distancing protocols. The study also aims to investigate predictors of trauma-symptoms, by analyzing how predictors measured during the COVID-19 pandemic are associated with change in PTSD symptoms from T1 to T2.