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Stress Disorders, Traumatic clinical trials

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NCT ID: NCT05461521 Active, not recruiting - Clinical trials for Stress Disorders, Post-Traumatic

Improving FAMily Members' Experience in the ICU

FAME
Start date: December 15, 2022
Phase:
Study type: Observational

The aim of the present research is to set up a large multicentric, prospective cohort of family members of patients admitted to intensive care. The data collected will concern the patients and their family members, the caregivers and the functioning of the services during the collection period. This cohort will allow: 1. to carry out a quantitative evaluation of post-traumatic stress disorder (PTSD) in a large number of family members, to determine the risk factors in relation to the characteristics of the family members, and to define a predictive model of PTSD in this population 2. to determine the factors related to the operating conditions of the resuscitation services that favor the occurrence of PTSD in the family members, 3. to create a biological bank from blood samples taken from family members, 4. to carry out a qualitative study allowing a psychological and sociological analysis of the experience of the family members concerning the hospitalization in intensive care of their loved one.

NCT ID: NCT05456958 Recruiting - Clinical trials for Post Traumatic Stress Disorder

Multi-session fMRI-Neurofeedback in PTSD

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

Post-traumatic stress disorder (PTSD) is a debilitating and highly prevalent psychiatric disorder that develops in the aftermath of trauma exposure (APA, 2013). PTSD has been strongly associated with altered activation patterns within several large-scale brain networks and, as such, it has been suggested that normalizing pathological brain activation may be an effective treatment approach. The objective of this proposed study is to investigate the ability of PTSD patients to self-regulate aberrant neural circuitry associated with PTSD psychopathology using real-time functional magnetic resonance imaging (rt-fMRI) neurofeedback. Here, the investigators are building upon previous single-session pilot studies examining the regulation of the amygdala and the posterior cingulate cortex (PCC) in PTSD (Nicholson et al., 2021) (Nicholson et al., 2016) by: (1) Examining the effect of multiple sessions of rt-fMRI neurofeedback and, (2) Comparing PCC- and amygdala-targeted rt-fMRI neurofeedback to sham-control groups with regards to changes in PTSD symptoms and neural connectivity.

NCT ID: NCT05455996 Not yet recruiting - Clinical trials for Post-Traumatic Stress Disorder

MDMA-Assisted Therapy for Stress Disorders in Healthcare Workers

Start date: October 2022
Phase: Phase 2
Study type: Interventional

The purpose of this study is to assess the safety and efficacy of MDMA-Assisted Therapy on Health Care Workers suffering from symptoms of Post-Traumatic Stress due to their work on the frontline of the COVID Pandemic.

NCT ID: NCT05441280 Recruiting - Insomnia Clinical Trials

Pimavanserin for Insomnia in Veterans With PTSD

PIP-II
Start date: June 26, 2023
Phase: Phase 2
Study type: Interventional

This is a preliminary randomized, double-blind, placebo-controlled trial comparing pimavanserin 34mg at bedtime vs. placebo for the treatment of insomnia associated with post-traumatic stress disorder.

NCT ID: NCT05429619 Active, not recruiting - Clinical trials for Post Traumatic Stress Disorder

Evaluating Implementation and Impact of PeerOnCall, a Mobile Health Approach to Peer Support for Canadian Public Safety Personnel

Start date: May 2, 2023
Phase:
Study type: Observational

A prospective cohort study design will be implemented across four sectors and multiple organizations sites to evaluate implementation and impact of the apps. Pre/post impact data will be collected over a six-month implementation period to assess whether the apps lead to increased Public Safety Personnel outreach to peer support (primary outcome), and to increased mental health literacy, and decreased mental distress (secondary outcomes). Recruitment will take place at three levels; 1) organizations (including knowledge users/organization champions), 2) peer support providers, and 3) public safety personnel employed within each participating organization. Sources of implementation and impact data for the six-month trial will include: 1) app utilization data, 2) knowledge user/organization champion interviews, 3) surveys with public safety personnel, 4) focus groups with peer support providers, and 5) implementation costs. Analysis will focus on both implementation and effectiveness to address the research questions related to the impact of the apps, as well as how the process and context of implementation shapes effectiveness.

NCT ID: NCT05427708 Recruiting - Anxiety Disorders Clinical Trials

Respiratory Training vs Interoceptive Exposure in the Treatment of Transdiagnostic Pathological Anxiety

Start date: August 22, 2022
Phase: N/A
Study type: Interventional

Purpose of the Research: The primary aim of the proposed study is to conduct a randomized parallel-group 3-arm clinical trial comparing two mechanistically distinct interventions for pathological anxiety - (1) Interoceptive Exposure (IE) utilizing graduated exposure to somatic cues (respiratory, cardiac, vestibular) with the primary aim of reducing fear responding to the presence of interoceptive perturbations; (2) Capnometry-Guided Respiratory Intervention (CGRI) aimed at raising end-tidal CO2 levels thereby lowering hyperventilation-induced respiratory alkalosis and its associated fear-eliciting somatic reactions; and (3) Psycho-education about anxiety and its effects (PsyEd), which will serve as a credible control comparator.

NCT ID: NCT05424146 Completed - Clinical trials for Post Traumatic Stress Disorder

Efficacy of Evidence-Based PTSD Treatment Via Prebiotic Supplementation

Start date: June 6, 2022
Phase: N/A
Study type: Interventional

Posttraumatic stress disorder (PTSD) is a debilitating psychiatric disorder, which results from exposure to traumatic events. Veterans are more than twice as likely to suffer from PTSD compared to civilians. Current interventions for the treatment of PTSD are evidence-based psychotherapies, such as Cognitive Processing Therapy (CPT). Therefore, we plan to compare Cognitive Processing Therapy (CPT) with and without a novel prebiotic bar designed to beneficially modulate the microbiota to determine the utility of this combined approach to positively impact PTSD symptoms. We will conduct a 12-week randomized, double-blind, placebo-controlled, cross-sectional trial in veterans with PTSD. Participants will be randomized to receive CPT + prebiotic or CPT + placebo. They will be provided a supply of prebiotic or non prebiotic bars for 12 weeks. At three different time points, participants will complete questionnaires and complete questionnaires and produce a stool sample ( weeks 1,2, and 12). All participants will be recruited from the two-week in-person Intensive Outpatient Program (IOP) at the Rush Road Home Program, where they will be receiving CPT.

NCT ID: NCT05422612 Recruiting - Clinical trials for Post Traumatic Stress Disorder

Department of Defense PTSD Adaptive Platform Trial - Master Protocol

Start date: November 2, 2023
Phase: Phase 2
Study type: Interventional

This is a Phase 2 randomized, double-blinded, placebo-controlled study that will evaluate multiple potential pharmacotherapeutic interventions for PTSD utilizing an adaptive platform trial design. Participants are randomized among the multiple cohorts in the study and the resulting randomization enables sharing/pooling of control participants, where all interventions may be compared to a common control (placebo). This master protocol describes the default procedures and analyses for all cohorts; treatment-specific procedures will be described in the Master Protocol cohort-specific appendices. Individual cohorts may have additional eligibility requirements, safety and efficacy procedures, or endpoints, which will be described in corresponding intervention-specific clinicaltrials.gov records.

NCT ID: NCT05419999 Active, not recruiting - Clinical trials for Post Traumatic Stress Disorder

Transcranial Direct Current Stimulation (tDCS) in Human Subjects With PTSD Receiving an Exposure-based, Behavioral Therapy

Start date: January 9, 2023
Phase: N/A
Study type: Interventional

The primary objective of this study is to evaluate the safety, feasibility, and psychological and physiological treatment benefits of transcranial direct current stimulation (tDCS), a noninvasive brain stimulation technique, when delivered in combination with Written Exposure Therapy (WET), for posttraumatic stress disorder posttraumatic stress disorder (PTSD).

NCT ID: NCT05415982 Completed - PTSD Clinical Trials

Diet Induced Ketosis for Patients With Posttraumatic Stress Disorder (PTSD), a Feasibility Study

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

Many patients suffering from posttraumatic stress disorder (PTSD) are resistant to established treatment consisting of psychotherapy. Patients often go years with this debilitating disorder without experiencing sufficient improvement. Approximately 1/3 of patients will drop out of treatment because of psychological burden and overactivation. A novel ketogenic diet treatment could amend established treatment, and potentially upregulate the threshold for exciting neurons in dysfunctional brain regions, mediated through various mechanisms. This may reduce PTSD symptoms, and thus enabling patients to respond to psychological treatment without getting overactivated and unable to process trauma. The purpose of this study is to investigate whether it is possible to carry out a ketogenic diet therapy for patients with PTSD for four weeks.