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Stress Disorders, Post-Traumatic clinical trials

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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: NCT05427500 Not yet recruiting - PTSD Clinical Trials

Stellate Ganglion Block in the Treatment of Posttraumatic Stress Disorder

Start date: September 1, 2022
Phase: Early Phase 1
Study type: Interventional

The most common treatment for Posttraumatic Stress Disorder (PTSD) is trauma-focused therapy and/or prescription of medication(s). However, these treatments may not directly reduce symptoms associated with PTSD, making it difficult for patients to be treated for this condition and recover. Stellate ganglion block (SGB) is a medical procedure that involves injection of a local anesthetic (a medication that causes reduced sensation/feeling in a given area) around the stellate ganglion, which is a collection of nerves near the base of the neck. This procedure causes a short-lived, temporary shutdown of nerve signals (up to 5-7 hours) and is commonly performed in Canada for certain pain and medical conditions. In the last decade, several studies, including those involving members of military groups, have shown that SGB can result in a rapid and sustained drop in symptoms related to PTSD such as overwhelming anxiety, increased irritability, heightened alertness, and exaggerated startle. Considering these results and the known safety of this procedure (as demonstrated by previous research and use in other illnesses), SGB has been increasingly used to treat PTSD among veterans in the United States but has not yet been evaluated in Canada. More research is thereby needed to use SBG as a method of PTSD treatment in Canada, and to better understand how it works to reduce symptoms associated with this condition. Health Canada, the organization which oversees clinical trials such as this one, has not approved the use of the SGB procedure for PTSD in the general population, however Health Canada has allowed the use of SGB in this study to better understand how it works and how it may be used in the future to treat PTSD-related symptoms in those who feel that common treatments are not effective.

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: NCT05422768 Active, not recruiting - PTSD Clinical Trials

PTSD Clinical Team Research Clinic (PCT Research Clinic)

Start date: November 16, 2020
Phase:
Study type: Observational

Part of the IRB_00136053 study was to look at the effectiveness of Warrior Renew and Warrior Renew+EAL interventions. Furthermore, demographic information on Veteran participants will be analyzed.

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: NCT05421494 Recruiting - PTSD Clinical Trials

The Effectiveness of Online Revised Written Exposure Therapy for PTSD

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

The study aims to examine the effectiveness of the online revised written exposure therapy (WET-R) for PTSD and subclinical PTSD among Chinese adults with a randomized controlled trial. The study will recruit 90 participants, with 60 randomized to the online WET-R group, and 30 randomized to the minimal contact control (MCC) group. The WET-R intervention consists of 5-7 one to one sessions. The primary outcome PTSD Symptom Scale - Interview for DSM-5 (PSSI-5) will be administered on baseline, post-treatment, 1-month follow-up, 3-month follow-up, and 6-month follow-up assessments.

NCT ID: NCT05421182 Completed - COVID-19 Clinical Trials

Psychological Impact of Medical Evacuations on Families of Patients Admitted to Intensive Care Unit for Severe COVID-19

IPES-CoV
Start date: June 30, 2021
Phase: N/A
Study type: Interventional

At the "Métropole Savoie" hospital, to deal with the daily influx of severe patients during the second wave of COVID-19, 23 patients had to be transferred away from their home city and far from their families as part of a medical evacuation (EVASAN). The purpose of the study is to investigate whether there is an association between medical evacuations and the occurrence of psychological disorders such as post-traumatic stress, anxiety or depression occurring within 6 to 10 months in families of evacuated patients. The investigators want to compare the prevalence of psychological disorders in the families of patients evacuated for a serious form of COVID-19 (cases) compared to that of families of patients not evacuated (controls) hospitalized for a serious form of COVID-19.

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).