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PTSD clinical trials

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NCT ID: NCT06464952 Recruiting - PTSD Clinical Trials

Microbiome Modulation With Prebiotics in PTSD and Cirrhosis

RESIST-PTSD
Start date: June 25, 2024
Phase: N/A
Study type: Interventional

Despite medical advancements, PTSD remains a major issue in Veterans1. Current treatment strategies have relatively poor adherence. In patients with PTSD and cirrhosis, there is greater cognitive impairment as well as changes in gut microbiome structure and function2,3. In addition, when there is concomitant cirrhosis, medication-related treatment options become even narrower from a safety and tolerability perspective and cognitive issues pertaining to cirrhosis could impact participation3. Changes in gut microbiome in Veterans with cirrhosis and PTSD compared to those with cirrhosis without PTSD is characterized by a greater relative expression of pathobionts and reduction in stool microbiome diversity with reduction in bacteria that produce beneficial short chain fatty acids (SCFA)2. Modulation of the gut microbiome in patients with cirrhosis and PTSD may be an important therapeutic target. In prior studies with cirrhosis alone, microbial modulation using diet, antibiotics such as rifaximin, probiotics, and fecal microbiota transplant have improved gut microbial diversity and clinical outcomes in some cases4,5. In patients with cirrhosis without PTSD and in patients with PTSD without cirrhosis there is emerging evidence regarding prebiotics and other forms of gut microbial modulation. Prebiotics are such an example6. Prebiotics are natural fibers derived from carbohydrates and can be beneficial to gut microbiota (good bacteria in the gut)6. Resistant starches (RS) are dietary fiber prebiotics found naturally in many foods including potatoes, plantains, and legumes6,7. In addition to being highly accessible, RS have been shown to be well tolerated with few adverse reactions. While no studies of RS exist in PTSD + cirrhosis patients, a meta-analysis of RS in IBD has shown RS to be an effective treatment in both animal and clinical studies where improvements in clinical remission and reduced mucosal damage were found7. However, there is insufficient data regarding patients with PTSD and cirrhosis regarding gut microbial structure and function modulation with dietary supplements such as resistant starches. These starches can improve SCFA production in elderly subjects, which could in turn affect the gut-brain axis favorably8.

NCT ID: NCT06403449 Recruiting - PTSD Clinical Trials

The Effectiveness of Group-Delivered Guided Written Exposure Therapy for PTSD and Subclinical PTSD Among Chinese Adolescents : A Pilot Study

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

The study aims to examine the effectiveness of the group-delivered guided written exposure therapy (G-WET) for post-traumatic stress disorder (PTSD) and subclinical PTSD among Chinese adolescents with a randomized controlled trial. The study will recruit 40 participants, with 20 randomized to the G-WET group and 20 randomized to the waiting list (WL) group. The G-WET intervention consists of 5-8 group sessions. The primary outcome CPSS-5-I (Child PTSD Symptom Scale-Interview Version for DSM-5) and PCL-5 ( PTSD Checklist-5) will be administered on baseline, post-treatment, 1-month follow-up, 3-month follow-up, and 6-month follow-up assessments.

NCT ID: NCT06394700 Recruiting - PTSD Clinical Trials

Written Exposure Therapy and App-Delivered Mindfulness Meditation for PTSD in China: A Pilot Study

Start date: November 11, 2021
Phase: N/A
Study type: Interventional

The goal of this study is to use a pilot RCT to assess the effectiveness of Written Exposure Therapy (WET) and a mindfulness-based app (MBA) for managing PTSD and comorbid insomnia in China. The main questions it aims to answer are: 1. Does WET alone reduce PTSD symptoms in Chinese patients with PTSD and subthreshold PTSD? 2. Does the addition of MBA to WET lead to greater reductions in comorbid insomnia symptoms compared to WET alone? Researchers will compare WET alone and MCC to see if WET provides benefits in managing PTSD. Researchers will compare WET plus MBA and WET group to see if the integrated MBA treatment provides additional benefits in managing insomnia. Participants will: - Undergo random assignment to one of three groups: WET, WET plus MBA, or MCC. - Receive clinical interviews for primary outcomes (PTSD symptoms) at baseline, posttreatment, and during follow-ups. - Provide self-reported data on PTSD symptoms and insomnia severity at multiple time points. - In the WET plus MBA group, additionally use a mindfulness-based app as part of their treatment.

NCT ID: NCT06390293 Recruiting - PTSD Clinical Trials

The Effectiveness of Group-Delivered Revised Guided Written Exposure Therapy for PTSD and Subclinical PTSD Among Chinese Adolescents

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

The study aims to examine the effectiveness of the group-delivered revised written exposure therapy (WET-R) for post-traumatic stress disorder (PTSD) and subclinical PTSD among Chinese adolescents with a randomized controlled trial. The study will recruit 70 participants, with 35 randomized to the WET-R group and 35 randomized to the waiting list (WL) group. The WET-R intervention consists of 5-8 group sessions. The primary outcome CPSS-5-I (Child PTSD Symptom Scale-Interview Version for DSM-5) and PCL-5 ( PTSD Checklist-5) will be administered on baseline, post-treatment, 1-month follow-up, 3-month follow-up, and 6-month follow-up assessments.

NCT ID: NCT06363968 Recruiting - PTSD Clinical Trials

Biomarkers in the Retina for Prognosticating Mental Health Treatments

BRIGHT
Start date: February 12, 2024
Phase: N/A
Study type: Interventional

Title: ERG as a potential biomarker of SSRI-responsive PTSD: A pilot study Posttraumatic stress disorder (PTSD) affects many individuals who experience a traumatic event. Previous studies suggest that there is a connection between the brain and the retina, and that the electroretinogram (ERG) may be a valuable biomarker to tell us more about signals in the brain that are related to mental health disorders like PTSD. The goal of this observational study is to examine the ERG waveform in veterans with PTSD before and after a single dose of the selective serotonin reuptake inhibitor (SSRI), sertraline. Sertraline is one of two FDA-approved medications for the treatment of PTSD. The main questions this pilot study aims to answer are: 1. How does sertraline, an SSRI, influence the ERG waveform in veterans with PTSD? 2. Is there a significant correlation between baseline ERG signals and the change in ERG following SSRI treatment? Participants will be asked to: - Undergo ERG recordings before and after a single dose of sertraline. - Provide relevant clinical information related to PTSD symptoms and treatment history. Following the initial study visits, participants will enter an optional open label phase of the study in which qualifying participants who initiate antidepressant treatment through routine clinical care will be invited back for a follow-up ERG recording.

NCT ID: NCT06302764 Recruiting - Stress Clinical Trials

Emergency Medical Staff Workload Analysis

Start date: October 1, 2023
Phase:
Study type: Observational

The aim of this study is to identify trauma determinants and leverage this understanding to develop solutions applicable to the prevention and treatment of PTSD among emergency medical personnel. By categorizing stimuli associated with traumatic professional experiences, the study aims to enhance existing therapeutic protocols through exposure therapy. The specific objectives are as follows: 1. Analysis and characterization of occupational workloads among doctors and emergency medical personnel, focusing on the scale of burdens associated with PTSD symptoms. 2. Development of categories for aggravating and potentially traumatizing stimuli within the medical staff of rescue teams. 3. Examination of the feasibility of incorporating the obtained results into cognitive-behavioral therapy protocols. 4. Assessment of the potential for implementing the results in solutions utilizing virtual reality technology. 5. Formation of an interdisciplinary international research team.

NCT ID: NCT06300255 Recruiting - Depression Clinical Trials

Evaluation of the H.O.O.V.E.S. Healing Intensives Program

Start date: April 24, 2024
Phase:
Study type: Observational

The aim of this study is to measure the impact of these H.O.O.V.E.S. healing intensives on Veteran participants using several psychological instruments. The investigators are planning to administer the demographic questionnaires and psychological instruments to Veteran participants before the healing intensives. Psychological instruments will be administered immediately pre-intervention, pre- and post-session for each session, post-intervention, 90, 120 and 360 days post-intervention. The primary aim is to assess for statistically significant changes pre- to post session and pre- to post-intervention.

NCT ID: NCT06285708 Recruiting - PTSD Clinical Trials

Enhancing the Effectiveness of Prolonged Exposure Among Suicidal Individuals With PTSD

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

The long-term goal of this study is to reduce suicidal thoughts and behaviors among treatment-seeking individuals who also have posttraumatic stress disorder (PTSD). Prolonged exposure (PE) and crisis response plan (CRP) have demonstrated empirical support for reducing suicide attempts as compared to treatment as usual. However, no studies to date have assessed their effectiveness when used in combination. In light of this knowledge gap, the primary objective of this study will be to test the effectiveness of PE augmented with CRP as compared to PE with care as usual (self-guided treatment plan), an active comparator, for the reduction of suicide ideations and attempts for individuals with comorbid PTSD.

NCT ID: NCT06261463 Recruiting - Depression Clinical Trials

Hybrid Type 1 Randomized Pilot Trial of a Peer-led Family and Social Strengthening Group Intervention for Refugee Families

Start date: May 31, 2024
Phase: N/A
Study type: Interventional

The proposed study draws on prior research to evaluate the feasibility, acceptability and explore preliminary effectiveness of Coffee and Family Education and Support, Version (CAFES2) using a pilot randomized type 1 hybrid effectiveness-implementation design. CAFES2 is a peer-led family and social strengthening multiple family group intervention that is designed to respond to multi-level needs of refugee families. Results of the trial will contribute to the emerging evidence base on family-based mental health interventions for refugee and newcomer communities. The trial will also generate new insights regarding implementation strategies needed to promote successful delivery of services by peer providers and the unique role of human-centered design practices for adaptation of mental health and psychosocial interventions.

NCT ID: NCT06203106 Recruiting - Clinical trials for Diabetes Mellitus, Type 2

NYSCF Scientific Discovery Biobank

Start date: November 10, 2022
Phase:
Study type: Observational

The New York Stem Cell Foundation (NYSCF) Research Institute is performing this research to accelerate diverse disease research using cells from the body (such as skin or blood cells) to make stem cells and other types of cells, conduct research on the samples, perform genetic testing, and store the samples for future use. Through this research, researchers hope to identify future treatments or even cures for the major diseases of our time.