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Stress Disorders, Post-Traumatic clinical trials

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NCT ID: NCT06279598 Recruiting - Clinical trials for Stress Disorders, Post-Traumatic

PT-STRESS Study: Predicting Treatment Success and Dealing With Non-response in the Treatment of PTSD

PT-STRESS
Start date: January 1, 2024
Phase: N/A
Study type: Interventional

The aim of this study is to increase understanding of the effectiveness and efficiency of psychological treatment for adult patients with posttraumatic stress disorder -PTSD- and to make it more personalized. Key questions: 1. Which predictors of treatment success influence treatment outcome of patients with PTSD who receive the three psychotherapeutic treatments investigated in this study? 2. Which specific moderators can be identified with regard to the different psychotherapies (Eye Movement Desensitization and Reprocessing -EMDR-; Prolonged Exposure -PE-; and Interpersonal Psychotherapy -IPT- in the second phase)? 3. In patients with PTSD, does offering another proven effective form of trauma-focused psychotherapy (PE after EMDR, or EMDR after PE) improve symptoms following insufficient response to a first trauma-focused treatment? 4. Is switching from a trauma-focused therapy to a non-trauma-focused treatment (IPT) a more effective strategy for dealing with non-response to a first proven effective psychotherapeutic treatment compared to switching to another trauma-focused therapy? 5. Are there differences in treatment tolerance and differences in dropout rates between PE, EMDR and IPT? Secondary goals: - Investigating the extent to which therapist allegiance to a specific therapy method affects outcomes; - Investigating whether the quality of therapy implementation or the treatment integrity ('adherence/ competence') affects treatment outcomes; - Investigating how much the quality of the therapeutic alliance influences outcomes. Participants receive treatment and will complete questionnaires. The study is conducted in two phases. Its aim is to compare two different trauma-focused treatments (EMDR and PE) for patients with PTSD to one another and with a nontrauma-focused psychotherapy (IPT) and to investigate possible predictors and moderators for treatment success. Patients will first be randomized to PE or EMDR in the first treatment phase. After this first phase, non-responders are re-randomized for a second phase of treatment. They receive either the alternative phase 1 trauma-focused psychotherapy or IPT as non-trauma-focused therapy. In phase 1 researchers will compare the PE and EMDR group to see which treatment is most effective for whom. In phase 2 researchers will compare the trauma-focused treatments (PE and EMDR group) with the nontrauma-focused treatment (IPT group) to see which treatment is most effective for whom.

NCT ID: NCT06276725 Recruiting - Clinical trials for Posttraumatic Stress Disorder

Writing Wrongs: Expressive Writing for Microaggressions

WW
Start date: March 18, 2024
Phase: N/A
Study type: Interventional

Racial and ethnic based stressors, such as microaggressions, are pervasive, distressing, and result in lasting negative repercussions for minoritized students at predominantly white institutions (PWIs). These racial and ethnic based stressors are experienced in addition to the universally experienced stressors of higher education. Negative repercussions of microaggressions include increased drop out or transfer rates, distress, fatigue resulting in decreased academic performance, and depression and posttraumatic stress symptoms. Expressive writing (EW) may be a scalable intervention for addressing the negative repercussions resulting from microaggressions experienced by minoritized students at PWIs. Previous research suggests that EW for stressful life events results in benefits such as reduced depression and posttraumatic stress symptoms, improved coping strategies, and reduced activity restriction. Despite such benefits, EW was not designed to specifically address microaggressions in a minoritized student population. Informed by the ADAPT-ITT model, our research group conducted a pilot study with similar procedures. This pilot study demonstrated the acceptability of an adapted version of the EW intervention titled Writing Wrongs (WW), as well as recommended future modifications for WW. In the current study we aim to conduct a randomized-controlled trial to establish the efficacy of WW in alleviating clinical symptoms. We hypothesize that WW will improve symptoms of racial and discriminatory trauma and symptoms of depression, anxiety, and posttraumatic stress over time and compared to an assessment-only condition. We will conduct exploratory analyses to examine short-term changes in affect within and across sessions and across conditions. We will recruit minoritized students enrolled at a PWI. Participants will complete a pre-intervention assessment prior to being randomized into the two conditions. Participants in the intervention condition will engage in three sessions of WW and complete measures of clinical symptoms across multiple time points (i.e., pre-intervention, immediately after the final writing session, one week after the final session). Participants in the assessment-only condition will be administered the same measures at the same timepoints and given access to the WW after completing the study. If found to be efficacious, WW has the potential to be widely disseminated to minoritized college students who experience microaggressions.

NCT ID: NCT06249386 Recruiting - Clinical trials for Alcohol Use Disorder

Adapting and Piloting Behavioral Activation for Veterans With Alcohol Use Disorder and Posttraumatic Stress Disorder

Start date: May 30, 2024
Phase: N/A
Study type: Interventional

The goal of this clinical trial is to compare an adaptation of Behavioral Activation, a behavioral intervention, to Relapse Prevention treatment, another behavioral intervention, in a sample of U.S. military veterans with co-occurring alcohol use disorder (AUD) and posttraumatic stress disorder (PTSD). The primary aims of this study are to: 1. Adapt Behavioral Activation to treat veterans with AUD/PTSD, 2. Evaluate the feasibility, acceptability, and preliminary effects of Behavioral Activation for AUD/PTSD, and 3. Explore geospatial analysis as a new method for measuring AUD/PTSD recovery. Participants will complete self-report and interview measures immediately before and immediately after treatment. Participants will also be asked to participate in passive geospatial assessment for 14-day periods immediately before and immediately after treatment. Participants will be randomized to treatment condition, which involves 8 sessions of either Behavioral Activation or Relapse Prevention, delivered individually by a trained study therapist.

NCT ID: NCT06237699 Recruiting - Quality of Life Clinical Trials

Effects of a Digital Diary on the Psychological Well-being of Former ICU Patients.

DIPIC
Start date: May 1, 2023
Phase:
Study type: Observational [Patient Registry]

Previous research on the impact of a diary on mental symptoms of PICS, PICS-F, and quality of life in former ICU patients and their relatives has focused specifically on a paper diary. While there has been research on the experiences of former ICU patients, relatives, and ICU nurses regarding the use of a digital diary, it is not known whether this diary has an impact on the psychological well-being and quality of life of former ICU patients and their relatives. A successful implementation of [the digital diary] enables this research. The aim of this study is, therefore, to provide an initial impression of the health-related effects of a digital diary on former ICU patients and their relatives.

NCT ID: NCT06234969 Recruiting - Clinical trials for Posttraumatic Stress Disorder

A Mechanistic Trial of the Neurobiology of Extinction Learning and Intraparietal Sulcus Stimulation

Start date: April 4, 2024
Phase: N/A
Study type: Interventional

This study will be the first of its kind to explore the impact of continuous theta burst stimulation (cTBS) to the intraparietal sulcus (IPS) on arousal symptoms among patients with posttraumatic stress disorder (PTSD). The investigators will demonstrate that IPS cTBS results in significant reduction in arousal (measured by startle response) compared to sham cTBS, that IPS cTBS interacts with extinction training to further improve arousal, and that there is a dose/response effect of cTBS on arousal. The investigators will also demonstrate that IPS cTBS significantly improves retention of extinction learning, the experimental analogue of exposure therapy.

NCT ID: NCT06218381 Recruiting - Clinical trials for Post Traumatic Stress Disorder

The Effects of Very Brief Exposure on PTSD in U.S. Combat Veterans

PTSD
Start date: March 22, 2024
Phase: N/A
Study type: Interventional

The goal of this clinical trial is to develop a new behavioral treatment for U.S. combat veterans with post-traumatic stress disorder (PTSD), very brief exposure to combat-related stimuli. The main questions it aims to answer are: 1. How does Very Brief Exposure (combat images and control everyday images) and Visible Exposure to combat stimuli affect brain activity and subjective fear ratings? 2. To what extent are participants aware of the stimuli presented and tolerating the exposures? All participants will view both very brief exposure and visible exposure to combat stimuli in the functional magnetic brain imaging (fMRI) scan. They will provide ratings of fear, awareness, and tolerability. Researchers will compare U.S. combat veterans with PTSD and healthy controls to confirm differences in brain region activation and ratings.

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.

NCT ID: NCT06193161 Recruiting - Clinical trials for Posttraumatic Stress Disorder

Prolonged Exposure for Swedish Immigrants

Start date: February 15, 2024
Phase: N/A
Study type: Interventional

The goal of this clinical trial is to compare therapist-guided internet delivered prolonged exposure (I-PE) in simple english to a waiting list condition for immigrants in Sweden diagnosed with post-traumatic stress disorder (PTSD). The main objectives are to establish feasibility and preliminary efficacy of I-PE for immigrants with PTSD in a single-blind, parallel-group superiority Randomized Controlled Trial (N=100) comparing I-PE with a waiting-list condition, starting with a nested pilot (N=30) to ensure feasible and acceptable recruitment and treatment strategies. Study participants will be randomly assigned to either eight weeks of I-PE or a waiting-list for the same amount of time on a 1:1 ratio without restriction. Feasibility and acceptability data will be reported including recruitment rate, sample demographics, data attrition, treatment adherence and a detailed dropout analysis. A preliminary investigation of the within-group effect size will also be conducted. Recruitment is designed to be broadly inclusive with minimal exclusion criteria.

NCT ID: NCT06185244 Recruiting - Clinical trials for Posttraumatic Stress Disorder

Efficacy of Internet-delivered Trauma-focused CBT for Young People With PTSD

Start date: March 11, 2024
Phase: N/A
Study type: Interventional

The goal of this clinical trial is to compare therapist-guided internet delivered trauma-focused cognitive behavior therapy (CBT) to an active control condition comprising therapist-guided internet delivered cognitive behavioral therapy containing relaxation techniques and psychoeducation for young people with post-traumatic stress disorder regarding efficacy and cost effectiveness. Young people with post-traumatic stress disorder will be randomly assigned to receive either 12 weeks of therapist-guided internet delivered trauma-focused cognitive behavior therapy (iTF-CBT) or therapist-guided internet delivered cognitive-behavioral therapy containing relaxation and psychoeducation.

NCT ID: NCT06179485 Recruiting - Clinical trials for Post-Traumatic Stress Disorder

Effect of Ketamine and Etomidate During RSI on Long Term Outcomes

RSI-LTO
Start date: April 6, 2022
Phase:
Study type: Observational

The RSI-LTO study collects long-term outcomes from the RSI trial (NCT05277896). One-third of adults who are intubated in the ED or ICU experience symptoms of posttraumatic stress disorder (PTSD). PTSD is a psychiatric disorder triggered by a "shocking, scary, or dangerous event." Critical illness, tracheal intubation, and mechanical ventilation can be traumatic and distressing events. Patients may recall the intubation procedure, the feeling of the breathing tube in their throat, or being unable to move ("paralyzed"). While on the breathing machine, patients may experience delirium, frightening hallucinations, and delusions. Patients with PTSD after critical illness can be hypervigilant, anxious, and troubled by intrusive thoughts, nightmares, and flashbacks that last months to years after critical illness and that PTSD negatively impacts patients' marriages, work, and quality of life and increases patients' risk of depression, anxiety, substance use disorder, and suicide. Ketamine may prevent PTSD symptoms by blocking the pathways in the brain's glutaminergic system that are responsible for the formation of traumatic memories In outpatients with chronic PTSD, a single dose of ketamine has been shown to reduce PTSD symptoms for up to 2 weeks. Even a modest reduction in PTSD would translate into tens of thousands of fewer cases of PTSD each year, more cases of PTSD each year than any other medical intervention evaluated to date.