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Stress Disorders, Post-Traumatic clinical trials

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NCT ID: NCT02335528 Completed - Depression Clinical Trials

SimCoach Evaluation: A Virtual Human Intervention to Encourage Servicemember Help-seeking for PTSD and Depression

Start date: October 2012
Phase: N/A
Study type: Interventional

SimCoach, a computer program featuring a virtual human that speaks and gestures in a videogame-like interface, is designed to encourage servicemembers, especially those with signs or symptoms of post-traumatic stress disorder (PTSD) or depression, to seek help to improve their psychological health. The assessment included a formative component assessing SimCoach's design, development, and implementation approaches, as well as a summative component assessing outcomes among participants in a user experience survey and a randomized controlled trial (RCT).

NCT ID: NCT02335125 Completed - Depression Clinical Trials

A Policy Relevant US Trauma Care System Pragmatic Trial for PTSD and Comorbidity Pilot

TSOS6
Start date: February 2015
Phase: N/A
Study type: Interventional

The goal of this pilot study is to develop and implement a larger scale, multi-site stepped collaborative care trial that targets injured patients with presentations of posttraumatic stress disorder (PTSD) and related comorbidities.

NCT ID: NCT02334566 Terminated - Clinical trials for Post-Traumatic Stress Disorder

Lending a Hand to Our Future: PTSD in Refugee Children and Youth

LHOF
Start date: August 2015
Phase: N/A
Study type: Interventional

Immigrant and refugee children and youth are the fastest growing segment of Canadian society, but their mental health is too often overlooked even though their high rates of symptoms are increasingly of concern. These children and youth face the same developmental challenges as other children, but migration and resettlement amplify challenges and also create additional risks. Although a literature about the effects of immigrant family life on the mental health of children exists, very little research has examined the specific extent and implications of post-traumatic stress disorder (PTSD) among refugee children and youth. In addition, the best practice intervention strategies that most optimally support their mental health difficulties have not been evaluated. This study investigates the effectiveness of a treatment intervention in a sample of refugee children: Narrative Exposure Therapy or NET and KIDNET (developed for younger children), selected due to their documented superiority relative to other forms of treatment for children and youth with PTSD.

NCT ID: NCT02329418 Completed - Clinical trials for Post Traumatic Stress Disorder

Written Document to Assist Family During Decision of Withholding and Withdrawing Life-sustaining Therapies in the Intensive Care Unit

LATA
Start date: September 2014
Phase: N/A
Study type: Interventional

Relatives of patients in situation of withholding and withdrawing life-sustaining therapies often show post traumatic stress disorder (PTSD) (60%)[1]. This number is even greater when family members are active in this decision (81%) or when communication is not optimal between medical team and family members. There are several ways to assist families of patients in intensive care units [2], amongst them the use of a written document to explain the environment, therapies and possible outcomes. Here the investigators want to test the impact of a written document in the context of end-of-life conference in intensive care units. Specifically, this research addresses wether such written support could decrease 3-months post-traumatic stress disorder, anxiety and depression exhibited by the closest family member or the patient representative.

NCT ID: NCT02322047 Completed - Clinical trials for Alcohol Use Disorder

Prazosin and Naltrexone (PaN) Study for Veterans With Alcohol Use Disorders

PaN
Start date: March 3, 2015
Phase: Phase 2
Study type: Interventional

The purpose of this study is to evaluate whether the combination of prazosin and naltrexone will decrease alcohol cravings and drinking in individuals who have problems with alcohol and have used alcohol at risky levels compare to naltrexone and placebo (Nal/Pl), prazosin and placebo (Praz/Pl), and double-placebo (Pl/Pl). We hypothesize that those assigned to both prazosin and naltrexone would report significantly greater decreases in percent drinking days and heavy drinking days as well as significantly greater reduction in craving from pre to post-treatment than those assigned to either single medication or double-placebo. Prazosin is a medication that is approved by the U.S. Food and Drug Administration (FDA) to treat people with high blood pressure. Some studies have shown that prazosin may also decrease nightmares and improve sleep in Veterans suffering from Posttraumatic Stress Disorder (PTSD). Animal studies have consistently found that prazosin is associated with decreased alcohol consumption and that the combination of prazosin and naltrexone outperforms either medication alone. The current study is evaluating an "off-label" use of prazosin to determine whether it is helpful in decreasing alcohol cravings and consumption among people with alcohol problems. "Off-label" means that the FDA has not approved the use of prazosin for alcohol problems. Naltrexone is a medication that is FDA approved for treating alcohol problems. This study is sponsored by the Department of Defense and the Congressionally Directed Medical Research Program (DoD/CDMRP). We expect approximately 120 participants in this study, which will run over approximately 4 years. Study participants will be involved in the study for 7 weeks, or until they complete the Final Assessment.

NCT ID: NCT02320799 Completed - Depression Clinical Trials

Randomized Controlled Trial of Interpersonal Psychotherapy for Depression and PTSD Among HIV+ Women in Kenya

Start date: September 2015
Phase: N/A
Study type: Interventional

The aim of this study is to conduct a 12-week IPT+TAU versus wait list TAU in a cohort of HIV+GBV+ women in Nyanza Province to relieve depression and PTSD and improve ARV adherence. This pilot study will provide data on the efficacy trends, acceptability and feasibility of our IPT intervention and will generate preliminary findings for an R01-funded intervention to test the intervention's efficacy for remediating the effects of GBV trauma on mental health and HIV-related outcomes. Hypothesis 1: IPT+ TAU will be more effective for reduction of depression and PTSD than TAU alone. Hypothesis 2: IPT+TAU will be acceptable and feasible.

NCT ID: NCT02313818 Completed - Clinical trials for Posttraumatic Stress Disorder

Variable-length Cognitive Processing Therapy for Combat-Related PTSD

Start date: June 2015
Phase: N/A
Study type: Interventional

The primary goal of this study is to improve the overall efficacy of cognitive processing therapy-cognitive-only version (CPT-C) in a sample of 130 active-duty service members through a variable length treatment.

NCT ID: NCT02305303 Completed - Clinical trials for Post-traumatic Stress Disorder

Diary for Severe Trauma

Qualitrau
Start date: November 9, 2014
Phase: N/A
Study type: Interventional

Treatment of severe trauma patients includes intensive cares. Both trauma and intensive care may lead to a post-traumatic stress disorder‬ and then to a decreased quality of life. Diaries may improve the frequency and the intensity of PTSD. Aim of investigator is to assess if diaries may improve quality of life after a severe trauma.

NCT ID: NCT02299583 Recruiting - Depression Clinical Trials

Controlled Trial of Early Intervention With Children and Adolescents Exposed to Nonrelational Traumatic Events

Start date: October 2014
Phase: N/A
Study type: Interventional

Background: International studies have shown that a substantial number of children and adolescents are exposed to potentially traumatic events. Many of these children and adolescents, some of whom will experience posttraumatic stress disorder (PTSD), are submitted to health care departments shortly after exposure as the most common types of traumatic events are accidental injury, serious somatic illness or death of someone close. There has been some research on early psychological interventions for prevention and treatment of PTSD. However, very little research has examined the efficacy of trauma-informed practice among health care professionals (HCPs). The present trial aims to evaluate and compare trauma-informed health care with usual practice. Methods/Design: The primary clinical question under investigation is the efficacy of an early, trauma-informed intervention for the prevention of PTSD in children and adolescents following exposure to a potentially traumatic event. The trail compares a standardized trauma-informed practice with usual care (no intervention) in health care departments receiving children and adolescents after exposure to determine if trauma-informed care is associated with a reduction in psychological outcome measures over time. Specifically, the investigators examine the efficacy of health care professional's active use of trauma-informed standards of action and a trauma training program for HCPs in the intervention group. The primary outcome will be a reduction in trauma, anxiety and depressive symptoms on self-reports in the active intervention compared to usual care. Discussion: This trial will be the first controlled trial to examine a trauma-informed intervention carried out by HCPs. It will provide the first evidence on the efficacy of health care delivered by trauma-educated HCPs using trauma-informed standards of action. A successful implementation of this protocol will support the thesis that prevention of PTSD among children and adolescents benefits from a focus on the practice of HCPs. If efficacious, the results will be a call for future research to extend the investigation of interventions from psychological treatment to HCP-based care.

NCT ID: NCT02295410 Completed - Clinical trials for Stress Disorders, Post-Traumatic

The Effects of Home-Based Telemental Health for Rural Veterans With PTSD

HBTMH
Start date: May 2013
Phase: N/A
Study type: Observational

The intent of this study is to assess whether cognitive functioning improves as Post-Traumatic Stress Disorder (PTSD) symptoms decrease as a step toward developing an objective measure of PTSD improvement. The study also evaluates the feasibility and effectiveness of home-based telemental health care (HBTMH) compared to usual care in the treatment of rural Veterans with posttraumatic stress disorder (PTSD). For this assessment-only study, the investigators plan to assess approximately 200 Veterans in total, of which 150 will be undergoing regular evidenced-based therapy (EBT) for PTSD, and 50 will be receiving other treatment as usual (TAU). The 150 veterans in the EBT group will be undergoing Cognitive Processing Therapy (CPT), Cognitive-Behavioral Couple Therapy (CBCT), Prolonged Exposure (PE), or Seeking Safety (SS) treatment for PTSD in clinic or via home-based telemental health (HBTMH). The study will also assess a comparison group of approximately 50 rural Veterans with PTSD diagnoses who are receiving treatment as usual (TAU) (neither EBT nor HBTMH). The HBTMH patients will be recruited from an Office of Rural Health (ORH) funded project to VA Pacific Island Health Care System (VAPIHCS), based at the National Center for PTSD (NCPTSD) and funded to offer 100 rural Veterans mental health treatment in their homes. This research protocol intends to assess rural veterans with PTSD who are being seen within this clinic versus those who have been referred for HBTMH yet who are ineligible for pragmatic purposes, with outcomes including feasibility, cost-effectiveness, and clinical effectiveness. The cognitive change will also be measured in patients with PTSD diagnoses receiving EBT PTSD treatment at VA clinics in the Pacific Islands.