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Stress Disorders, Traumatic clinical trials

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NCT ID: NCT02764983 Completed - Clinical trials for Traumatic Brain Injury (TBI)

Occupational Therapy Driving Intervention for Returning Combat Veterans.

Start date: January 2013
Phase: N/A
Study type: Interventional

Driving is a portal into general life functioning, and impaired driving skill can pose a serious threat to the combat veterans (CV), passengers and others; and involves increased risk of subsequent injuries, medical expenses and legal sequelae. Motor vehicle crashes (MVC) among post deployed CV are one of the top four causes of injury and disability, hospitalization, and outpatient visits across the military, and are a leading cause of death among Army service members. The risk of motor vehicle (MV) death is significantly increased in years immediately following return from the battlefield. In sum, the effects of Traumatic Brain Injury (TBI)/ Post Traumatic Stress Disorder (PTSD) and other blast related injuries, combined with the "battlefield" mindset and lack of community reintegration programs place CV at risk for MVC and fatalities. On-road assessments, the gold standard, presents a risk for crash or adverse advents in this population of CV. Alternately, simulated driving evaluation measures driving performance in a safe, accurate and objective manner with evidence of absolute and relative validity when compared to real world (on-road) driving. Knowing participants can or cannot safely resume driving, and providing rehabilitation for those with a potential for resuming safe driving could result in: increased safe driving behaviors; avoidance of injuries, collisions, citations and participants residua; and resuming safe driving with its attendant benefits in the realms of family functioning, participation in society and satisfaction with life. The overarching objective of this proposal is to discern, after clinical and simulated driving performance testing , if Occupational Therapy Driving Intervention (OT-DI) can improve the safe driving performance (less errors) over the short term (immediately following intervention) and intermediate term (3 months).

NCT ID: NCT02761161 Completed - Depression Clinical Trials

Treatment of Sleep Disturbances in Trauma-affected Refugees

PTF5
Start date: March 2016
Phase: Phase 4
Study type: Interventional

The overall aim of this study is to examine the effects of sleep enhancing treatment in refugees with PTSD.

NCT ID: NCT02759185 Completed - Clinical trials for Posttraumatic Stress Disorder

Pilot Study of the Safety and Efficacy of Four Different Potencies of Smoked Marijuana in 76 Veterans With PTSD

Start date: January 2, 2017
Phase: Phase 2
Study type: Interventional

This pilot study gathered preliminary evidence of the safety and efficacy of four potencies of smoked cannabis to manage chronic, treatment-resistant PTSD among veterans: (1) High THC/ Low CBD (High THC), (2) Low THC/High CBD (High CBD), (3) High THC/ High CBD (THC/CBD) and (4) Low THC/Low CBD (placebo). The study will produce preliminary evidence to help elucidate the potential effects of THC, CBD, or a combination of both constituents to reduce PTSD symptoms. Smoked cannabis will be tested in two stages of three weeks each (Stage 1 and Stage 2), with a two-week cessation period after each stage, verified by blood/urine cannabinoid analysis. The primary objective was to compare three active concentrations of smoked cannabis and placebo on PTSD symptom severity measured by CAPS-5 total severity scores during Stage 1.

NCT ID: NCT02754557 Completed - Clinical trials for Post Traumatic Stress Disorder

Physiological Augmentation of Mindfulness Meditation

PAMM
Start date: March 2016
Phase: N/A
Study type: Interventional

The purpose of the study is to compare the efficacy of a physiologically-augmented breath-focused mindfulness-based intervention to reduce symptoms of dissociation that are associated with psychological trauma, as well as symptoms of posttraumatic stress disorder (PTSD). The study will evaluate whether physiological augmentation produces a greater change in dissociative symptoms, meditative engagement and attentional control, compared to non-augmented mindfulness. The augmentation comprises physiological feedback in the form of a vibration on the wrist. Vibrations are delivered by a device that will be placed on a participant's arm; the device vibrates in proportion to the person's breath.

NCT ID: NCT02749253 Completed - Clinical trials for Post Traumatic Stress Disorder

Sudarshan Kriya Yoga (SKY) in Post Traumatic Stress Disorder: a Feasibility Study

Start date: June 2016
Phase: N/A
Study type: Interventional

This pilot study is designed to investigate the feasibility of sudarshan kriya yoga (SKY) program in adults with post traumatic stress disorder (PTSD) resulting from a wide range of trauma experience. SKY incorporates standardized collection of breathing techniques which are known to positively influence the autonomic nervous system and stress response system. Both these systems are dysregulated in PTSD.

NCT ID: NCT02734212 Completed - Clinical trials for Post Traumatic Stress Disorder

Ending Self Stigma for PTSD

ESS-P
Start date: November 2015
Phase: N/A
Study type: Interventional

Veterans with PTSD report that stigma and fear of stigma have a chilling effect on their participation in mental health treatment. Despite the widely-documented effects of stigma on the recovery of individuals with mental illnesses and research demonstrating harmful consequences of internalized stigma, including decreased hope, self-esteem, personal motivation, and persistence regarding illness management, no interventions are currently available to assist Veterans with PTSD in combating the impact of internalized stigma. The goal of this research is to develop and pilot-test an intervention to provide Veterans with PTSD the skills to cope effectively with stigma and to mitigate the internalization of stigmatizing beliefs and stereotypes. To accomplish this purpose, Ending Self Stigma (ESS), an intervention composed of evidence-based methods for combating internalized stigma for serious mental illness, will be modified and tested to address issues particular to PTSD.

NCT ID: NCT02724787 Completed - Clinical trials for Chronic Post-Traumatic Stress Disorder

Using Emotion Regulation to Decrease Aggression in Veterans With PTSD

(EMDA)
Start date: June 13, 2016
Phase: N/A
Study type: Interventional

Impulsive aggression (IA) is common among Veterans with posttraumatic stress disorder (PTSD), and PTSD is one of the most prevalent post deployment mental health conditions affecting Afghanistan and Iraq Veterans. An inability to manage one's emotions (emotion dysregulation) is an underlying mechanism of IA. Reducing IA and increasing use of PTSD evidence-based psychotherapies are two critical missions for the Veterans Health Administration. This research supports these missions by providing a 3-session emotion regulation training (Manage Emotions to Reduce Aggression) to Veterans in order to teach them how to manage emotions and prepare for PTSD treatment. This is an open trail, so all Veterans who meet the inclusion criteria will be allowed to receive the treatment. Each Veteran's level of aggression and emotion dysregulation will be measured at the beginning and end to the treatment. By enhancing Veterans' abilities to cope with trauma-related emotions and feel equipped to initiate PTSD treatments, this research aims to help Veterans decrease IA and ultimately recover from PTSD.

NCT ID: NCT02723344 Completed - Clinical trials for Post Traumatic Stress Disorder

Biological Signatures, Probiotic Among Those With mTBI and PTSD

Start date: August 1, 2016
Phase: Phase 1
Study type: Interventional

Exaggerated inflammation in the body and brain is thought to play a role in the vulnerability to and aggravation and perpetuation of adverse consequences among those with co-occurring mild TBI (mTBI) and post-traumatic stress disorder (PTSD). The proposed study begins the process of investigating the use of a natural immunoregulatory/anti-inflammatory probiotic to treat chronic symptoms associated with co-occurring mTBI and PTSD among Veterans. By looking at the impact of probiotic supplementation on biological signatures of increased inflammation, as reflected by the gut microbiota, gut permeability, and biomarkers of peripheral inflammation, this study may lead to the identification of a novel intervention for the treatment of symptoms associated with these frequently co-occurring conditions.

NCT ID: NCT02723097 Completed - Clinical trials for Post Traumatic Stress Disorder (PTSD)

A Pilot Test of the Relaxation Response Resiliency Program (3RP) in Spanish Speaking World Trade Center Survivors With Post Traumatic Stress Disorder (PTSD)

Start date: March 1, 2016
Phase: N/A
Study type: Interventional

The objective of this protocol is to test the feasibility and acceptability of the Relaxation Response Resiliency Program (3RP), a psychotherapy treatment providing a variety of mind body skills and interventions to decrease medical and mental health symptoms and build resilience, in Spanish-speaking World Trade Center (WTC) survivors, and to examine its clinical effectiveness to reduce Post Traumatic Stress Disorder (PTSD), depression, anxiety, and lower respiratory symptoms (LRS) and improve psychosocial functioning.

NCT ID: NCT02720016 Completed - Clinical trials for Post Traumatic Stress Disorder

Cognitive-Behavioral Conjoint Therapy (CBCT) Project

CBCT
Start date: October 3, 2016
Phase: N/A
Study type: Interventional

Untreated posttraumatic stress disorder (PTSD) is a costly condition associated with impairment in functioning across a host of psychosocial domains including occupational and academic functioning, marital and family functioning, parenting, and socialization. Impairment is not limited to Veterans with PTSD because the entire family is affected, particularly the Veteran's intimate partner. PTSD symptoms can produce negative effects on both members of the dyad. Despite the need for treatment, many Veterans and their families do not access PTSD-related services due to a number of barriers to accessing care (e.g., living in rural or remote areas where no specialty services exist, concerns about stigma around using mental health services, limited clinic hours to accommodate patient schedules). The objective of this study is to assess whether providing Cognitive-Behavioral Conjoint Therapy, in which PTSD symptoms and intimate relationship functioning are addressed, to Veterans and their romantic partners in their homes via clinical video teleconferencing leads to better outcomes compared to office based treatment.