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Stress Disorders, Traumatic clinical trials

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NCT ID: NCT02769312 Completed - Clinical trials for Chronic Post-Traumatic Stress Disorder

Theta-Burst Neuromodulation for PTSD

TBS
Start date: April 1, 2016
Phase: Phase 1/Phase 2
Study type: Interventional

The purpose of the proposed study is to evaluate initial feasibility and efficacy of Theta Burst Transcranial Magnetic Stimulation (TBS) as an adjunct treatment for Veterans with PTSD. Primary outcomes measures include a feasibility of TBS procedures, with secondary outcome measures focusing on changes in PTSD symptom severity and quality of life and social/occupation functioning.

NCT ID: NCT02765672 Completed - Clinical trials for Traumatic Brain Injury (TBI)

Effectiveness of a Driving Intervention on Safe Community Mobility for Returning Combat Veterans

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

The main objective of this study is to discern if an Occupational Therapy Driving Intervention (OT-DI) improves fitness to drive abilities of Combat Veterans and also investigate if results leads to reduced driving errors on the driving simulator and an on-road test. The driving behavior of 260 Combat Veterans will be studied on a driving simulator at baseline after which they will be randomized into control and intervention groups. The intervention group will receive sessions of Occupational Therapy Driving Intervention by a trained driving rehabilitation specialist. The control group on the other hand will receive driving safety education sessions by a driving safety professional. Both groups will be evaluated for driving performance on the driving simulator to ascertain whether there have been changes in the number of driving errors at two and three months upon enrollment. Caregiver responses on driving behavior of Combat Veteran and public driving records from The Department of Motor Vehicles will be analyzed to for changes in number of driving errors.

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: NCT02737488 Terminated - Trauma Clinical Trials

Helping Children With Trauma

Start date: February 1, 2016
Phase: Phase 3
Study type: Interventional

The purpose of this study is to evaluate if a trauma treatment called Trauma Systems Therapy (TST) decreases children's mental health symptoms (such as acting out, not controlling their emotions, etc.) as a result of a traumatic event (or events). A traumatic event or events can include experiencing or witnessing violence, excessive bullying, war, car accident, serious injury, getting mistreated or anything else that makes one feel scared or frightened. Children/teens who experience traumatic events have been shown to be at higher risk of poor mental and physical health. Trauma can impact family life, school life and interpersonal relationships well into adulthood. Unfortunately, most children who have experienced traumatic events do not undergo treatment. Although promising treatments do exist, most do not address the complexity of trauma, particularly related to ongoing stress and threats to safety in their environments. One hundred and twenty eligible youth will be randomized to receive either treatment with TST at NYU's Child Study Center or trauma treatment as usual (TAU) at a community mental health clinic. It is hypothesized that: - Youth receiving TST will demonstrate a greater decrease in Post-Traumatic Stress Disorder (PTSD) symptoms at the 3, 6, and 9-month follow-up assessments compared to youth receiving treatment as usual (TAU) in the community. - Youth receiving TST will demonstrate a greater decrease in symptoms of depression, anxiety and problem behaviors (aggression, violence, self-destructive behaviors, etc.) at the 3-, 6- and 9-month follow-up assessments compared to youth receiving TAU. - Youth receiving TST will have fewer acute mental health service events, such as psychiatric hospitalizations and ED visits compared to youth receiving TAU. - Greater fidelity to the TST model is associated with better treatment outcomes among youth receiving TST.

NCT ID: NCT02734602 Recruiting - Clinical trials for Major Depressive Disorder

Imaging SV2A in Mood Disorders

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

This study is designed to examine SV2A density in MDD and PTSD as a correlate of synaptic density, and to determine whether ketamine administration will reverse the synaptic loss in vivo in human subjects. To our knowledge, this is the first human study to examine SV2A in vivo in MDD and PTSD and to use the first known drug (ketamine) that rapidly reverses synaptic loss to determine whether ketamine administration could restore some of the structural changes associated with depression and PTSD. After a screening process to determine eligibility, all subjects will participate in an MRI, and 2-3 PET scans with the administration of ketamine for one of the scans. Cognitive testing and a stress test may also be done on scan days.

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.