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Stress Disorders, Post-Traumatic clinical trials

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NCT ID: NCT02808468 Completed - Clinical trials for Posttraumatic Stress Disorder

Brief Restructuring Intervention Following Trauma Exposure

BRITE
Start date: March 1, 2015
Phase: N/A
Study type: Interventional

The broad aim of this study is to develop and test a brief intervention that can be implemented in the immediate weeks following sexual assault to decrease likelihood of developing posttraumatic stress disorder (PTSD) or alcohol misuse. The first phase of the study will enroll 6 women to complete a brief, cognitive therapy protocol and provide feedback on the intervention (open trial). The second phase of the study will recruit 76 women to complete either the intervention (38 women) or assessment only (38 women) to test the effects of the intervention on both PTSD symptoms and alcohol use behavior as compared to natural recovery following assault.

NCT ID: NCT02807662 Completed - Clinical trials for Posttraumatic Stress Disorder

Meeting the Needs of Pregnant Women With PTSD in Prenatal Care

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

The objectives of this research study are to screen 750 pregnant women at risk of trauma-related stress symptoms, and adapt and test an evidence-based intervention for pregnant women with PTSD and sub-threshold PTSD symptoms served by two public payer community health centers.

NCT ID: NCT02803125 Completed - Clinical trials for Posttraumatic Stress Disorder

Improving Psychosocial Functioning in Older Veterans With PTSD

Start date: November 14, 2017
Phase: N/A
Study type: Interventional

The purpose of this project is to develop an intervention to improve psychosocial functioning and quality of life for older Veterans with partial or full PTSD.

NCT ID: NCT02791464 Completed - Clinical trials for Stress Disorders, Post-Traumatic

Transcendental Meditation and Reduced Trauma Symptoms in Women Inmates

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

The pilot study investigates the potential benefits of the Transcendental Meditation program in reducing trauma, including PTSD, in female prisoners. Subjects will be randomly assigned to either the TM program or a wait list control group for a period of four months.

NCT ID: NCT02789982 Completed - Clinical trials for Post-traumatic Stress Disorder

Using Reconsolidation Blockade to Treat Trauma Related Disorders After Paris Attacks: an Effectiveness Study

PARIS-MEM
Start date: May 27, 2016
Phase: Phase 3
Study type: Interventional

The purpose of this study is: (1) to examine the effectiveness of reconsolidation blockade as a treatment for trauma-related disorders, (2) to evaluate the feasibility of implementing this new treatment on a large scale in a short delay. This clinical trial as been set up in response to the Paris attacks to increase treatment capacity of the AP-HP (Assistance Publique des Hopitaux de Paris) hospital network.. Reconsolidation blockade will be compared to treatment as usual (TAU), on symptoms reduction after 6 weeks of treatment. In order to measure effectiveness and cost-utility, socioeconomic measures, quality of life and social functioning outcomes will be measured pre- and post-treatment as well as 3 and 12 months after study enrollment.

NCT ID: NCT02774642 Completed - Chronic Insomnia Clinical Trials

Integrated CBT-I and PE on Sleep and PTSD Outcomes (Impact Study)

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

This study aims to examine whether integrating insomnia and PTSD treatment will enhance sleep, PTSD, and quality of life outcomes. This is a randomized control trial comparing integrated evidence based CBT-I into PE (CBTI-PE) versus to a non-active sleep component plus PE (hygiene-PE) to optimize PTSD, sleep, and quality of life outcomes in 90 Veterans. Such benefits would further the VA's commitment to improving the mental health, recovery, and community reintegration of Veterans detailed in the 2014-2020 VHA Strategic Plan. Findings from the proposed study offer a unique opportunity to determine the malleability of mechanisms (e.g., Total sleep time, Sleep efficiency) that can improve recovery outcomes among this vulnerable population and to inform future treatment development and research. Improved PTSD, insomnia, and quality of life outcomes can decrease risk of chronic impairment and ultimately help affected Veterans live richer, more productive lives.

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: NCT02766296 Completed - Clinical trials for Posttraumatic Stress Disorder

Emotional Working Memory Training for Veterans With PTSD Symptoms

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

PTSD is characterized by recurrent intrusion of trauma-related memories and images that cause significant distress and impairment to the affected individuals. The current project aims to examine whether computerized emotional working memory training (eWMT) can help improve working memory capabilities and reduce trauma-related emotional symptoms among individuals with elevated trauma-related symptoms. Participants will be randomly assigned to one of the two computerized training programs. At baseline, post-training, and 1-month follow-up, participants will be assessed with respect to their emotional symptoms and working memory-related cognitive performance. Pending successful outcomes, this study will provide important knowledge that will guide the future efforts to develop an effective, accessible, and cost-efficient intervention program.

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).