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Stress Disorders, Post-Traumatic clinical trials

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NCT ID: NCT03062540 Terminated - PTSD Clinical Trials

Safety and Efficacy Study of TNX-102 SL in Patients With Military-related PTSD

HONOR
Start date: March 27, 2017
Phase: Phase 3
Study type: Interventional

This is a 12-week, multicenter, randomized, double-blind, placebo-controlled, fixed-dose study that will investigate the efficacy and safety of 5.6 mg TNX-102 SL (2 x 2.8 mg tablets)-a sublingual formulation of cyclobenzaprine. Following successful screening and randomization, eligible patients will have a telephonic visit at week 2 and then return regularly to the study clinic for monthly visits for assessments of efficacy and safety.

NCT ID: NCT03058302 Completed - Depression Clinical Trials

Study of Effectiveness and Implementation of a Mental Health Intervention With Conflict-affected Communities in Ukraine

Start date: January 2017
Phase: N/A
Study type: Interventional

This project aims to contribute to the development of a community mental health care system while directly serving the conflict affected population in east Ukraine. This project is being supported by USAID's Victims of Torture Fund. In the Spring of 2015, the Johns Hopkins University (JHU) Applied Mental Health Research Group (AMHR) was invited to make a site visit to Ukraine with USAID to make an initial assessment of current mental health problems, service capacities, and treatment need. AMHR and USAID were requested by community-based partners to provide training and support in evidence based trauma treatment for people affected by war and displacement. Extensive conflict within the borders of Ukraine is a new experience for most Ukrainians, and local psychologists and psychotherapists were not prepared for wide-spread need or trained in appropriate methods of treatment for affected populations. JHU and USAID began activities in Ukraine in June 2015 and have identified the counseling intervention, Common Elements Treatment Approach (CETA), as appropriate and relevant for this context. Community providers from the three trial sites (Kyiv, Kharkiv, and Zaporizhia) have been trained in CETA as counselors and local supervisors. An ongoing training and supervision model (Apprenticeship Model) is being implemented in the three study sites. These three sites contain significant numbers of military veterans (demobilized soldiers from the ongoing conflict) and internally displaced persons (IDPs). Adult IDPs and Veterans from the three study sites will be recruited and screened to identify those with elevated depression and/or posttraumatic stress symptoms and impaired functioning. This study will be conducted as a 3-armed randomized controlled trial. This study will test to see if both the long and a short version of CETA are effective compared to a wait-control condition.

NCT ID: NCT03056157 Completed - Clinical trials for Post-traumatic Stress Disorder

Psychosocial Rehabilitation After Moral Injury and Loss With Adaptive Disclosure

Start date: March 1, 2018
Phase: N/A
Study type: Interventional

The aim of this study is to determine the efficacy of Adaptive Disclosure for Moral Injury and Loss (AD-MIL), a combat-specific psychotherapy for war-related PTSD stemming from Moral Injury (MI) and traumatic loss (TL) with Iraq and Afghanistan War Veterans with PTSD. AD-MIL will be compared to Present Centered Therapy (PCT). AD-MIL is a modified version of Adaptive Disclosure (AD), which has been modified and extended to solely treat MI and TL by targeting psychological and behavioral obstacles to occupational, relationship, and family functioning, as well as quality of life. PCT is a manualized evidenced-based PTSD treatment used in several large-scale PTSD trials. The primary end-point is psychosocial functioning (improvements in social, educational and occupational functions and improvements in quality of life). Secondary end-points include PTSD, depression, and shame and guilt. The investigators will also explore the impact of AD-MIL on anger and aggressive behaviors, suicidal ideation, and alcohol abuse.

NCT ID: NCT03051074 Completed - Clinical trials for Major Depressive Disorder

Examining the Effects of Reduced Environmental Stimulation on Anxiety

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

The studies proposed in this protocol aim to explore the anxiolytic properties of floating as it relates to the central and autonomic nervous system.

NCT ID: NCT03048929 Completed - Clinical trials for Posttraumatic Stress Disorder

Inflammation and Threat Sensitivity in PTSD

K01
Start date: April 1, 2019
Phase: Early Phase 1
Study type: Interventional

The overall goals of this study are to examine the relationship between chronic inflammation and threat and reward sensitivity, and to determine the effects of acute inflammation on threat sensitivity, in individuals with and without moderate to severe PTSD symptoms. The investigators will first conduct an observational study to examine the relationship between chronic inflammation and neural and behavioral measures of threat sensitivity. Then, the investigators will conduct a randomized, double-blind, placebo-controlled, between-subjects study to examine the effects of acute inflammation on neural and behavioral measures of threat sensitivity.

NCT ID: NCT03045016 Completed - Clinical trials for Acute Stress Disorder

Efficacy of Prazosin in Preventing Post-traumatic Stress Disorder

PRAZOSTRESS
Start date: April 21, 2017
Phase: Phase 2
Study type: Interventional

After a traumatic event such as an accident or an assault, victims may experience intense stress symptoms that may evolve into "post-traumatic stress disorder" (PTSD). It is a frequent and serious pathology, which can be complicated by depression, addiction or suicide. Few means are available to prevent PTSD in people who have just undergone trauma. Prazosin is an antihypertensive drug that blocks α1 adrenaline receptors which could help to stop the vicious circle of stress and prevent the development of the disease. The objective of this study is to demonstrate the efficacy of prazosin to prevent PTSD in patients who visit an emergency department after trauma.

NCT ID: NCT03039361 Completed - Clinical trials for PostTraumatic Stress Disorder

Equine Assisted Psychotherapy for PTSD

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

The purpose of this study is to assess the efficacy of Equine Assisted Psychotherapy on PTSD symptoms in veterans with PTSD as compared with existing care. The investigators' hypothesis is: EAP Participants' will experience decreased PTSD symptoms following participation in a 6-week Equine Assisted Psychotherapy program.

NCT ID: NCT03039231 Completed - Clinical trials for Stress Disorders, Post-Traumatic

Investigation of the Freespira Breathing System in the Treatment of Post Traumatic Stress Disorder (PTSD)

Start date: February 1, 2017
Phase: N/A
Study type: Interventional

This study will test the efficacy of the Freespira Breathing System in adults with post traumatic stress disorder (PTSD).

NCT ID: NCT03033069 Completed - Clinical trials for Stress Disorders, Post-Traumatic

A Study of Flexible Dose Brexpiprazole as Monotherapy or Combination Therapy in the Treatment of Adults With Post-traumatic Stress Disorder (PTSD)

Start date: January 26, 2017
Phase: Phase 2
Study type: Interventional

To evaluate the safety, efficacy and tolerability of brexpiprazole (with placebo) as monotherapy or combination therapy with Zoloft (sertraline) in adults with PTSD.

NCT ID: NCT03019497 Completed - PTSD Clinical Trials

Cognitive-behavioral Therapy for Treatment of Post-traumatic Stress Disorder and Related Problems

CBT-PTSD-RP
Start date: January 2017
Phase: N/A
Study type: Interventional

The purpose of this study is to evaluate the efficacy of a form of cognitive behavioral therapy (CBT) in a population of individuals with PTSD and common related problems (depression, anxiety or sleep disorders, pain, psychosocial stressors, low social support, substance use disorder). Half of the participants will receive a cognitive behavioral therapy with specific modules for the treatment of related problems (CBT-E) and the other half of participants will receive therapy without specific modules (CBT-C). The main assumption is that participants treated in the CBT-E condition will present a lower level of symptom intensity of PTSD and a higher remission rate than those in the CBT-C condition during the post-treatment assessment. As a secondary objective, an analysis of the different parameters of effectiveness of the two forms of CBT (e.g., average number of sessions required to reach remission, treatment strategies used) will be performed.