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Stress Disorders, Post-Traumatic clinical trials

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NCT ID: NCT01574118 Terminated - Clinical trials for Chronic Posttraumatic Stress Disorder

Enhancing Exposure Therapy for Post-traumatic Stress Disorder

Start date: April 2012
Phase: Phase 2
Study type: Interventional

This study is investigating a new brief psychotherapy for post-traumatic stress disorder (PTSD) which, modifies an already proven psychotherapy for PTSD by adding two new components and modifying several others. The goal of the study is to determine whether this experimental treatment outperforms the well-established standard treatment.

NCT ID: NCT01571245 Completed - Clinical trials for Post Traumatic Stress Disorder

Predicting Treatment Response Using Psychophysiologic Reactivity Measures

Start date: April 2012
Phase: N/A
Study type: Observational

Objective psychophysiologic reactivity data may be useful for predicting post-traumatic stress disorder (PTSD) treatment response. Given the variety of PTSD treatments and the lack of a clearly superior treatment, a reliable and valid approach to predicting treatment response is needed. Specific Aims: 1). Evaluate the clinical utility of psychophysiologic reactivity measures to predict overall PTSD symptom response among OEF/OIF/OND (Operation Enduring Freedom/Operation Iraqi Freedom/Operation New Dawn) veterans receiving treatment for PTSD. 2). Evaluate the clinical utility of psychophysiologic reactivity measures to predict psychosocial functioning and health-related quality of life (HRQoL) response among OEF/OIF/OND veterans in treatment for PTSD. Exploratory). Develop psychophysiologic, neuropsychological, and/or self-report models to predict PTSD symptom response to pharmacotherapy, psychotherapy, and combined pharmacotherapy/psychotherapy. The investigators will divide psychophysiologic reactivity predictors into two groups: heart rate variability and attentional bias (eye gaze tracking and modified Stroop). The investigators will collect observational and longitudinal data from a treatment-seeking sample of 50 OEF/OIF/OND veterans with PTSD recruited from the Central Arkansas Veterans Healthcare System (CAVHS) Mental Health Clinics.

NCT ID: NCT01569685 Completed - Depression Clinical Trials

The Treatment of Traumatised Refugees With Sertraline Versus Venlafaxine in Combination With Psychotherapy

PTF3
Start date: April 2012
Phase: Phase 4
Study type: Interventional

Background: The treatment of traumatised refugees is one of the areas within the field of psychiatry with the weakest evidence for the different types of treatment. This is a problem for both patients and doctors as well as for society. The treatment of choice today for Post Traumatic Stress disorder (PTSD) is antidepressants from the subgroup of Selektive Serotonin Reuptake Inhibitors (SSRI), among these the drug Sertraline. The evidence for the use of these drugs as treatment for chronically complex PTSD in traumatised refugees is however very limited and a large part of the group is estimated to be insufficiently treated with this type of medicine. Venlafaxine is an antidepressant from the subgroup of dual action product which means that is works on several pathways in the brain. Among others it influences the area in the brain that is responsible for the enhanced anxiety and hyperarousal experienced by traumatised refugees and which is found to be enlarged among patients suffering from PTSD. All together there is not sufficient evidence to conclude which type of medical and psychological treatment that is most efficient when it comes to the treatment of traumatised refugees. Also there is a lack of studies which examines social functioning and the relation between psychosocial resources and outcome from treatment. Furthermore there is a lack of knowledge of predictors of treatment outcome for the individual patients. This study seeks to produce some of this evidence. Method: This study is expected to include approximately 150 patients randomised into two different groups. The patients are treated with Setraline or Venlafaxine depending on the group the randomised to. Patients in both groups are getting the same version of manual based Cognitive Behavioural Therapy that is specially adapted to this group of patients. The treatment period is 6-7 month. The trial endpoints are PTSD-and depression symptoms and social functioning all measured on internationally validated ratings scales. Furthermore the study will examine the relation between expected outcome of treatment from a range of predictors and the actual treatment results for the individual patient. Results: Altogether this study will bring forward new standards for clinical evaluation and treatment of traumatised refugees and the results are expected to be used in reference programmes/clinical guidelines.

NCT ID: NCT01569022 Completed - Clinical trials for Obstructive Sleep Apnea

A Randomized Cross Over Trial of Two Treatments for Sleep Apnea in Veterans With Post-Traumatic Stress Disorder

Start date: November 1, 2012
Phase: N/A
Study type: Interventional

Sleep disturbances are cardinal features of Veterans with post traumatic stress disorder (PTSD). In particular, obstructive sleep apnea is reported to occur more frequently in patients with PTSD compared to those without PTSD and contribute to worsening cognitive and behavioral functions. Continuous positive airway pressure (CPAP) is considered the treatment of choice for OSA but adherence to CPAP in Veterans with PTSD is poor compared to the general population. The proposed study aims at comparing the efficacy, tolerability, and adherence of oral appliances-an alternative therapy to OSA- to CPAP. The study is instrumental in identifying the optimal OSA therapy for Veterans with PTSD and the OSA phenotype that would predict oral appliance response

NCT ID: NCT01566058 Completed - Anxiety Clinical Trials

Impact of the BB Box System on Postpartum Maternal Anxiety, Post Traumatic Stress and Mother-child Relationships

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

The main objective of this study is to compare the degree of maternal anxiety at Day 3 postpartum in mothers who did or did not have access to a video communication system (BB-Box system) from the time of initial separation with their baby.

NCT ID: NCT01564667 Completed - Clinical trials for Posttraumatic Stress Disorder

Attention Bias Modification Treatment for Warzone-Related Posttraumatic Stress Disorder (PTSD)

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

Veterans with Posttraumatic Stress Disorder (PTSD) will be randomly assigned to either Attention Bias Modification Treatment (ABMT) designed to reduce bias toward threat or a placebo control condition not designed to change attention patterns. Outcome measures will be PTSD, anxiety, depression, and alexithymia symptoms as measured by standard psychological interviews and questionnaires. Participants will also be invited to participate in physiological testing before and after receiving AMBT or placebo to serve as additional outcome measures and assess brain functioning, heart rate, and muscle tension. The investigators expect to see significant PTSD symptom reduction in the Attention Bias Modification Treatment (ABMT) group relative to the placebo control group in which no symptomatic relief is expected. At the end of the study, if ABMT is shown to be effective, we will offer active ABMT to those participants randomly assigned to the placebo arm if they would like to receive the treatment.

NCT ID: NCT01560728 Completed - Clinical trials for Post-Traumatic Stress Disorder

Bringing What Works to Youth in Corrections: A Trauma Intervention

Start date: November 2012
Phase: Phase 1/Phase 2
Study type: Interventional

Youth with mental illnesses are disproportionately represented in juvenile correctional facilities and limited evidence exists about effective treatments in this setting. This study will adapt Trauma-Focused Cognitive Behavioral Therapy (TF-CBT), a treatment found to be efficacious in community settings, to the correctional setting and study the feasibility of its implementation. Conducted within Texas youth correctional facilities, the findings will be rapidly disseminated in the state. The goal is to enhance the TF-CBT approach to meet the unique needs of incarcerated youth and the correctional system, one of the priorities outlined in the National Institute of Mental Health Strategic Plan.

NCT ID: NCT01556074 Completed - Insomnia Clinical Trials

Evaluation of Yoga for Sleep Disturbances in Post Traumatic Stress Disorder (PTSD)

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

The primary objective of this preliminary study is to estimate sleep outcome effect sizes and determine feasibility for a novel yoga treatment of insomnia in participants with post traumatic stress disorder (PTSD). Additional objectives are to evaluate relationships of sleep outcomes with measures of other PTSD symptoms, psychosocial health and possible mechanisms of action.

NCT ID: NCT01556048 Completed - Clinical trials for Major Depressive Disorder

Pilot Study of Behavioral Activation for Prolonged Grief

Start date: February 2009
Phase: Phase 1
Study type: Interventional

The Institute of Medicine identifies Prolonged Grief (PG) as a critical under-addressed public health problem for which are no empirically supported treatments. The purpose of this application is to pilot-test Behavioral Activation (BA) therapy for PG. BA is a well supported, stand alone intervention for depression and recently applied to posttraumatic stress disorder, which reduces rumination and avoidance behaviors that otherwise thwart access to natural rewarding contingencies and resources. The treatment focuses on promoting stable, active routines, self-care behaviors, enhanced self-efficacy, and reengagement with pleasurable activities and significant social resources. Rumination, disengagement, and low self-efficacy are defining features of PG. Further, in response to loss of intimates, the key factors that differentiate resilient people from those that have difficulties adapting is the maintenance or fast resumption of social and occupational functioning. Thus, the main hypothesis of this study is that BA for PG will result in clinically significant reductions in rumination and functional disengagement. This is a preliminary small-scale pilot assessment of potential efficacy and feasibility of completing a large scale study of BA for PG.

NCT ID: NCT01555554 Terminated - Clinical trials for Post-traumatic Stress Disorder

Perioperative Propranolol in Patients With Post Traumatic Stress Disorder (PTSD)

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

Understanding what treatments may facilitate perioperative care of Veterans with posttraumatic stress disorder (PTSD) is of great importance to the U.S. health care system. Patients with PTSD are characterized by elevated central nervous system catecholamine concentrations and exaggerated and prolonged adrenergic responses to stress stimuli. At present, there are no data on the effects of perioperative beta blocker therapy in patients with PTSD, despite the rising significance of PTSD in Veteran populations. This prospective, double-blind study proposes to randomize 150 Veterans with PTSD scheduled for orthopedic, thoracic or vascular surgery at the San Francisco VA Medical Center to either a 14-day course of propranolol or placebo. This study will then follow these Veterans for a one-year period to evaluate the effects of the intervention on Veterans' surgical outcomes. The investigators hypothesize that patients with PTSD randomized to the propranolol group will demonstrate a reduced incidence of perioperative and postoperative morbidity and mortality.