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Posttraumatic Stress Disorder clinical trials

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NCT ID: NCT03068325 Active, not recruiting - Clinical trials for Posttraumatic Stress Disorder

Trauma-Focused Equine-Assisted Therapy (TF-EAT) for Veterans With PTSD

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

This study seeks to examine feasibility, acceptability, safety, and preliminary efficacy of trauma-focused Equine-Assisted Therapy (EAT) for veterans with posttraumatic stress disorder (PTSD). While several well-studied, validated treatments for PTSD exist, some individuals find these treatments ill-suited, ineffective, or undesirable. EAT is an alternative therapy widely used by organizations, such as PATH International Equine Services, that endorse its effectiveness for treating a variety of mental health issues. These claims have drawn criticism because the published research contains glaring methodological flaws, making it difficult to assess how effective these therapies actually are (Anestis et al., 2014). Equine-assisted therapies present a unique treatment modality that might effectively treat PTSD, particularly for individuals who have difficulty with other treatment modalities. In EAT, a psychotherapist and equine specialist work together to help the patients negotiate interactions with a horse using structured interventions or activities.

NCT ID: NCT02737098 Active, not recruiting - Clinical trials for Posttraumatic Stress Disorder

TOP Implementation Project

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

The Veterans Health Administration (VHA) provides care to 3.3 million Veterans living in rural areas, comprising 36% of all VHA enrollees. In 1995, VHA began expanding its system of Community Based Outpatient Clinics (CBOCs) in order to improve access for the geographically dispersed Veteran population. There are now approximately 900 CBOCs delivering a range of services to approximately 64% of VHA enrollees. While these CBOCs have dramatically improved access to first class primary care services, it has been more challenging to deliver specialty mental health care to rural Veterans. Evidence based specialty mental care practices developed for large VA Medical Centers are often not feasible to deploy in small CBOCs and thus not accessible to rural Veterans. Rural Veterans with posttraumatic stress disorder (PTSD) treated at CBOCs experience little to no improvement in their symptoms over time. A major contributor of poor PTSD outcomes is that trauma-focused evidence-based psychotherapy is not being provided to Veterans in the CBOC setting. Moreover, travel barriers prevent most rural Veterans from receiving trauma-focused evidence-based psychotherapy at large VHA Medical Centers (VAMC). Telemedicine Outreach for PTSD (TOP) is a technology-facilitated virtual care clinical intervention that is designed to enhance access to evidence based psychotherapy and pharmacotherapy. The VHA Office of Rural Health and Office of Connected Health and Telehealth Services intend to deploy the TOP intervention nationally. This project will lay the ground work for this national implementation initiative. The goal of this implementation project is to support the national deployment of the TOP intervention and evaluate its clinical effectiveness in routine care. The specific aims are to compare the cost and effectiveness of alternative implementation strategies to promote uptake of TOP and assess impact on access and PTSD outcomes. The project will be conducted at 6 VAMCs and affiliated CBOCs without on-site psychologists trained in trauma-focused evidence-based psychotherapy. The total anticipated sample size will be 600. The TOP clinical intervention is delivered by a virtual care team comprising a CBOC provider, and a telephone care manager, telepsychologist and telepsychiatrist located at the VAMC. The telephone care managers will coordinates care. The telepsychologists will deliver of trauma-focused evidence-based therapy. The telepsychiatrists will provide psychiatric consultation. The standard VA implementation strategy will follow standard procedures for deploy clinical practices in the VA include disseminating support materials, providing technical assistance and transfer funds to hire clinical personnel. The enhanced implementation strategy will add external facilitation to the standard VA implementation strategies. External facilitation will begin with an assessment of the current workflow at the VHA Medical Center and the affiliated CBOCs. The external facilitation team will then generate a clinical workflow chart that describes the current process of care. With advice from the external facilitation team, local staff will then incorporate the clinical process of the TOP intervention into the current clinical workflow chart. The project will compare the standard VA implementation strategy to the enhanced implementation strategy. All VAMCs will receive the enhanced implementation strategy if they need it, but the time period during which they will receive the enhanced implementation strategy will be randomized. This will allow us to determine whether more patients are reached by the TOP intervention during standard implementation compared to enhanced implementation. This design will also allow us to document improvements in perceived access and PTSD outcomes for patients at sites that successfully implement the TOP intervention. Data will be collected from patient survey and chart review for all patients sampled for the evaluation. Participating patients will complete a baseline survey and 3 follow-up surveys. The reach implementation outcome measure will be specified as the proportion of sampled patients who received the TOP intervention. PTSD outcomes will be specified as a continuous change in patient self-reported symptom severity between baseline and follow-up. Perceived access will be measured using items specifically developed for the project. Provider adoption will be assessed with qualitative interviews of all CBOC clinicians treating a sampled patient as well as members of the TOP intervention team. Costs - The investigators will measure the cost of both implementation strategies both prospectively and retrospectively. The investigators will collect data on implementation activities during both the standard VA and enhanced implementation strategies.

NCT ID: NCT02641496 Active, not recruiting - Clinical trials for Obstructive Sleep Apnea

Cognitive Behavioral Therapy to Increase CPAP Adherence in Veterans With PTSD

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

Approximately 20 million Americans suffer from Obstructive Sleep Apnea (OSA) creating risks for major health problems, including dementia, heart attack, and stroke. Obesity, a growing problem for Americans and Veterans alike, is the greatest risk factor for the development of OSA. Male gender and smoking, other OSA risk factors, are common in Veterans. Given the high comorbidity of these risk factors in Veterans, OSA presents a significant health burden to Veterans. The investigators' prior work provides evidence that OSA occurs in up to 69% of Vietnam-era Veterans with PTSD. OSA is easily treated; however, 15-30% of OSA patients are non-compliant with continuous positive airway pressure (CPAP), the standard OSA treatment. The proposed research aims to facilitate adherence to CPAP treatment by testing a novel cognitive-behavioral therapy intervention in Veterans with PTSD. If successful, it may represent an approach that could be applied to the rehabilitation of other chronic conditions with similar barriers to care.

NCT ID: NCT02404402 Active, not recruiting - Clinical trials for Traumatic Brain Injury

LED Treatment to Improve Cognition and Promote Recovery in TBI

LED-TBI
Start date: May 1, 2015
Phase: N/A
Study type: Interventional

This study investigates the efficacy of a novel neuromodulation treatment, light emitting diodes (LED), on cognition, neuropsychiatric status and quality of life in individuals with traumatic brain injury (TBI).

NCT ID: NCT02391402 Active, not recruiting - Clinical trials for Traumatic Brain Injury

Cognitively Augmented Behavioral Activation for Veterans With Comorbid TBI/PTSD

CABA
Start date: May 4, 2015
Phase: N/A
Study type: Interventional

The primary objective of this study is to evaluate the efficacy of Cognitively Augmented Behavioral Activation (CABA), a new hybrid treatment for Veterans diagnosed with comorbid mild Traumatic Brain Injury (mTBI) and posttraumatic stress disorder (PTSD). The study's specific goals are to determine whether: 1) CABA reduces PTSD symptoms in Veterans with mTBI/PTSD, 2) CABA reduces cognitive-related functional impairment in Veterans with mTBI/PTSD, 3) CABA results in improvements in depression symptoms, cognitive functioning, and quality of life in Veterans with mTBI/PTSD; and 4) CABA is an acceptable treatment for Veterans with mTBI/PTSD. The overall goal is to develop an evidence-based manualized treatment for comorbid mTBI/PTSD that can be readily implemented in Veterans Health Administration (VHA) treatment settings.

NCT ID: NCT01649141 Active, not recruiting - Clinical trials for Posttraumatic Stress Disorder

Trauma-Focused Cognitive Behavior Therapy for Youth: Effectiveness in a Community Setting

Start date: August 2006
Phase: N/A
Study type: Interventional

This effectiveness study is being conducted to determine whether Trauma-Focused Cognitive Therapy (TF-CBT), a treatment model developed in specialty clinics by experts in the treatment of child sexual abuse, can be effectively transported to a state-contracted community mental health agency in the state of Delaware and used effectively by clinicians with little prior TF-CBT experience. The sample is comprised of youths receiving public mental health services and with diverse trauma histories.

NCT ID: NCT01221883 Active, not recruiting - Clinical trials for Posttraumatic Stress Disorder

Prevention of Posttraumatic Stress Disorder (PTSD) With Diazepam

Start date: May 2013
Phase: Phase 4
Study type: Interventional

PTSD is a pervasive and frequent disorder. Early psychological treatment - but not pharmacology - effectively prevent PTSD. Current pharmacological studies did not include treatment given immediately after trauma exposure. However, a recent study of opiates suggests that their early administration may reduce the likelihood of developing PTSD - possibly by mitigating early post-traumatic distress (UCR) - within an adequate window of time. Benzodiazepines are often used to reduce anxiety and agitation during stressful situations - including traumatic event. These compounds may increase the likelihood of developing PTSD when administered few days after the traumatic event - but their effect as an immediate intervention has not been studied - despite their frequent and uninformed use at this stage. This work will evaluate the effect of diazepam - a BZ compound - on PTSD symptom trajectory following traumatic event in a randomized controlled design. Following the studies of opiates it is hoped that diazepam, administered within hours of the traumatic event, and before the first night sleep (a memory consolidating condition) will reduce the likelihood of developing PTSD. However, an adverse effect cannot be excluded, and thus the investigators posit a bidirectional hypothesis. The importance of this work is that it will provide the necessary evidence to sanction a frequently practiced use of benzodiazepines.

NCT ID: NCT01157429 Active, not recruiting - PTSD Clinical Trials

D-cycloserine Adjunctive Treatment for Posttraumatic Stress Disorder (PTSD) in Adolescents

Start date: June 2010
Phase: Phase 2
Study type: Interventional

The purpose of this study is to show whether D-cycloserine in combination with cognitive behavioral therapy (CBT) is more effective than CBT alone to reduce symptoms of posttraumatic stress disorder (PTSD) in 13-18 year-old children.

NCT ID: NCT01090180 Active, not recruiting - Clinical trials for Posttraumatic Stress Disorder

Extinction of Fear Memories With Glucocorticoids in Veterans With PTSD

VA CORT
Start date: April 2010
Phase: N/A
Study type: Interventional

The purpose of this study is to examine the effects of glucocorticoid administration following traumatic memory reactivation on psychiatric symptoms in veterans with combat-related PTSD, in addition to examining the effects of glucocorticoid administration following traumatic memory reactivation on physiological responses to veteran's personal combat memories. The following hypotheses will be tested: 1. Subjects who receive an exogenous glucocorticoid after traumatic memory reactivation will demonstrate fewer PTSD and depression symptoms one week later, compared to those who receive a placebo after traumatic memory reactivation. 2. The glucocorticoid reduction effects will be cumulative; that is, reduction will persist, and further post-reactivation glucocorticoid administration will further reduce symptoms 3. Decreases in PTSD and depression symptoms will persist at 1, 3, and 6 months for subjects receiving an exogenous glucocorticoid compared to those subjects receiving placebo 4. Subjects who receive an exogenous glucocorticoid after traumatic memory reactivation will demonstrate decreased physiological responses one week later, compared to those who receive a placebo after traumatic memory reactivation. 5. As with the psychological measures, suppression of the physiological measures will demonstrate both persistence over time and accumulation with subsequent post-reactivation glucocorticoid administration.

NCT ID: NCT01044160 Active, not recruiting - Clinical trials for Posttraumatic Stress Disorder

Stress, Adjustment And Growth In Children With Cancer And Their Parents

Start date: July 7, 2009
Phase:
Study type: Observational

This proposal examines trauma and growth responses in the childhood cancer experience. It addresses a number of gaps and unanswered questions in the literature, while integrating several distinct but related lines of research. The rationale for this proposal is outlined briefly as follows: 1. Traumatic stress models focused on pathology dominate pediatric psychosocial oncology research despite empiric evidence of low levels of post-traumatic stress in this population. 2. The assumption of 'cancer as a traumatic event' has biased research designs (including lack of control comparisons) to focus on deficits and pathological outcomes. 3. This deficit-oriented approach has stimulated the development of interventions to treat or prevent PTSD, which may be unnecessary or even harmful. 4. Theoretical and empiric evidence suggests that a more common response to traumatic stress is growth and positive change, but posttraumatic growth phenomenon have been understudied in pediatric populations. 5. Cognitive and personality factors are important determinants of PTSD and positive growth outcomes, and some constructs from positive psychology theory may be particularly relevant in children with cancer. 6. Empirically, parents of children with cancer appear to be at higher risk of PTSD/PTSS, although results are not unequivocal, and the same research biases have applied to parental outcomes. This proposal includes assessment of parental PTSS and PTG, both as an outcome and a predictor of child outcomes.