Identification of Neuroimaging-Based Biomarkers in the Treatment of Posttraumatic Stress Disorder
Posttraumatic stress disorder (PTSD) is prevalent mental illness (~9% life-time) that results from exposure to trauma. As it is associated with vastly heterogeneous origins, accurate diagnosis and optimal treatment strategies are sometimes very difficult to achieve. No known biomarker exists, which makes it difficult to assess treatment response and functional outcomes. The recent brain imaging studies have suggested that PTSD patients show abnormal brain connectivity measured by functional magnetic resonance imaging (fMRI). The investigators propose that cognitive processing therapy may ameliorate this functional connectivity abnormality which may be related with their symptomatic improvement.
NCT03229915 — Stress Disorders, Post-Traumatic
Status: Completed
http://inclinicaltrials.com/stress-disorders-post-traumatic/NCT03229915/
Pilot Test of a Self-Management Program for Completers of Trauma-Focused Therapy
Veterans who complete trauma-focused therapies (TFTs) report improvements in posttraumatic stress disorder symptoms, quality of life, and social and role functioning. However, many also report uncertainty regarding their ability to maintain and build upon progress made during TFTs following the end of treatment. Veterans who recently completed a course of TFT believe the likelihood of their ongoing success would be bolstered by mental health services that support additional practice and reinforcement of skills learned in TFT. Currently no evidence-based approach for post-TFT care exists; however, Veterans' reported treatment needs are well-suited to a therapist-assisted self-management approach. The objective of this project is to complete Stage 1 (intervention refinement and piloting) of the Stage Model of Treatment Development for a post-TFT therapist-assisted self-management program designed to help Veterans maintain or build upon gains made in TFT, increase self-efficacy for managing their PTSD symptoms, and enhance community engagement. The aims of the project are to: 1) Refine a self-management treatment protocol through eliciting feedback from experienced TFT providers on a draft of the self-management program, 2) Conduct a pilot open trial to assess the acceptability and feasibility of the self-management program, and 3) Explore the effects of the program on Veterans' confidence in managing their PTSD and Veterans' functioning, quality of life, community engagement, and mental health symptoms.
NCT03225859 — Posttraumatic Stress Disorder
Status: Completed
http://inclinicaltrials.com/posttraumatic-stress-disorder/NCT03225859/
Striatal Dopamine Transporter Density in Post-Traumatic Stress Disorder (PTSD)
This research study is being done to try to find a way to accurately diagnose post-traumatic stress syndrome (PTSD) in combat veterans.Diagnostic biomarkers have made invaluable contributions to the diagnosis and treatment monitoring of many diseases and disorders. Unfortunately, PTSD currently lacks a reliable and compelling clinically-relevant biomarker. The absence of a viable biomarker impairs efficient and confident diagnosis of PTSD, with diminished effective care options often resulting.
NCT03216434 — Post-traumatic Stress Disorder
Status: Not yet recruiting
http://inclinicaltrials.com/post-traumatic-stress-disorder/NCT03216434/
Effect of D-cycloserine on a Short Imagery Rescripting Intervention for Subclinical PTSD
This study aims to investigate the utility of d-cycloserine (DCS) for enhancing the effect of a novel psychosocial intervention, imagery rescripting (ImRs), in adults with mild to moderate PTSD symptoms after experiencing a traumatic event such as sexual or physical assault, serious accident, etc. Participants will receive 4 sessions of either cognitive behavioral therapy with imagery rescripting or cognitive behavioral therapy with imaginal exposure and will receive study medication (DCS or Pill placebo) prior to Session 2 and Session 3.
NCT03216356 — PTSD
Status: Withdrawn
http://inclinicaltrials.com/ptsd/NCT03216356/
Placebo-Controlled Study of the Effects of Oxytocin on Attentional Bias and Startle in PTSD
The investigators will test whether intranasal oxytocin (24 IU vs placebo) will induce effects on attention bias and startle comparable to those the investigators have shown to be induced by the presence (vs absence) of a service dog in Veterans diagnosed with PTSD. This possibility is suggested by a 2015 study showing that urinary oxytocin levels are elevated in association with mutual gaze between dogs and their owners.
NCT03211013 — Posttraumatic Stress Disorder
Status: Completed
http://inclinicaltrials.com/posttraumatic-stress-disorder/NCT03211013/
Transcranial Infrared Laser Stimulation (TILS) of Prefrontal Metabolism and Function in Post-traumatic Stress Disorder (PTSD)
This study evaluates the effects of transcranial infrared laser stimulation (TILS) on prefrontal metabolism and hemodynamics in veterans with post-traumatic stress disorder (PTSD). The subjects will receive six TILS interventions and one sham intervention in a course of seven weeks.
NCT03209882 — Post-traumatic Stress Disorder (PTSD)
Status: Terminated
http://inclinicaltrials.com/post-traumatic-stress-disorder-ptsd/NCT03209882/
Pilot Evaluation of the VetChange Mobile App for Veterans With PTSD Who Engage in Problem Drinking
Concept: Alcohol misuse is common among Veterans with PTSD. It has been proposed that this high comorbidity is the result of "self-medication," with alcohol being used to alleviate common PTSD symptoms (e.g., hyperarousal, sleep problems). Given this high prevalence and functional relationship, researchers at the BSD of the NCPTSD developed the VetChange self-management website to concurrently address these conditions. In a large scale RCT, VetChange has shown efficacy to reduce both alcohol misuse and PTSD symptoms. Unfortunately, the recently launched publicly available VetChange website (Vetchange.org) has been plagued by a high rate of visitors not completing the mandatory registration process, which is required for repeated use. Based on the promising findings of the VetChange research, the D&T Division partnered with the BSD Division to develop the VetChange mobile app, which is set to be released to the public very soon. However, unlike the VetChange website, the app has not yet been evaluated and has the advantage of allowing users to easily obtain it without having to register and repeatedly log on through an Internet connection. This research partnership between the D&T and BSD Divisions will extend and enhance an ongoing successful cross-center collaboration in a high priority topic for the larger Center. The purpose of this proposal is to conduct a pilot evaluation of the VetChange mobile app in order to test its feasibility, acceptability, and potential efficacy to reduce alcohol consumption, PTSD severity, and improve psychosocial functioning among Veterans with PTSD who exhibit signs of problem drinking. In this study, 280 Veterans with problem drinking and clinically significant PTSD symptoms will be recruited using social media and randomized in equal numbers to receive one of four conditions: 1) Assessment only, 2) VetChange mobile app only, 3) AFT plus the VetChange mobile app supplemented with a package of supportive accountability tools (VetChange+). In addition to receiving the mobile app, VetChange+ participants will receive SMS reminders to log drinking behavior using the mobile app. The investigators will track objective use of the VetChange mobile app to assess feasibility, and this usage data will also be used in real-time to tailor the content of text messages provided to participants in the VetChange+ condition. Participants will complete measures of alcohol use, functional well-being, and PTSD symptoms at baseline and again after 8 weeks (posttreatment). At post-treatment, participants in the VetChange app arms of the study will also be asked to report their level of satisfaction with the app and to complete a brief qualitative evaluation of their experience using the VetChange mobile app. Results of this pilot study will be used to characterize the feasibility, acceptability, and potential efficacy of a mobile app-based self-management intervention to reduce problem drinking behavior in Veterans with PTSD, will inform optimization of the intervention, and will serve as the foundation for subsequent proposals for extramural funding.
NCT03208738 — Post-Traumatic Stress Disorder
Status: Not yet recruiting
http://inclinicaltrials.com/post-traumatic-stress-disorder/NCT03208738/
CCTAP: Cognitive Control Training for Treatment of AUD-PTSD
The primary objective of this study is to evaluate the feasibility of the revised brain training program with individuals diagnosed with Alcohol Use Disorder (AUD) and Post-Traumatic Stress Disorder (PTSD).
NCT03200028 — Alcohol Use Disorder
Status: Completed
http://inclinicaltrials.com/alcohol-use-disorder/NCT03200028/
Evaluation of a Mobile Phone App for Veterans With PTSD
The purpose of this study is to evaluate a mobile phone app designed to help Veterans with PTSD. Participants in this study will be randomized to receive one of 2 possible mobile phone apps. The term "randomized" means that which app a participant receives will not be based on any characteristic or behavior of the participant, but will be determined solely by chance like a flip of a coin.
NCT03199742 — Stress Disorders, Post-Traumatic
Status: Completed
http://inclinicaltrials.com/stress-disorders-post-traumatic/NCT03199742/
Improving PTSD Treatments for Adults With Childhood Trauma
The aim of this project is to investigate the effectiveness of phase-based trauma-focused therapy (PBT) and intensive trauma-focused therapy (I-TFT) for adult patients with PTSD related to childhood abuse. We will carry out a RCT, randomizing 150 patients to receive either standard TFT, PBT or i-TFT. The effects will be assessed at two endpoints of treatment (4, 8 and 16 weeks) and after a 6 and 12 months follow-up in an intention-to-treat analysis.
NCT03194113 — Post Traumatic Stress Disorder
Status: Completed
http://inclinicaltrials.com/post-traumatic-stress-disorder/NCT03194113/