Active clinical trials for "Combat Disorders"

In comparison to the general population, U.S. military and Veterans are at an increased risk for developing both substance use disorders (SUD) and Post Traumatic Stress Disorder (PTSD). Current research has shown that there is a high comorbidity of SUD and PTSD, and although there are a number of treatments for SUD and PTSD independently, there are very few effective methods to simultaneously treat both disorders. Because of this substantial gap in the treatment of both SUDs and PTSD, it has become essential to develop a combined treatment that would address and treat both disorders. Individuals, specifically U.S. military and Veterans, with SUD/PTSD have unique needs that require a specialized treatment approach. This designed approach would employ cognitive-behavioral therapy (CBT) to treat the SUD, in conjunction with Prolonged Exposure therapy to treat the PTSD. Prolonged Exposure (PE) is an empirically supported and evidence-based treatment that is currently regarded as the "gold standard" psychosocial treatment for PTSD. In combination with CBT, this treatment would address both disorders in hopes of reducing substance use and PTSD symptomatology.

The primary aim of this project is to examine whether administration of D-Cycloserine (DCS), a partial N-methyl-D-aspartate (NMDA) receptor agonist that has been shown to facilitate fear extinction, enhances the therapeutic benefit of exposure-based cognitive behavioral therapy (CBT) in OEF/OIF veterans with PTSD.

This study will provide measures of safety and efficacy of the NightWare digital therapeutic system (iPhone + Apple watch + proprietary application) for the treatment of nightmare disorder associated with post-traumatic stress disorder (PTSD)-related sleep disturbance and the impact of improved sleep with the NightWare digital therapeutic system. The investigators hypothesize that the NightWare digital therapeutic system will significantly improve sleep quality in participants with PTSD-Related nightmares and poor sleep quality.

Objectives and Rationale: With up to 20% of U.S. service members returning from Iraq and Afghanistan with PTSD symptoms, a critical need exists for treatments that are both effective and efficient, enabling the greatest number possible to be treated to remission. As a highly efficacious treatment and the one with the most scientific support, Prolonged Exposure (PE) is recommended by the Institute of Medicine and being rolled out by the Departments of Defense and Veterans Affairs to help heal our war fighters' psychological wounds. A major barrier to that roll-out, however, is that PE is typically delivered in 90-minute sessions. This is difficult for military mental health providers, who because of large patient loads and pressure to see as many patients per day as possible, limit therapy sessions to 60 minutes. The primary aim of this randomized clinical trial is to determine whether PE sessions can be reduced to 60 minutes without compromising the treatment's high success rate. Preliminary evidence suggests that patients may greatly benefit from PE even when the time spent recalling and recounting the trauma memories during sessions (a key procedure called imaginal exposure) is shortened to fit into a 60-minute session. To test this hypothesis, the trial will enroll 160 San Antonio-area active duty service members who will be randomly assigned to receive PE treatment with 60- or 90-minute sessions. In an additional effort to learn more about how PE helps patients recover - and thereby gain insights to further enhance treatment benefit - the study investigators will examine what causes reductions in PTSD symptoms during PE by examining self-reported and physiological markers (e.g., heart rate reactivity) between the two treatment groups. Research Applicability and Impact: If PE can be shown to maintain high success rates with shorter sessions, more military clinicians could offer this powerful therapy, as it would fit within time constraints of their heavy workload. This would potentially help thousands of our nation's warriors recover from the devastating psychological effects of PTSD and maintain their military careers, heal hurting relationships, and reengage in meaningful life activities. This study would further benefit the military and the general public by enhancing the readiness of our Armed Forces and reducing the public cost of service members' lost work time or veterans' disability benefits. Overloaded VA providers and even civilian therapists, who often limit sessions to 60 minutes due to insurance reimbursement requirements, may also be more likely to utilize the shorter treatment format, increasing access to evidence-base care for veterans and civilians. In addition, insights from the study's examination of biomarkers and underlying mechanisms of PE could be used to enhance care for service members, veterans, and the general public. Study risks are minimal, as a small proportion of patients may see temporary symptom increases as they deal with traumatic memories, but this is part of the recovery process. Patients receiving the shorter treatment sessions potentially may realize a lower level of treatment benefits, but preliminary evidence suggests there is good reason to believe their treatment will be equally as successful as those receiving traditional PE.

The purpose of this study is to compare the response of veterans with PTSD without an optimal response to paroxetine to quetiapine augmentation versus placebo.

It is urgent to make evidence-based treatments (EBTs) for military personnel readily accessible in order to meet the growing demand for effective and efficient treatment for posttraumatic stress disorder (PTSD) in a timely manner. Effective EBTs for PTSD are available, but barriers to accessing care can deter military personnel from receiving treatment. Web-treatments represent an innovative way to overcome these barriers. The efficacy of previously developed web-treatments for PTSD appear promising, however, they are not based on treatment protocols with strong empirical support for their efficacy. No study to date has examined web-treatment of PTSD using a well-established treatment program. The purpose of this open trial is to examine the efficacy of 10 sessions of a web-version of Prolonged Exposure (PE), "Web-PE," delivered over 8-weeks in 40 active-duty military personnel and veterans with PTSD who deployed post 9-11. Up to 60 individuals will be consented to obtain data from 40 for analysis. Participants will be assessed at pre-treatment and 1- and 3-months after treatment completion.

The purpose of this study is to implement a unique evidence-based intervention program to help military families deal with the critical issue of combat injury and its impact on current and future family health and functioning. The study is a randomized study. The study will compare the effects of the newly designed FOCUS-CI (Families OverComing Under Stress - Combat Injury) with the existing standard of care (SoC) at three military medical rehabilitation sites (Walter Reed Amry Medical Center, Brooke Army Medical Center and Madigan Army Medical Center) on key aspects of family health and functioning.

This project represents the first randomized clinical trial of psychotherapy for older veterans with posttraumatic stress disorder (PTSD). It will compare relaxation training (RT) to prolonged exposure therapy (PE). The project will also examine whether cognitive impairment influences psychotherapy outcome. Primary hypotheses: (1) Subjects in the PE condition will have significantly less severe PTSD symptoms, depressive symptoms, and functional impairment than subjects in the RT condition at posttest; (2) Executive functioning will modify the response to both treatments, such that those with impaired executive functioning will demonstrate a smaller reduction in PTSD symptoms (representing less clinically significant change).

The purpose of this randomized controlled trial is to compare the efficacy and potential biological mechanisms of action of 10 sessions of a web-version of Prolonged Exposure (PE), "Web-PE," delivered over 8-weeks to 10 sessions of Present Centered Treatment (PCT) delivered over 8-weeks by a therapist in 120 active duty military personnel with PTSD. Up to 170 individuals will be consented to obtain data from 120 for analysis. Participants will be assessed at pre-treatment, mid-treatment, and 1-, 3- and 6-months after treatment completion.

This trial will evaluate the efficacy and efficiency of Trauma Management Therapy (TMT; Frueh, Turner, Beidel, 1996; Beidel, Frueh, Uhde, under preparation), which combines individual virtual reality (VR) assisted exposure therapy with group social and emotional rehabilitation skills training (will be superior to a treatment consisting of the same VR- exposure and group psychoeducational group therapy. TMT will be conducted in traditional 17-week format, and a 3-week intensive treatment format. Outcome will be assessed using relevant clinical, process, and cost outcomes. Additionally, investigators will assess the potential of olfactory stimulation as a trigger for PTSD symptoms of intrusive thoughts and re-experiencing. Therefore, this proposal will integrate clinical and neurobiological assessment studies designed to understand the role of these factors in the etiology, maintenance, and treatment of PTSD.