The Role of Exercise in the Treatment of PTSD
This is an 8-week experimental, repeated-measures clinical trial randomizing 120 Service Members with symptoms of PTSD into one of four groups: 1) imaginal exercises of exposure therapy only, 2) aerobic exercise only, 3) imaginal exercises augmented with aerobic exercise, or 4) self-care.
NCT02649127 — Posttraumatic Stress Disorder
Status: Completed
http://inclinicaltrials.com/posttraumatic-stress-disorder/NCT02649127/
Cognitive Behavioral Therapy to Increase CPAP Adherence in Veterans With PTSD
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.
NCT02641496 — Obstructive Sleep Apnea
Status: Active, not recruiting
http://inclinicaltrials.com/obstructive-sleep-apnea/NCT02641496/
Trauma-sensitive Yoga for Female Veterans With PTSD Who Experienced Military Sexual Trauma
In this study, we are evaluating the effectiveness of a yoga intervention to treat posttraumatic stress disorder (PTSD), its associated symptoms of chronic pain and insomnia, and biological and physiological responses to trauma and PTSD in women Veterans who experienced military sexual trauma (MST). If effective, this yoga intervention could reduce PTSD symptoms and chronic pain, improve sleep quality, and decrease the body's automatic "fight or flight" stress response and the damage this stress response causes in the body, including heart disease and diabetes. This intervention could improve these women Veterans' quality of life and social functioning, for example, going to work and having satisfying relationships with family and friends. This study may support an innovative, complementary and alternative PTSD treatment for women Veterans who experienced MST. This new, evidence-based PTSD treatment could supplement current PTSD treatments. Clinical guidelines for this yoga intervention could be implemented nationally in the VA health care system.
NCT02640690 — Stress Disorders, Post-traumatic
Status: Completed
http://inclinicaltrials.com/stress-disorders-post-traumatic/NCT02640690/
Effectiveness of PTSD Treatment For Suicidal and Multi-Diagnostic Clients
The present project has two primary aims: (1) to examine the effectiveness of a multi-component implementation strategy in improving adoption and adherence to the Dialectical Behavior Therapy Prolonged Exposure (DBT PE) protocol, and (2) to evaluate the feasibility, acceptability, and effectiveness of the DBT PE protocol in a sample of individuals receiving DBT in public mental health agencies. This study uses a hybrid type 2 effectiveness-implementation design to simultaneously test the clinical effectiveness of DBT + DBT PE and to evaluate an adaptive, multi-component implementation strategy. The effectiveness trial will use a quasi-experimental, controlled design to evaluate outcomes among DBT clients with PTSD who do versus do not receive the DBT PE protocol and outcomes will be benchmarked to those obtained in research settings.
NCT02615197 — Suicide
Status: Completed
http://inclinicaltrials.com/suicide/NCT02615197/
Peer Supported Web-based CBT for OEF/OIF Veterans With PTSD and Substance Misuse
Veterans who served in Iraq and Afghanistan have high rates of co-morbid PTSD symptoms and hazardous substance use (HSU). Evidence-based treatments for these problems are available in VA specialty clinics, but multiple barriers lead to low utilization of these treatments. Novel treatment approaches are needed. Previous research supports that 1) primary care-mental health integration (PC-MHI) services are associated with increased treatment engagement, 2) technology-based interventions are well accepted by Veterans and are more effective when delivered with professional support, and 3) Veteran peer services are associated with improved treatment engagement, patient motivation, and overall functioning. This study will add a Peer-Support component to an existing Web-based Cognitive Behavioral Treatment (CBT) for PTSD and HSU called Moving Forward. Preliminary data analyses from our NIAAA-funded trial indicate that participants who used Moving Forward more had larger reductions in PTSD symptoms. Qualitative feedback supports that Veterans want interpersonal interactions while receiving treatment and need help engaging in the treatment more fully. Therefore, this pilot study will investigate if adding peer support to Moving Forward improves patients outcomes. A randomized controlled trial (N=30) comparing Moving Forward to Peer-Supported Moving Forward will be conducted. The peer support component will consist of semi-structured brief sessions conducted weekly for the 12 weeks of study treatment by a VA-certified peer support specialist. Peers will receive study-specific training and weekly supervision from clinicians that are part of the study staff. Primary outcomes will include process outcomes (treatment engagement, patient satisfaction) and clinical outcomes (PTSD symptoms, alcohol and substance use, quality of life).
NCT02611843 — Substance Use Disorders
Status: Completed
http://inclinicaltrials.com/substance-use-disorders/NCT02611843/
Randomized, Controlled Trial of Art Therapy During Cognitive Processing Therapy for PTSD
This is a randomized, controlled trial of adjunctive art therapy during cognitive processing therapy for PTSD.
NCT02610049 — Post-traumatic Stress Disorder
Status: Terminated
http://inclinicaltrials.com/post-traumatic-stress-disorder/NCT02610049/
Interpersonal Therapy for Veterans With PTSD
Interpersonal problems such as relationship conflict and social isolation are common among Veterans with PTSD and serve as barriers to successful posttraumatic adjustment. The main interventions for PTSD at VA facilities, i.e., Prolonged Exposure, Cognitive Processing Therapy, and Trauma-Focused CBT, do not directly target these relationship difficulties and many Veterans do not complete these treatments. Couple and family approaches for PTSD address relationship problems, but logistical problems make it difficult for couples to attend sessions and these approaches do not involve Veterans who are socially isolated or unmarried. There is accumulating evidence that Interpersonal Psychotherapy (IPT) for PTSD may be effective in reducing symptoms and improving interpersonal functioning. This study, a randomized controlled trial, aims to provide evidence regarding whether IPT for PTSD could be a useful addition to current treatments delivered at the VA.
NCT02586064 — Posttraumatic Stress Disorder
Status: Completed
http://inclinicaltrials.com/posttraumatic-stress-disorder/NCT02586064/
Efficacy and Safety of Repeated Intravenous Subanesthetic Ketamine Infusions Among Veterans With Treatment Resistant Depression Comorbid With Chronic Post-Traumatic Stress Disorder: A Proof-of-concept Study
The relationship between depression and trauma is well established. Co-occuring depression and post-traumatic stress disorder (PTSD) are associated with more severe symptoms and lower levels of functioning. Veterans with both depression and PTSD have been shown to be at much higher risk of suicide than individuals with only one of these disorders. Ketamine has been shown to have rapid antidepressant effects and also therapeutic action over PTSD symptoms. The purpose of this study is to see whether ketamine, when given as repeated infusions, can produce quick and sustained improvement in depression and PTSD symptoms for individuals who have not had their symptoms effectively treated by current treatments.
NCT02577250 — Stress Disorders, Post-Traumatic
Status: Completed
http://inclinicaltrials.com/stress-disorders-post-traumatic/NCT02577250/
Improving Functional Outcomes of Veterans With PTSD and Tobacco Dependence
Veterans with PTSD have high rates of smoking (34%-86% vs. 18% in the general population) and have substantial difficulties with quitting tobacco. Despite the significant morbidity and mortality associated with smoking, no smoking cessation treatments exist that intensively target PTSD symptoms as an obstacle to quit smoking, although this is a significant barrier to quitting for many Veterans. In addition, no smoking cessation treatments have a large emphasis on improving the functioning of Veterans with PTSD and tobacco dependence, although both PTSD and tobacco use negatively affect functioning across physical, mental health, and social domains. The goal of this SPiRE project is to evaluate Acceptance and Commitment Therapy for Veterans with PTSD and Tobacco Use (ACT-PT), which is an acceptance and mindfulness-based smoking cessation treatment for Veterans with PTSD and tobacco dependence. ACT-PT specifically targets smoking cravings related to PTSD symptoms and memories of trauma, in addition to difficulties managing PTSD symptoms. negative affect and nicotine withdrawal symptoms during quit attempts. ACT-PT includes structured intervention components that guide Veterans to replace smoking as a coping strategy for PTSD symptoms and memories with alternative coping strategies (e.g., mindfulness, acceptance). And healthy living activities (e.g., engaging in work, expanding social networks, engaging in physical exercise) that are consistent with Veterans' values. This project involves a small randomized clinical trial study of Veteran smokers with PTSD and tobacco dependence randomized to one of two different types of psychosocial treatment: ACT-PT versus the American Lung Association's Freedom From Smoking Program [FFS]. This study has two primary aims: 1) evaluate the relative feasibility and acceptability of the two interventions (including ease of recruitment, randomization proportion, staff and Veteran acceptance of the treatment, retention rates, treatment adherence, fidelity, ease of the assessment process), and 2) evaluate the preliminary efficacy of ACT-PT vs. FFS with the primary outcomes of tobacco use, PTSD symptoms, health-related quality of life, and functional impairment.
NCT02576899 — Posttraumatic Stress Disorder
Status: Completed
http://inclinicaltrials.com/posttraumatic-stress-disorder/NCT02576899/
Pilot Study Examining the Impact of a Cognitive Processing Therapy (CPT) Group for Patients With Co-Occurring Borderline Personality Disorder and Posttraumatic Stress Disorder
Even though borderline personality disorder (BPD) and posttraumatic stress disorder (PTSD) commonly co-occur, few studies have examined PTSD treatment among individuals with BPD. Additionally, many PTSD research studies exclude individuals with BPD due to their complexity and concerns regarding risk. This study aims to investigate the effectiveness of Cognitive-Processing Therapy Group (an evidenced-based treatment for PTSD) for individuals with these co-occurring disorders following completion of a Dialectical Behavioural Therapy Program (an evidenced-based treatment for BPD). The investigators are using a repeated measures pre and post design. Data will be collected prior to participants starting the CPT group, throughout the duration of the CPT group (i.e., weekly), and following the completion of the CPT group.
NCT02574429 — Posttraumatic Stress Disorder
Status: Completed
http://inclinicaltrials.com/posttraumatic-stress-disorder/NCT02574429/