Clinical Research Directory

Trauma BPE Prolonged Exposure Therapy for Injured Individuals Admitted to a Level I Trauma Center

The purpose of this research is to determine if a brief treatment method is effective for preventing posttraumatic stress disorder (PTSD) and a number of other concerns following injury.

Assessing Trauma-related Links Between Affective and Metabolic Systems

KEY INFORMATION: The purpose of this study is to understand how insulin resistance (how your body processes sugar) and PTSD might be related. The goal is to improve the health of Veterans in three ways: 1. Understanding health risks: The investigators want to learn why Veterans with post-traumatic stress disorder (PTSD) are more likely to develop medical problems related to insulin resistance, such as diabetes. 2. Testing effects of a medication: The investigators are testing whether prazosin, a medication that studies have shown may address some PTSD symptoms, can also improve how the body responds to insulin. If it does, this could point to a specific biological pathway that could be targeted for development of new treatments to prevent insulin resistance and diabetes in Veterans with PTSD. 3. Links to depression. The investigators will also look at whether insulin sensitivity affects depression symptoms in people with PTSD. This may inform future research into treatments for PTSD.

Mindful RAVANS Study

This pilot study is testing a new treatment for people who still have frequent headaches months after a mild traumatic brain injury, with about half of the participants coming from military or veteran backgrounds. The treatment, called "Mindful RAVANS," pairs a guided breathing meditation with gentle electrical stimulation delivered through a small clip in the left ear, timed so the stimulation pulses each time the person breathes out. The idea is that stimulating the vagus nerve, which helps calm the body's stress response, while practicing mindfulness may ease headaches, stress, and other lingering concussion symptoms. Participants are randomly assigned so that three out of four get the real treatment and one out of four gets a look-alike "fake" version, and everyone attends four 30-minute sessions over two weeks, followed by online surveys at two, four, and eight weeks. Because it's an early-stage study, the main goal isn't to prove the treatment works but to find out whether people can stick with it, find it comfortable, and like it enough to justify a larger trial.

Dose Optimization of MDMA-Assisted Therapy for PTSD

This open label, within-subjects dose optimization trial will investigate the optimal number of MDMA-Assisted Therapy treatment cycles (i.e., one MDMA session and three integration sessions) in a sample of U.S. veterans with PTSD. Participants will complete from one to five cycles of MDMA-AT.

Impact of Cognitive Behavioral Therapy on PTSD-CVD Link

This is a pilot randomized controlled trial to assess the impact of a first-line treatment for posttraumatic stress disorder (PTSD) (Cognitive Processing Therapy; CPT) versus waitlist control on mechanisms of cardiovascular disease (CVD) risk. Further, this study will test the hypothesis that CPT reduces CVD risk through its effects on inflammation and autonomic function and that these changes are driven by changes in stress-related neural activity (SNA)

Testing a PTSD m-Health Intervention to Improve Alcohol Treatment Outcomes

The purpose of this study is to learn whether a mobile health application (mHealth App) for posttraumatic stress disorder (PTSD) with brief support can help individuals who are in treatment for alcohol problems.

Integrated CBT to Improve Functioning in Veterans With Anxiety and Substance Use

Individual with anxiety and post-traumatic stress disorder often use alcohol in ways that could cause them harm. Treating both mental health concerns and alcohol use at the same time can help reduce difficulties engaging in multiple treatments. The investigators are evaluating how a cognitive behavioral therapy program that helps Veterans with anxiety, posttraumatic stress disorder, and alcohol use at the same time can help improve the participants lives.

CHW-Enhanced Trauma Recovery

This pilot study will evaluate the feasibility, acceptability, and preliminary effectiveness of the Trauma Resilience and Recovery Program Plus (TRRP+), a Community Health Worker-enhanced intervention designed to improve behavioral health engagement and recovery among adult trauma survivors with unmet social needs. One hundred adult trauma patients admitted to the Medical University of South Carolina (MUSC) Level I Adult Trauma Center who screen positive for risk of posttraumatic stress disorder (PTSD) or depression and report at least one unmet social need will receive TRRP+ services. Participants will complete assessments at baseline, 1 month, and 3 months after enrollment. The study will also examine implementation barriers and facilitators to support future dissemination and scale-up of the intervention.

Evaluation of Trauma Center-Based Intervention for Adolescent Traumatic Injury Survivors

Pediatric traumatic injury (i.e., injury of sudden onset and severity requiring immediate attention) is the leading cause of death and morbidity among US adolescents and are associated with mental health and health risk outcomes, including posttraumatic stress and depression (affecting between 19-42%), deficits in physical recovery, social functioning and quality of life, which if unaddressed, may contribute to increased use of health care services. The investigators partnered with three accredited Level I and II pediatric trauma centers to conduct a multi-site hybrid 1 effectiveness-implementation trial with 300 adolescent (ages 12-17) traumatic injury patients to assess the extent to which the Trauma Resilience and Recovery Program (TRRP), a scalable and sustainable, technology-enhanced, multidisciplinary stepped model of care, promotes improvement in quality of life and emotional recovery and gather preliminary data on the potential for TRRP to be implemented in other Level I trauma centers. Directly in line with NICHD's Pediatric Trauma and Critical Illness Research and Training (PTCIB) Strategic Research and Training agenda, this study will provide valuable data on the efficacy, preliminary effectiveness and potential for implementation of an innovative, cost-effective, sustainable technology-enhanced intervention designed to address the unique needs of adolescent injury patients and mitigate short- and long-term impact of injury on mental health, quality of life, and overall well-being.

Mobile Anger Reduction Intervention

Difficulty controlling anger is the most commonly reported reintegration concern among combat Veterans, especially those with a diagnosis of posttraumatic stress disorder (PTSD). Problematic anger is associated with significant functional impairment. In the current project, the investigators will compare the Mobile Anger Reduction Intervention (MARI) with a health education mobile intervention (HED) among Veterans with PTSD and problematic anger. Participants will be randomized to the MARI or HED condition. The hypothesis is that participants in the MARI condition will experience greater anger reductions and functional improvements relative to the HED condition.

tAN for PTSD and OUD in Buprenorphine Therapy

The goal of this research study supported by the HEAL Initiative (https://heal.nih.gov) is to investigate the effects transcutaneous auricular neurostimulation (tAN), as delivered through the Sparrow Ascent device, on helping people with co-occurring posttraumatic stress disorder (PTSD) and opioid use disorder (OUD) start and continue buprenorphine treatment. The main questions it aims to answer are: * Does the tAN help participants with OUD and PTSD remain in buprenorphine therapy for three months after starting use of the device (i.e., randomization to treatment condition)? * Do participants find the Sparrow Ascent device to be acceptable and use it? * Do participants find the Sparrow Ascent device to be tolerable and comfortable to use? * Do participants find the Sparrow Ascent device to be easy to use with their buprenorphine therapy? * Do participants follow the minimum recommended dose schedule for the Sparrow Ascent device most of the time? Participants will complete a baseline assessment to make sure that they are eligible to participate in the study. The assessment captures information about demographics, substance use and treatment history, opioid withdrawal symptoms and craving, difficult life experiences and PTSD symptoms, mental health and treatment history, quality of life, and recovery resources. After the assessment is complete and the participant has been inducted on buprenorphine as part of standard care, they are randomized to one of two treatment conditions: active tAN and placebo. Participants are trained on how to use the device and return for 12 weekly research visits to check on recent substance use and craving, PTSD symptoms, and their experience using the device. After 12 weeks of using the device, participants will complete a post-active treatment assessment that is nearly identical to the baseline assessment to see if there have been changes in these areas. Researchers will access the medical record to determine whether there is a current prescription for buprenorphine at three months and six months after randomization.

Using Data Science To Center Patient Perspectives in Mechanism Discovery

Including patient perspectives when developing new therapy interventions is crucial because it can help to understand response heterogeneity and promote engagement. Yet, analyzing patient interview data is difficult and time-consuming. This study aims to explore the potential for natural language processing and deep learning to analyze patient interviews and identify potential ways in which therapy leads to psychological change. This study will recruit participants from an existing clinical service that offers a 16-week online group therapy model (and adjunct individual therapy sessions) called Program for Alleviating and Resolving Trauma and Stress (PARTS) based on a therapy called Internal Family Systems (IFS). The investigators will use a mixed methods approach, applying natural language processing and deep learning to develop models that identify potential mechanisms of change. These models will be based on patient perspectives of psychological change, as expressed in interviews, and be compared to models based on clinical measures.

Intensive Multi-Couple Therapy for PTSD Versus Relationship Education in Military Couples

The goal of this clinical trial is to test an abbreviated, intensive, multi-couple group version of cognitive-behavioral conjoint therapy for PTSD (AIM-CBCT for PTSD) in an active military and veteran population. The main questions it aims to answer are: * Does AIM-CBCT for PTSD improve PTSD symptoms? * Does AIM-CBCT for PTSD improve associated symptoms (e.g., depression), romantic partner distress, and couple relationship satisfaction? Participants will participate in a two-day retreat in which they are taught and practice skills to decrease PTSD symptoms and enhance their relationships. Researchers will compare AIM-CBCT for PTSD to the Prevention and Relationship Education Program (PREP) to determine whether it is superior to an evidence-based relationship education curriculum that is also delivered in a two-day multi-couple group format.

Piloting Virtual Reality Environments to Treat PTSD in Healthcare Workers

Healthcare workers and COVID-19 patients may experience psychological distress consequent to the pandemic, and are at particularly elevated risk for experiencing posttraumatic stress disorder (PTSD), based on evidence from previous infectious disease outbreaks. The best-validated treatment for PTSD is exposure therapy. Exposure therapy help patients suffering from PTSD to revisit and overcome their traumatic experiences. Including virtual reality in exposure therapy has a long history in treating PTSD; and has been used to treat military veterans and first-responders following 9/11. The investigators are developing and testing a virtual environment to treat PTSD including sub threshold PTSD symptoms in HCWs who experience occupational related trauma (e.g., working with COVID-19 patients) and COVID-19 patients. An independent evaluator will assess symptoms of PTSD and other psychopathology, using structured clinical interviews and self-report measures with well-established psychometric properties, at baseline, halfway through treatment, after completion of treatment, and at three-months post-treatment. Participants will complete ten ninety minute sessions (in-person or remotely), twice a week for five weeks aimed at mitigating their symptoms of PTSD. Remote participants will receive VR headsets after the baseline assessment and will keep them for the duration of the study. The pilot study will aim to demonstrate the feasibility and the tolerability of the virtual reality intervention in these populations.

Focused Ultrasound for PTSD in Veterans

The goal of this study is to develop a new, non-invasive brain stimulation modality called low intensity focused ultrasound (FUS) as a psychiatric rehabilitation treatment for posttraumatic stress disorder (PTSD). FUS delivers energy comparable to that involved in diagnostic ultrasound but in a millimeter-sized envelope. Unlike currently available methods, the maximal FUS energy is delivered at a distance from a transducer on the scalp. Therefore, its promise is that it can deliver focal and reversible modulation to deeper brain regions involved in PTSD. The investigator team has previously conducted first-in-human research in FUS, and this study builds upon that work to conduct a phase II, dose-finding study. This study will pursue two Aims; the first is whether FUS to the amygdala can improve symptoms, and the second will evaluate whether FUS improves function by reduced disability, over a 1-month period. Short and longer-term effects of FUS will be measured and all FUS parameters are within FDA-defined safety thresholds for diagnostic ultrasound.

Testing a Scalable Model of Care to Improve Patients Access to Mental Health Services After Traumatic Injury

The purpose of this study to learn about patients' experience with the Trauma Resilience and Recovery program (TRRP) and/or the enhanced care group.

Impact of Post-Traumatic Stress Disorder Treatment by Reconsolidation Therapy on Fibromyalgia Syndrome

The aim of the study is to demonstrate a significant improvement in quality of life specific to patients with fibromyalgia syndrome in patients with fibromyalgia syndrome with comorbid posttraumatic stress disorder, treated with reconsolidation blockade. Patients receive a treatment with propranolol associated with reconsolidation blockade of traumatic story once a week during 6 weeks, with evaluation at inclusion and at 3 months.

Psilocybin and Methylenedioxymethamphetamine (MDMA) for Post-traumatic Stress Disorder (PTSD)

The purpose of this study is to assess the safety and effectiveness of co-administered MDMA and psilocybin in military Veterans with a diagnosis of Posttraumatic Stress Disorder (PTSD). To apply or learn more, please view our website: https://hopkinspsychedelic.org/pamvet

Exploring Efficacy of Multi-Mode Cognitive Processing Therapy (CPT) for PTSD

This study is a longitudinal, multicenter, single-blind, two-arm randomized controlled trial designed to evaluate the effectiveness of Multi-Modal Cognitive Processing Therapy (MMCPT) for individuals with posttraumatic stress disorder (PTSD). Participants will be randomly assigned to either the intervention group receiving MMCPT or a control group receiving treatment-as-usual (TAU). The intervention follows the standard CPT manual developed by Resick and consists of twelve weekly 90-minute individual sessions. The primary outcomes include PTSD symptom severity assessed by the Clinician-Administered PTSD Scale for DSM-5 (CAPS-5) and the PTSD Checklist for DSM-5 (PCL-5). Secondary outcomes include sleep quality (actigraphy, PSQI), anxiety (STAI), depression (HDRS-17), remission rate, and posttraumatic growth (PTGI). Assessments will occur at baseline, mid-treatment, post-treatment, and at 3-, 6-, 9-, and 12-month follow-ups.

Resilient Roots: Supporting Youth and Families

Resilient Roots is integrated into the TRANSFORM Center to promote translation of research findings into clinical interventions, to inform the next generation of research on child abuse and neglect (CAN), and to facilitate dissemination of research and practice knowledge/skills to varied stakeholders. Exposure to CAN frequently results in long-term detrimental effects on mental health. For youth who have experienced socioecological stress, the trauma associated with CAN may be compounded by stress and trauma deriving from experiences of stress in their communities. Interventions to address specific socioecological stress for symptomatic youth receiving human centered mental health services are lacking, and use of mental health services that are acceptable to families are too often misaligned with their representation in the population in general and overrepresentation in the child welfare system specifically. Incorporating support for families in enhancing socialization and coping skills specific to addressing contextual stress and trauma has relevance for public health. Although Trauma-Focused Cognitive Behavioral Therapy (TF-CBT) is an evidence-based treatment for children who have experienced CAN, determining best practices for implementing enhanced TF-CBT with socialization components is urgently needed to address these gaps and provide optimal intervention. Resilient Roots is a pilot study within a RE-AIM/PRISM framework (including Reach, Effectiveness, Adoption, Implementation, and Maintenance with emphasis on contextual factors at multiple levels of the implementation setting) that will incorporate stakeholder perspectives and evaluate the incorporation of socialization into enhanced TF-CBT, while identifying barriers and facilitators to implementation to guide future larger-scale trials.

Neurosteroids for Treatment of PTSD in Veterans

This study seeks to determine if pregnenolone can improve symptoms of PTSD and other symptoms that commonly occur with PTSD in Iraq/Afghanistan-era Veterans. The total study duration for each participant is 10 weeks. Eligible Veterans with PTSD will receive either pregnenolone or placebo throughout the study duration and will complete mental and physical health assessments at each study visit. Eligible participants will attend 6 in-person study visits and receive several short "check-in" phone calls.

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

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.

Enhancing Week-long Psychological Treatment for PTSD With Ketamine

The purpose of this study is to test if the combination of ketamine, vs midazolam, with an intensive trauma-focused psychotherapy will be more effective in relieving post-traumatic stress disorder (PTSD). This week-long treatment has the potential to produce a significant therapeutic effect that otherwise would take months to occur. The study will also focus on learning about the neurophysiological changes produced by the proposed clinical trial.

Positive Processes and Transition to Health (PATH)

The R33 will be a randomized controlled trial to replicate changes in the targets (unproductive processing, avoidance, reward deficits) from the R61 phase in a larger sample of 135 participants who have experienced a destabilizing life event involving profound loss or threat, report persistent stressor-related symptoms of PTSD and/or depression, and are elevated on symptoms related to 2 of the 3 therapeutic targets. Additionally, this study will examine Positive Processes and Transition to Health (PATH)'s impact on stressor-related psychopathology in comparison to Progressive Muscle Relaxation (PMR). In the R33 phase, the investigators will examine changes in target mechanisms predicting improvements in PTSD and depressive symptoms, as well as feasibility and acceptability. Patients will receive 6 sessions of PATH or PMR (with 2 boosters, if partial responders). Primary targets will be assessed at pre-treatment, week 3, post-treatment, and at 1- and 3-month follow-up; secondary targets at pre-treatment, weekly during treatment, post-treatment, and at 1- and 3-month follow-ups.