PTSD

The Redefine Study (COMP202) is testing COMP360 to see if it may reduce post-traumatic stress disorder (PTSD) symptoms when administered alongside monitoring and support from a trained study team. COMP360 is a lab-made form of the naturally occurring chemical compound psilocybin.

The goal of this clinical trial is to evaluate the safety and effectiveness of the gammaCore non-invasive vagus nerve stimulation (nVNS) device as an additional treatment for symptoms of post-traumatic stress disorder (PTSD) in adults. The vagus nerve connects the brain with many organs and systems in the body and plays a role in regulating stress and emotional responses. The gammaCore device is a handheld, rechargeable medical device that delivers gentle electrical stimulation to the vagus nerve through the skin on the side of the neck. By stimulating this nerve, the device may help reduce PTSD symptoms. gammaCore is cleared by the U.S. Food and Drug Administration (FDA) for the treatment and prevention of migraine and cluster headache. It has not yet been approved for the treatment of PTSD. This study is being conducted to better understand whether this type of stimulation may help improve PTSD symptoms and to evaluate its safety when used for this purpose. The main questions this study aims to answer are: * Is non-invasive vagus nerve stimulation safe for people with PTSD when used regularly at home? * Does treatment with the gammaCore device improve PTSD symptom severity over time? In this study, approximately 40 adults with PTSD will participate in an open-label pilot study. Participants will first complete a 4-week baseline period in which their PTSD symptoms are monitored. This allows researchers to understand each participant's symptoms before starting the intervention. Participants will then begin a 12-week treatment period using the gammaCore device at home. During this time, participants will apply the device to the side of the neck for short stimulation sessions each day as instructed by the study team. Participants will attend six study visits, some conducted remotely and some in person. These visits include screening, training on how to use the device, and follow-up assessments. During the study, participants will complete questionnaires and clinician-administered assessments that measure PTSD symptoms and quality of life. Researchers will also monitor participants for any side effects or medical problems related to the device. By collecting information on symptoms, safety, and device use, this study will help researchers understand whether non-invasive vagus nerve stimulation could become a useful treatment option for people living with PTSD.

The proposed study will test whether a working memory training (WMT) program improves fear extinction learning and its underlying neural circuitry in Veterans with posttraumatic stress disorder (PTSD). WMT is designed to improves the ability to maintain task-relevant information in mind. The project will further validate the relationship between working memory and fear extinction using novel computational and multivariate analyses that link to specific PTSD symptoms. If WMT can enhance fear extinction learning, then WMT may be a powerful adjunctive treatment that can enhance exposure therapy outcomes or be leveraged as a stand-alone treatment. This project supports the Department of Veteran Affairs mission of developing viable targets of treatment for Veterans with PTSD.

Veterans with posttraumatic stress disorder (PTSD) need more effective treatments. Existing options can have limited adherence and can be very time-consuming. As such, alternative interventions are needed. Transcranial magnetic stimulation (TMS) has been FDA-cleared for depression since 2008 and has recently been cleared to treat smoking cessation and obsessive-compulsive disorder. It has demonstrated promise for reducing PTSD symptom severity but standard TMS has a significant time requirement. This study will compare an accelerated 5-day form of TMS versus sham for PTSD, characterizing efficacy and durability. This project will provide important information that can be implemented in the near term for Veterans with PTSD.

The goal of this study is to test whether anesthesia-induced experiences can help alleviate symptoms of PTSD in an (1) open-label trial (Phase I) and (2) single-center double-blind, randomized, active-comparator (dose-controlled) participant-and assessor-blinded Phase 2 clinical trial (Phase II) in a non-surgical setting. Participants will undergo EEG-guided propofol anesthesia during which they will be either (1) receiving a sedation protocol associated with dream experiences upon emergence (Dream Condition), and/or (2) a sedation protocol associated with non-dream experiences (Non-Dream Condition). The investigators will then investigate whether the Dream Condition is associated with a larger reduction in PTSD symptoms than the Non-Dream Condition.

The purpose of this study is to investigate justice-involved Black/African American female adolescents' (JI BAFAs; N=35) self-reported outcomes: stress, posttraumatic stress disorder (PTSD), recidivism, etc., as well as their parents/caregivers' (P/Cs; N=35) stress and pre- and post- intervention results along with their views of an adapted intervention.

This pilot study will examine the safety, tolerability, acceptability, and efficacy of combination psilocybin + psychotherapy to decrease PTSD symptoms. Participants will be randomized into two different treatment groups, allowing the investigators to directly compare PE augmented with psilocybin and psilocybin-assisted psychotherapy.

The goal of this clinical trial is to learn if a family-based treatment called Parenting-STAIR-Modular (PSTAIR-M) can help military parents recover from trauma, strengthen emotion regulation skills, and improve parent-child relationships. Participants will be trauma-exposed active-duty Service Members (SM) or their spouses who screen positive for PSTD and/or depression, and one identified child (ages 2-10). The main questions it aims to answer are: 1) Does PSTAIR-M reduce parental PTSD and depression symptoms, lower parenting stress, and improve child behavior compared to treatment-as-usual?; and 2) Is PSTAIR-M feasible and acceptable when delivered to military families stationed overseas? Researchers will compare PSTAIR-M to treatment-as-usual (TAU) to see if PSTAIR-M leads to greater improvements in parental PTSD, depression, parenting stress, emotion regulation, child maltreatment risk, and child behavior than usual care. Participants will: 1) attend 12-16 weekly, 1-hour online treatment sessions with their assigned clinicians, 2) complete three 1-hour online assessments administered by research staff, 3) engage with their child in three 15-30-minute online, observed play sessions, 4) have assessments and observed play sessions audio and video recorded.

The goal of this study is to examine changes in blood biomarkers following hyperbaric oxygen therapy (HBOT) in military veterans with traumatic brain injury and persistent post-concussive symptoms. The main questions it aims to answer are: 1. Does HBOT produce measurable changes in inflammatory, neurotrophic, and neuronal injury biomarkers from baseline to completion of a 40-session treatment protocol in veterans with TBI and PCS? 2. Does the presence of comorbid PTSD influence biomarker responses to HBOT among veterans with TBI and PCS? Participants will: Complete medical and behavioral health evaluations to determine eligibility. Provide blood samples before treatment and after the final session. Receive 40 HBOT sessions at 2.0 ATA, generally two sessions per day with at least four hours between sessions. Approximately 34 veterans will participate. All participants will receive HBOT; there is no comparison group.

The purpose of this study is to determine the safety and efficacy of HB-1, versus placebo in male and female adult patients aged 18 to 65 years, inclusive, with Post-Traumatic Stress Disorder (PTSD).

Veterans with mild traumatic brain injury (mTBI) and post-traumatic stress disorder (PTSD) commonly experience cognitive impairments including attention and executive function deficits that interfere with their ability to engage in productive personal and social activities. Of the limited interventions available to address cognition, none rigorously train attention beyond strategy management. This study will evaluate an innovatively combined strategy training known as Goal Management Training plus computerized attention training in Veterans with mTBI/PTSD. Preliminary testing suggests an effectiveness in improving problem solving, attention and functional tasks in a small number of Veterans. Considering these promising results, cost effectiveness, and the demand for access to care from Veterans living in rural areas, a Randomized Controlled Trial will determine and compare the effects of this treatment, administered either in-person or via telehealth, on executive function, attention, other aspects of cognition and real life functional tasks.

PTSD is a chronic mental health condition that drastically reduces an individual's quality of life Dextrose injection with a small needle has been used for chronic pain patients and observational results have shown it to be effective in reducing anxiety, brain fog, and depression in patients with PTSD. This randomized trial will compare dextrose injection with an injection control of normal saline (NS)

Post-traumatic stress disorder (PTSD) is a psychiatric disorder than may develop following a traumatic event including serious incidents, natural or human-caused disasters, violence, death of a loved one, receipt of traumatic news, or serious illness/hospitalization. While half of US adults experience trauma in their lifetime, most do not develop PTSD. However, those who do develop the disorder may have significant impairments and risk for functional dysfunction across multiple domains. While short term symptoms are the most common, some individuals develop chronic PTSD. These individuals may experience frightening and intrusive thoughts and memories of the event (flashbacks), have sleep disturbances, feel numb or detached, and be easily startled (hypervigilance). This trial is a double-blind placebo controlled study of cannabidiol (CBD) for symptoms of PTSD in adults using liquid structure Formulation (Nantheia ATL5). Participants complete three weeks of baseline data collection including assessments of activity and sleep. Intervention is Nantheia ATL5 or placebo. Dose is initiated at 400mg BID and maintained over 8 weeks. Standardized symptom profile measurements, clinician assessments, laboratory testing, and suicide screening is completed throughout.

The goal of this clinical trial is to test how exercise affects learning and memory processes relevant to the treatment of PTSD. Participants will complete a baseline intake followed by two experimental sessions. During the first experimental session, participants will undergo an MRI session of imaginal exposure to traumatic memory cues followed by 30-minutes of moderate intensity exercise or low intensity exercise. Participants will complete a second session of imaginal exposure with MRI 24 hours later.

The goal of this study is to assess Parenting STAIR Modular (PSTAIR-M), a promising and innovative intervention for military-connected mothers (MCM) who have experienced trauma and their young children (ages 2-10). PSTAIR-M aims to help mothers manage the strong feelings that sometimes happen after experiencing something scary or stressful, as well as to better connect with their children and manage their behavior effectively. The main questions the study aims to answer are: from pre-treatment to post-treatment 1) Does PSTAIR-M reduce maternal PTSD and/or depression symptoms?, and 2) Does PSTAIR-M improve parental functioning? Participants will: 1) attend 12-16 weekly, 1-hour online treatment sessions with their assigned clinicians, 2) complete three 1-hour online assessments administered by research staff, 3) engage with their child in three 15-30-minute online, observed play sessions, 4) have assessments and observed play sessions audio and video recorded. Participants may also be invited to participate in an optional, 30-minute online one-on-one qualitative interview, which would be audio and video recorded and would cover participants' experiences with the intervention, the clinic sites, and their providers.

The primary aim of this study is to investigate the effect of Internet-delivered Acceptance and commitment therapy for youth with PTSD and comorbid chronic pain. A pilot study (no randomization; N=5-10) will be conducted to test the intervention and assessment procedures. The participants will go through an active internet-based ACT treatment focused on education about PTSD, value-based exposure for the traumatic memory and avoided situations, and behavior change through exercises targeting the processes mindfulness, cognitive defusion and acceptance. The treatment is delivered on a safe internet platform. Participants have planned telephone contact with their assigned psychologist 3 times during the program and can also contact their psychologist via a message system in the platform and expect answer within 48 hours.

Anxiety disorders such as post-traumatic stress disorder (PTSD) and generalized anxiety disorder (GAD) affect a large number of individuals with a significant portion of patients failing to improve with current treatments. The purpose of this study is to understand the brain mechanisms that produce fear and anxiety in humans. To accomplish this goal, we will measure the brain activity along with the heart rate and skin perspiration of patients while they are completing tasks on a computer. Some of the tasks will also use a virtual reality headset and transport the patient in a video game-like environment. These tasks will expose the participants to various levels of fear-provoking images. Participants with responsive neurostimulation (RNS) implants will be enrolled under Pro00117931 at Duke, but their results for fear and anxiety tasks will be reported under NCT05120635.

The goal of this clinical trial is to learn how transcranial magnetic stimulation (TMS) affects brain circuits involving the amygdala in adults with posttraumatic stress disorder (PTSD). The main questions it aims to answer are: * Can MRI-guided TMS engage the amygdala by stimulating an individualized brain target connected to the amygdala? * Does stimulation of this individualized target engage the amygdala differently than stimulation of control sites? * Does a 6-week course of active TMS, compared with sham TMS, change amygdala responses and physiological responses to fear? Researchers will compare active TMS with sham TMS to evaluate changes in the targeted brain circuit and fear-related responses. Participants will: * Receive active or sham TMS every weekday for 6 weeks * Undergo MRI scans with TMS before and after the 6-week intervention to measure brain responses to stimulation * Participate in fear learning and memory tasks while physiological responses are measured * Undergo additional MRI scans, clinical assessments, questionnaires, and cognitive testing * Complete remote follow-up assessments at 1, 6, and 12 months after the intervention

The investigators want to test a treatment for posttraumatic stress disorder (PTSD) especially designed for military veterans and service members with mild or moderate traumatic brain injuries (TBI) and PTSD. The treatment will include individual psychotherapy sessions to manage PTSD.

The overall strategy is to recruit veterans with PTSD who report minimal current cannabis use but are interested in or considering therapeutic cannabis to manage mental health symptoms (anxiety, depression, PTSD and/or suicidality). The information gained from this study could lead to the development of new treatments for persons who suffer from post-traumatic stress disorder and maintain better mental health.

The purpose of this study is to culturally adapt and evaluate an empowerment self-defense (ESD) program (i.e., IMpower) for AI/AN women who have experienced SV in their lifetime and currently experiencing moderate to severe levels of depression and/or PTSD symptoms (primary outcomes). Previous research with non-AI/AN women finds that ESD reduces depression and PTSD symptoms, but no research has examined ESD among AI/AN survivors despite calls from our tribal partners to implement ESD with AI/AN adult women survivors. The investigators have assembled an interdisciplinary expert team and Elders/Traditional Knowledge Keepers (TKKs) as well as Survivor Advisory Board (SAB) in the proposed work.

Cognitive processing therapy (CPT) and prolonged exposure therapy (PE) were widely disseminated as recommended posttraumatic stress disorder (PTSD) treatments. However, post-9/11 Veterans with PTSD rarely initiate CPT or PE, especially as an initial treatment. Little research has explored the combinations and sequences of psychosocial and medication treatments that Veterans receive ("treatment sequences"). One common and understudied treatment sequence begins with stabilization treatment, which is designed to prepare Veterans for CPT or PE. There is a significant research gap in understanding how treatment sequence affects initiation of CPT or PE. The proposed research is an innovative, mixed-methods approach to assessing the impact of variability in treatment sequence, including stabilization treatment, on initiation of CPT or PE and applying this knowledge by developing a health services intervention that facilitates timely transition to CPT or PE. Research aims can improve PTSD treatment by increasing initiation of and reducing disparities in CPT/PE.

Posttraumatic stress disorder (PTSD) is a chronic and often treatment-resistant psychiatric condition that emerges following exposure to trauma and is characterized by intrusive thoughts, emotional dysregulation, and cognitive impairments. In Israel, the prevalence of PTSD has increased significantly in the aftermath of the October 7, 2023 terror attacks, emphasizing the urgent need for more effective, accessible, and personalized interventions. Existing treatments, such as trauma-focused CBT and SSRIs, remain only partially effective, with side effects that reduce adherence and limit long-term recovery. The proposed randomized controlled trial will assess and compare two promising treatment modalities: (i) a new pharmacological combination of reboxetine and methylphenidate, designed to enhance noradrenergic and dopaminergic pathways involved in attention and emotional regulation, and (ii) dog-assisted therapy (DAT), a non-pharmacological, group-based intervention shown to reduce PTSD symptoms and improve functioning. One hundred sixty adults with PTSD will be randomized into four groups: pharmacological treatment, placebo, DAT, or occupational therapy. The study will use validated clinical scales (CAPS-5, GAD-7, CAARS, DLQ, WHOQOLBREF) alongside neurophysiological tools (EEG, EDA, ASAT-based EMG). Data will feed into a machine-learning model to identify predictors of treatment response and support the development of personalized, neurobiologically informed approaches.

Post-traumatic stress disorder (PTSD) and substance use disorders (SUD) are two of the most common and debilitating mental health conditions afflicting military Veterans. PTSD and SUD frequently co-occur and are associated with poorer treatment outcomes. The investigators' team developed a trauma-focused intervention, Concurrent Treatment of PTSD and Substance Use Disorders Using Prolonged Exposure (COPE), which is identified by the VA as a gold standard of behavioral healthcare and was designated as a first-line treatment in the 2025 APA Clinical Practice Guideline for PTSD. However, a critical barrier to ensuring that Veterans with co-occurring PTSD/SUD receive evidence-based treatment is a lack of provider training. This project directly addresses this critical gap by developing a new web-based training program for providers (COPEWeb).

PRE-EMPT will assemble a cohort of 150 participants from three populations (low risk, intermediate risk, and high risk for self-harm). We will obtain clinical assessments, structural and functional MRI utilizing tasks pioneered by our team to assess cognitive control (CC) and emotion regulation (ER), and peripheral circular RNA (circRNA) levels to characterize the molecular brain states associated with behavioral risk. The clinical, imaging, and transcriptomic data will be fused and jointly analyzed to increase the accuracy of our risk prediction models. PRE-EMPT in three separate Aims will then prospectively assess three promising and innovative interventions for their potential to reduce suicidal ideation and alter activity in key neural networks: 1) neurofeedback (NF) using real-time fMRI with simultaneous electroencephalography (EEG), 2) a form of transcranial magnetic stimulation (TMS) called accelerated intermittent theta burst stimulation (aiTBS) with dose optimization through electric field modeling; and 3) psilocybin assisted therapy (PSI), with flexible dosing plan to maximize the depth of psychedelic experience. These therapies were chosen based on our team's prior work in all three interventions demonstrating rapid action and large effects.