Post Traumatic Stress Disorder (PTSD)

The purpose of this study is to learn more about the effectiveness of a prescription wrist-wearable device called NightWare (NW) on improving sleep in Veterans with nightmares related to posttraumatic stress disorder (PTSD). The investigators also want to learn whether it improves cardiovascular health among this population.

Participants in this study will have already been enrolled in another research study: Combining Stellate Ganglion Block with Prolonged Exposure for PTSD, NCT05889741. The investigators are using a Sleep Profiler, EEG headband to monitor a participants brainwaves while they sleep to see what effects the Stellate Ganglion Block injection has on their sleep. Participants will wear the headband for 3 nights before the injection and then 3 nights after the injection. Participants will also complete self-report questionnaires regarding their sleep prior to the injection and following the injection. Approximately 40 participants will be included in this study. This study is a nested observational study whereby participants in the parent study who elect to participate will have their sleep assessed using the EEG headband device and self-reported sleep measures performed.

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 exposure to a potential traumatic event (PTE) is common in the general population. This exposure may lead to psychiatric disorders such as acute stress disorder (ASD) and post-traumatic stress disorder (PTSD). Previous exposure to PTE is a well-known risk factor for ASD and PTSD. This may rely on the so called "kindling" which consists in a increasing sensitization of thememory circuits and emotional regulation through this previous and/or repeated exposure. An early psychological intervention may prevent these diseases or at least decrease the symptoms and improve functional functioning. Defusing is an early and brief psychotherapeutic interview technique which aims at encouraging a victim exposed to a PTE to express her/his own experience concerning the PTE. Some preliminary results reported that defusing could alleviate the emotional distress induced by a PTE. The PREDEKIT study hypothesizes that defusing prevents the sensitization (kindling) induced by a potentially traumatic event. This study is a prospective, randomized, controlled, multicenter trial with blinded outcome assessment. Participants can be included in the study they are exposed to a PTE and tif they can receive a defusing intervention in the very early phase following the PTE (first 24 hours). The test group will receive defusing while the control group will receive First Psychosocial Aid Primary and secondary outcomes will assess emotional distress, intrusive symptoms, physiological outcomes relevant for the stress response (blood pressure, heart rate, electrodermal activity). The last evaluation takes place 1 month after the PTE

The purpose of this research study is to find out how Zulresso®/brexanolone influences Posttraumatic Stress Disorder (PTSD) symptoms and alcohol use.

The overall objective of the proposed study is to determine if Dexmedetomidine HCl (BXCL501) is safe for treatment of alcohol use disorder (AUD) with comorbid posttraumatic stress disorder (PTSD) in an outpatient setting and also shows potential signals of efficacy thereby supporting the conduct of later phase clinical trials.

The goal of this pilot clinical trial is to learn if a faster brain stimulation schedule is practical, safe, tolerable, and acceptable. This study looks at accelerated intermittent theta burst stimulation, or accelerated iTBS. This is a non-invasive type of magnetic brain stimulation. This study is for adults with post-traumatic stress disorder (PTSD) and major depressive disorder (MDD). The main questions this study aims to answer are: 1. Can participants complete six short brain stimulation sessions per day for five days? 2. Is this treatment schedule safe and tolerable for participants? 3. What changes occur in depression symptoms, PTSD symptoms, anxiety, quality of life, and brain activity over time? Participants will: 1. Complete health screening and baseline assessments. 2. Receive six short sessions of magnetic brain stimulation per day for five days. 3. Have their brain activity measured using an EEG recording. 4. Return for a post-treatment assessment at Week 2 and follow-up visits at Week 5 and Week 12.

This study is testing a new version of a treatment called the Reconsolidation of Traumatic Memories Protocol for Children (RTM-C Protocol). The RTM Protocol™ is already proven to help adults with post-traumatic stress disorder (PTSD) by reducing distressing memories, flashbacks, and nightmares. The children's version is specially adapted to meet the needs of children aged 6-14, using child-friendly language, games, and animated tools. The purpose of this study is to find out whether the RTM-C Protocol can safely and effectively reduce post-traumatic stress symptoms in children who have experienced trauma. We also want to know whether children, parents, and therapists find the method acceptable and easy to use. Children and their parents will take part in a series of sessions with a trained specialist. Parents will join an initial session to provide information and give consent. Children will then have up to six therapy sessions, during which they learn to safely "replay" their difficult memories in imaginative ways that reduce their fear. Parents and children will complete questionnaires about symptoms before and after the sessions, as well as at 1 and 6 months after completion. Study Question: Can the RTM-C Protocol reduce post-traumatic stress symptoms in children and improve their daily functioning (such as relationships, learning, and happiness)? Study Hypothesis: RTM-C Protocol will lead to a significant reduction in PTSD symptoms in children, with improvements maintained at follow-up, and will be rated as acceptable and feasible by children, parents, and therapists.

This study evaluates the implementation and clinical effectiveness of the Trauma Resilience and Recovery Program (TRRP 2.0), a technology-enhanced behavioral health intervention designed for trauma center patients. TRRP 2.0 integrates screening, monitoring, and referral services for posttraumatic stress disorder (PTSD), depression, and substance use disorder (SUD). The study uses a two-phase design across two trauma centers: a usual care phase followed by implementation of TRRP 2.0. A total of 300 adult trauma patients will be recruited and followed for 3 months to assess behavioral health service utilization and clinical outcomes.

Post-traumatic stress disorder (PTSD) is a pathology that impairs the quality of life of sufferers. In military personnel, it can lead to military incapacity. This psychopathology is characterized by confrontation with one or more traumatic events in the individual's life history. Symptoms include cognitive and mood disorders, avoidance, hyperactivation (hypervigilance and anger) and intrusions (flashbacks and nightmares). Studies show that the prevalence of PTSD in military personnel fluctuates considerably from one situation to another (pre-deployment/post-deployment, etc.). In these at-risk populations, the often more complex PTSD clinic may also account for the heterogeneity of prevalences observed. Nevertheless, PTSD tends to become chronic in military personnel, making it particularly difficult to return to a "previous" state. In French casualties, beyond the symptoms already mentioned, complaints focus on difficulties in social interaction situations involving others in social life (attachment style to others) and in everyday life (public transport, supermarket shopping, social interactions, presence of crowds...). In the context of post-traumatic stress disorder, the investigators would like to explore the processes of social cognition that enable people to interact in their environment, in relation to biological, psychosocial and physiological variables that may constitute risk or maintenance factors for the pathology.

The goal of this randomized controlled trial is to evaluate the efficacy of psilocybin administered with Acceptance and Commitment Therapy (ACT) as an intervention to reduce post-traumatic stress disorder (PTSD) symptom burden in adult (aged 18-65) survivors of intimate partner violence (IPV). This trail will test the following 2 aims: AIM 1 : To compare the efficacy of a therapeutic psilocybin dose at improving outcomes on the PCL-5 and CAPS-5 as compared to an active control psilocybin dose in IPV survivors with chronic PTSD. AIM 2: To evaluate the efficacy of psilocybin on quality of life, cognitive function, motor ability, depression, anxiety, and cognitive flexibility. Participants will be asked to: * Complete a 2 part screening process * Attend a baseline assessment * Complete a psychoeducation preparation session(s) * Attend psilocybin administration session (receive high dose \[25mg\] or low dose psilocybin \[1mg\]) * Complete 5-6 weekly sessions of ACT * Repeat outcome measures at 1-week, 4 weeks, 3 months (online questionnaires only), and 6 months post-psilocybin administration.

Post-traumatic stress disorder (PTSD) is commonly treated with trauma-focused psychotherapy, including prolonged exposure therapy and eye movement desensitization and reprocessing (EMDR). Patients frequently also use psychotropic medications for insomnia, anxiety, or other PTSD-related symptoms. In a previous cohort study of more than 6,000 adults with PTSD treated in 2021-2024 (https://doi.org/10.1159/000549259), psychotropic co-medication was associated with less improvement in PTSD symptoms after adjustment for 27 baseline covariates; the overall association persisted at 6-month follow-up. Antidepressants overall, and amitriptyline and mirtazapine specifically, showed the most consistent associations across sensitivity analyses. Whether discontinuing these medications before psychotherapy improves treatment outcome remains unknown. This policy-driven natural experiment investigates whether tapering and discontinuing selected psychotropic medications before intensive trauma-focused psychotherapy is associated with greater improvement in PTSD symptoms than continuing the same medications during psychotherapy. In late 2026, the same specialized trauma treatment center (PSYTREC) will introduce a revised medication-review policy. Medication use and indication are verified, and amitriptyline, mirtazapine, quetiapine, topiramate, zolpidem, and zopiclone are tapered and discontinued before psychotherapy when prescribed off-label for PTSD-related symptoms and when discontinuation is considered clinically appropriate and safe. Patients treated under the 2026 policy will be compared with similar patients treated in 2021-2024 who used the same medication but continued it during psychotherapy. Statistical adjustment will further account for clinically relevant baseline differences. Sensitivity analyses will assess whether changes in psychotherapy outcomes over calendar time could explain the findings by examining matched patients whose medication management was unaffected by the policy. The main hypothesis is that discontinuation before trauma-focused psychotherapy is associated with greater reduction in PTSD symptoms. Longer-term PTSD outcomes and the clinical feasibility of medication discontinuation will also be evaluated.

Intrusive memories of traumatic events are a core feature of Post-Traumatic Stress Disorder (PTSD) and can cause substantial distress and functional impairment. Existing trauma-focused treatments are effective but often require deliberate recollection of traumatic experiences, which can be distressing for some individuals. Previous experimental studies in healthy participants found that masked reactivation of trauma-related cues, followed after a brief interval by a visuospatial interference task using Tetris gameplay, reduced the frequency and emotional intensity of intrusive memories. Building on these findings, the present randomized controlled trial evaluates the efficacy of this intervention in trauma-exposed individuals experiencing three or more intrusive memories per week.

Intrusive traumatic memories frequently trigger severe distress and psychological disorders such as post-traumatic stress disorder (PTSD). Traditional therapies require explicit trauma recall, which often causes severe patient distress and may lead to treatment avoidance. To address this, our study introduces a less aversive intervention that combines unconscious visual processing with bilateral eye movements to reduce intrusive traumatic memories. Utilizing a randomized, three-arm design, we will compare standardized trauma-related images, patient-provided images, and neutral images, all paired with bilateral eye movements. We plan to recruit participants who have experienced severe trauma and report at least 5 intrusive memories per week, with a target final sample of 40 participants per arm. The primary outcome is the frequency of intrusive memories. Secondary and additional outcomes include PTSD severity, as measured by the Clinician-Administered PTSD Scale for DSM-5 (CAPS-5), the PTSD Checklist for DSM-5 (PCL-5), and the Impact of Event Scale (IES), as well as depression, anxiety, borderline symptoms, functional improvement, subjective intervention distress, and dropout rates.

This study aims to characterize emotional dysregulation in complex post-traumatic stress disorder (cPTSD) and to determine the extent to which it can promote the distinction with borderline personality disorder (BPD) and post-traumatic stress disorder (PTSD). As emotional dysregulation is a dynamic process whose phenomenological manifestations are labile, associated with physiological modifications and modulated by cognitive processing, a multiple methodology associating measurements in a real-life ecological context with measurements performed in the hospital will be preferred. Overall, this study proposes to capture, for the first time, the clinical manifestations associated with cPTSD from the perspective of emotional dysregulation and its underlying processes

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

This study explores whether participating in an 8-week Brazilian Jiu-Jitsu (BJJ) program is linked to changes in trauma-related symptoms among first responders. Many first responders experience ongoing stress or exposure to traumatic events, and some prefer physical, movement-based activities rather than traditional clinical services to support their well-being. In this study, participants will attend BJJ classes one to two times per week for eight weeks. They will also complete short daily and weekly questionnaires about mood, stress, and well-being, write brief weekly reflections, and participate in a one-on-one interview after the program. The study aims to understand both symptom patterns and participants' personal experiences with emotional regulation and overall wellness during the program. This study does not provide mental health treatment and will not diagnose or treat PTSD. Instead, it examines whether BJJ, as a non-clinical physical activity, may offer supportive benefits for first responders.

Post-traumatic stress disorder (PTSD) develops after life-threatening events, with domestic violence and sexual assault being major risk factors. An innovative approach using traumatic memory reactivation with propranolol has shown promise in reducing PTSD symptoms. This study aims to compare the efficacy of propranolol with trauma-focused psychotherapy in women suffering from severe PTSD after violence.

The purpose of this research study is to learn about how Shared Decision Making, when used to decide treatment, impacts treatment engagement, retention, and outcomes for active duty military personnel seeking treatment for posttraumatic stress disorder (PTSD). Shared Decision Making between the service member and the therapists will be used to match patients to 1 of 3 different types of therapy for PTSD: (1) Prolonged Exposure (PE) therapy, (2) Cognitive Processing Therapy (CPT), or (3) Written Exposure Therapy (WET) in 1 of 2 different frequencies: (1) massed (daily) or (2) spaced (weekly).

The VA wants to understand what type of integrative and whole health approaches are helpful for Veterans. The study is comparing two primary care based mental health treatments, a mindfulness class that teaches mindfulness meditation and a problem-solving class that teaches problem-solving skills and how to build resilience, for Veterans who are experiencing symptoms of anxiety, depression, and/or PTSD. The goal of the study is to understand if the classes reduce symptoms of anxiety, depression, and/or PTSD and increase overall functioning.

Post-traumatic stress disorder (PTSD) is a highly prevalent and debilitating condition among veterans and active-duty military personnel, with rates as high as 30% in certain combat-exposed populations. Conventional treatments such as prolonged exposure therapy and pharmacotherapy have limited efficacy and high dropout rates, highlighting the need for novel, rapidly effective interventions. Transcranial magnetic stimulation (TMS) has been well established for treatment-resistant depression (TRD). Traditional TMS, which involves 6 to 7 weeks of daily, weekday scalp-targeted treatment, shows open-label response and remission rates of 58.1% and 30%, respectively. However, such protocols may be impractical for military personnel with limited medical leave. A new form of accelerated TMS (aTMS) that involves 10 imaging-guided treatments per day for 5 consecutive days has demonstrated substantial antidepressant benefits within days and response rates of 69% at 1-month follow-up. This protocol has not been tested for PTSD, in part because there was no causally informed brain circuit target. In this study, the investigators will test aTMS for PTSD using a novel PTSD circuit that the investigators have derived.

Post-Traumatic Stress Disorder (PTSD) and trauma-related symptoms are often characterized by recurrent intrusive memories that cause distress and interfere with daily functioning. Although trauma-focused interventions such as Eye Movement Desensitization and Reprocessing (EMDR) may be effective, they often involve engagement with trauma-related memories, which can be distressing for some individuals and may affect treatment acceptability. This randomized controlled trial will evaluate a standardized eye-movement-based procedure for trauma-exposed individuals experiencing recurrent intrusive memories. Participants will be randomly assigned to one of several memory-related task conditions involving eye movements. The study will assess the frequency and distress of trauma-related intrusive memories at prespecified assessment points, as well as PTSD symptoms, intervention-related distress, acceptability, and safety. Findings from this trial may help inform the development of tolerable approaches for targeting trauma-related intrusive memories.

The rationale for the use of inhalational cannabis to potentially treat PTSD symptoms is based on the many reports of cannabis attenuating PTSD symptom expression among individuals with PTSD, including veterans. Study MJP2 is intended to build off MJP-1 through use of a larger sample size, a parallel study design, and subjective bias mitigation methods to re-examine the use of inhaled high THC-containing cannabis versus placebo for management of PTSD symptoms in a U.S. Veteran sample. Together these studies are intended to provide valuable insights on the already widespread use of cannabis in individuals with PTSD, for which there is currently a lack of controlled evidence available reflective of this real-world use.

Brief Title: PTSD Risk Prediction Model for EICU Survivors Official Title: Development and Validation of a Risk Prediction Model for Post-Discharge Post-Traumatic Stress Disorder in Emergency Department-Admitted EICU Survivors Study Type: Observational Brief Summary: This study aims to develop and validate a risk prediction model for post-traumatic stress disorder (PTSD) at 1 month after hospital discharge in adult survivors of emergency intensive care unit (EICU) care. PTSD is a common and serious psychological condition that can occur after a life-threatening medical event. Many EICU survivors experience persistent stress responses, sleep problems, avoidance behaviors, and difficulty returning to normal life after leaving the hospital. This prospective observational cohort study will enroll approximately 800 adult patients who are admitted to the EICU through the emergency department at Sir Run Run Shaw Hospital and other participating centers. Participants will be followed up at 1 month after EICU discharge to complete the Clinician-Administered PTSD Scale for DSM-5 (CAPS-5), a diagnostic interview for PTSD. Clinical data collected during the emergency department stay and EICU course-including vital signs, laboratory tests, treatments, and severity of illness-will be used to build statistical models to predict which patients are most likely to develop PTSD. The study does not involve any experimental treatments or additional procedures beyond routine clinical care. Results from this study may help healthcare providers identify high-risk patients early and provide timely psychological support and follow-up care. Detailed Description: Background: Advances in critical care medicine have enabled an increasing number of emergency critical care patients to survive to ICU or hospital discharge. However, a substantial proportion of survivors experience persistent psychological sequelae, including post-traumatic stress disorder (PTSD), which significantly impairs quality of life. Patients admitted to the EICU via the emergency department are exposed to multiple stressors during the early phase-sudden life-threatening illness, pain, hypoxia, altered consciousness, mechanical ventilation, sedation, and separation from family-which may serve as important risk factors for subsequent PTSD. Objectives: To develop and validate a risk prediction model for predicting 1-month post-discharge PTSD in adult patients admitted to the EICU via the emergency department. Study Design: This is a prospective observational cohort study conducted at Sir Run Run Shaw Hospital, Zhejiang University School of Medicine (coordinating center) and multiple other centers. Study Population: Adult patients (≥18 years) admitted to the emergency department and subsequently transferred to the EICU, with an ICU length of stay of at least 24 hours, who survive to EICU discharge and have a Glasgow Coma Scale score ≥12 at discharge or follow-up. Sample Size: Approximately 800 patients (approximately 200 per center if 4 centers participate), calculated based on an estimated 25% PTSD prevalence at 1 month post-discharge, with 6-8 candidate predictors, expected Nagelkerke R² of 0.15, target shrinkage of 0.90, and accounting for 15%-20% attrition. Data Collection: All variables are routine clinical observation and laboratory parameters, categorized into six domains: (1) baseline susceptibility variables (demographics, social support, psychiatric history, trauma history, prior ICU admission, substance use, chronic disease burden); (2) emergency admission phase variables (mode of admission, severity, vital signs, etiology, early labs, emergency treatments); (3) first 24 hours in EICU variables (severity scores, organ support, sedation/analgesia, neurological status, nursing exposures, early complications); (4) cumulative EICU exposure variables (duration of organ support, cumulative sedation/analgesia, mechanical ventilation duration, physical restraints, delirium, infections, major complications); (5) disease process and treatment-related variables (severe infection, respiratory failure, AKI, ARDS, transfusion, emergency surgery, intubation, CPR); and (6) 1-month post-discharge follow-up (CAPS-5 diagnostic PTSD assessment). Primary Outcome Measure: CAPS-5-diagnosed PTSD at 1 month post-EICU discharge. Statistical Analysis: Three types of prediction models will be developed: (1) an early model using variables available within the first 6 hours from emergency department presentation to EICU admission; (2) a discharge-updated model adding ICU exposure, treatment interventions, complications, and pre-discharge information; and (3) a dynamic digital model further adding post-discharge electronic follow-up and digital phenotyping data. Candidate modeling approaches include logistic regression, LASSO/ElasticNet penalized regression, random forest, gradient boosting trees, XGBoost/LightGBM, and support vector machines. Model performance will be evaluated for di

This is an open-label pilot study designed to evaluate the safety, tolerability, and preliminary clinical effects of psilocybin-enhanced trauma-focused psychotherapy in individuals with post-traumatic stress disorder (PTSD). Participants will receive a structured therapeutic protocol that includes preparatory sessions, two psilocybin administration sessions (15 mg followed by 25 mg), and integration sessions based on a trauma-focused therapeutic approach. The primary objective of the study is to assess the safety and tolerability of psilocybin administration in this clinical population. Secondary objectives include evaluating changes in PTSD symptom severity, as measured by the Clinician-Administered PTSD Scale (CAPS-5), at 30 days following treatment. This pilot study will include 13 participants and is intended to inform the feasibility and design of a subsequent randomized controlled trial.