Clinical Research Directory

Effects of Stellate Ganglion Block in Post-traumatic Stress Disorder

This study will enroll patients meeting Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) criteria for post-traumatic stress disorder (PTSD). Following an initial screening visit, clinical assessment, and enrollment, subjects will be randomized into treatment and placebo arms. Both cohorts will undergo a pre-intervention functional magnetic resonance imaging (fMRI) of their brain. Treatment subjects will receive unilateral two-level stellate ganglion block via ultrasound-guided injection of anesthetic (bupivacaine) into the cervical sympathetic tissue; placebo subjects will receive an identical volume of saline via the same procedures. At approximately 4 weeks post-procedure, both cohorts will then undergo a post-intervention clinical assessment. Finally, both cohorts will undergo a post-intervention fMRI of their brain.

MDMA-Assisted Therapy for Veterans With PTSD and Alcohol Use Disorder

The study investigators are conducting the first randomized placebo-controlled trial of MDMA-assisted therapy with a comorbid sample of military Veterans with a co-occurring diagnosis of Alcohol Use Disorder (AUD) and Post-Traumatic Stress Disorder (PTSD). This novel experimental treatment package consists of three once-monthly Experimental Sessions of therapy combined with a divided-dose of MDMA HCl, along with non-drug preparatory and integrative therapy. The primary objective of the proposed project is to evaluate safety and clinical outcomes of MDMA-assisted therapy compared to identical psychotherapy with low dose ("active placebo") MDMA for the treatment of PTSD-AUD in military Veterans. The Primary Outcome measures, the Clinician Administered PTSD Scale (CAPS-5) and Inventory of Psychosocial Functioning (IPF), will evaluate changes in PTSD symptoms and psychosocial outcomes over time. Changes in drinking outcomes will also be evaluated (via the Timeline Followback, TLFB).

Intensive Treatment Versus Standard Weekly Prolonged Exposure for Adults With Post-Traumatic Stress Disorder

The goal of this clinical trial is to compare a novel, massed treatment format of prolonged exposure to gold standard trauma focused cognitive behavioral therapy (weekly delivered prolonged exposure) for post-traumatic stress disorder. The objective with this study is to investigate efficacy, mechanisms of change and cost effectiveness of intensive prolonged exposure (I-PE) in regular Swedish psychiatric care. Adult patients with post-traumatic stress disorder will be randomly assigned to receive either gold standard prolonged exposure weekly for 15 weeks or 5 days of intensive treatment with the addition of three booster sessions dispersed 1, 2 and 4 weeks after completion of the massed treatment period. Qualitative interviews will be conducted with therapists to explore their experiences of delivering intensive treatment for PTSD, with particular focus on perceived benefits and challenges, clinical processes, patient engagement, and the impact of the intensive format on therapeutic work.

Nitric Oxide (NO) and Endothelial Dysfunction in Women With PTSD

This research study is conducted to better understand why women with post-traumatic stress disorder (PTSD) have higher risk of cardiovascular disease as they get older. This study looks at how trauma and PTSD affect blood vessels in young women by testing whether the dietary supplement beetroot juice might help improve the function of blood vessels in women suffering from PTSD.

Evaluation of a Trauma-Informed Partner Violence Intervention Program

The goal of this study is to conduct a randomized controlled trial (RCT) comparing outcomes between two programs to reduce intimate partner violence (IPV)- the Strength at Home (SAH) program and a standard, state-approved IPV intervention program, Treatment as Usual (TAU). Primary outcomes will include self- and partner-reported physical and psychological IPV. Secondary outcomes will include self-reported PTSD symptoms, alexithymia, alcohol use problems, and treatment satisfaction, assessed across five time points.

TMS-fNIRS Personalized Dosing

The intent of this study is to establish technical feasibility in a clinical population (PTSD, with or without mild TBI) of personalized TMS-fNIRS technology. Thereby demonstrating the utility of transcranial magnetic stimulation - functional near-infrared spectroscopy (TMS-fNIRS) technology as a direct measure of frontal brain activity, potentially replacing the indirect motor threshold procedure that may lead to improper dosing of TMS. Personalized TMS-fNIRS technology will guide therapy for depression, post-traumatic stress disorder (PTSD), and/or traumatic brain injury (TBI)

Stepped Care for Posttraumatic Stress Disorder Study

Less than 20% of people with PTSD receive any treatment. This study extends a program of research by the investigator focused on developing adaptive (stepped) interventions for PTSD. The adaptive intervention sequences a digital mental health intervention (DMHI) and brief trauma- and skills-focused treatments for PTSD. The selected treatments are brief and scalable and less burdensome to systems of care. These treatments are: web-administered Skills Training in Affective and Interpersonal Regulation (webSTAIR), Brief STAIR, and Written Exposure Therapy (WET).

An Evaluation of the Safety and Efficacy of TSND-201 for the Treatment of PTSD (EMPOWER-1)

This study is evaluating the safety and efficacy of TSND-201 in adults with PTSD. Eligible participants will enter a 4-week Treatment Period where they will be randomized 1:1:1 to receive one of two doses of TSND-201 or placebo, once per week. Following the Treatment Period, participants will enter an 8-week Follow-up Period.

A Brief Intervention for PTSD - BWRT

The purpose of this study is to investigate if a novel brief intervention for Posttraumatic stress disorder (PTSD) is comparable to other traditional clinical interventions for symptom reduction.

Non-Trauma Intervention to Treat PTSD for Veterans and Service Members Suffering From a TBI

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.

Walk With Me (WWM) for Perinatal Grief

The goal of this clinical trial is to learn if the Along With Me web-based intervention works to decrease posttraumatic stress symptoms and suicidal ideation among bereaved parents following pregnancy and early infant loss. It will also learn whether peer guides provide additional improvements on these outcomes. The main questions it aims to answer are: • Do people who receive Along With Me or Along With Me plus a Peer Guide compared to services as usual have lower posttraumatic stress symptoms and suicidal ideation than those who do not receive the intervention? Researchers will compare Along With Me and Along With Me plus a Peer Guide to services as usual (referrals made in the hospital setting) to see if Along With Me works to prevent and address posttraumatic stress symptoms and suicidal ideation. Participants will: * Receive access to a mobile app with approximately 10 therapeutic modules about how to manage grief and other symptoms. * Receive check-ins with a Peer Guide (in the Peer Guide condition only)

Web-administered STAIR for Patients on Behavioral Health Waitlists

Posttraumatic stress disorder (PTSD) is a significant public health challenge with population prevalence rates in the US between 6.1 to 9.2%. There are large racial and socioeconomic inequities in access to PTSD treatment, as up to half (30-50%) of patients in safety net clinical settings meet criteria for PTSD, yet only 13% receive any behavioral health treatment. Workforce shortages are one major barrier to accessing care. Additional barriers to care can include heightened mental health stigma and mistrust of health services. Digital mental health interventions (DMHIs) may be suitable within the continuum of care for PTSD in hospital settings, given their potential for rapid-access, scalability, and the high acceptability of DMHI among individuals with high stigma and social needs. Among the available DMHIs for PTSD, the investigators have selected web-administered Skills Training in Affective and Interpersonal Regulation (webSTAIR), based on emerging scientific evidence and a close collaboration with Boston Medical Center (BMC) users (patients and providers) in a previous pilot study in primary care. The aim of this randomized study is to implement webSTAIR at BMC in the Recovery from Stress and Trauma through Outpatient Care, Research, and Education (RESTORE) Center's subspecialty clinic.

Mindfulness-based Psilocybin Therapy for PTSD

The goal of this study is to learn how psilocybin delivered with mindfulness-based therapy may help symptoms of posttraumatic stress disorder (PTSD). This is an assessor-blinded, randomized, controlled study in participants with PTSD. The study will investigate the changes in brain activity, connectivity, and microstructural neuroplasticity assessed using EEG/EMG and multimodal MRI measures after administration of one oral dose of psilocybin, accompanied either with standard "psychological support" only; or with standard support plus Mindfulness-based Cognitive Therapy (MBCT).

CO2 Reactivity as a Biomarker of Non-Response to Exposure-Based Therapy

Anxiety-, obsessive-compulsive and trauma- and stressor-related disorders reflect a significant public health problem. This study is designed to evaluate the predictive power of a novel biomarker based on a CO2 challenge, thus addressing the central question "can this easy-to-administer assay aid clinicians in deciding whether or not to initiate exposure-based therapy?"

Cannabidiol as a Treatment for PTSD and PTSD Comorbid With TBI

This will be a randomized placebo controlled study to test the efficacy of cannabidiol (CBD) as a treatment for symptoms of post-traumatic stress disorder (PTSD). Subjects, 120 in total, will be males and females with PTSD, half of which will have comorbid mild traumatic brain injury (TBI). There will be three study arms, each with 40 subjects: 1) Oral CBD 400 mg daily; 2) Oral CBD 800 mg daily, and 3) Placebo daily. Treatment duration will be 8 weeks. The primary outcome will be change in PTSD symptoms as measured by change in the Clinician-Administered PTSD Scale (CAPS-5) total score.

Wayne State Warriors Marijuana Clinical Research Program: Cannabinoid Adjunct to Prolonged Exposure & Recovery

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.

A Pilot Study of Trauma-Focused Cognitive-Behavioral Therapy for Treatment of Post-traumatic Stress in Adults.

Post-traumatic stress disorder (PTSD) is a mental health condition that's triggered by the experience of potentially traumatic events. Complex PTSD (CPTSD) includes additional symptoms that account for a disturbance of the organization of the self. Randomized controlled trials have shown that trauma-focused cognitive behavioral therapy (TF-CBT) is effective in reducing PTSD symptoms; however, there is insufficient evidence to support the effectiveness of this intervention for CPTSD. The present study aims to evaluate the feasibility and acceptability of TF-CBT therapy for complex presentation (TF-CBT-CP) in a videoconference modality in adults diagnosed with PTSD or CPTSD who are treated at community mental health care services (CMHCS, COSAM in Spanish) and the Hospital of the Maule Region, Chile. This pilot study will use a mixed design. The quantitative component will consist of a one-group pre-post-follow-up design, which will include 13 adults diagnosed with PTSD or CPTSD referred to care at CMHCS or hospitals of the Maule Region, Chile. Telephone interviews will collect qualitative data relevant to the study's acceptability. Participants will receive TF-CBT-CP therapy. It consists of 16 weekly 60-minute sessions of trauma-focused cognitive behavioral therapy for complex presentations. To determine the feasibility of TF-CBT-CP therapy, eligibility, recruitment, participation, activity completion, retention, exit, and dropout rates will be considered. To establish the acceptability of the protocol, participant satisfaction with the recruitment, assessment, and treatment process and reporting of reasons for non-participation or dropout will be assessed. Furthermore, secondary outcomes consider the reduction of PTSD and CPTSD symptomatology, depression, and anxiety and the improvement of indicators of emotional regulation and psychological well-being.

Effect of Aquatic Therapy and Subsequent Training on Veterans With PTSD

This project investigates the effect of Aquatic Therapy followed by group training for 50 veterans diagnosed with PTSD. Around 40% of Danish veterans experience insufficient benefit from current standard treatments, especially regarding sleep and quality of life. The study is a single-group, pre-post feasibility study, where participants receive 16 weeks of individual aquatic therapy (twice weekly) in a 34 °C pool, followed by 16 weeks of group-based aquatic exercise (once weekly). Participants are recruited through military psychiatric clinics and veteran organizations. The primary outcome is change in PTSD symptoms measured by the PCL-M questionnaire. Secondary outcomes include sleep quality (PSQI), quality of life (WHO-5), anxiety and depression (HSCL-25), and social participation. Data are collected before, after, and at one-year follow-up. The study also evaluates feasibility in terms of recruitment, adherence, acceptability, and follow-up rates. The aim is to achieve clinically relevant reductions in PTSD symptoms, improved sleep, and enhanced quality of life. The project is conducted in collaboration with military psychiatric services, and veteran organizations, and is managed by Gentofte Hospital. The intervention is considered safe and non-invasive, and all ethical and data protection regulations are followed. The project will provide rapid access to new treatment, generate knowledge for national implementation. Previous studies indicate marked and lasting improvements in sleep, symptoms, and quality of life, supporting reintegration into work and social life.

Psilocybin-Assisted Cognitive Processing Therapy for Chronic PTSD

This is an open-label trial evaluating feasibility, tolerability, safety and efficacy of psilocybin assisted cognitive processing therapy for chronic Posttraumatic Stress Disorder (PTSD).

Advanced Wireless Augmented Reality-Enhanced Exposure Therapy for Posttraumatic Stress Disorder

The goal of this trial is to test how augmented reality exposure therapy (ARET) may potentiate the effects of traditional exposure therapy administered to U.S. military personnel diagnosed with PTSD. 40 adult males and females over the age of 18 that have served, or are currently serving, in the U.S. military, with a current diagnosis of PTSD, will be recruited. Participants will be randomized into two groups: 20 participants will receive ARET + traditional ET, with the remaining 20 to receive traditional ET only. The main questions this trial aims to answer are: * what are the different clinical and psychosocial functioning outcomes between veterans/active-duty personnel with PTSD who receive ARET + traditional ET versus traditional ET only * what are the differences in acceptance and satisfaction of treatment, between ARET + traditional ET and the traditional ET-only group

MOSAIC (MOthers' AdvocateS In the Community) for Pregnant Women and Mothers of Children Under 5 With Experience of Intimate Partner Violence

The purpose of this R34 exploratory research proposal is to conduct formative work for a larger randomized controlled trial (RCT) evaluating the effectiveness of the "Mother AdvocateS In the Community (MOSAIC) Plus" intervention to reduce depressive and PTSD symptoms and prevent additional IPV among pregnant women and mothers with children under 5 experiencing IPV. The MOSAIC Plus intervention will integrate IPT principles and skills into the MOSAIC intervention in order to expand it to address consequences of IPV, including depression and PTSD symptoms. The proposed study will enroll pregnant women who report experience of IPV in the past 6 months, and who screen positive for elevated depressive and/or PTSD symptoms. The intervention lasts 6 months after enrollment.

Building Ukraine's Strength in PTSD Treatment and Research

The Lux4UA project aims to support mental health treatment in Ukraine, especially for those who have experienced traumatic events due to the ongoing conflict and forced displacement. As rates of Post-Traumatic Stress Disorder (PTSD) rise among civilians, military personnel, and refugees, the need for effective trauma care becomes urgent. PTSD is a mental health condition that can develop after experiencing trauma, leading to flashbacks, nightmares, anxiety, and other symptoms that significantly impact daily life. This project introduces an innovative method called the Reconsolidation of Traumatic Memories (RTM) Protocol, which helps individuals reduce distressing memories and trauma-related symptoms. Unlike traditional therapies, the RTM Protocol aims to quickly alleviate PTSD symptoms without requiring patients to relive or discuss in detail their traumatic experiences, which can sometimes be overwhelming. Instead, it employs carefully guided imaginary exercises to help patients reprocess and feel less emotional distress when recalling traumatic memories. This structured approach can lead to significant improvements in just three to five sessions. The Lux4UA project brings together mental health professionals and researchers from Ukraine, Luxembourg, and the United States to test how well this treatment works in Ukraine and to understand if it can be easily integrated into the country's mental health system. By studying the RTM Protocol in three main settings-hospital care and outpatient (walk-in) clinics for veterans and therapy practices for civilians-the project will assess the treatment's effectiveness for people with different needs and backgrounds. It will also evaluate how comfortable and satisfied both mental health practitioners and patients are with the treatment. A key part of the project is training Ukrainian mental health professionals in the RTM Protocol. This training ensures that local mental health professionals are well-prepared to deliver the treatment and support trauma survivors long after the project ends, building a sustainable mental health system in Ukraine. The project will involve careful monitoring of how patients respond to the treatment, paying special attention to their well-being throughout each session. To evaluate the treatment's success, the project will measure changes in PTSD symptoms, as well as signs of anxiety and depression that often accompany trauma. The project will also assess the RTM Protocol's adaptability to Ukrainian needs, seeing if any modifications are necessary to better suit the local context.

Sleep and Emotion Processing in Adolescent Post-traumatic Stress Disorder

The goal of this clinical trial is to characterize the role of sleep, emotion processing, and daily affect in post-traumatic stress disorder (PTSD) and whether improving sleep quality using slow wave activity enhancement will impact next-day affect in youth. Participants will attend 4 study visits: * A clinical and trauma assessment visit * A testing day that may include cognitive testing, surveys, and an MRI. * An overnight sleep study following one week of at-home sleep recordings with the device in the sham condition * An overnight sleep study following one week of at-home sleep recordings with the device in the sleep enhancement condition

rTMS-augmented Written Exposure Therapy for PTSD

Post-traumatic stress disorder (PTSD) is prevalent and represents a high healthcare burden among Veterans. Repetitive transcranial magnetic stimulation (rTMS) is a brain-based therapy that may be effective for treating PTSD. The theorized mechanism of rTMS is enhancement of emotional flexibility via the dorsolateral prefrontal cortex node of the brain's cognitive control network. Given this mechanism of action, adding rTMS to an evidence-based psychotherapy (EBP) for PTSD may enhance treatment effects. Written exposure therapy (WET) is a brief EBP for PTSD found to reduce attrition compared to lengthier first line treatments. In this study, the investigators will determine if active rTMS added to WET compared with sham rTMS added to WET results in improved PTSD outcomes. The investigators will also determine if emotional flexibility is a mechanism of symptom improvement. This work will improve upon PTSD intervention and inform the mechanism of treatment effectiveness for Veterans suffering from PTSD.