Clinical Research Directory

Redefine Study: A Study Evaluating the Efficacy, Safety, and Tolerability of COMP360 in Participants With Post-traumatic Stress Disorder

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.

MentalGym™ and NeuroBrave™ Guided Wearable-Assisted Physiology Regulation Training for PTSD (PRTP)

This randomized controlled trial (RCT) will evaluate the effectiveness of a digital biofeedback-based intervention ("Mental Gym®") designed to reduce Posttraumatic Stress Disorder (PTSD) symptoms and improve mental health. The intervention combines daily HRV biofeedback exercises using a wearable device (Garmin watch), a dedicated mobile application, and weekly group guidance sessions. A delayed-intervention control group design will be used. To account for expected attrition and ensure a final sample of 60 participants, approximately 80 subjects will be recruited. Physiological and self-report data will be collected pre- and post-intervention, weekly during the intervention, and at follow-ups (3 months post-intervention). The study population consists of combat veterans diagnosed with PTSD.

Validation of an Algorithm for Predicting Awakenings Associated With Trauma-related Nightmares, Based on the Analysis of Physiological Patterns in Military and Former Military Patients Suffering From Post-traumatic Stress Disorder

The goal of this clinical trial is to validate an artificial intelligence algorithm called CAUD-PIN (CAUchemar Detection on INdividualized Parameters) to predict nightmare-related awakenings in military personnel and veterans suffering from post-traumatic stress disorder (PTSD). The main question it aim to answer is : * Can the CAUD-PIN algorithm detect physiological patterns preceding trauma-related nightmare awakenings with a sensitivity greater than 80%? * What physiological signals best predict the occurrence of a trauma-related nightmare awakening? Participants will: Wear two non-invasive devices at home - an EEG headband and a wrist-worn sensor bracelet - for 15 consecutive nights Press a button on the bracelet each time they wake up from a nightmare Complete sleep and daytime diaries every evening and morning Attend two clinical assessments (at enrollment and at the end of the study, one month later) at one of the three participating military hospitals The algorithm will be applied to the recorded data after collection and does not intervene in real time or affect participants' standard medical care in any way.

Effects of Mindfulness and Self-regulation Training on Anxiety, Depression, PTSD, and Leadership

The goal of this study is to measure the effects of Mindfulness-based Mind Fitness Training (MMFT) on anxiety, depression, post-traumatic stress disorder, sleep quality, and leadership.

Treatment for PTSD and Tinnitus

In this study, researchers are examining the best sequence of interventions for posttraumatic stress disorder (PTSD) and tinnitus. Participants will either receive psychotherapy for PTSD first (Cognitive Processing Therapy; CPT), followed by treatment for tinnitus (Cognitive Behavioral Therapy for Tinnitus; CBT-t); or vice-versa. We also aim to identify changes in brain functioning after receiving therapy.

Dexmedetomidine Combined With Transcutaneous Vagus Nerve Stimulation (taVNS) Can Reduce the Incidence of PTSD in Trauma Patients After Surgery

Emergency trauma surgery patients, due to the dual stress effects of sudden trauma events (such as car accidents, falls, engineering accidents) and surgical trauma, have a significantly higher incidence of post-traumatic stress disorder (PTSD) compared to the general population. This disease, characterized by intrusive memories, avoidance behaviors, negative changes in cognitive emotions, and increased arousal, not only severely hinders patients' postoperative psychological recovery and reduces their quality of life, but may also prolong hospital stays, increase the risk of readmission, and impose a heavy medical and economic burden on families and society. Dexmedetomidine, as a highly selective α₂-adrenergic receptor agonist, possesses sedative, anxiolytic, analgesic, and sympatholytic effects. By regulating the locus coeruleus-norepinephrine system, it can alleviate perioperative stress responses, reduce postoperative anxiety and delirium incidence. In recent years, multiple studies both domestically and internationally have confirmed its potential to prevent PTSD by inhibiting the encoding and consolidation processes of trauma-related memories. In randomized clinical trials, administering dexmedetomidine during and after surgery has been shown to reduce the incidence of PTSD in trauma patients. However, when used alone, some patients still develop PTSD, indicating room for improvement in preventive efficacy. Additionally, there are risks of adverse reactions such as hypotension and bradycardia, which limit its application in certain populations. As a non-invasive vagus nerve stimulation technique, transcutaneous vagus nerve stimulation (taVNS) exerts its effect by stimulating the vagus nerve branches in the cavum concha. It has the advantages of simple operation, high safety, and can be implemented during the perioperative period. It has been proven to regulate the stress response and emotional processing of the central nervous system, reduce stress response scores, and has the potential for perioperative analgesia. However, there is limited research on its early prevention after emergency trauma surgery, and no exploration of synergistic effects with dexmedetomidine. Currently, there is no clinical research on the use of dexmedetomidine combined with taVNS for the prevention of post-traumatic stress disorder (PTSD) in patients undergoing emergency trauma surgery at home and abroad. Existing research mostly focuses on single drugs or single neuroregulation techniques, and there are limitations such as small sample size, short follow-up time, and uncontrolled confounding factors such as perioperative pain and delirium, making it difficult to meet the clinical demand for efficient and safe PTSD prevention schemes.

Multi-component Family Intervention to Lower Depression and Address Intimate Partner Violence in Nepal

Intimate Partner Violence (IPV) is a major public health problem in low- and middle-income countries (LMICs). Globally, an estimated 30% of women report physical or sexual violence by an intimate partner in their lifetime. IPV is a well-established social driver of mental health problems, and doubles the rate of depression and post-traumatic stress disorder (PTSD). Interventions like cognitive behavioral therapy (CBT) can improve depression after women experiencing IPV exit abusive relationships. However, despite ongoing violence, many young women in LMICs are less likely to divorce or separate from their husband. But ongoing IPV severely limits mental health recovery and increases the risks of suicide. Another important factor in many LMICs is that young women often live in extended, multi-generational households, where studies have shown that mother-in-laws (MILs) play a critical role in young married women's autonomy and freedom of movement, substantially affecting her mental health. The pathways via which multiple family members and ongoing IPV affect young women's mental health in LMICs is very poorly understood. There is an urgent need to design and assess interventions that: a) improve mental health and reduce IPV; b) engage husbands and MILs, and not just women experiencing IPV; and c) elucidate pathways via which IPV-related drivers affect mental health. This study's research team, with over 16 years of experience in Nepal, conducted a pilot study introducing the Multi-component family Intervention to Lower depression and Address intimate Partner violence (MILAP). MILAP, which translates to "unity and reconciliation" in Nepali, showed promise in reducing depression and IPV among families (comprising women, husbands, and mothers-in-law). Based on these favorable results, the investigators now propose a 12-month randomized controlled trial (RCT) to assess the effectiveness of MILAP in addressing depression, IPV, and PTSD among young married women in Nepal. The goal of this RCT is to assess the effectiveness of MILAP, understand mechanisms of change for MILAP's effectiveness, and conduct a cost-effectiveness analysis. The specific aims of this study are: AIM 1: Conduct a 12-month RCT to assess the effectiveness of MILAP on depression, IPV, and PTSD among young married women in Nepal. AIM 2: Conduct a mixed-methods assessment of theorized mechanisms of change for MILAP's effectiveness. AIM 3: Conduct a cost-effectiveness analysis of MILAP for depression and IPV. Participants of this study will receive either MILAP or enhanced usual care, and will answer questions about depression, IPV and PTSD at baseline, at 1 month and every 3 months until 1-year.

Empowering Perinatal Adolescents Through Writing

This is a feasibility and acceptability study of Written Exposure Therapy (WET) for PTSD in pregnant and postpartum adolescents and youth with PTSD.

Nutrition for Trauma Community Survey

The survey will help investigators learn everything about how people view and respond to trauma from a holistic perspective through body (nutrition), mind (mental health rejuvenation and renewal), and spirit (faith-based) lens. Researchers aim to evaluate if such practices will be effective in helping participants with significant life challenges due to trauma, negative life events, or extremely stressful events will recover from these types of lifestyles. The responses will be used to shape the integrative protocols that the investigators develop for professionals involved with trauma clients. This can help increase recovery rates and lead to productive lives.

Diet and Microbiome Interactions: Application in Posttraumatic Stress Disorder in Adults Consuming Vegetable Drinks

The gut microbiome has been shown to impact various facets of human health, including mental health. Studies have shown that populations with more agrarian lifestyles tend to have fewer chronic diseases and mental health issues than industrialized populations. A possible factor in these differences is the loss of co-evolved gut microbial taxa that has occurred with Westernization. This hypothesis, termed "Old Friends Hypothesis" suggests that the loss of certain gut microbes leads to immune dysregulation and increased chronic inflammation that contributes to development of cancers, cardiometabolic diseases and even neuroinflammation that can lead to negative behavioral and mental health outcomes. Other studies have shown that increasing the intake of plant foods may help increase diversity of the microbes in the gut and that this increased diversity could lead to better health outcomes in humans. The investigators propose to evaluate daily consumption of a drink consisting of a high diversity of plants (30 plant species) for four weeks on the diversity of the gut microbiome, biological signatures of inflammation, quality of life, sleep quality, and PTSD symptoms among persons with a diagnosis of PTSD. The investigators hypothesize that four weeks of daily consumption of this high plant diversity beverage (30 plant species) will increase gut microbiome ɑ-diversity, reduce markers of systemic inflammation, and improve PTSD symptom severity relative to daily consumption of a beverage containing only three plant species.

An Integrative, Digital Health Approach to Veteran-Centered PTSD Care

The goal of this study is to test the effectiveness of a stress self-management mobile health system (smartphone app + wearable sensor) alongside an intense physical cycling intervention to reduce symptoms of stress in a veteran population. The main questions this study aims to answer are: Does a mobile stress self-management system alongside intensive physical activity reduce the amount of physiologically detected, via machine-learning algorithm, stressful moments or PTSD hyperarousals? Can a mobile stress self-management system alongside intensive physical activity reduce symptoms of stress, anxiety, and depression on self-assessments like PCL-5, GAD-7, and PHQ-8? Participants will: Use a stress self-management system called First Watch Device (FWD) and confirm/deny detected stress moments on the app for a 2 month period. Use FWD self-management features as coping stragies for mental health and stressors for a 2 month period. Participate in the Project Hero 1-week Ride 2 Recovery Challenge events in the middle of the study.

Adaptation of the STAIR-NT for First Responders

This study is a randomized controlled pilot examining the implementation of an adapted intervention, Skills Training in Affective and Interpersonal Regulation-Narrative Therapy (STAIR-NT), among a first responder population with a history of TBI and PTSD.

ONE-P TMS Military Veterans

The aim of this study is to examine the feasibility and tolerability of a one-day protocol of repetitive transcranial magnetic stimulation with D-cycloserine (DCS) as an augmentation strategy in military personnel and veterans who have PTSD.

Virtual Reality and Post Traumatic Stress

Northern Ireland has a legacy of trauma-related mental health problems and a higher estimated prevalence of post-traumatic stress disorder (PTSD) than other comparable post-civil conflict societies. Trauma-Focused Cognitive Behavioural Therapy (TF-CBT) is an effective treatment for PTSD and is currently recommended by the National Institute For Health and Social Care Excellence (NICE) as the first line of clinical treatment. During therapy, clients with PTSD revisit the trauma memory to process what has occurred. This technique is known as Imaginal Exposure (IE) which can be a difficult process. Clients can be highly avoidant and emotionally distant from trauma memories, making it challenging to engage with the exposure process. When trauma has occurred several decades previously, traumatic memories may be difficult to access, resulting in poor treatment outcomes. Technology such as Virtual Reality (VR) can aid this process, as patients can enter a world that exposes them to the traumatic memory in a controlled therapeutic way which has shown to be effective in the treatment of PTSD. VR is yet to be used in routine clinical settings. The investigators are proposing to create low-cost VR environments via 360° video and a new process called VR Photoscan, which will allow a clinical setting to use this beneficial tool to support patients who are receiving TF-CBT to treat PTSD. This is a three-arm intervention feasibility study using a mixed methods evaluation framework designed to explore the acceptability of low-cost VR as an adjunct within existing TF-CBT therapy. Participants will be split into 3 groups of 5: Group one (N=5) to use 360° Video alongside standard TF-CBT. Group two (N=5) to use VR Photo Scan alongside standard TF-CBT. Group three (N=5) is a control group that will only receive TF-CBT. The individuals selected for the technological interventions will be offered the opportunity of a personalized 360° video / VR Photoscan environment to aid their therapy session. Pre and post-measures will be collected from participants and semi-structured interviews will be held with participants at the end of their therapy and with the clinicians who have delivered the intervention. This protocol aims to investigate the potential of low-cost VR technology in supporting PTSD treatment, addressing both the practical and theoretical challenges of immersive trauma therapy. By examining the feasibility of 360° video and VR Photoscan, the study hopes to contribute valuable insights into VR's applicability in clinical mental health settings.

Mpata Yathu Trial for Young Women in Zambia

This randomized controlled trial evaluates Mpata Yathu ("Our Space"), a trauma-informed, church-based counseling intervention for adolescent girls and young women in Lusaka, Zambia who have experienced gender-based violence and are living with or at risk for HIV. The intervention is delivered by lay counselors who provide individual problem-solving therapy and referrals for mental health, HIV, and GBV-related services. Participants are assigned to receive counseling immediately or after a three-month waitlist period. The study examines mental health, HIV-related outcomes, and the feasibility, acceptability, and fidelity of delivering this community-based intervention.

Intergenerational Risk and Resilience of Rohingya in Displacement

The iRRRd study is an ongoing prospective longitudinal prenatal birth cohort study based in Cox's Bazar, Bangladesh. Between February 2023 and March 2024, 2,888 pregnant women were enrolled (approximately 80% Rohingya refugees living in camps, 20% Bangladeshi host community). The study aims to investigate (1) the effects of being conceived, gestated, born, and raised in contexts of conflict and forced displacement on child health and development; (2) the mechanisms underlying the intergenerational transmission of conflict and displacement trauma to offspring; and (3) the sources of heterogeneity in these associations across individual, social, biological, and contextual risk and protective factors. Five waves of data collection have been completed: prenatal recruitment (Wave 1), third-trimester follow-up for a subset of the sample (Wave 2), birth (Wave 3), 28 days postpartum (Wave 4), and 6 months postpartum (Wave 5, completed April 2025; N=2,526). This registration covers Wave 6, the 36-month follow-up, in which target children are assessed when they reach 36 months of age. Anticipated enrollment for this wave is approximately 2,200 mother-child dyads. Waves 1-5 were conducted without preregistration due to logistical and timing constraints inherent to launching large-scale research in a complex humanitarian context. Design and preparation for the 36-month wave began in June-July 2025, and field piloting of study procedures and measures began in September 2025. Follow-ups with children reaching 36 months of age began in late May 2026. The original planning estimate of March 2026 reflected the 36-month mark for the earliest-born children in the cohort (first births occurred in March 2023); the ±2-month eligibility window (Part 5) accommodated the modest delay to actual fieldwork start. Up to the first week of August, fieldwork progressed slowly with a smaller number of enumerators, as several measures were still being refined and modified based on ongoing piloting. We consider this wave officially launched once onboarding and training of an expanded group of data collectors is complete and the pace of follow-ups picks up with number of children turning 36 months of age. All field activities that predate this registration are considered piloting and have served to iron out remaining logistical, technical, and language issues, and to finalize decisions on tool and item selection. No data have been analyzed, with the exception of measures for which psychometric properties needed to be examined to inform modification and selection decisions.

Study of the Effectiveness of VRET Combined With tDCS in the Treatment of PTSD in Ukrainian Veterans and Civilians

A new method is being tested to assist individuals in Ukraine with Post-Traumatic Stress Disorder (PTSD), including veterans and civilians affected by war. The study is a collaboration among Ukrainian healthcare institutions and the Charité Berlin. What is PTSD? PTSD can occur after a distressing or traumatic experience, such as exposure to war. It can result in persistent negative memories, nightmares, heightened nervousness, or avoidance of reminders associated with the event. Purpose of the Study Two innovative treatments for PTSD are being tested: 1. Virtual Reality Therapy: This approach uses specialized goggles to create a safe and realistic virtual environment where individuals can confront memories and process emotions with guidance from a therapist. 2. Brain Stimulation Therapy (tDCS): This method applies a gentle electrical current to the scalp to support improved emotional regulation by the brain. The study aims to determine whether combining these two treatments is more effective than using virtual reality therapy alone. Participant Involvement Participants will: * Attend 10 therapy sessions over several weeks. * Use virtual reality goggles to engage with safe scenarios related to their memories, guided by a therapist. * Potentially receive brain stimulation therapy during some virtual reality sessions. * Learn relaxation techniques to help manage stress and enhance emotional control. Potential Benefits for Participants * These treatments may reduce symptoms such as intrusive memories, anxiety, and depression. * Participants may experience increased calmness, resilience, and improved ability to manage daily life. This study also has the potential to advance PTSD treatment methods for others in the future.

Evaluation of Restory - an Online Trauma Treatment for Victims of Sexual Abuse

This project aims to evaluate Restory - a newly developed anonymous, iCBT prolonged exposure therapy program specifically tailored for victims of sexual abuse - using a pre-registered randomized controlled trial with waitlist control. The primary research question is whether Restory is more effective than a waitlist control in reducing PTSD symptom severity score, as measured by PCL-5.

Assessing of Behavioral Risk and Response to Electromagnetic and Psychedelic Therapies

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.

Improving Brain Stimulation Through Imaging

There are two protocols, one involving rTMS therapy in people with treatment resistant depression and one involving tDCS in people with stress from the COVID 19 pandemic. Clinic-Based rTMS Therapy: Repetitive pulse transcranial magnetic stimulation (rTMS) is a noninvasive treatment that involves stimulating the brain; however, treatment benefit depends on placing a TMS coil in the correct place on the head to reach critical brain regions below. Clinicians typically use scalp-based targeting, a process in which rather than using MRI guidance to target brain regions for stimulation, they use landmarks on the scalp. Several researchers, including the investigators' lab, showed that the current scalp-based targeting techniques do not position stimulation above the correct brain region, and patients fail to respond. The investigators propose to improve clinical scalp-based targeting by comparing it to MRI guided targeting. The most common clinical population receiving rTMS therapy is depressed patients. The investigators' plan is to study the accuracy of certain scalp-based rules in patients with depression. Accurate brain stimulation targeting is critical for effective rTMS therapy. Home-Based Neuromodulation: For participants who are not undergoing rTMS therapy who have COVID-19 distress, we are offering a combined home-based neuromodulation (transcranial electrical stimulation) and focused psychotherapy program dedicated to improving the same outcome measure, quality of life. Transcranial electrical stimulation (tES) stimulates the brain over a large region; however, we are able to model with brain imaging which brain regions receive the strongest stimulation. Our goal is still to examine stimulation precision, but we will test whether strength of tES in the same brain regions that rTMS is targeting will also lead to improved quality of life. We will also carefully assess whether it is possible to measure healthy functioning, an outcome in the rTMS study, because sheltering in place may reduce activities and thus distort our measure. We will also test whether our psychotherapy intervention will mitigate this effect and, if so, we may make it available to all those depressed Veterans in whom we're studying the effect of neuromodulation on functioning.

Self-Compassion, Health, and Empowerment

Intimate partner violence (IPV) can have serious and lasting effects on women's mental health and well-being. Chinese immigrant women in the United States often face additional barriers to obtaining IPV and mental health support, including language, cultural, and social challenges. There is a need for culturally appropriate interventions that improve access to care and address the mental health needs of this underserved population. The purpose of this study is to evaluate the efficacy of the Self-Compassion, Health, and Empowerment (SHE) intervention, a culturally tailored mobile health (mHealth) program designed for Chinese immigrant women experiencing IPV. Participants will be randomly assigned to either the SHE intervention or an attention control program and will complete study assessments over a 12-month follow-up period. The results of this study will help determine whether the SHE intervention improves mental health and well-being among Chinese immigrant women experiencing IPV and may provide evidence for an accessible, culturally appropriate intervention that can be implemented more broadly.

Accelerated Transcranial Magnetic Stimulation for Post-Traumatic Stress Disorder

This study tests a new brain stimulation treatment for post-traumatic stress disorder (PTSD), a condition that affects millions after trauma, causing symptoms like flashbacks, avoidance, mood changes, and heightened alertness. The investigators will enroll 15 adults (ages 18-65) with PTSD. First, participants get a brain scan (fMRI) to map their unique brain connections between areas involved in fear and control-the right amygdala (fear center) and right dorsolateral prefrontal cortex (control area). Using this personalized map, the investigators will apply accelerated transcranial magnetic stimulation (TMS), a safe, non-invasive method using magnetic pulses to adjust brain activity. Treatment lasts 5 days (10 short sessions daily, totaling 90,000 pulses) targeting the identified spot to strengthen control over fear responses. The study checks if this approach is practical, safe (tracking side effects like headaches), and shows early signs of reducing PTSD symptoms (measured by questionnaires and interviews). Follow-up lasts 3 months, with repeat scans to see brain changes. This study will see if personalized, fast-paced TMS targeting the disrupted fear-control brain circuit in PTSD can be feasible and safe, and preliminarily reduce symptoms by improving brain connectivity, potentially offering a quicker alternative to standard treatments.

The Effect of Early Intervention on the Incidence of Posttraumatic Stress Disorder After Intensive Care Hospitalization Due to Sepsis

In recent years, the survival rate among intensive care patients has improved due to advancements in diagnosing severe infections and the use of broad-spectrum antibiotics. However, many survivors face long-term complications, known as Post-Intensive Care Syndrome (PICS), including physical, cognitive, and psychological impairments such as post-traumatic stress disorder (PTSD), anxiety, and depression. Approximately 9-27% of ICU survivors develop these symptoms, particularly those hospitalized due to sepsis. Common risk factors include traumatic hospital experiences, delirium, and extended mechanical ventilation. Despite the prevalence of these issues, most medical centers lack structured models for screening and early intervention, highlighting the need for evaluations of early intervention strategies to support at-risk patients post-discharge and improve their quality of life.

Understanding Non-invasive Vagus Nerve Stimulation Effects in PTSD

The goal of this study is to determine how non-invasive brain stimulation (delivered through the ear called vagus nerve stimulation) affects fear learning processes in people who have experienced psychological trauma. To answer these questions, we measure bodily responses (heart rate, sweat, startle) and questionnaires. The main questions it aims to answer are: Does non-invasive vagus nerve stimulation help reduce anxious arousal? Does non-invasive vagus nerve stimulation help dampen learned fear?