Clinical Research Directory

Project STRONGER: Stepped Care for Opioid Use Disorder Treatment Engagement and Recovery

Using a hybrid type 1 effectiveness-implementation approach, this study aims to evaluate the impact of a novel stepped care model ("PCT+2HOPE") versus treatment as usual (TAU) on increasing retention in community-based medication for opioid use disorder (MOUD) treatment among women who have experienced intimate partner violence (W-IPV). PCT+2HOPE includes Present-Centered Therapy (PCT+) with stepped care as indicated by moderate, severe, or extreme PTSD-related impairment in psychosocial functioning to Helping to Overcome PTSD through Empowerment (HOPE), two evidence-based behavioral interventions adapted for women with opioid use disorder (OUD). We will examine the effectiveness of PCT+2HOPE vs. TAU on the primary outcome (i.e., retention in MOUD treatment) and secondary outcomes related to trauma (i.e., PTSD-related impairment in psychosocial functioning and depression), substance use (i.e. OUD symptom severity, extra-medical opioid use \[i.e., use of prescription opioids without a doctor's prescription; in greater amounts, more often, longer than prescribed, or for a reason other than a doctor said they should be used\], and recovery), and empowerment. We will explore the extent to which the effectiveness of PCT+2HOPE vs. treatment as usual differs based on access to basic needs. We will also conduct an implementation-focused process evaluation.

Nurse-Led PTSD Treatment in Primary Care

Purpose of the Study Post-traumatic stress disorder (PTSD) is a common and serious condition, but many people cannot get the help they need because there are not enough mental health specialists (like psychologists or psychiatrists) available. This study is testing a new program called NurseNET. The goal of NurseNET is to train nurses to provide a proven, short-term trauma treatment called Narrative Exposure Therapy (NET). Why This Study is Important Most people see their nurse or doctor for health concerns. Because nurses are highly trusted and already work on the front lines of healthcare, they may be in the best position to offer PTSD treatment quickly and conveniently. This study aims to see if nurse-led care can bridge the gap between patients and the treatment they deserve. What the Study Involves Researchers will enroll 100 participants who have symptoms of PTSD. Participants will work with a trained nurse in a primary care setting to complete the NurseNET program. The Treatment: The program consists of 4 to 6 sessions. During these sessions, the nurse helps the patient talk through their life story and process difficult memories in a safe, supportive way. What We Are Measuring: The research team will look at several factors to see if the program is successful: Effectiveness: Do PTSD symptoms improve after working with the nurse? Feasibility and Acceptability: Do patients and nurses find this type of care easy to use and helpful? Health Impact: Since PTSD is linked to heart health, the study will also look at whether the treatment improves things like blood pressure or physical activity levels. Goal of the Research By the end of this study, researchers hope to show that nurses can safely and effectively provide trauma care. If successful, this model could be used across the United States to make PTSD treatment much easier to access for everyone.

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.

Psychosocial Factors and Efficacy of Remote Cognitive Remediation for Post-Traumatic Stress Disorder

The goal of this clinical trial is to evaluate whether computer-based brain training can help adults with post-traumatic stress disorder (PTSD). Individuals with PTSD often experience difficulties with memory, attention, concentration, and problem-solving, which can significantly affect their daily lives, work performance, and overall quality of life. These cognitive challenges can hinder trauma recovery and reduce the effectiveness of standard PTSD treatments. The main questions this study seeks to address are: Does specialized brain training improve PTSD symptoms compared to regular computer games? Does brain training enhance cognitive functions such as memory, attention, processing speed, and executive functioning? Does brain training improve quality of life and daily functioning? Do participants' self-efficacy and perceived social support influence treatment outcomes? Researchers will compare two approaches: a specialized cognitive training program (HAPPYneuron Pro) with strategy teachings and quality-of-life discussions, versus engaging computer games with quality-of-life discussions, to determine which is more effective for people with PTSD. Study Design Participants will be randomly assigned to one of two groups for an 8-week program: Cognitive remediation training group: Complete computerized cognitive exercises and strategy teachings specifically designed to strengthen memory, attention, and executive functions, combined with quality-of-life discussions. Control group: Complete engaging computer games combined with quality-of-life discussions. Schedule Both groups will follow the same schedule: One online session per week, in small and consistent groups of 6 participants. Each 60-minute session consists of 30 minutes of computer activities followed by 45 minutes of group discussion. One at-home individual homework exercise per week (30 minutes at home). Total time commitment: 1h45 per week for 8 weeks. Assessments All participants will complete three comprehensive assessment sessions: before treatment, immediately after the 8-week program, and 3 months later. Assessments include neuropsychological testing and questionnaires on PTSD symptoms, depression, anxiety, quality of life, satisfaction with life, social support, cognitive failures, and self-efficacy. Significance This research evaluates a new, accessible and remotely deliverable approach for PTSD treatment. Current evidence-based treatments often do not directly target the cognitive impairments experienced by many individuals with PTSD. Compensation Participants will receive $35 for each completed assessment (maximum $105). Control group participants will gain access to the cognitive remediation training program after completing their participation.

Psilocybin-assisted Therapy for Post-Traumatic Stress Disorder in Survivors of Intimate Partner Violence

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.

Mind-body Skills Groups for War-Related Trauma in Adolescents in Gaza

The goal of this clinical trial is to learn if mind-body skills groups can reduce posttraumatic stress disorder and emotional and behavioral problems in war-traumatized adolescents in Gaza. The main questions it aims to answer are: * Do mind-body skills groups reduce posttraumatic stress disorder symptoms in war-traumatized adolescents in Gaza? * Do mind-body skills groups reduce emotional and behavioral problems in war-traumatized adolescents in Gaza? Researchers will compare the results of adolescents who do not attend mind-body skills groups to adolescents who attend mind-body skills groups see if those who attend groups have less posttraumatic stress disorder symptoms and emotional and behavioral problems. Participants will: * Be screened to determine whether they qualify to be in the study * If they qualify, they will attend 5 mind-body skills group sessions (if they are not in the control group) * Fill out research packets before the first session, after the last session, and at 2-month follow-up.

Inhaled Cannabis for Treatment of PTSD

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.

Developing Innovative PTSD Treatment for Children

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.

Shared Decision Making in PTSD Treatment

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).

EMDR vs. CBT for PTSD

This study compares two evidence-based therapies, Eye Movement Desensitization and Reprocessing (EMDR) and Cognitive Behavioral Therapy (CBT), in reducing symptoms of post-traumatic stress disorder (PTSD) among adults affected by the 2023 Kahramanmaraş earthquakes in Türkiye. A total of 89 participants diagnosed with PTSD were randomly assigned to one of three groups: EMDR therapy, CBT therapy, or a no-treatment control group. Each participant in the treatment groups received 12 weekly, one-on-one, 50-minute therapy sessions delivered remotely via a secure online platform. PTSD and related symptoms (depression, anxiety, and emotion dysregulation) were assessed at three time points: before therapy (T1), after the 6th session (T2), and after the 12th session (T3). This study aims to evaluate which therapy yields stronger improvements in PTSD and related psychological outcomes when delivered remotely in a disaster-affected population.

Effectiveness of Informational and Educational Tools to Improve the Experience of Relatives of ICU Patients. RELIEF, a Platform Trial

The admission of a patient to an intensive care unit (ICU) is associated with high levels of acute stress, anxiety, and depression among relatives, as well as extreme emotions such as fear, guilt, distress, and helplessness. In addition to these emotions, relatives also struggle to understand the information provided by the medical team-only half of the information is fully understood. These emotional and cognitive difficulties can become obstacles in decision-making processes and may have medium- and long-term consequences on their psychological well-being, particularly in terms of post-traumatic stress disorder (PTSD), anxiety, and depression. Three months after the patient is discharged from the ICU, one-third of relatives exhibit symptoms of PTSD. The aim of this research is to propose a variety of informational and educational tools to improve relatives' understanding of both the ICU context and the information provided, with the goal of reducing the risk of developing PTSD in the months following the patient's discharge or death.

Effectiveness of Trauma Treatment in the Specialist Health Care Services

Post-traumatic stress disorder (PTSD) is a common mental illness. Treatments for PTSD are regarded as highly effective, but a large-scale, prospective, longitudinal randomized controlled trial comparing the effectiveness of these treatments has been requested by the research community. This study aims to conduct a comprehensive investigation into the effectiveness of two prominent PTSD therapies, eye movement desensitization and reprocessing (EMDR) and cognitive therapy for PTSD (CT-PTSD), within the Norwegian specialist health care services. The study aims to compare the therapy effectiveness, including their impact on comorbid disorders, complex PTSD symptoms, and functional outcomes post-treatment. Patients will be randomly assigned to EMDR or CT-PTSD and given manualized therapy aligned with their treatment goals. Each arm aims to recruit 135 patients, resulting in a total sample size of 270 patients. The main objective of this study is to examine the growth curves of the two methods and how patient characteristics affect their developments. Secondary short-term aims include (1) investigating the impact of EMDR and CT-PTSD on complex PTSD symptoms, (2) assessing effects on other clinical conditions and functional outcomes, and (3) exploring whether the therapeutic alliance mediates treatment effects. Secondary long-term aims are (1) to assess the long-term effects of EMDR and CT-PTSD on PTSD symptoms and (2) to explore the impact of extended or additional treatments on outcomes.