# Post-Traumatic Stress Disorder (PTSD) 

Post-traumatic stress disorder (PTSD) is a disorder that can develop after exposure to a shocking, scary, or dangerous event. Anyone can develop PTSD at any age, including war veterans, children, and people who have been through a physical or sexual assault, abuse, accident, disaster, or other serious event. Some people develop PTSD after a friend or family member experiences harm or dies unexpectedly. People who have PTSD may feel stressed or frightened, even when they are not in danger. Learn more about post-traumatic stress disorder (PTSD).

## Featured Studies

Featured studies include only those **currently recruiting participants**. Studies with the most recent start date appear first.

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### Intervention to Enhance Coping and Help-seeking Among Youth in Foster Care **

**Study Type:** Interventional**Start Date:** April 15, 2024**Eligibility:** 16 Years to 20 Years, Does Not Accept Healthy Volunteers**Location(s):** Portland State University, Portland, Oregon, United States    

This study will deploy a scalable secondary prevention program that leverages existing foster youth transition services to improve mental health functioning and service use before and after exiting foster care. Our short-term objective is to remotely test a group intervention called Stronger Youth Networks and Coping (SYNC) that targets cognitive schemas influencing stress responses, including mental health help-seeking and service engagement, among foster youth with behavioral health risk. SYNC aims to increase youth capacity to appraise stress and regulate emotional responses, to flexibly select adaptive coping strategies, and to promote informal and formal help-seeking as an effective coping strategy. The proposed aims will establish whether the 10-module program engages the targeted proximal mechanisms with a signal of efficacy on clinically-relevant outcomes, and whether a fully-powered randomized control trial (RCT) of SYNC is feasible in the intended service context. Our first aim is to refine our SYNC curriculum and training materials, prior to testing SYNC in a remote single-arm trial with two cohorts of 8-10 Oregon foster youth aged 16-20 (N=16). Our second aim is to conduct a remote two-arm individually-randomized group treatment trial with Oregon foster youth aged 16-20 with indicated behavioral health risk (N=80) to examine: (a) intervention group change on proximal mechanisms of coping self-efficacy and help-seeking attitudes, compared to services-as-usual at post-intervention and 6-month follow-up: and (b) association between the mechanisms and targeted outcomes, including emotional regulation, coping behaviors, mental health service use, and symptoms of depression, anxiety, and PTSD. Our third aim is to refine and standardize the intervention and research protocol for an effectiveness trial, including confirming transferability with national stakeholders.

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### A Precision Medicine Approach to Target Engagement for Emotion Regulation **

**Study Type:** Interventional**Start Date:** September 29, 2023**Eligibility:** 18 Years and Older, Does Not Accept Healthy Volunteers**Location(s):** University of Kentucky, Lexington, Kentucky, United States    

The proposed study is designed to first test whether teaching people personalized or standardized emotion regulation skills leads to greater decreases in daily negative emotion intensity. Second, using data from an initial sample, the investigators will prospectively assign an independent sample of participants to receive their predicted optimal or non-optimal skills to determine if it is feasible and efficacious to match participants to the most appropriate training condition. Results of these studies may identify the mechanisms by which emotion regulation interventions impact emotional functioning and allow for the development of personalized, evidence-based, and scalable emotion regulation interventions.

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### Alpha-Amino-3-Hydroxy-5-Methyl-4- Isoxazole Propionic Acid Receptor Components of the Anti-Depressant Ketamine Response **

**Study Type:** Interventional**Start Date:** September 7, 2023**Eligibility:** 18 Years to 60 Years, Does Not Accept Healthy Volunteers**Location(s):** Yale University, New Haven, Connecticut, United States    

The proposed study will assess the combined effect of perampanel and ketamine on the anti-depressant response in individuals with treatment resistant depression. The purpose of this study is to test the hypothesis that stimulation of Alpha-Amino-3-Hydroxy-5-Methyl-4- Isoxazole Propionic Acid receptors (AMPAR) is critical to the anti-depressant response of ketamine.

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### Enhancing Week-long Psychological Treatment for PTSD With Ketamine **

**Study Type:** Interventional**Start Date:** August 21, 2023**Eligibility:** 21 Years to 70 Years, Does Not Accept Healthy Volunteers**Location(s):** Yale University School of Medicine, New Haven, Connecticut, United States    

The purpose of this study is to test if the combination of ketamine, vs midazolam, with an intensive trauma-focused psychotherapy will be more effective in relieving post-traumatic stress disorder (PTSD). This week-long treatment has the potential to produce a significant therapeutic effect that otherwise would take months to occur. The study will also focus on learning about the neurophysiological changes produced by the proposed clinical trial.

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### Targeting the Default Mode Network: A TMS-fMRI Study **

**Study Type:** Interventional**Start Date:** August 2, 2023**Eligibility:** 18 Years to 55 Years, Does Not Accept Healthy Volunteers**Location(s):** VA Palo Alto, Palo Alto, California, United States    

In post-traumatic stress disorder (PTSD), intrusive, traumatic, autobiographical memories lead to anxiety symptoms. Recent work suggests a new repetitive pulse transcranial magnetic stimulation (rTMS) brain target that might bring relief. Since this proposed target is not well understood, the goal of the study is to use functional magnetic resonance imaging (fMRI) to identify the brain regions and networks that change with rTMS stimulation at this target area in PTSD patients. Ultimately, this would lead to a personalized approach to rTMS treatment of PTSD based on brain imaging that can be used in a future clinical trial.

Participants will be asked to complete psychological testing and questionnaires as well as an initial MRI and two separate TMS-fMRI sessions. Total participation time across all visits is estimated to be five to six hours.

Research participation will take place at VA Palo Alto as well as at Stanford University.

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### Reducing Psychological Barriers to PrEP Persistence Among Pregnant and Postpartum Women in Cape Town, South Africa **

**Study Type:** Interventional**Start Date:** July 1, 2023**Eligibility:** Females, 15 Years and Older, Accepts Healthy Volunteers**Location(s):** Gugulethu Midwife Obstetric Unit (MOU), Cape Town, Western Cape, South Africa    

Pregnant women in South Africa (SA) are at high risk of HIV acquisition. Pre-exposure prophylaxis (PrEP) use during pregnancy is both safe and effective in preventing HIV. However, posttraumatic stress (associated with intimate partner violence and/or other traumas) and depression negatively impact PrEP adherence among women in SA. Addressing posttraumatic stress and depression will likely improve PrEP adherence and persistence (i.e., sustained PrEP adherence over time) during pregnancy and breastfeeding, which are periods of dramatically increased HIV risk. The overarching goal of this proposal is to develop and test the feasibility and acceptability of a cognitive behavioral intervention that targets common underlying factors of posttraumatic stress and depression to improve PrEP adherence and persistence during pregnancy and the postpartum transition. The specific aims of the project are to (1) explore the mechanisms by which posttraumatic stress and depression impact PrEP adherence and persistence during pregnancy via qualitative interviews; (2) develop a brief PrEP adherence and persistence intervention (~4 sessions) that reduces the negative impact of psychological mechanisms common to posttraumatic stress and depression on PrEP use, and builds behavioral skills to improve self-care; and (3) evaluate the feasibility, acceptability, and signals of preliminary efficacy of the intervention, which will be integrated into antenatal care, in a pilot randomized controlled trial. All data will be collected in the Midwife Obstetrics Unit (MOU) in Gugulethu, a peri-urban settlement and former township community outside of Cape Town, SA.

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### Reducing Posttraumatic Stress Disorder (PTSD) Symptoms in Frontline Health Care Workers **

**Study Type:** Interventional**Start Date:** May 16, 2023**Eligibility:** 18 Years and Older, Does Not Accept Healthy Volunteers**Location(s):** ProMedica, Fremont, Ohio, United States; University of Michigan, Ann Arbor, Michigan, United States    

This study is being completed to address PTSD symptoms in Health System workers after the COVID-19 pandemic. Specifically, the study team is testing whether an adapted PTSD treatment (talk therapy) effectively treats PTSD when provided in Employee Assistance Programs (EAPs).

The central hypothesis is that Prolonged Exposure for Primary Care (PE-PC) will reduce PTSD symptoms and improve functioning, compared to EAP Treatment as Usual (TAU).

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### A Deployment Focused Pragmatic Trial of Optimal Stepped Care Intervention Targeting PTSD and Comorbidity for Acutely Hospitalized Injury Survivors Treated in US Trauma Care Systems **

**Study Type:** Interventional**Start Date:** January 9, 2023**Eligibility:** 18 Years and Older, Does Not Accept Healthy Volunteers**Location(s):** Harborview Medical Center, Seattle, Washington, United States    

This investigation is a randomized pragmatic trial of a brief stepped care intervention delivered from an acute care medical trauma center that may both reduce the symptoms of posttraumatic stress disorder (PTSD) and diminish emergency department health service utilization.

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### Cognitive Processing Therapy (CPT) Memory Support (MS) Study **

**Study Type:** Interventional**Start Date:** January 4, 2023**Eligibility:** 18 Years and Older, Does Not Accept Healthy Volunteers**Location(s):** VA Boston Healthcare System, Jamaica Plain, Massachusetts, United States    

The efficacy of psychological interventions for posttraumatic stress disorder (PTSD) is likely limited by the difficulty participants have learning and remembering important therapy content. Accordingly, the present study will examine the utility of integrating a Memory Support (MS) intervention into Cognitive Processing Therapy (CPT), an empirically supported and widely disseminated treatment for PTSD. MS was designed to integrate techniques aimed at facilitating encoding, consolidation, and retrieval of new learning into existing treatments, and has been shown to improve outcomes when integrated into cognitive therapy for depression. A pilot randomized controlled trial (n=52) comparing CPT with Memory Support (CPT+MS) to CPT-alone will be conducted. Study participants will be adults diagnosed with PTSD.

The primary aim of the trial will be to determine if CPT+MS will lead to greater memory and learning of therapy content relative to CPT-alone, and to establish the acceptability and feasibility of integrating MS into CPT. Secondary aims include a preliminary examination of treatment efficacy, as indicated by the magnitude of changes in PTSD symptoms between conditions, and target validation, as indicated by associations between memory and learning of therapy content and treatment response. Exploratory analyses will examine several indicators of baseline memory-related cognitive functioning as predictors of memory and learning of therapy content, providing preliminary data to inform future research on personalized application of MS. Results of the trial will advance scientific knowledge about methods for optimizing memory and learning as a mechanism for improving PTSD treatment outcomes.

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### Neural Connectivity During Therapy for Adolescent PTSD **

**Study Type:** Interventional**Start Date:** November 29, 2022**Eligibility:** 12 Years to 17 Years, Does Not Accept Healthy Volunteers**Location(s):** UT Health Department of Psychiatry, San Antonio, Texas, United States    

Posttraumatic stress disorder in adolescence impairs neurobiological networks underlying cognitive, social and emotional skills. Neuroimaging research that seeks to identify the neural mechanisms of treatments for PTSD could lead to novel treatments, but progress has been slow using current methods. The proposed study uses an innovative approach to identify neural mechanisms of specific phases of trauma-focused therapy for youth with PTSD, allowing a new understanding of brain changes associated with the process of therapy.

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

**Study Type:** Interventional**Start Date:** November 2, 2022**Eligibility:** 18 Years to 70 Years, Does Not Accept Healthy Volunteers**Location(s):** Boston University, Boston, Massachusetts, United States; The University of Texas at Austin, Austin, Texas, United States    

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?"

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### Cognitive Processing Therapy (CPT) for Posttraumatic Stress Disorder and Borderline Personality Disorder (PTSD-BPD) **

**Study Type:** Interventional**Start Date:** October 1, 2022**Eligibility:** 18 Years to 65 Years, Does Not Accept Healthy Volunteers**Location(s):** Palo Alto University, Palo Alto, California, United States    

Posttraumatic Stress Disorder (PTSD) with co-occurring Borderline Personality Disorder (BPD) (i.e., PTSD-BPD) is common (as high as 58%), debilitating, costly, and limited treatment options available for this population. PTSD-BPD is associated with even greater functional impairment and higher healthcare burden than either disorder alone. There are surprisingly few treatments available for this clinical profile, despite its association with major negative health outcomes, cost, and morbidity. There is a pressing need to innovate treatments that can effectively and efficiently treat PTSD-BPD. The existing treatments used for PTSD-BPD are lengthy, laborious, resource-intensive, and require complete cessation of suicidal behaviors prior to treatment. Furthermore, no integrated treatment has been innovated to deliver the active ingredients to efficiently affect the mechanisms underpinning this comorbidity. The investigators propose to examine an adapted version of a first-line PTSD intervention, Cognitive Processing Therapy, augmented with a Suicide Risk Management, i.e., (CPT+SRM) as a brief (12 sessions) and more parsimonious treatment alternative that strategically targets shared mechanisms underpinning PTSD and BPD. The purpose of this pilot study is to 1) collect initial feasibility, acceptability, and safety data on this adapted treatment, 2) conduct a pilot randomized clinical trial evaluating the efficacy of CPT+SRM versus Treatment as Usual (TAU) + SRM, and 3) evaluate two targets (i.e, improvements in emotional intensity and cognitive dysfunction) as mechanisms leading to change in our primary outcomes. Both treatment conditions will be administered via telehealth.

Potential benefits include reduction in participants' PTSD, BPD and other mental health symptoms. Additionally, this work could benefit the community by improving the treatment repertoire for PTSD-BPD. Potential risks include emotional distress, suicidality, and/or self-harm. Participants may experience discomfort and/or distress while discussing participants trauma(s) and mental health. These risks will be mitigated using a suicide risk management protocol which therapists in the assessment of risk and protective factors of suicide, followed by documentation for the decision-making around the management of risk.

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### CPT-L to Improve Outcomes for Individuals With HIV and PTSD **

**Study Type:** Interventional**Start Date:** July 13, 2022**Eligibility:** 18 Years and Older, Does Not Accept Healthy Volunteers**Location(s):** Medical University of South Carolina, Charleston, South Carolina, United States    

This study plans to adapt and examine the acceptability and feasibility of an evidence-based PTSD treatment that has reduced other HIV transmission behavior (e.g., sexual risk), Cognitive Processing Therapy (CPT), at an HIV clinic as a strategy to improve HIV outcomes in this population.

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### Circadian Influence on Prolonged Exposure Therapy for PTSD **

**Study Type:** Interventional**Start Date:** July 1, 2022**Eligibility:** 25 Years to 45 Years, Does Not Accept Healthy Volunteers**Location(s):** VA Boston Healthcare System, Boston, Massachusetts, United States    

Proposed research will examine time-of-day effects on trauma-related fear extinction using Prolonged Exposure Therapy (PE) telemedicine for Posttraumatic Stress Disorder (PTSD) in the National Center for PTSD (NCPTSD). The primary mechanistic outcome measure will be change in psychophysiological reactivity to script-driven imagery (SDI-PR) measured, in person, at pre-treatment, after 5 PE sessions (mid-treatment), and after all 10 PE sessions (post-treatment). A secondary mechanistic outcome will be session-to-session reduction in peak subjective units of distress (SUDS) ratings to imaginal exposures. The primary clinical outcome will be change in Clinican Administered PTSD Scale (CAPS-5) severity score; a secondary clinical outcome will be session-to-session reduction in self-reported PTSD symptoms using the PTSD checklist (PCL-5). Participants meeting inclusion criteria (described below) will be randomized to either PE sessions that begin from 07:00 to a time no later than 2 hours past a participant's customary rise time, or to the last treatment session of the day beginning at 16:00 or later (26 per arm). Participants will complete daily at-home imaginal-exposure homework within the same time frame as their PE sessions are scheduled, i.e., within 2 hours of awakening for morning (AM) group and between 16:00 and 2 hours before bedtime for late afternoon (PM) group.

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### Testing Adaptive Interventions to Improve Posttraumatic Stress Disorder Treatment Outcomes in Federally Qualified Health Centers **

**Study Type:** Interventional**Start Date:** June 23, 2022**Eligibility:** 18 Years and Older, Does Not Accept Healthy Volunteers**Location(s):** Upper Great Lakes Family Health Care Center, Menominee, Michigan, United States; Cherry Health, Grand Rapids, Michigan, United States; Hamilton Community Health Network, Flint, Michigan, United States; Grace Health, Battle Creek, Michigan, United States; Unity Care NW, Bellingham, Washington, United States; CommUnityCare Health Centers, Austin, Texas, United States; Western North Carolina Community Health Services, Asheville, North Carolina, United States; Family Care Health Centers, Saint Louis, Missouri, United States; Sterling Area Health Center, Sterling, Michigan, United States; Family Medical Center of Michigan, Monroe, Michigan, United States; MidMichigan Community Health Services, Houghton Lake, Michigan, United States    

This trial is being completed to develop a stepped-care talk therapy model for patients with PTSD. Specifically, this study is testing whether beginning with one type of therapy is better than beginning with another type of therapy, and whether moving to a different therapy after four sessions is more helpful than staying with the same therapy, depending on how well it is working.

The central hypothesis is that beginning with a low- or medium-intensity PTSD intervention and then titrating intensity based on early indications of response will result in clinically significant PTSD symptom reduction with parsimony of resources.

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### PTSD Treatment for Incarcerated Men and Women: NIMH **

**Study Type:** Interventional**Start Date:** June 6, 2022**Eligibility:** 18 Years and Older, Does Not Accept Healthy Volunteers**Location(s):** Psychiatric Institute and Clinic, Madison, Wisconsin, United States    

Study examining the feasibility of and psychological response to group Cognitive Processing Therapy (CPT) in incarcerated men and women with Post-traumatic stress disorder (PTSD). The study will be conducted in male and female incarcerated populations and will include 2 groups of 10 individuals for CPT in both populations (i.e., 40 participants total; 20F/20M). The study will run for up to 2 years. Participants can expect to be participating in study for up to 22 weeks.

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### Telehealth 2.0: Evaluating Effectiveness and Engagement Strategies for CPT-Text for PTSD **

**Study Type:** Interventional**Start Date:** March 22, 2022**Eligibility:** 18 Years to 75 Years, Accepts Healthy Volunteers**Location(s):** Stanford University, Palo Alto, California, United States; Talkspace LLC, New York, New York, United States; University of Texas Health Sciences Center at San Antonio, San Antonio, Texas, United States    

There is a pressing need to increase capacity to treat PTSD related to or exacerbated by the COVID-19 pandemic. Texting-based therapy holds promise to increase capacity and reduce barriers to delivering evidence-based treatments (EBTs), but ongoing engagement in digital mental health interventions is low. This study will compare a texting-based EBT for PTSD to culturally-informed texting-based treatment for PTSD as usual, and it will also compare a unique incentive strategy to typical platform reminders aimed to prevent early discontinuation in therapy. This online study is open to individuals who live in 13 different states.

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### Facilitation of Extinction Retention and Reconsolidation Blockade in PTSD **

**Study Type:** Interventional**Start Date:** March 4, 2022**Eligibility:** 18 Years to 55 Years, Does Not Accept Healthy Volunteers**Location(s):** Boston University School of Medicine, Boston, Massachusetts, United States    

Purpose: About 6.4% of the U.S. population suffers from posttraumatic stress disorder (PTSD). Trauma-focused psychotherapies are generally effective in PTSD, but responses vary greatly across individuals and PTSD subpopulations. Neurobiological factors impacted by life experiences, stress, and genetics can affect treatment responses. These factors can alter brain capacities needed to reprocess traumatic memories prevent them from triggering intensely distressing, disruptive, out-of-place responses.

For example, during psychotherapy for PTSD, trauma memory activation engages two competing brain processes that affect recovery: "extinction" versus "reconsolidation" of trauma-related emotional, physiological, and behavioral responses. This study tests whether a single intravenous (IV) dose of allopregnanolone (Allo) compared to placebo (which is non-active):

promotes consolidation of extinction learning (sub-study 1) or blocks reconsolidation physiological responses triggered by aversive memories (sub-study 2).

The study also tests whether Allo compared to placebo affects retention of non-aversive memories.

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### Fear and Avoidance in PTSD Patients **

**Study Type:** Interventional**Start Date:** July 1, 2021**Eligibility:** 18 Years to 70 Years, Accepts Healthy Volunteers**Location(s):** NYU Langone Health, New York, New York, United States    

The purpose of this research study is to study how the brain learn to avoid certain stimuli or situations using an experimental paradigm. The big goal is to measure brain responses and subject's feelings and expectations when they are learning to actively avoid experimental stimuli, and how fear extinction learning and monetary cost can change how and when subjects are to avoid.

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### Effects of Delta9-tetrahydrocannabinol (THC) on Retention of Memory for Fear Extinction Learning in PTSD: R33 Study **

**Study Type:** Interventional**Start Date:** April 15, 2021**Eligibility:** 18 Years to 60 Years, Does Not Accept Healthy Volunteers**Location(s):** Eugene Applebaum College of Pharmacy and Health Sciences, Detroit, Michigan, United States    

The goal of this study is to look at how a type of drug called cannabinoids are related to the processing of fear signals, the experience of emotions and fear, and the pattern of activity in the brain that is involved in these processes and how this relates to the treatment of post-traumatic stress disorder (PTSD). PTSD is an anxiety disorder that occurs after experiencing a traumatic event(s) and is characterized by unwanted memories of the trauma(s) through flashbacks or nightmares, avoidance of situations that remind the person of the event, difficulty experiencing emotions, loss of interest in activities the person used to enjoy, and increased arousal, such as difficulty falling asleep or staying asleep, anger and hypervigilance. The information gained from this study could lead to the development of new treatments for persons who suffer from anxiety or fear-based disorders.

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### Improving Therapeutic Learning for PTSD **

**Study Type:** Interventional**Start Date:** February 18, 2021**Eligibility:** Females, 21 Years to 50 Years, Accepts Healthy Volunteers**Location(s):** University of Texas, Austin, Texas, United States    

The proposed project seeks to demonstrate the engagement of post-exposure dopamine neurotransmission and downstream acute reorganization of dopaminergic resting-state neural networks as a means of increasing consolidation of extinction memories formed during analogue exposure therapy in adult women with PTSD. Participants will include 120 women aged 21-50 with a current diagnosis of PTSD related to physical or sexual assault, English speaking, and medically healthy. Participants will complete the stages of the study across 2-3 days, depending on participant need.

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### A Randomized Trial of ImpACT+, a Coping Intervention for HIV Infected Women With Sexual Trauma in South Africa **

**Study Type:** Interventional**Start Date:** February 18, 2021**Eligibility:** Females, 18 Years and Older, Does Not Accept Healthy Volunteers**Location(s):** University of Cape Town, Cape Town, South Africa    

ImpACT+ (Improving AIDS Care after Trauma+), is an individual-level coping intervention to address traumatic stress and HIV care engagement among South African women with sexual trauma histories. We propose a full-scale randomized controlled trial to examine the effect of ImpACT+ on clinical outcomes in the period after ART initiation and to understand mental health and behavioral mechanisms through which viral suppression can be achieved. ImpACT+ will target women who are initiating ART in order to take advantage of a window of opportunity in HIV care and maximize care engagement. The aims are to test the effectiveness of ImpACT+ and explore its potential for implementation.

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### Effect of TMS on PTSD Biomarkers **

**Study Type:** Interventional**Start Date:** February 15, 2021**Eligibility:** 18 Years to 65 Years, Does Not Accept Healthy Volunteers**Location(s):** Grady Hospital, Atlanta, Georgia, United States    

The study will (1) assess feasibility of a TMS treatment in an underserved population; (2) determine if this TMS treatment protocol improves PTSD symptoms and biological markers of PTSD such as brain functioning and startle responses; (3) define new brain targets for future TMS studies; (4) provide the first data for individual differences, which will help personalize treatment for PTSD patients; (5) improve knowledge of the neurobiology of PTSD and treatment response.

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### PTSD, AUD, and Interpersonal Conflict: Within-person Associations **

**Study Type:** Interventional**Start Date:** December 4, 2020**Eligibility:** 18 Years to 60 Years, Does Not Accept Healthy Volunteers**Location(s):** Sioux Falls VA Health Care System, Sioux Falls, South Dakota, United States; The University of South Dakota, Vermillion, South Dakota, United States    

The present study seeks to increase understanding of Alcohol Use Disorder (AUD) and Posttraumatic Stress Disorder (PTSD) among veterans, an important public health concern. We will study the effects of regulatory deficits and sleep disturbance on the dynamic course of PTSD and AUD. The study will investigate whether a short, computerized training in the laboratory will alter maladaptive response biases and reduce associations between sleep disturbance, affect and behavioral dysregulation, AUD symptoms, and PTSD symptoms in the real world.

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### Trauma Informed Treatment Algorithms for Novel Outcomes **

**Study Type:** Interventional**Start Date:** October 5, 2020**Eligibility:** 18 Years and Older, Does Not Accept Healthy Volunteers**Location(s):** Center for Trauma Care and Research Organization, Phnom Penh, Cambodia    

This randomized controlled trial (RCT) will examine the feasibility, acceptability, and preliminary efficacy of a beginning treatment for Post-Traumatic Stress Disorder (PTSD) with Behavioral Activation (BA). Cambodian men and women who screen positive for PTSD will be randomized to receive six individually delivered sessions of either: 1) Stabilization Techniques alone (ST); or 2) ST+BA. After two months, all participants who continue to report clinically meaningful elevations in PTSD will receive Eye Movement Desensitization Reprocessing (EMDR). All participants will complete a follow-up assessment at four months post-randomization.

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### A Hybrid Type 2 Trial of Trauma-Focused Cognitive Behavioral Therapy and a Pragmatic Individual-Level Implementation Strategy **

**Study Type:** Interventional**Start Date:** August 27, 2020**Eligibility:** 7 Years to 85 Years, Accepts Healthy Volunteers**Location(s):** University of Washington, Seattle, Washington, United States    

This research project is a hybrid type 2 effectiveness-implementation trial that simultaneously examines (1) the effectiveness of a trauma-focused intervention for youth in the education sector and (2) the impact of a theory-driven pragmatic implementation strategy designed to increase the adoption, fidelity, and sustainment of evidence-based treatments (EBTs). This trial will include 120 clinicians and 480 students, and it is designed to test the cost effectiveness and impact of Trauma-Focused Cognitive Behavioral Therapy (TF-CBT) in a new setting that increases access to mental health care - schools (Aim 1); test the cost effectiveness, immediate impact, and sustained impact of the Beliefs and Attitudes for Successful Implementation in Schools (BASIS) implementation strategy on proximal mechanisms and implementation outcomes (Aims 2a, 2b, 2d); and conduct sequential mixed-methods data collection to explain residuals (i.e., clinicians whose implementation behavior is unaccounted for by the mediation model) (Aim 2c).

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### Wakȟáŋyeža (Little Holy One) **

**Study Type:** Interventional**Start Date:** November 18, 2019**Eligibility:** 18 Years and Older, Accepts Healthy Volunteers**Location(s):** Fort Peck Tribal Head Start, Poplar, Montana, United States    

The overall goal of this study is to develop, adapt and evaluate an intergenerational prevention intervention, named "Wakȟáŋyeža (Little Holy One)," with Native American caregivers on a Northern Plains reservation and the caregivers' 2-to-5-year-old children. The intervention aims to: 1) reduce symptoms of historical trauma and everyday stress among parents/caregivers, 2) improve parenting, and 3) improve children's emotional and behavioral developmental outcomes to reduce future risk for suicide and substance use.

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### Neuroendocrine Risk for PTSD in Women **

**Study Type:** Interventional**Start Date:** November 11, 2019**Eligibility:** Females, 18 Years to 35 Years, Does Not Accept Healthy Volunteers**Location(s):** Grady Memorial Hospital, Atlanta, Georgia, United States    

This study will test for effects of estradiol (E2) on PTSD symptoms and functional magnetic resonance imaging (fMRI) indicators of stress vulnerability, in naturally-cycling women who are not using hormonal birth control. Enrollment will be targeted to create three groups within two cohorts (early follicular phase and luteal phase):

PTSD: Women who meet Diagnostic and Statistical Manual of Mental Disorders (DSM-5) criteria for PTSD Trauma-Exposed (TC): Women matched for age and trauma exposure severity but without PTSD Healthy Control (HC): Women matched for age, but without trauma history or psychiatric disorder (self-reported)

Women will be recruited through Grady Trauma Project (GTP), a large longstanding study of civilian trauma and PTSD conducted at Grady Memorial Hospital in Atlanta, Georgia.

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### Neuroeconomics of Social Behavior Following Trauma Exposure **

**Study Type:** Observational**Start Date:** November 14, 2017**Eligibility:** Females, 18 Years to 45 Years, Accepts Healthy Volunteers**Location(s):** McLean Hospital, Belmont, Massachusetts, United States    

This study will use a neuroeconomic paradigm with state-of-the-art imaging protocols to probe abnormal social reward processing underlying social withdrawal in symptomatic trauma-exposed women. By also gathering self-report measures of social anhedonia, performance on non-social and social reward valuation tasks, and measures of real-world social functioning including social network size, we aim to specify how alterations in social reward processing result in social withdrawal and functional impairment.

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### Imaging Cannabinoid Receptors Using Positron Emission Tomography (PET) Scanning **

**Study Type:** Observational**Start Date:** July 31, 2010**Eligibility:** Males, 18 Years to 55 Years, Accepts Healthy Volunteers**Location(s):** Connecticut Mental Health Center, Clinical Neuroscience Research Unit, New Haven, Connecticut, United States    

The aim of the present study is to assess the availability of cannabinoid receptors (CB1R) in the human brain. CB1R are present in everyone's brain, regardless of whether or not someone has used cannabis. The investigators will image brain cannabinoid receptors using Positron Emission Tomography (PET) imaging and the radioligand OMAR, in healthy individuals and several conditions including 1) cannabis use disorders, 2) psychotic disorders, 3) prodrome of psychotic illness and 4) individuals with a family history of alcoholism, 5) Post-Traumatic Stress Disorder 6) Opioid Use Disorder using the PET imaging agent or radiotracer, [11C]OMAR. This will allow us to characterize the number and distribution of CB1R in these conditions. It is likely that the list of conditions will be expanded after the collection of pilot data and as new data on cannabinoids receptor function and psychiatric disorders becomes available.

Those in the cannabis us disorder arm of the study will have a PET scan on at least three occasions: once while smoking as usual, once after 48-hours of abstinence from cannabis, and a final time after 4 weeks of abstinence. Additional scans may be conducted within the 4 weeks and the last scan may be conducted well beyond 4 weeks. Similarly, while most schizophrenia patients may get scanned just once, a subgroup of patients may get scanned more than once. For example to tease out the effects of medications, unmedicated patients may get scanned while unmedicated and again after treatment with antipsychotic medications. Similarly prodromes may get scanned while in the prodromal stage off medications, on medications and after conversion to schizophrenia.