Clinical Research Directory

Whole Health in VA Mental Health: Omnis Salutis

Recent Veterans of the Afghanistan and Iraq conflicts are presenting in VA care with high rates of posttraumatic stress disorder (PTSD), depression, anxiety, and substance use disorders. Difficulties with social relationships and community reintegration are common functional impairments with these disorders. VA is transforming to a Whole Health, patient-centered system of care that will address these issues as part of health care. In a previous study, Omnis Salutis (OS) was developed with Veteran and clinician input. OS is a three-session intervention in which Veterans learn about Whole Health and practice communicating their health mission to providers and social supports. OS was shown feasible to deliver, acceptable to Veterans, and preliminarily effective at improving physical, mental, and social functioning. This study will use a large, multisite randomized controlled trial to test the impact of OS on Veterans' social and physical functioning and Veteran engagement in mental health care. Results will support broad delivery of OS throughout the VA.

Postnatal Debriefing After Adverse Obstetric Events

Adverse or unexpected obstetric events can negatively affect women's psychological well-being and childbirth experience, increasing the risk of postpartum traumatic stress. However, structured postnatal debriefing is not routinely implemented in clinical practice, and evidence regarding its effectiveness remains limited. This randomized controlled trial aims to evaluate the effect of a structured postnatal debriefing conducted within the first 24 hours after childbirth in women who have experienced an adverse or unexpected obstetric event. Participants will be randomly assigned to either an intervention group receiving structured debriefing or a control group receiving usual postpartum care. The primary outcome is childbirth-related trauma at 6 weeks postpartum. Secondary outcomes include birth satisfaction, early post-traumatic stress symptoms, and clinical maternal and neonatal outcomes. This study will provide evidence on whether structured postnatal debriefing improves psychological outcomes and contributes to more patient-centered obstetric care

Mismatch vs. Standard Intervention During Memory Reconsolidation Blockade With Propranolol: Effect on Psychophysiological Reactivity During Traumatic Imagery

The proposed R21 project will attempt to further develop a novel intervention for posttraumatic stress symptoms inspired by the science of memory reconsolidation. Work in normal humans has shown that when a stable, consolidated memory is reactivated (i.e., retrieved) under appropriate conditions, it reverts to an unstable state, a process referred to herein as deconsolidation. In such a state, the memory is susceptible to the action of various "amnestic" agents that may inhibit its reconsolidation, thereby weakening it. The β-adrenergic blocker propranolol (PPNL) possesses such amnestic properties. More recent research has found that in order to initiate deconsolidation, there must be a prediction error, or mismatch, between what is expected and what occurs when the memory is reactivated. Prior placebo-controlled, randomized clinical trials (PBO-RCT) from our laboratory have found that when propranolol is administered concomitant with the reactivation of a psychologically traumatic memory, the memory is weakened, as revealed by subsequent lower physiological (heart rate, skin conductance, facial electromyogram) responding during script-driven mental imagery. Clinical applicability was evaluated in a PBO-RCT, in which PTSD participants receiving propranolol underwent six weekly sessions of 10-20 min of "standard" (STD) traumatic memory reactivation stimulated by reading a narrative. At post-treatment, these participants showed a greater reduction of PTSD symptoms compared to participants who had taken PBO. The goal of the proposed study is to test whether intentionally incorporating innovative mismatch (MM) into traumatic memory reactivation can improve upon physiological responding during script-driven mental imagery. Participants will be randomized to one of 2 treatment arms: STD/PPNL and MM/PPNL. A baseline assessment will measure psychophysiological responsivity to script-driven mental imagery (target measure). PPNL will be administered 90-min prior to each of six weekly 10-20 min. traumatic memory reactivation sessions. In the MM condition, a different, unexpected mismatch (e.g., singing the narrative) will be incorporated into the reactivation. In the STD condition, the participant will read the narrative the same way each time. The focus of the R21 proposal will be to assess whether the MM/PPNL group shows lower subsequent physiological responses than the STD/PPNL group

Enhancing the Effectiveness of Cognitive Behavioral Therapy Using Non-invasive Brain Stimulation

The purpose of the proposed study is to examine if a repeated treatment of High Definition Transcranial Direct Current Stimulation (HD-tDCS) can increase the functional connectivity between the left ventrolateral prefrontal cortex and posterior cingulate, which may further enhance the effects of cognitive behavioral therapy with mindfulness classes.

Resettled Refugee Families for Healing

The goal of this type I hybrid effectiveness-implementation trial is to test a family strengthening (FS) model delivered through multiple family groups (MFG) combined with a virtual peer mentoring program called TeenAge Health Consultants (Virtual TAHC) aimed at addressing emotional and behavioral problems among youth born in the U.S. to parents resettled as refugees. The specific aims of the study are: Aim 1: To systematically adapt an evidence-based family strengthening (FS) model delivered through multiple family groups (MFG) combined with a peer mentoring program (Virtual TAHC) (Goal 1). Aim 2: To assess preliminary short- and long-term impact of the combination intervention (MFG + Virtual TAHC) on behavioral emotional disorders (aggressive behavior, antisocial behaviors, anxiety, depression, and Posttraumatic Stress Disorder \[PTSD\]) related to intergenerational trauma among SGRC in the trial (Goal 2). Aim 3: Utilizing mixed methods and applying the Exploration, Preparation, Implementation, Sustainment (EPIS) framework, examine implementation strategies, facilitators, and barriers of the RRF4H intervention (Goal 3). Participants will receive: 1. Family strengthening intervention delivered through multiple family groups (MFG) where children and one of their biological parents will participate in 16 weekly group sessions to discuss common problems and how to address them. 2. The youth in the intervention will participate in a peer mentorship program called TeenAge Health Consultants (TAHC) consisting of 16 weekly virtual sessions where they interact with other youth to learn about important topics including how to deal with conflict, stay out of trouble, deal with stress, avoid drugs and other topics. Researchers will compare the intervention group to a control group that will receive the usual care to see if the intervention group shows improvement in symptoms compared to the usual care group.

Group-based Stabilization and Skill Training for Patients With Lasting Posttraumatic Reactions in Mental Health Care

This study evaluates the addition of a group based stabilization and skill-training intervention to individual out-patient treatment for long lasting post-traumatic reactions. Half of the participants will receive the combined treatment while the other half will receive individual treatment as usual.

fMRI to Examine the Effect of CBTm to Increase Resiliency for PTSD

A substantial proportion of public safety personnel (PSP) develop service-related posttraumatic stress disorder (PTSD). PTSD is associated with a range of negative outcomes and its exact underlying neurophysiological mechanism is still not well understood. Cognitive behavioral therapy (CBT) is commonly prescribed to treat PTSD, and recent studies suggest that it may be effective in preventing the condition. We have developed a 5-session class focused on teaching introductory CBT skills to prevent and manage psychological distress, and we are currently in the process of launching a clinical trial to demonstrate its effectiveness in preventing PTSD and related conditions in PSP. In the proposed adjunctive study to this trial, we will quantitate the brain connectivity signature that is specific to the PTSD-resilience, and examine whether the classes increase this resilience-related brain mechanism.

MOCHA: Embedded Inpatient Mental Health Care for High-Risk Perinatal Patients

Pregnant and postpartum patients hospitalized for medical complications experience high rates of depression, anxiety, and trauma-related symptoms, yet access to timely psychiatric care during obstetric hospitalization is limited. Project MOCHA integrates early mental health screening, trauma-informed psychotherapy, and structured follow-up into routine inpatient maternity care for individuals at elevated clinical risk. This single-arm implementation study examines the feasibility, acceptability, and fidelity of delivering a Collaborative Mental Health Care Program within a high-risk obstetric inpatient setting. The program includes brief inpatient psychotherapy, symptom monitoring, and post-discharge follow-up over three months. Preliminary changes in depression, anxiety, attention-deficit hyperactivity disorder, and posttraumatic stress symptoms will be assessed to inform future effectiveness trials and broader health system integration.

Assessing Social Learning and Course Delivery Timing in Internet-delivered Cognitive Behaviour Therapy for Public Safety Personnel

This study is a randomized factorial trial designed to evaluate unguided (i.e., purely self-help), transdiagnostic internet delivered cognitive behaviour therapy tailored for public safety personnel with tunneled of personalized course delivery and with or without the incorporation of social learning resources.

Using the Multiphase Optimization Strategy to Adapt Cognitive Processing Therapy

Cognitive Processing Therapy (CPT) consists of discrete therapeutic components that are delivered across 12 sessions, but most Veterans never reach session 12, and those who drop out receive only 4 sessions on average. Veterans drop out because of time constraints, logistics, and lack of perceived benefit. Unfortunately, Veterans who drop out prematurely may never receive the most effective components of CPT and continue to experience symptom-related distress and numerous other negative outcomes, including lost productivity, substance use, later-life physical disability, reduced quality of life, and increased risk of suicide. The overall objective of this study is to adapt CPT into a brief, effective format. The rationale is that identifying the most effective intervention components and delivering only those components will make CPT deliverable in a shorter timeframe, thus improving efficiency, reducing drop-out related to poor treatment response, and ensuring that Veterans receive the most beneficial components of treatment, which will significantly improve their quality of life.

Overcontrol and Suicide in PTSD

High standards and self-discipline are prized in military culture, but drawbacks of overcontrol are often ignored. Overcontrol is characterized by over-regulated behavior and cognitive rigidity, driven by an intense need for perfection and control. It is frequently observed in people with obsessive-compulsive (OC) spectrum disorders, especially OC Personality Disorder (OCPD). Their inclination to set high expectations for others can strain social bonds. When grappling with mental health challenges, overcontrolled individuals often do so with limited social support, and as a result, tend to be at greater risk of developing more severe mental health symptoms, or suicidal thoughts and behaviors, over time. New treatments are needed to improve social functioning in these vulnerable Veterans. Adding brain stimulation to psychotherapy is one method that might speed learning of social skills discussed in therapy. However, before this technology can be developed and tested more broadly, the investigators must make sure that the methods used to measure social functioning and related brain circuits are acceptable to most potential patients and can be used consistently. In this pilot project, the investigators aim to recruit trauma-exposed Veterans with overcontrolled traits and study the feasibility and acceptability of: 1. Our recruitment strategy and social functioning and mental health symptom assessments 2. A three-session, weekly fMRI protocol. 3. A three-week online protocol for remote monitoring of social and emotional functioning.

Enhancing PTSD Treatment Outcomes by Improving Patient-Provider Communication

The purpose of this clinical trial is to learn whether existing treatments for posttraumatic stress disorder (PTSD) can be improved. Two treatments for PTSD, cognitive processing therapy (CPT) and prolonged exposure (PE) will be studied. CPT and PE are effective treatments that are widely available, but interventions are needed to improve patient outcomes in these treatments. The investigators have developed an Adjunctive Writing intervention for Amplifying Response and Engagement (AWARE), which was designed using health communication strategies to enhance CPT and PE by improving communication between patients and therapists about patients' experiences in treatment. This research will investigate whether adding AWARE to CPT and PE will lead to better treatment outcomes compared to CPT and PE provided as usual without AWARE. AWARE includes a brief writing task asking patients about their experiences in treatment, as well as guided therapist responses to improve patient-therapist communication about patients' experiences in treatment. In the first phase of the study (case series phase), CPT or PE with AWARE will be provided to four adults with PTSD to pilot test adding AWARE to CPT and PE, seek patient and provider feedback, and refine AWARE. The first four participants who enroll will be part of the case series and will receive CPT or PE with AWARE. Then, in the second phase of the study, the randomized controlled trial (RCT) phase, the investigators will enroll 50 more adults with PTSD who will be randomly assigned (like flipping a coin) to receive CPT/PE as usual or CPT/PE with AWARE. It is expected that 25 participants will be randomized to CPT/PE with AWARE and 25 participants will be randomized to receive CPT/PE provided as usual. The goals of the RCT phase are to study whether AWARE is acceptable to patients, whether it is feasible to add AWARE to CPT and PE, and whether adding AWARE to CPT and PE improves patient-therapist communication and treatment outcomes compared to CPT/PE as usual.

A Study of a Novel EEG Neurofeedback System for PTSD Treatment

The goal of this clinical trial is to learn if training with the Prism system can reduce PTSD symptoms in US military Veterans and civilians with PTSD. Prism is a form of neurofeedback training that uses EEG signals to promote self-regulation of brain function. The main question this study aims to answer is: Does Prism training lead to decreased PTSD symptoms in US Veterans and civilians when used in addition to usual PTSD treatment? Researchers will compare Prism training to a sham training (a look-alike training that does not provide real feedback on brain activity) to see if Prism training decreases PTSD symptoms. Participants will: * Complete two one-hour in-person training sessions a week for about 8 weeks (15 sessions) * Complete two booster training sessions one month and two months after finishing the main training course * Participate in three detailed interviews: one before training, a second after nine weeks of training, and a third one month after the last booster training session (about 20 weeks after the initial visit)

MDMA for Co-occurring PTSD and OUD After Childbirth

This is an open-label study of the use of MDMA Assisted Therapy for postpartum people with co-occurring Post Traumatic Stress Disorder (PTSD) and Opioid Use Disorder (OUD). The study protocol has been adapted from the Phase 3 studies sponsored by the Multidisciplinary Association for Psychedelic Studies (MAPS) for PTSD. Due to the high rate of concurrence of PTSD and OUD, people with OUD may experience great benefit from the treatment of their PTSD with MDMA-assisted therapy based on the phase 2 and 3 studies for PTSD. Use of MDMA-assisted therapy in this population has the potential to be of benefit for their OUD and maternal- infant attachment. This study will serve to explore the feasibility and safety of offering MDMA-assisted therapy for treatment of PTSD in postpartum people with opioid use disorder. The CAPs 5 (PTSD) is the primary outcome, the Timeline Follow-Back (TLFB) for opioid use is the secondary outcome and other assessments of opioid use disorder, effects on maternal-infant attachment, social connectedness and other mental health outcomes are exploratory. The study will be conducted at the University of New Mexico Health Sciences Center located in Albuquerque New Mexico. In addition to northern New Mexico being an epicenter of the current opioid use disorder epidemic in the United States there is a long-standing history of multigenerational use of illicit opioids in many communities of northern New Mexico. There are high rates of opioid use disorder on pregnancy and accompanying Neonatal Opioid Use Withdrawal Syndrome (NOWS) in Albuquerque, Santa Fe, and surrounding communities.

Parental EMDR Therapy After a Baby's Stay in the NICU

This randomized clinical trial evaluates the effectiveness of eye movement desensitization and reprocessing (EMDR) therapy in reducing symptoms of post-traumatic stress disorder (PTSD). Participants with PTSD symptoms will be randomly assigned in a 1:1 ratio to either immediate EMDR in addition to treatment as usual (EMDR+TAU) or delayed EMDR following an initial treatment-as-usual period (TAU+EMDR). Randomization will be stratified by sex. PTSD symptoms will be assessed using the PTSD Checklist for DSM-5 (PCL-5) at baseline (T1), after the first treatment period (T2), and after the second treatment period (T3). The primary outcome is PTSD symptom severity measured by the PCL-5 at T2, comparing participants receiving EMDR+TAU with those receiving TAU alone during the first treatment period. Secondary outcomes include clinically meaningful improvement in PTSD symptoms, defined as a reduction of at least 10 points on the PCL-5, symptom change during the initial treatment-as-usual period, the effect of delayed EMDR, and the durability of the EMDR treatment effect over time.

Psilocybin for the Treatment of Veterans With Post-Traumatic Stress Disorder

The primary aim of this study is to assess the safety and efficacy of psilocybin-assisted therapy in the treatment of post-traumatic stress disorder in United States military Veterans.

Transcutaneous Vagal Nerve Stimulation in Veterans With Posttraumatic Stress Disorder

This study effects the effects of transcutaneous cervical vagal nerve stimulation (tcVNS) or a sham control on brain, physiology, and PTSD symptoms in Veterans with posttraumatic stress disorder (PTSD). Veterans undergo brain imaging and physiological measures in conjunction with traumatic scripts before and after three months of twice daily treatment with tcVNS or sham stimulation at home.

Service Dogs and Prolonged Exposure Therapy for Military-Connected PTSD

This study investigates the impact of Service Dog partnership on the effectiveness of Prolonged Exposure Therapy. We will learn whether Service Dog partnership in combination with Prolonged Exposure Therapy treatment can help Veterans with PTSD.

Impact of ERCS on Perceived Stress in Patients Hospitalized in the Post-resuscitation Rehabilitation Service

Surviving an intensive care unit hospitalization (ICU) can be the beginning of a long rehabilitation journey, hindered by symptoms of stress, PTSD, anxiety, and depression. In order to improve the care of these patients, it's essential to explore effective non-pharmacological approaches to reduce stress. Many non-drug techniques are being developed to alleviate the physical and psychological pain of patients. Energy Resonance by Skin Stimulation (ERCS) is a noninvasive method of soothing and supporting the patient. This technique is based on the energetic principles of traditional Chinese medicine. It relies on a "listening contact" through the stimulation of cutaneous points to create resonance and transmit vibrational and wave messages in the tissues. ERCS has various applications, whether for the management of acute or chronic pain, emotional disorders such as fear, anxiety, and depression. Our study aims to assess the effects of ERCS on the perceived stress of patients hospitalized in the post-ICU rehabilitation service. By demonstrating its potential impact on both physical and psychological recovery, this research could support the integration of RESC into care protocols and open new perspectives for stress management in hospital settings

Multi-site, Longitudinal Trial Evaluating the Efficacy, Mechanisms, and Moderators of Service Dogs for Military Veterans With PTSD

Posttraumatic stress disorder (PTSD) among military Veterans is a critical public health concern. Veteran suicide rates exceed those of the general population, with the disorder creating a mental health challenge that is costly and debilitating. The majority of Veterans with PTSD also have comorbid mental health diagnoses, such as generalized anxiety disorder, substance abuse disorder, and major depression. The treatment of Veteran PTSD and comorbid disorders represents an important therapeutic and rehabilitation problem. The disorder is complex and difficult to treat, with high treatment dropout and nonresponse rates spurring some Veterans to seek complementary integrative health strategies. One promising complementary strategy is the provision of a trained service dog. Initial evidence across multiple research groups highlights service dogs as a promising complement to evidence-based practices that can offer short-term improvements. However, the long-term effectiveness, mechanisms of action, and moderators of efficacy remain largely unknown. Thus, the overarching objective of this proposal is to understand how, why, and for whom PTSD service dogs are most effective. To address this objective, the present project will assess the longitudinal efficacy and dose-response curve of service dogs for Veteran PTSD symptomology and psychosocial functioning. The research design will consist of a two-arm, randomized clinical trial (RCT) with longitudinal assessments over a period of 15 months. Results are expected to elucidate the clinical impact of service dogs for military Veterans with PTSD, as well as the biobehavioral mechanisms of action and characteristics that moderate efficacy. These outcomes will support the long-term goal of accelerating complementary and integrative health interventions, through optimized and evidence-based service dog interventions. As such, this project will further advance the scientific understanding of human-animal interactions for psychosocial health.

Remotely Administered tDCS to Improve Cognitive Function in Veterans With mTBI and PTSD Principal Investigator

Traumatic brain injury (TBI) and post-traumatic stress disorder (PTSD) are common combat-related conditions that can result in impairments in cognition, including memory, attention and multi-tasking. There are few effective interventions to improve cognition in Veterans with cognitive impairment due to these conditions. Non-invasive brain stimulation techniques, like transcranial direct current stimulation (tDCS), can be used to stimulate activity in areas of the brain to optimize recovery and rehabilitation. In this study, the investigators are conducting a randomized controlled trial of tDCS to improve cognitive function in Veterans with cognitive impairment due to co-morbid TBI and PTSD. TDCS is remotely administered and paired with cognitive training.

ACT for Veterans With IBD and Mental Health Challenges

Many Veterans with gastrointestinal disorders, such as inflammatory bowel disease (IBD), also have mental health conditions. IBD and mental health conditions can worsen one another through the brain-gut axis, leading to dramatic deficits in psychosocial functioning and quality of life (QOL). Yet, few Veterans with comorbid IBD and mental health conditions receive psychotherapy and no evidence-based psychotherapies have been tested in Veterans with these comorbidities. Adapting brief acceptance and commitment therapy (ACT) to the specific to the needs of these patients and embedding treatment into routine gastroenterology care may increase Veterans' access to efficient and effective rehabilitative care. This study aims to adapt and test an integrated, 1-Day ACT intervention tailored to the specific needs of Veterans with IBD and mental health conditions to improve psychosocial functioning and QOL.

Enhancing Mental and Physical Health of Women Veterans 3.0

Women Veterans are the fastest growing segment of VA users, with most users in midlife. This dramatic growth has created challenges for VA to ensure that appropriate services are available to meet women Veterans' needs, and that they will want and be able to use those services. Furthermore, few VA improvement efforts have focused on women Veterans' health and health care in midlife. The EMPOWER QUERI 3.0 Program is a cluster randomized type 3 hybrid implementation-effectiveness trial testing two strategies designed to support implementation and sustainment of evidence-based practices for women Veterans in at least 18 VA facilities from 4 regions.

A Transdiagnostic Sleep Health Intervention for Veterans With PTSD

Sleep disturbance is a major problem in Veterans with posttraumatic stress disorder (PTSD). This study will test a version of a sleep treatment that's been shown to be effective in the general population, with some changes to tailor it to the needs of Veterans with PTSD and sleep disturbance.