Clinical Research Directory

Examining 3,4-methylenedioxymethamphetamine (MDMA) Effects on Psychological, Relational and Hyperarousal-Related Neural Reactivity Mechanisms in Veterans With PTSD and Moral Injury

Despite being exposed to a high level of potentially traumatic experiences due to exposure to combat, military veterans have poor response rates to traditional PTSD treatments, in some reports, just 1/3 of veterans recover using traditional treatments. In recent years 3,4-methylenedioxymethamphetamine (MDMA), a psychedelic drug has demonstrated a significant treatment potential for severe and treatment resistant PTSD though not specifically in a veteran population. Additionally, even in groups where participants receive a placebo, the effect of the psychedelic treatment formulation, intensive, focused and respectful structure, appears to have promising effects. Indeed, in the current psychedelic literature, the setting and mind with which participant approach psychedelic therapy, significantly contributes to the treatment effect. The current study proposes to address the major gaps in the theoretical literature by examining the proposed mechanisms by which MDMA enhances the "window of tolerance" for PTSD therapy, specifically in those with comorbid symptoms of moral injury; namely by reducing hyperarousal and enhancing connection (to self and others) and whether MDMA assisted therapy is more successful in reducing PTSD in veterans compared to a matched somatic experiential PTSD treatment, Somatic Experiental Acceptance Intensive Trauma-based therapy, (SEA-IT) which builds upon the promising placebo results, enhancing them with somatic and acceptance based treatment protocols.

Mobile-Based Resilience Intervention for Moral Injury, Compassion Fatigue, and Distress in ICU Nurses

Critical care nurses are routinely exposed to high acuity, mortality, end-of-life decisions, and long rotating shifts, which can lead to moral injury, compassion fatigue (burnout and secondary traumatic stress), and psychological distress. This randomized controlled trial will test the effectiveness of ICU Resilience, an 8-week, self-paced, Arabic-language mobile-based workplace resilience intervention, in reducing these outcomes among full-time nurses working in the intensive care units of Beni-Suef University Hospitals, Egypt. One hundred sixty nurses will be randomly allocated 1:1 to the intervention or a control arm. The intervention is grounded in Conservation of Resources theory and an integrated cognitive-reappraisal and psycho-spiritual resilience framework, organized around psychological, emotional, social, and professional resources. Each weekly module includes a micro-learning video, an audio-guided exercise, an interactive digital tool, and a daily one-minute micro-practice, covering psychoeducation, mindfulness and somatic regulation, cognitive reappraisal, self-compassion, meaning-making, social support, practical coping, and relapse prevention. Control participants receive usual workplace orientation and routine hospital support and are offered the app after the final assessment. Moral injury, burnout, secondary traumatic stress, psychological distress, and resilience will be measured with self-report scales at baseline, immediately after the intervention (week 8), and at one-month follow-up (week 12).

Coping and Adaptation for Recovery From Moral Injury: A Group Intervention for Clinical Psychology Residents

Moral distress may arise when health care professionals are unable to act in accordance with their professional values or believe that they have participated in, witnessed, or been unable to prevent situations that conflict with those values. Repeated or particularly difficult experiences may affect emotional well-being, professional identity, and the meaning associated with clinical work. This single-group pilot study will evaluate the feasibility, acceptability, and preliminary effects of Coping and Adaptation for Recovery from Moral Injury (CARE-MI), a four-session group intervention for clinical psychology residents in Spain. Each 90-minute session addresses one of four components: moral awareness, emotional flexibility, moral repair, and professional flourishing. The program is designed to help participants recognize morally difficult experiences, respond more flexibly to associated thoughts and emotions, review responsibility in a fair and contextualized way, and protect the values and resources needed for professional practice. Participants will complete assessments before and after the intervention. Changes in moral distress and psychological well-being will be examined, together with indicators of intervention feasibility and acceptability.

A Comprehensive Group Intervention for Psychosocial Personnel at Risk of Stress and Moral Injury

The objective of this randomized controlled trial is to evaluate the effectiveness of the CARE-MI group intervention in reducing symptoms of post-traumatic stress and moral injury in support staff working with individuals diagnosed with physical or mental health conditions (psychosocial personnel). The study also seeks to assess its impact on symptoms of anxiety and depression, as well as its potential to improve overall well-being. We will conduct a multicomponent study involving several pre-existing teams from collaborating centers, allowing the intervention to be evaluated in different institutional settings. This is a multilevel randomized trial, with each group randomly assigned, through blinded allocation using a computer program, to either the intervention group or a wait-list control group. Participants will be assessed at three time points: pre-intervention, post-intervention, and at a 6-month. This trial is part of a larger research project that includes several related studies. Each study addresses a specific population and/or intervention, but all share the overarching aim of Coping and adaptation for recovery from moral injury.

Comparing Two Moral Injury Treatments

Purpose of this study: The purpose of this study is to evaluate the effectiveness of two psychological treatments for moral injury: Acceptance and Commitment Therapy for Moral Injury and Present Centered Therapy for Moral Injury. The main questions it aims to answer are: 1. Determine the efficacy of ACT-MI for building functional recovery among 180 warzone deployed Veterans. 2. Identify barriers and facilitators to implementing ACT-MI in VA mental health clinics or a national telehealth hub in preparation for future dissemination efforts. Participants will be asked to: * Complete a two to two and a half hour initial assessment session online using videoconferencing. Participants will be asked to complete surveys and questionnaires. * Be randomized to either ACT-MI or PCT-MI * Meet with the study clinicians for 15 virtual outpatient sessions (12-group and 3-individual sessions). * Complete a post-treatment assessment session offered online using videoconferencing within one week of treatment completion to complete surveys and questionnaires. * Complete one- and three-month follow-up assessments offered online using videoconferencing to complete surveys and questionnaires.

A Study of Moral Distress, Moral Injury and Post-Traumatic Stress for Nurses

The goal of this descriptive study is to examine levels of moral distress (MD), moral injury (MI), \& post-traumatic stress (PTS) levels among nursing staff at Mayo Clinic. The main questions this study aims to answer are: 1. Determine the levels of MD, MI, and PTS symptoms experienced by nurses who participate in the study. 2. Evaluate differences in MD, MI, and PTS symptoms by setting, specialties, and geographic locations. 3. Examine demographic and professional characteristics that are associated with high levels of MD, MI and PTS.

Professional Contributions and Social Value in High-Acuity Medical Care Settings

This study will explore experiences in high-acuity medical care settings, such as emergency, trauma, intensive care, and related clinical areas. These settings often involve heavy workloads, complex care decisions, teamwork, and communication among many people. The study will invite healthcare professionals, patients, important family caregivers, and other related people to share their experiences. Participants may complete questionnaires, take part in interviews, or complete a later online survey. The study will ask about work experiences, care experiences, communication, support needs, teamwork, and the value of professional contributions in these settings. The goal of this study is to better understand important but less visible contributions in high-acuity medical care, such as teaching, coordination, communication, and support. The findings may help identify areas that can be considered in future research, hospital improvement, workforce development, and policy discussion.

Moral Injury in French Healthcare Workers

Healthcare professionals are facing an escalating crisis, with burnout rates ranging between 40% and 60% and a growing intention to leave the profession, affecting one in five physicians and one in four nurses in the coming years. While current interventions focused on individual resilience, such as mindfulness, peer support, and workload management, have been promoted as solutions, they have failed to bring about systemic improvements. This raises the question of whether other factors, such as Moral Injury, play a key role in this crisis. Moral Injury is an emerging concept that highlights the profound misalignment between healthcare workers' professional values and the reality of their practice, often exacerbated by organizational and economic constraints. The objective of this study is to describe the manifestations of Moral Injury among healthcare professionals in France. By establishing the first large-scale assessment of Moral Injury among healthcare professionals in France, this study aims to identify key organizational and personal risk factors contributing to this phenomenon. The use of Structural Equation Modeling will help build a robust theoretical model that clarifies the underlying mechanisms of Moral Injury and its interactions with broader health issues. The findings will support the development of targeted interventions focused on systemic organizational changes to improve healthcare workers' well-being and guide public health policies.

Moral Injury Study Among Healthcare Professionals in Psychiatric Facilities in the PACA Region

Healthcare professionals working in psychiatric settings face demanding working conditions characterized by high rates of burnout and specific constraints, such as the deprivation of patients' liberty. \*Moral Injury\* (MI), a relatively recent concept, extends beyond burnout by focusing on the distress arising from ethical conflicts and the dissonance between professional values and the realities of clinical practice. Although the concept has begun to emerge from a theoretical perspective, particularly in the United States, it remains largely unknown in France and has yet to be investigated in psychiatric settings at the international level. The hypothesis is that MI plays a central role in healthcare professionals' psychological distress and contributes to the major recruitment and retention crisis affecting public psychiatric institutions. This crisis is reflected, for example, in a 40% vacancy rate for hospital physician positions in public facilities, with particularly acute shortages in child and adolescent psychiatry. The demographic crisis in child and adolescent psychiatry is unprecedented, marked by a 30% decline in the workforce over the past decade and projections suggesting a further 50% reduction within the next ten years. At the same time, mental health disorders among adolescents-particularly suicide attempts among girls-have increased substantially since the COVID-19 pandemic. This study aims to explore the organizational, individual, and systemic factors associated with Moral Injury in order to better understand and prevent this form of professional suffering.

General Psychological Distress, PTSD, and Co-Morbidities in Healthcare Workers Consequent to Occupational Trauma

It is expected that large numbers of healthcare workers experience a broad range of psychological reactions and symptoms including anxiety, depression, moral distress, and trauma symptoms that will cause both significant suffering as well as occupational and social impairment. The purpose of this study is to find interventions which are helpful in treating psychological distress in healthcare workers adversely affected by occupational-related trauma. There are two phases of the study. All participants will take part in Phase I, which consists of 4 sessions over a two-week period of either a narrative writing intervention or a medical music intervention. Participants will be randomly assigned to the narrative writing intervention or medical music intervention. After Phase I, participants will be re-assessed. Healthcare workers who meet criteria for PTSD will be given the option to participate in Phase II of the study, in which they will be offered a choice between one of two evidence-based treatments for PTSD: Interpersonal Therapy (IPT) or Exposure Therapy (ET). Both treatments are comprised of ten 75-minute sessions scheduled twice weekly. Participants will be allowed to choose a preferred treatment in Phase II. After Phase II participants will complete a final assessment concluding the study. All interventions will be offered using distance technology.

Role Model-Based Ethics Education and Moral Injury Prevention in Second-Year Medical Students

This study examines whether role model-based ethics education can reduce moral injury and perceived stress, and improve resilience, among second-year medical students in Taiwan. Students participated in a general education ethics course and self-selected into one of two groups: a standard-intensity group receiving role model narratives and guided handouts, or an enhanced-intensity group receiving the same content plus reflective writing assignments and live guest appearances by featured practitioners. Validated questionnaires measuring moral injury (MIDS), perceived stress (PSS-14), and resilience (CD-RISC-10) were administered before and after the course. Open-ended written responses were also collected and analyzed. The study aims to inform early curricular integration of ethics education in medical training and to identify instructional designs that support moral agency without inadvertently promoting emotional disengagement.

Mental Health Clinician / Chaplain Collaboration

The goal of this clinical trial is to learn if the intervention can be delivered by VA chaplains and if it is acceptable for veterans who have symptoms of moral injury (guilt, shame, isolation) and are receiving VA mental health treatment. The main questions it aims to answer are: Can the study team enroll veterans for this intervention and complete data collection? Will veterans complete the intervention? There is no comparison group. Participants will will complete a baseline and 6-month interview and participate in up to 12 intervention sessions with a VA chaplain. The intervention will focus on facilitating forgiveness and community connection.

Consulting After Combat: Interviewing Veterans to Develop a Therapy to Restore Functioning and Reintegration After Moral Injury Events

Despite the VA's best efforts to treat the psychosocial impact of war, many combat Veterans report lingering difficulty reintegrating into meaningful post-deployment lives. War is among the most extreme forms of human experience but, for many, wartime trauma was treated using models transported from civilian single-incident trauma contexts. Veterans have unique needs and experiences that require culturally responsive and sensitive conceptualizations and treatments. Patient-centered care is improved by providing multiple effective treatment options and this project, if successful, could have a significant impact on VA care. This CDA-2 project has the potential to offer innovative treatment for traumatized combat Veterans who otherwise may not find full relief from PTSD. Clinical research practice will be advanced by employing state-of-the-art user-centered design methods combined with expert clinical feedback to develop an effective and usable group treatment manual that will meet VA needs.

Integrative Bilateral Cervical Sympathetic Blocks for Trauma-Related Symptoms in Special Operations Veterans: A Prospective Case Series

This study prospectively evaluates the effects of Integrative Bilateral Cervical Sympathetic Block (BCSB) on trauma-related symptoms in Special Operations Veterans, comparing outcomes in those receiving BCSB alone versus BCSB combined with structured integrative therapy. Using standardized FDA-approved dosing, validated symptom measures, and strict safety criteria, the study aims to determine whether this dual-level autonomic intervention improves PTSD-related and TBI-related symptoms, and whether pairing the procedure with therapy enhances durability and overall clinical benefit.