Clinical Research Directory

CABG-AI-Supported Discharge Education

This randomized controlled trial will evaluate the effectiveness of artificial intelligence-supported individualized discharge education for patients undergoing coronary artery bypass graft (CABG) surgery. Participants will be assigned to either the intervention group, which will receive personalized AI-generated discharge education delivered through a nurse-avatar video in addition to standard verbal education, or the control group, which will receive standard discharge education only. The study will compare postoperative pain, anxiety, physiological stress response, recovery, and satisfaction with discharge education between the two groups. Outcomes will be measured during hospitalization and at the routine postoperative follow-up visit. The findings may help improve patient education methods and postoperative recovery in cardiac surgery patients.

Neurobiological Mechanisms of Stress in Youth With Chronic Widespread Pain

Chronic widespread pain (CWP) is a common chronic pain condition in youth and often associated with significant pain-related and psychosocial impairment. Understanding the neurobiological mechanisms that may underlie pediatric chronic pain and pain-related impairment can inform future treatments to ameliorate patients' suffering, making it a critical area of empirical investigation.

Enhancing Resiliency and Optimizing Readiness in Military Personnel

Security Force Assistance Brigades (SFABs) are specialized United States Army units formed to train, advise, assist, enable and accompany operations with allied and partner nations. Security Force Assistance Brigades are composed of roughly 800 senior military personnel, primarily commissioned and non-commissioned officers selected from regular Army units across a wide range of military specialties. Because of the high operational tempo (OPTEMPO) of these units, individual resiliency is of utmost importance in maintaining readiness to successfully execute critical, high-stress missions. Acceptance and Commitment Training (ACT) is an evidence-based intervention with strong potential to enhance resiliency by bolstering psychological flexibility along with other factors which have been demonstrated to optimize individual and group performance. This project will compare an Acceptance and Commitment Training-based resiliency-enhancement training program as compared to training as usual in 600 3rd Security Force Assistance Brigades soldiers stationed at Fort Hood in Killeen, Texas. Assessment measures related to resilience will be administered before and after training as well as before and after deployment. Assessments will be conducted at baseline, and every 4 months thereafter for a total of 16-months.

Foundational Programs to Combat Clinician Stress

This is a prospective, randomized, controlled clinical trial in which clinicians from University of Pennsylvania Health Systems (UPHS) including Penn Medicine- Lancaster General Health (LGH) and Massachusetts General Hospital (MGH) are offered a well-known program to help reduce clinician burnout: Sudarshan Kriya Yoga (SKY) Breathing and Sahaj Meditation Intervention.

Biology, Identity & Opportunity Study

This study will implement an intervention designed to promote ethnic and racial identity development. It is hypothesized that the intervention will have positive effects on ethnic-racial identity development, stress biology (including sleep hours and quality and diurnal cortisol profiles), emotional well-being, executive functioning, and academic outcomes, particularly for minority youth.

Impact of OnabotulinumtoxinA (BOTOX®) on Stress

The purpose of this prospective single-center, blinded\*, randomized, proof-of-concept study is to determine whether OnabotulinumtoxinA (BOTOX®) injections will change the level of stress perceived by generally healthy adult female participants. It is hypothesized that BOTOX® injections will be associated with decreases in perceived stress levels, measured by scores on the Perceived Stress Scale (PSS) questionnaire. The primary outcome measure is a chronological decrease in PSS scores between any two points of the study period. Comparison of the placebo- and BOTOX®-treated participant scores will either support or disprove the study hypothesis. Qualified participants who meet the study requirements, including a one-time completion of basic laboratory testing before treatment. The treatment visit starts on day-1 of a 12-week period, which consists a total of four clinic visits and one online visit, which involve: * vital signs and Body Mass Index (BMI) measurements * basic/interval history and physical * 2 Perceived Stress Scale (PSS) questionnaires * injection of 64 units of either BOTOX® or sterile salt solution * stay for 60-minutes after treatment for monitoring and to complete study tasks

Daoist Zhanzhuang and Human Flourishing

This project investigates the impact of Daoist Zhanzhuang (sometimes spelled as Chan Chuang) on human flourishing, and explores the physiological, psychological, and spiritual mechanisms. This study will be a two-arm randomized controlled trial, with mixed-methods and repeated-measures assessment of outcome variables. The two arms will include an active control condition (i.e., sham wall squat) and the Daoist Zhanzhuang condition. Outcome variables will include physiological measures of heart rate variability and inflammatory biomarkers, psychological scales of human flourishing variables, phenomenological interviews of mystical experiences, and daily ecological momentary assessment of human flourishing and mysticism. Randomly assigned into two conditions, 120 participants will complete a three-week intensive practice phase with 9 in-person sessions, followed by a nine-week self-guided practice phase with 4 in-person check-in sessions, and 3 follow-up practice and assessment sessions. Complete assessment (physiological measures, psychological scales, and phenomenological interviews) will be administered at five time points: T1 at about two weeks before the intervention, T2 at the end of the three-week intensive practice, T3 at the end of the 3-month intervention, T4 at the 6-month follow-up, and T5 at the 12-month follow-up. In addition, daily ecological momentary assessment of flourishing variables and practice-induced experiences will be administered daily after the practice for the entire 3-month intervention period.

Autonomic Modulation Training for Police Exposed to Post-Traumatic Stress Injuries

Police officers are exposed to hazardous, disturbing events that impose stress and long-term trauma. Upwards of 15-26% of public safety personnel (PSP) report one or more mental health symptoms. Accumulated stress and posttraumatic stress injuries (PTSI) result in chronic physical and mental health disorders including anxiety, depression, substance abuse, and cardiovascular disease. PTSI are related to reduced occupational performance, absenteeism, and risky behaviour, with implications for both police and public safety. Recent empirical evidence and government reports highlight a mental health and suicide crisis among various PSP sectors in Canada. Prior research forms an urgent call for evidence-based programs that build resilience and wellness capacity to prevent PTSI symptoms before they manifest as severe, chronic, diagnosable disorders. The current study addresses the limited effectiveness issues associated with existing interventions for PTSI among PSP and also considers sex and gender as central determinants of health. Advances in physiology and neuroscience demonstrate that resilience is maintained by the healthy functioning of psychophysiological systems within the body. Objective biological measures have shown that chronic stress and trauma disrupt both psychological and physiological functioning, eroding resilience and reducing wellness capacity. Traditional interventions to build resilience among PSP have not adequately addressed the physiological underpinnings that lead to mental and physical health conditions, as well as burnout and fatigue following trauma. Together with previous empirical research lead by the NPA, the current proposal addresses this gap in PSP intervention research by employing Autonomic Modulation Training (AMT), a biological approach to building resilience and wellness capacity among PSP exposed to PTSI. Prior research shows that core AMT techniques effectively reduce psychophysiological stress and mental health symptoms in clinical and non-clinical populations. Further, research has shown that AMT techniques improve police health and occupational performance when completed during scenario-based, in-person training. The aim of the proposed study is to test if a web-based delivery of AMT for police officers can build resilience and wellness capacity, and reduce symptoms of PTSI with similar effectiveness as in-person training. An additional novel scientific contribution of the current proposal includes an examination of sex and gender in baseline biological presentation of PTSI among police, and in response to a resilience building intervention.