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Clinical Trials: Stress Disorders
IRB No. 14-193CH-6.2 (Dr. Damion Grasso, PI): Prenatal Exposure to Stress
The purpose of the repository is to build a research program focused on epigenetic influences of early childhood exposure to violence and disruption in the development of the stress response system. The work will continue the focus on the glucocorticoid receptor gene FKBP5 and it's companion molecules in the stress response pathway.
IRB No. 22-146O-1 (Dr. Wizdom Powell, PI): Project BrEAtHe (Brothers, Reclaiming, Emotional, Awareness, Tranquility, Healing & Existence): Disrupting Racism-related Stress, Trauma, & Problematic Substance Use
Project BrEAtHe is a research study to create a program focused on mindfulness and stress reduction specifically tailored to young adult Black males (18 to 29 years old) residing in Durham, NC and in Hartford, CT. We plan to use a mobile app on a cell phone to better understand ';real-time'; feedback of experiences of stress due to racism. We are interested in learning about the recruitment and retention of Black males participating in mindfulness based practices. We are also interested in receiving feedback about options to modify and scale a Mindfulness Based Stress Reduction intervention and its preliminary effects on reducing physical and emotional stress reactions and poor coping mechanisms like marijuana and alcohol use linked to everyday racism and discrimination.
IRB No. 21-143OSC-1 (Dr. Damion Grasso, PI): Impact of Perinatal Pandemic-Related Stress on the Early Caregiving Environment, Infant Functioning, DNA Methylation, and Telomere Length
The current study seeks to recruit a diverse cohort of women and their partners who were in the final two trimesters of pregnancy during the COVID-19 pandemic. Phase 1 of the study will involve a large-scale survey (N=2,000) of these individuals to assess perinatal stress exposure occurring in the context of the pandemic. Phase 2 will involve selecting individuals from the Phase 1 survey to establish two subgroups with high (n=200) and low (n=200) perinatal pandemic-related stress exposure to participate in a comprehensive and longitudinal assessment protocol, including interviews, parent-child interactions, an infant stress paradigm, and biological sample collection. Aims are to: (1) use person-centered latent class analysis of perinatal pandemic-related experiences to identify unique profiles that vary on the types and quantity of stress exposure and differentially associate with race/ethnicity, caregiver-reported perceived stress, emotion dysregulation, PTSD, parenting, and infant dysregulation (stress-reactivity and emotional/behavioral problems) in the large Phase 1 survey cohort (N=2,000); (2) Compare infants with high and low perinatal pandemic-related stress and examine caregiver emotion dysregulation, PTSD, and responsive parenting as potential mediators of this relationship in the longitudinal Phase 2 cohort (N=400); and (3) identify differentially methylated regions of DNA and differences in telomere length and changes over time in infants in high v. low perinatal stress groups. Assessment procedures will integrate the experiences and functioning of both the mother and partner when considering implications for offspring. This work will yield mechanistic insight on how pandemic-related stress, caregiver emotion dysregulation, and PTSD influence multiple aspects of the caregiving environment and infant outcomes and is expected to directly inform perinatal public health interventions as the COVID-19 pandemic continues and its sequelae unfold.
IRB No. 25-016H-2 (Dr. Andrea Shields, PI): Bringing Residents, Fellows and Nurses Back to the Bedside to Support a Mother’s Road to Recovery: Interdisciplinary Trauma-Informed Care Curriculum for Perinatal Care
Physician recognition of impending trauma is highly important to prevent and mitigate possible patient distress. Pregnant women with a history of trauma and adverse childhood experiences can have higher levels of pregnancy related trauma which can exacerbate anxiety, depression, and PTSD symptoms. Trainees in OB/GYN and Labor and Delivery, including residents, fellows, and nurses, not only struggle with recognition of pregnancy-related trauma, but have experienced a higher level of burnout impacting the physician-patient relationship. Our goal is to improve recognition and management of pregnancy-related trauma while embodying a culture of mindfulness amongst OB/GYN residents, fellows, and nurse trainees.