A Randomized Clinical Trial on Mindfulness for African American Mothers Postpartum

This project is a first step to assess a culturally-tailored Mindfulness Intervention for African Americans Postpartum (MAAP). Elevated perinatal depressive symptoms are more common among disadvantaged African American women (AAW), 40-60%, compared to the national average,11-14 and AAW are almost four times as likely to have postpartum posttraumatic stress (13.4% vs 3.5%).15 Further, AAW are twice as likely to have a low birth weight infant (13.2% vs. 7%)16 and 1.6 times more likely to deliver preterm (16.3% vs. 10.2%) compared to non-Hispanic White women.17 AAW with preterm/low birthweight infants are at increased risk for psycho-behavioral disturbances and related impairments of infant development. This is a critical public health disparity.

The MAAP intervention is culturally adapted for AAW and includes using an AAW interventionist, providing course material that use written and artistic expressions of AAW with illustrations that portray AAW, creation of a community among research participants, inclusion of self-empowerment strategies, and the use of storytelling that resonates with AAW experience. The Investigators propose a randomized clinical trial to test the MAAP intervention compared to an Educational Program. This study aims to determine the extent to which MAAP affects psycho-behavioral symptoms and evaluate the effects of MAAP on pro- and anti-inflammatory biomarkers (proinflammatory cytokines and oxytocin). The Investigators will measure stress, depressive symptoms, anxiety, poor sleep, posttraumatic stress, fatigue, pro-inflammatory cytokines, and oxytocin to determine relationships among these variables and the MAAP intervention versus the Educational Program. The Investigators hypothesize participants in the MAAP intervention will have greater improvement of psycho-behavioral symptoms compared to participants in the Educational Program. The Investigators also hypothesize women in the MAAP intervention will have a greater decrease in pro-inflammatory cytokines and a greater increase in oxytocin compared to the Educational Program. The findings of this study will lay the groundwork for future research by identifying best-practice recruitment strategies, refining measurement strategies, and evaluating feasibility and acceptability.

A member of the research team, NICU nurses, and physicians will identify eligible subjects by daily unit census report. Multiple culturally competent strategies will be used to maximize subject recruitment and retention of AAW. The Investigators will be using an AAW interventionist, providing course material that use written and artistic expressions of AAW with illustrations that portray AAW, creation of a community among research participants, inclusion of self-empowerment strategies, and the use of storytelling that resonates with AAW experience. For recruitment, a NICU healthcare provider will make the first contact with a potential participant and then the PI or perinatal research assistant will further explain the study and informed consent. After informed consent, women will be randomized. The biostatistician will prepare sealed envelopes, using a block size of 4 participants. The MAAPI intervention and the Educational Program have a fixed time of 8 weeks, and will be run continuously allowing for 6 start times per year. Eight weeks will also serve as the recruitment time frame per cohort, estimating cohort size between 3-5 participants per group. Data will be collected at 3 times for both groups: T1=1st week session; T2= 4th week session; T3 = 8th week (conclusion). T1 will correspond to the first face to face meeting of the MAAP intervention or Educational Program. T1 data will be collected at the beginning of week 1 procedures for both the MAAP group and the Educational Program group. The Investigators estimate an ample recruitment window of 2 months per group will allow assembly of a cohort of at least three participants per group. using this design, the range of time elapsed from birth to a woman's entry into the intervention will vary and will be controlled in the statistical analysis.

Women randomized to the MAAP intervention will complete an 8 week (2hr/wk) hybrid adapted Kabat- Zinn's MBSR. MAAP intervention includes activities related to spirituality, self-empowerment, interdependence, and story-telling, which are salient to AAW. Session topics include 1) Tasting your Life, 2) Seeing and Believing, 3) The scent of Roses, 4) When Life Hurts, 5) Hearing Your Own Cries, 6) Embracing Inner Peace, 7) Holding On, 8) Welcoming Stillness. A manual has been developed for the MAAPI intervention with detailed protocols for each session. Face to face sessions (weeks 1, 4, and8) will be in a quiet room with movable chairs to allow group sitting or free floor space. Sessions for weeks 2, 3, 5, 6, 7 will be virtual classes offered via Zoom. Women will receive practice links and a program work book (5th grade level) containing objectives and weekly MAAP activities. Individual weekly home practice is expected. Type and minutes of home practice will be recorded in weekly logs. Program attendance, type, amount of practice, and changes in mindfulness (Five Facet Mindfulness Questionnaire) will be included in data analysis.

Participants randomized to the Educational Program will complete an 8 week (2hr/wk) hybrid educational program matched in duration, frequency, delivery method, and data collection to the MAAP intervention.Like MAAP, it will be delivered using a hybrid format (virtual Zoom and face-to-face sessions). Face-to-face sessions (weeks 1, 4, & 8) will be in a quiet room with movable chairs to allow group sitting or free floor space. Sessions for weeks 2, 3, 5, 6, 7 will be virtual classes offered via Zoom. At session week 1, participants will set up the Zoom app to ensure capabilities. Session topics are: 1) Perineum and Incision Care, 2) Safe Sexual Practices, 3) Understanding Infant Feeding Methods, 4) How to communicate Effectively with your Child's Health Care Providers, 5) Healthy Eating, 6) Infant Changing and Baths, 7) Infant Safety at Home, and 8) Utilizing Support from Family and the Community. Program content and objectives were reviewed by content experts (Neonatal Nurse Practitioner and Women's Health Nurse Practitioner. Sessions will be given in groups by an African American expert perinatal clinician/educator (not the PI) for all cohorts. Fidelity will be similar to that described for the MAAP intervention. Content will be "set" and delivered consistently across cohorts. Subject receipt will be monitored by attendance. Sessions will not include content on stress reduction (yoga, meditation, etc). Classes will be given in the same setting as the MAAP intervention, at the same time but on a different evening, to avoid crossover (diffusion) of effects.