Clinical trial NCT05280938: Mindfulness for African Americans Postpartum
Official title: A Randomized Clinical Trial on Mindfulness for African American Mothers Postpartum
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Mental Disorders of Mother, Postpartum
Lead sponsor: Loyola University
Sponsor class: OTHER
Collaborators: name: National Institute of Nursing Research (NINR)
First posted: 2022-03-15
Enrollment: 47
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: A randomized clinical trial (RCT) design will be used to compare an 8-week Mindfulness for African Americans Postpartum (MAAP) intervention to an 8-week Educational Program (active comparison group). The primary objective is to evaluate the effectiveness of MAAP to decrease maternal psycho-behavioral symptoms and to improve mother/infant bonding. To better meet the needs of new mothers, MAAP will use a online form of delivery (i.e., group synchronous virtual Zoom). A secondary objective is to explore proinflammatory cytokines and oxytocin as possible biological mechanisms by which the MAAP intervention might decrease psycho-behavioral symptoms and improve mother/infant bonding. The MAAP intervention includes best approach and is culturally adapted based on prior evidence and expert opinion, and it addresses weaknesses in rigor of prior studies.

Detailed description: 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.

The Investigators will use strategies to maximize retention and decrease missing data. These strategies include: 1) Establish project identity to increase subject engagement with the study. 2) Provide phone calls and texts one day prior to weekly session; on-going contacts with subjects. 3) Train nurse research assistants in subject retention strategies and subject follow-up. 4) Women who miss a session (face to face or virtual) will be telephoned to determine reason for absence and address any concerns that may inhibit participation in the project. If the Investigators are unable to reach participants by phone, the Investigators will leave a letter by the infant bedside, and mail a letter to her home address. Participants whose infants have been discharged will have the option of bringing their infants to the face to face sessions and scheduling home visits for data collection of saliva samples and questionnaires at T1, T2, and T3. Recruitment and retention progress and issues will be addressed with the study Mentoring Team and the Data Safety Monitoring Board. Multiple culturally adapted strategies will be used to maximize subject recruitment and retention of AAW. These include mindfulness sessions incorporating the concepts of spirituality, self-empowerment, and interdependence. The MAAP interventionist and the Research Assistant running the Educational Program will both identify as single or multiracial African American or black. Additionally, the MAAP workbook is specific to AAW, including writings and artistic expressions by AAW, and use of images of AAW in meditation/yoga poses. Our research plan already uses some of the recommended recruitment and retention strategies (i.e., compensation and consideration of personal or family medical problem).

The study was designed to enroll 40 participants, 20 in the MAAP intervention and 20 in the Education Program. The sample size of 40 was computed based on our primary hypothesis, that the MAAP intervention will have a greater improvement of psycho-behavioral symptoms, decreased pro-inflammatory cytokines, and increased oxytocin in African American women with a preterm/low birthweight infant compared to the Educational Program. Based on our pilot and published data, the effect size was estimated at 0.70 for anxiety, 0.45 for prenatal stress and 0.8 for sleep quality, 0.40 for depressive symptoms and 0.36 for proinflammatory cytokines. A sample size of 40 will achieve 80% power, given current effect size estimates per aim. To determine the extent to which the MAAP intervention improves maternal psycho-behavioral symptoms the Investigators will use growth curve analysis (HLM). HLM model longitudinal data by allowing random effects to account for repeated measures on participants over 3 times, and to evaluate change in trajectories over time. HLMs allow for analysis of unbalanced data across time points, increasing power and reducing bias. HLM analysis will evaluate the effects of the MAAP intervention on change in proinflammatory cytokines and oxytocin levels. Models will control for maternal age and gestational age at delivery.

Eligibility criteria: Inclusion Criteria:

In order to be eligible to participate in this study, an individual must meet all of the following criteria.

1. Participants must identify as African American/Black and have given birth to an infant
2. Participants will be over the age of 18 and able to speak and read English at a 5th grade level or above.
3. Participants must be willing to comply with study procedures including completion of an 8-week intervention or educational program, provide saliva samples 3 times at session 1, 4, and 8, answer questionnaires concerning demographics, and psycho-behavioral health symptoms, and be available for in person and virtual sessions during the duration of the study.
4. Participants must be willing to adhere to the MAAP intervention.
5. Participants must have access to a smart phone and agree to download the free app Zoom
6. Participants must sign and date an informed consent document -

Exclusion Criteria:

An individual who meets any of the following criteria will be excluded from participation:

1. Participants will be excluded from the study if they are currently using immune medications such as steroids, whether prescribed or not
2. Participants are excluded from the study if they have a diagnosis or disease process (physical or psychological) that precludes participation in the MAAP intervention.

Primary outcomes:
measure: Parental Stress Level
timeFrame: Baseline (week 1)
measure: Parental Stress Level
timeFrame: mid treatment (week 4)
measure: Parental Stress Level
timeFrame: end of treatment (week 8)
measure: Depressive Symptoms
timeFrame: Baseline (week 1)
measure: Depressive Symptoms
timeFrame: mid treatment (week 4)
measure: Depressive Symptoms
timeFrame: end of treatment (week 8)
measure: Anxiety Level
timeFrame: Baseline (week 1)
measure: Anxiety Level
timeFrame: mid treatment (week 4)
measure: Anxiety Level
timeFrame: end of treatment (week 8)
measure: Elevated Posttraumatic stress
timeFrame: Baseline (week 1)
measure: Elevated Posttraumatic stress
timeFrame: mid treatment (week 4)
measure: Elevated Posttraumatic stress
timeFrame: end of treatment (week 8)
measure: Sleep Quality
timeFrame: Baseline (week 1)
measure: Sleep Quality
timeFrame: mid treatment (week 4)
measure: Sleep Quality
timeFrame: end of treatment (week 8)
measure: Fatigue Symptoms
timeFrame: Baseline (week 1)
measure: Fatigue Symptoms
timeFrame: mid treatment (week 4)
measure: Fatigue Symptoms
timeFrame: end of treatment (week 8)
measure: Mindfulness
timeFrame: Baseline (week 1)
measure: Mindfulness
timeFrame: mid treatment (week 4)
measure: Mindfulness
timeFrame: end of treatment (week 8)
Secondary outcomes:
measure: Pro-inflammatory cytokines
timeFrame: Baseline (week 1)
measure: Pro-inflammatory cytokines
timeFrame: mid treatment (week 4)
measure: Pro-inflammatory cytokines
timeFrame: end of treatment (week 8)
measure: oxytocin
timeFrame: Baseline (week 1)
measure: oxytocin
timeFrame: mid treatment (week 4)
measure: oxytocin
timeFrame: end of treatment (week 8)
Other outcomes:
Locations:
city: Maywood
country: United States
facility: Loyola University Medical Center
state: Illinois
Study officials:
References: