Mindfulness for African Americans Postpartum

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.

Conditions

• Mental Disorders of Mother, Postpartum

Interventions

BEHAVIORAL

MAAP

Women randomized to the MAAP intervention will complete an 8 week (2hr/wk) hybrid adapted Kabat-Zinn's MBSR.(Kabat-Zinn, 1990) MAAP intervention includes activities related to spirituality, self-empowerment, interdependence, and story-telling, which are salient to AAW.(Watson-Singleton et al., 2019) 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.

BEHAVIORAL

Educational Program

The 8-week Educational Program will be 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 in person visits). Sessions will be given in groups by an expert perinatal clinician/educator for all cohorts. Content will be "set" and delivered consistently across cohorts. Sessions will be audiotaped and rated for achievement of objectives and consistency of delivery. Deviations will be promptly addressed. 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.

Sponsors & Collaborators

• National Institute of Nursing Research (NINR)

  collaborator NIH

• Loyola University

  lead OTHER

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

55 Years

Sex

FEMALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2022-02-07

Primary Completion

2024-07-31

Completion

2024-07-31

Countries

• United States

Study Locations