NCT05280938
Mindfulness for African Americans Postpartum
NA
COMPLETED
NCT05280938
INTERVENTIONAL
A Randomized Clinical Trial on Mindfulness for African American Mothers Postpartum
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.
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.
Mental Disorders of Mother, Postpartum
- PREVENTION
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- Type: BEHAVIORAL
- Name: MAAP
- Description: 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.
- Arm Group Labels: MAAP Intervention
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- Type: BEHAVIORAL
- Name: Educational Program
- Description: 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.
- Arm Group Labels: Educational Program
- Loyola University