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Mindfulness for Postpartum Mental Health (MAAP Trial)

N/A
Recruiting
Research Sponsored by Loyola University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Participants will be over the age of 18 and able to speak and read English at a 5th grade level or above
Participants must be willing to comply with study procedures including completion of an 8-week intervention or educational program, provide blood or 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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up end of treatment (week 8)
Awards & highlights

MAAP Trial Summary

This trial will compare an 8-week mindfulness intervention specifically for African American women with a preterm infant to an 8-week educational program, in order to evaluate the effectiveness of the mindfulness intervention in decreasing maternal psycho-behavioral symptoms and improving mother/infant bonding.

Who is the study for?
This trial is for African American/Black mothers over 18 who recently gave birth, can engage in English at a 5th grade level or higher, and are willing to participate in an 8-week program. They must be able to attend virtual sessions, provide samples for study purposes, and use Zoom on a smartphone. Excluded are those on immune medications like steroids or with conditions that limit participation.Check my eligibility
What is being tested?
The trial compares the Mindfulness for African Americans Postpartum (MAAP) intervention against an educational program to see if MAAP reduces postpartum mental symptoms and enhances mother/infant bonding. It's delivered online via Zoom over eight weeks and will also explore biological changes related to the interventions.See study design
What are the potential side effects?
Since this trial involves non-medical interventions such as mindfulness training and education programs, traditional medication side effects aren't expected. However, participants may experience emotional discomfort when discussing personal experiences.

MAAP Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am over 18 and can speak and read English well.
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I am willing to follow the study's requirements, including attending sessions and providing samples.

MAAP Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~end of treatment (week 8)
This trial's timeline: 3 weeks for screening, Varies for treatment, and end of treatment (week 8) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Anxiety Level
Depressive Symptoms
Elevated Posttraumatic stress
+4 more
Secondary outcome measures
Pro-inflammatory cytokines
oxytocin

MAAP Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: MAAP InterventionExperimental Treatment1 Intervention
The MAAP intervention is an 8-week adapted mindfulness intervention based upon Kabat-Zinn's MBSR. The intervention includes spirituality, self-empowerment, interdependence, and story-telling which are salient to AAW. Session topics include Tasting Your Life, Seeing and Believing, The Scent of Roses, When Life Hurts, Hearing Your Own Cries, Embracing Inner Peace, Holding on, Welcoming Stillness. Each session will include an introduction, opening mindfulness practice, class responses to the previous week, review guidelines for class, guided individual reflection, group go-around/discussion, yoga, abdominal breathing, body scan, conclusion, and home practice. Face to face sessions 1, 4, 8 will be in a quiet room to allow group sitting or free floor space. Sessions 2, 3, 5, 6, are virtual on the zoom app. Participants receive practice links and a program workbook. Program attendance, type/amount of practice (weekly logs), and changes in mindfulness will be included in data analysis.
Group II: Educational ProgramActive Control1 Intervention
The Education Program (attention control group) will be an 8-week educational program matched in duration and frequency to the MAAP intervention. 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. Sessions will be given in groups by the same expert clinicians/educators for all cohorts. Subject receipt of the attention control will be monitored by attendance. Control group instructor will not include content on stress reduction or methods (yoga, meditation, etc.) taught in the MAAPI intervention. Classes will be given in the same setting as the MAAPI intervention, at the same time but on a different evening, to avoid crossover of effects.

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Who is running the clinical trial?

Loyola UniversityLead Sponsor
156 Previous Clinical Trials
30,882 Total Patients Enrolled
National Institute of Nursing Research (NINR)NIH
576 Previous Clinical Trials
10,375,093 Total Patients Enrolled

Media Library

MAAPI Clinical Trial Eligibility Overview. Trial Name: NCT05280938 — N/A
Postpartum Mental Disorders Research Study Groups: MAAP Intervention, Educational Program
Postpartum Mental Disorders Clinical Trial 2023: MAAPI Highlights & Side Effects. Trial Name: NCT05280938 — N/A
MAAPI 2023 Treatment Timeline for Medical Study. Trial Name: NCT05280938 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the total enrollment of this medical trial?

"Affirmative, according to clinicaltrials.gov the trial is currently engaging potential participants. This investigation first appeared on February 7th 2022 and was last amended on March 4th 2022. 40 individuals are needed from a sole medical center."

Answered by AI

Am I eligible to partake in this trial?

"This study requires 40 individuals aged 18 to 55 that are clinically diagnosed with a mental disorder. Furthermore, participants must identify as African American/Black and have given birth to an infant within the last year. Additionally, they need to be proficient in English at or above 5th grade level, agreeably complete an 8-week program of intervention or education; provide blood/saliva samples thrice during session 1, 4 & 8 respectively; answer questionnaires regarding demographics and psycho behavioural health symptoms over the course of the trial; accept MAAPI intervention guidelines and possess access to a smart phone along with downloading Zoom application for free. Lastly, participant's"

Answered by AI

Are there any open slots to join this investigation?

"The information on clinicaltrials.gov declares that this experiment is still seeking suitable patients. The trial commenced its recruitment process on February 7th 2022 and the latest update was posted March 4th 2022."

Answered by AI

Is the upper age limit for this trial cohort greater than eighty-five years?

"The age range for inclusion in this medical trial is 18-55 years old."

Answered by AI
~1 spots leftby May 2024