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The DC Mother-Infant Behavioral Wellness Program

NCT05345834 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 700

Last updated 2025-07-24

No results posted yet for this study

Summary

This randomized controlled study will examine the effectiveness of patient navigation with culturally adapted cognitive-behavioral interventions and peer support groups for low-income Black/of African Descent pregnant women who are experiencing stress, anxiety, and/or depression.

Conditions

  • Perinatal Depression
  • Perinatal Anxiety
  • Prenatal Stress

Interventions

BEHAVIORAL

Patient Navigation

Participants in arm 2 will receive patient navigation provided by humans (rather than e-navigation) to provide personalized care to include support, resources, and referrals to address psychosocial issues that arise during the perinatal period. Patient navigation is available to participants through 12 months postpartum.

BEHAVIORAL

Adapted Cognitive-Behavioral Therapy

Participants who do not meet diagnostic criteria (Group 2a) will participate in a prevention group which includes 8 sessions based on culturally adapted CBT for Black/ of African descent populations facilitated by mental health professionals. Participants who meet diagnostic criteria (Group 2b) will participate in individual treatment which includes 12 sessions based on culturally adapted CBT for Black/ of African descent populations.

Sponsors & Collaborators

  • George Washington University

    collaborator OTHER

  • Patient-Centered Outcomes Research Institute

    collaborator OTHER

  • Children's National Research Institute

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-08-22
Primary Completion
2026-11-30
Completion
2026-11-30

Countries

  • United States

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05345834 on ClinicalTrials.gov