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Improving Outcomes for Low-Income Mothers With Depression

NCT03221556 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 231

Last updated 2024-09-19

Study results available
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Summary

This is a randomized comparative effectiveness trial to improve outcomes among pregnant and post-partum women with symptoms of depression. Both interventions under study will be based in the patient-centered medical home setting at Boston Medical Center - specifically, in prenatal clinic or in the general pediatrics clinic. The study is a type 1 hybrid effectiveness-implementation trial of 230 mothers with clinically significant depressive symptomatology. Of the 230 subjects, half will receive the Engagement-Focused Care Coordination intervention; the other half will receive the Problem Solving Education intervention. Outcomes for mothers will be assessed every 2 months throughout a 12 month follow-up period. This trial is funded by a contract with PCORI, the Patient-Centered Outcomes Research Institute.

Conditions

  • Post Partum Depression

Interventions

BEHAVIORAL

Engagement-Focused Care Coordination (EFCC)

Engagement interviewing is embedded within a traditional PCMH structure using motivational interviewing and shared decision making; it explores treatment options in the context of a patient's life circumstances, and helps her work through ambivalence to receiving care. In one to two sessions, providers disclose the probable diagnosis of depression, provide psycho-education, present treatment options, and engage clients in shared decision making to determine the most appropriate referral.

BEHAVIORAL

Problem Solving Education (PSE)

Problem solving sessions are one-on-one, workbook-based interactions. Sessions comprise seven sequential steps: 1-defining a problem, 2-establishing goals for problem resolution, 3-generating multiple solution alternatives, 4-Implementing decision making guidelines, 5-evaluating and choosing solutions, 6-Implementing the preferred solutions, and 7-evaluating the outcome.

Sponsors & Collaborators

  • Patient-Centered Outcomes Research Institute

    collaborator OTHER

  • Boston University

    collaborator OTHER

  • Boston Medical Center

    lead OTHER

Principal Investigators

  • Michael Silverstein, MD MPH · Boston University

Study Design

Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-02-05
Primary Completion
2020-06-16
Completion
2020-06-16

Countries

  • United States

Study Locations

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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 NCT03221556 on ClinicalTrials.gov