Improving Outcomes for Low-Income Mothers With Depression

Boston Medical Center (BMC)

Status: Completed

Conditions: Post Partum Depression

Treatments: Behavioral: Engagement-Focused Care Coordination (EFCC); Behavioral: Problem Solving Education (PSE)

Study type: Interventional

Funder types: Other

Identifiers

NCT03221556

H-36434

AD-1603-34662 (Other Grant/Funding Number)

Details and patient eligibility

About

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.

Full description

This is a type 1 hybrid effectiveness-implementation trial of 230 mothers with clinically significant depressive symptomatology being conducted at Boston Medical Center (BMC). The effectiveness component of the study (which is the trial registered on ClinicalTrials.gov) is a pragmatic, parallel group randomized trial that measures patient-reported outcomes over 12 months of follow-up. The implementation portion comprises a series of qualitative interviews to discern barriers and facilitators to intervention implementation.

The investigators will enroll 230 mothers with clinically significant depressive symptomatology according to the Edinburgh Postnatal Depression Scale (EPDS), a widely used screening instrument valid during pregnancy and in the postpartum period.

Engagement-Focused Care Coordination will be compared to Problem Solving Education (PSE). Whereas Engagement-Focused Care Coordination emphasizes referral to formal depression services following a brief engagement session, PSE offers initial depression treatment onsite, followed by referral to further care if depressive symptoms persist or worsen. Patients in both arms will have access to the same array of community-based mental health services upon referral. Both intervention arms are designed to be peer-delivered; thus, the investigators will enlist their existing team of PCMH family advocates - a group of women (approximately age-matched with our study participants) - to serve as intervention providers. To minimize contamination across comparators, this team will be divided into those trained in Engagement Interviewing and those trained in PSE.

Enrollment: 231 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Woman is pregnant and receives prenatal care at BMC; or is biological mother of 0 to 18-month-old child receiving care at BMC pediatric primary care clinic
• Woman has EPDS score ≥ 10
• Woman comfortable speaking and receiving information in English or Spanish
• Woman has no current source of mental health care, defined as having no more than one mental health care appointment in the last 3 months; OR, if more than one appointment, woman has no upcoming appointment

Exclusion criteria

• Woman under 18 years of age

• Woman endorses suicidality

• Woman exhibits signs of psychosis or is cognitively limited*

  • As part of the informed consent process, we will administer the MacArthur Competence Assessment Tool for Clinical Research (MacCAT-CR), which has been validated in populations of depressed and schizophrenic adults

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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231 participants in 2 patient groups

Engagement-Focused Care Coordination (EFCC)

Active Comparator group

Description:

The brief intervention in Engagement-Focused Care Coordination is the Engagement Interview. In this model, providers meet one to two times with mothers who screen positive for depression, and use techniques of shared decision-making to help mothers process the results of the screen; explore treatment options; and connect with formal mental health services. Engagement-Focused Care Coordination emphasizes referral to formal mental health services.

Treatment:

Behavioral: Engagement-Focused Care Coordination (EFCC)

Problem Solving Education (PSE)

Active Comparator group

Description:

The brief Problem Solving Education (PSE) is a six-session cognitive-behavioral program. PSE offers immediate intervention in the PCMH, followed by referral to further treatment if symptoms persist.

Treatment:

Behavioral: Problem Solving Education (PSE)