Improving Outcomes for Low-Income Mothers With Depression

NCT ID: NCT03221556

Last Updated: 2024-09-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 231 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-02-05
• Study Completion Date: 2020-06-16

Brief 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.

Detailed 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.

Conditions

Post Partum Depression

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: TRIPLE

Study Groups

Engagement-Focused Care Coordination (EFCC)

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.

Group Type: ACTIVE_COMPARATOR

Engagement-Focused Care Coordination (EFCC)

Intervention Type: BEHAVIORAL

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.

Problem Solving Education (PSE)

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.

Group Type: ACTIVE_COMPARATOR

Problem Solving Education (PSE)

Intervention Type: BEHAVIORAL

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Patient-Centered Outcomes Research Institute

OTHER

Sponsor Role: collaborator

Boston University

OTHER

Sponsor Role: collaborator

Boston Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Michael Silverstein, MD MPH

Role: STUDY_DIRECTOR

Boston University

Locations

Boston Medical Center

Boston, Massachusetts, United States

Countries

United States

References

Elansary M, Kistin CJ, Antonio J, Fernandez-Pastrana I, Lee-Parritz A, Cabral H, Miller ES, Silverstein M. Effect of Immediate Referral vs a Brief Problem-solving Intervention for Screen-Detected Peripartum Depression: A Randomized Clinical Trial. JAMA Netw Open. 2023 May 1;6(5):e2313151. doi: 10.1001/jamanetworkopen.2023.13151.

Reference Type: DERIVED

PMID: 37171819 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

AD-1603-34662

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

H-36434

Identifier Type: -

Identifier Source: org_study_id