Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-24 @ 11:16 PM
Ignite Modification Date:
2025-12-24 @ 11:16 PM
NCT ID:
NCT03221556
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.
Study:
NCT03221556
Study Brief:
Protocol Section:
NCT03221556