Improving Outcomes for Low-Income Mothers With Depression
| Status: | Enrolling by invitation |
|---|---|
| Conditions: | Depression, Depression |
| Therapuetic Areas: | Psychiatry / Psychology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 5/24/2018 |
| Start Date: | February 5, 2018 |
| End Date: | March 2020 |
Improving Outcomes for Low-Income Mothers With Depression: A Comparative Effectiveness Trial of Two Brief Interventions in the Patient-Centered Medical Home.
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.
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.
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.
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.
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 receives Medicaid insurance
- Woman comfortable speaking and receiving information in English or Spanish
- Woman has no current source of mental health care
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
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