PRogram In Support of Moms: An Innovative Stepped-Care Approach for Obstetrics and Gynecology Clinics



Status:Recruiting
Conditions:Depression
Therapuetic Areas:Psychiatry / Psychology
Healthy:No
Age Range:18 - 55
Updated:4/6/2019
Start Date:April 2016
End Date:September 2021
Contact:Padma Sankaran, MA
Email:padma.sankaran@umassmed.edu
Phone:508-856-8505

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The primary goal of this study is to develop, evaluate, and share a new low-cost program for
Obstetrics/Gynecology (Ob/Gyn) practices which will help to improve depression treatment for
women during pregnancy and after childbirth.

Upwards of 1 in 5 women suffer from depression during pregnancy or within a year after giving
birth. It has negative effects on birth outcomes, infant attachment, and children's
behavior/development. Maternal suicide causes 20% of postpartum deaths in depressed women.
Although the vast majority of perinatal women are amenable to being screened for depression,
screening alone does not improve treatment rates or patient outcomes. Ob/Gyn practices need
supports in place to adequately address depression in their patient populations. Thus, the
Investigators developed and pilot tested the PRogram In Support of Moms (PRISM), to create a
comprehensive intervention that is proactive, multifaceted, and practical. PRSIM aims to
improve perinatal depression treatment and treatment response rates through: (1) access to
immediate resource provision/referrals and psychiatric telephone consultation for Ob/Gyn
providers; (2) clinic-specific implementation of stepped care, including training support and
toolkits; and, (3) proactive treatment engagement, patient monitoring, and stepped treatment
response to depression screening/assessment. PRISM builds on a low-cost and widely
disseminated population-based model for delivering psychiatric care in primary care settings
developed by our team. Because it uses existing infrastructure and resources, PRISM, has the
potential to be feasible, sustainable and transportable to other practice settings. The
Investigators will compare PRISM vs. enhanced usual care (access to resource
provision/referrals and psychiatric telephone consultation) in a clinical trial in which
Investigators will randomize 12 Ob/Gyn practices to either PRISM or enhanced usual care
intervention. Provider and staff participants will participate in either PRISM or enhanced
usual care, depending on what intervention their practice is assigned to. The Investigators
will compare the effectiveness of PRISM vs. enhanced usual care to improve depression
severity and treatment participation in pregnancy through 12 months postpartum among 300
patients (n=150/group, 25 per clinic). The Investigators will also determine change in
knowledge, attitudes, and practices toward depression screening and treatment in the PRISM
group compared to enhanced usual care group.

Inclusion Criteria:

1. Female

2. Age 18-55 years

3. English speaking

4. >4 weeks gestational age (GA) until 4 months postpartum

5. Receiving care from one of the 12 participating practices (six will participate in
PRISM (intervention group) and six will have access to enhanced usual care (comparison
group)

6. Edinburgh Postnatal Depression Scale score (EPDS) ≥10

7. Able to communicate in written and spoken English; and

8. Cognitively able to participate in informed verbal consent

Exclusion Criteria:

1. Lack of verbal and written English fluency

2. Under age 18 or over age 55

3. Ongoing substance abuse

4. Screen positive for bipolar disorder via the MDQ (Mood Disorder Questionnaire)

5. Prisoner

Inclusion criteria for provider participants:

Prenatal care providers and support staff including physician, advanced practice nurse,
nurse, patient care assistant, psychologists and social workers serving women at the
recruited clinical sites

Exclusion criteria for provider participants:

Not a prenatal care provider or support person as indicated above from one of the study
designated sites
We found this trial at
1
site
Worcester, Massachusetts 01655
Phone: 508-856-8505
?
mi
from
Worcester, MA
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