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

Not Applicable

Completed

Conditions: Depression

Interventions: Behavioral: PRogram In Support of Moms (PRISM)
Behavioral: MCPAP for Moms

Registration Number: NCT02760004

Lead Sponsor: University of Massachusetts, Worcester

Brief Summary: 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.

Detailed Description: 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. PRISM 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. MCPAP for Moms which provides access to resource provision/referrals and psychiatric telephone consultation, in a clinical trial in which Investigators will randomize 10 Ob/Gyn practices to either PRISM or MCPAP for Moms (Massachusetts Child Psychiatry Access Program for Moms) - intervention. Patient participants will participate in either PRISM or MCPAP for Moms, depending on what intervention their practice is assigned to. The Investigators will compare the effectiveness of PRISM vs. MCPAP for Moms to improve depression severity and treatment participation in pregnancy through 13 months postpartum among 340 patients (n=170/group).

Recruitment & Eligibility

Status: COMPLETED

Sex: Female

Target Recruitment: 312

Inclusion Criteria

Female
Age 18-55 years
English speaking
>4 weeks Gestational age (GA) until 4 months postpartum
Receiving care from one of the 10 participating practices (five will participate in PRISM (intervention group) and five will have access to MCPAP For Moms (comparison group)
Edinburgh Postnatal Depression Scale score (EPDS) ≥10
Able to communicate in written and spoken English; and
Cognitively able to participate in informed verbal consent

Exclusion Criteria

Lack of verbal and written English fluency
Under age 18 or over age 55
substance use disorder as determined by the questions in 4 Ps questionnaire
Screen positive for bipolar disorder via the Mood Disorder Questionnaire (MDQ)
Prisoner
Women participating in 'Moms do care' study

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Prism Intervention	PRogram In Support of Moms (PRISM)	PRogram In Support of Moms (PRISM)
MCPAP for Moms Intervention	MCPAP for Moms	MCPAP for Moms (Massachusetts Child Psychiatry Access Program for Moms)

Primary Outcome Measures

Name	Time	Method
Change in Edinburgh Postnatal Depression Scale Score (EPDS)	Baseline up to 13 months postpartum	EPDS - Edinburgh Postnatal Depression Scale is an instrument used to measure depression. The score range is 0 to 30. A higher score means more depressed. Depressed perinatal patients receiving care from practices enrolled in PRISM will experience more improvement in depression symptoms than patients receiving care from the MCPAP for Moms practices (2 point difference-of-difference in EPDS).

Secondary Outcome Measures

Name	Time	Method
Participants Initiating Treatment	Baseline to up to 13 months postpartum	Number of depressed perinatal patients receiving care from practices enrolled in PRISM who initiated treatment measured by attendance (i,e. one initial mental health assessment or treatment visit) as compared to women receiving care from practices enrolled in MCPAP for Moms.
Participants Sustaining Mental Health Treatment	Baseline to up to 13 months postpartum	Sustainment of mental health treatment for depressed perinatal patients receiving care from practices enrolled in PRISM. as measured an average ≥1 mental health visit every 1 month until remission of symptoms or study assessment) as compared to women receiving care from practices enrolled in MCPAP for Moms.