Clinical trial NCT02760004: PRogram In Support of Moms: An Innovative Stepped-Care Approach for Obstetrics and Gynecology Clinics
Official title: PRogram In Support of Moms: An Innovative Stepped-Care Approach for Obstetrics and Gynecology Clinics
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Depression
Keywords: Depression
Lead sponsor: University of Massachusetts, Worcester
Sponsor class: OTHER
Collaborators: name: Centers for Disease Control and Prevention
First posted: 2016-05-03
Enrollment: 312
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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).

Eligibility criteria: 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 10 participating practices (five will participate in PRISM (intervention group) and five will have access to MCPAP For Moms (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. substance use disorder as determined by the questions in 4 Ps questionnaire
4. Screen positive for bipolar disorder via the Mood Disorder Questionnaire (MDQ)
5. Prisoner
6. Women participating in 'Moms do care' study

Primary outcomes:
measure: Change in Edinburgh Postnatal Depression Scale Score (EPDS)
timeFrame: Baseline up to 13 months postpartum
Secondary outcomes:
measure: Participants Initiating Treatment
timeFrame: Baseline to up to 13 months postpartum
measure: Participants Sustaining Mental Health Treatment
timeFrame: Baseline to up to 13 months postpartum
Other outcomes:
Locations:
city: Worcester
country: United States
facility: UMass Medical School/UMass Memorial Medical Center
state: Massachusetts
Study officials:
affiliation: University of Massachusetts Medical School/UMass Memorial Health Care
name: Nancy Byatt, DO, MS, MBA
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Massachusetts Medical School/UMass Memorial Health Care
name: Tiffany A Moore Simas, MD, MPH, MEd
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Massachusetts Medical School/UMass Memorial Health Care
name: Jeroan J Allison, MD, MS
role: PRINCIPAL_INVESTIGATOR
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