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Completed

NCT Number: NCT02760004

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

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.

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Key information

Age range

18 year–55 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

UMass Medical School/UMass Memorial Medical Center

Worcester, Massachusetts, 01655, United States

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

PRogram In Support of Moms (PRISM)

Behavioral
  • Access to MCPAP for Moms
  • PRogram In Support of Moms Toolkit with Stepped Care Algorithms
  • Support clinic specific implementation using the Addressing Problems Through Organizational Change (APTOC) platform
  • Customization of depression screening for each practice
  • Proactively engage and track all women who screen +ve on the Edinburgh Postnatal Depression Scale(EPDS)
  • Employ psychoeducation and Motivational Interviewing to engage patients with depression
  • medical assistant champion and psychiatrist contact bi-weekly to review cases
  • Stepped care treatment to depression screening/assessment

Other names: Rapid Access to Perinatal Psychiatric care in Depression

MCPAP for Moms

Behavioral
  • 30-60 minute presentation on perinatal depression
  • Access to telephonic psychiatric consultation with MCPAP for Moms perinatal psychiatrist for Ob/Gyns
  • Access to Ob/Gyn provider assessment and treatment recommendations via one-time face-face MCPAP for Moms psychiatrist patient evaluation
  • Access to assessment and treatment protocols in Provider Toolkit
  • Resource provision/referrals

Primary outcomes

  1. Change in Edinburgh Postnatal Depression Scale Score (EPDS)

    Time frame: 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 outcomes

  1. Participants Initiating Treatment

    Time frame: 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.

  2. Participants Sustaining Mental Health Treatment

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

University of Massachusetts, Worcester

Other

Collaborators

  • Centers for Disease Control and Prevention

Registry information

Acronym: PRISM

Important dates

Study start
2017
Primary completion
2022
Study completion
2022
First posted
May 3, 2016
Registry last updated
Jun 10, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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