NCT02935504

Brief Summary

The primary goal of this study is to evaluate the PRogram In Support of Moms (PRISM) that aims to improve women's access to and participation in perinatal depression treatment and thereby improve depression outcomes

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
33

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2014

Typical duration for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2014

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2016

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

October 4, 2016

Completed
13 days until next milestone

First Posted

Study publicly available on registry

October 17, 2016

Completed
Last Updated

May 1, 2018

Status Verified

April 1, 2018

Enrollment Period

2.3 years

First QC Date

October 4, 2016

Last Update Submit

April 30, 2018

Conditions

Perinatal Depression

Keywords

DepressionPregnancyPostpartum

Outcome Measures

Primary Outcomes (1)

  • Depression Severity

    To compare changes in depression severity as measured by Edinburgh Postnatal Depression Scale (EPDS) from baseline to follow-up (10-35 weeks) among pregnant and postpartum women in PRISM versus MCPAP for Moms.

    Baseline to 10-35 weeks follow-up

Secondary Outcomes (1)

  • Provider Fidelity

    Baseline to 1 year follow-up (post intervention)

Study Arms (2)

Program In Support of Moms PRISM

EXPERIMENTAL

PRISM includes MCPAP for Moms and training, implementation support, and toolkits for Ob/Gyn practices on depression screening, assessment and treatment.

Behavioral: PRogram In Support of Moms (PRISM)

MCPAP for Moms

ACTIVE COMPARATOR

Consists of access to psychiatric consultation and resources and referrals through MCPAP for Moms - MCPAP for Moms is available free of charge to all Ob/Gyn practices in Massachusetts.

Behavioral: MCPAP for Moms

Interventions

PRogram In Support of Moms (PRISM)BEHAVIORAL

PRISM Intervention Provider and staff training Webinar Delivered in person Engage providers - Registered Nurses (RN) and Patient Care Assistants (PCA) and ensure they attend: Toolkit Care coordination Psychiatric consultation Implementation support 1. Engage clinic leaders and staff 2. Identify leadership group and prepare for change 3. Assess readiness to implement PRISM 4. Identify steps to achieve goals 5. Implement PRISM components into the clinic 6. Support, encourage and sustain change Office prompts Screening procedures Plus all MCPAP for Moms intervention

Also known as: Rapid Access to Perinatal Psychiatric care in Depression, RAPPID
Program In Support of Moms PRISM
MCPAP for MomsBEHAVIORAL

MCPAP for Moms Provider and staff training Delivered via web RN and PCA admin staff recommended to attend 30-60 minute presentation on perinatal depression Access to telephonic psychiatric consultation with MCPAP for Moms perinatal psychiatrist for Ob/Gyns Access to one-time face-face evaluation with patient by a MCPAP for Moms psychiatrist for assessment and treatment recommendations for Ob/Gyn provider Access to Provider Toolkit which includes assessment and treatment protocols (available at www.mcpapformoms.org) Resource provision/referrals

MCPAP for Moms

Eligibility Criteria

Age18 Years - 55 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Female
  • Age 18-55 years
  • English speaking
  • weeks gestational age (GA) or 2-12 weeks postpartum
  • Receiving care from one of the 4 participating clinics (2 clinics which will participate in PRISM and 2 with access to MCPAP for Moms)
  • Edinburgh Postnatal Depression Scale score (EPDS) ≥10
  • Able to communicate in written and spoken English; and
  • Cognitively able to participate in informed consent

You may not qualify if:

  • Lack of verbal and written English fluency
  • Under age 18 or over age 55
  • Current active substance use disorder
  • Bipolar disorder diagnosis as determined by the Mini-international Neuropsychiatric Interview (M.I.N.I.)
  • Psychotic component to illness as determined by the M.I.N.I.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (15)

  • Switzerland: Department of Health Statistics and Informatics; Information EaRCotWHO. The Global Burden of Disease: 2004 update; 2008.

    BACKGROUND

  • Grote NK, Bridge JA, Gavin AR, Melville JL, Iyengar S, Katon WJ. A meta-analysis of depression during pregnancy and the risk of preterm birth, low birth weight, and intrauterine growth restriction. Arch Gen Psychiatry. 2010 Oct;67(10):1012-24. doi: 10.1001/archgenpsychiatry.2010.111.

    PMID: 20921117BACKGROUND

  • Paulson JF, Keefe HA, Leiferman JA. Early parental depression and child language development. J Child Psychol Psychiatry. 2009 Mar;50(3):254-62. doi: 10.1111/j.1469-7610.2008.01973.x. Epub 2008 Oct 23.

    PMID: 19175819BACKGROUND

  • Deave T, Heron J, Evans J, Emond A. The impact of maternal depression in pregnancy on early child development. BJOG. 2008 Jul;115(8):1043-51. doi: 10.1111/j.1471-0528.2008.01752.x.

    PMID: 18651886BACKGROUND

  • Lindahl V, Pearson JL, Colpe L. Prevalence of suicidality during pregnancy and the postpartum. Arch Womens Ment Health. 2005 Jun;8(2):77-87. doi: 10.1007/s00737-005-0080-1. Epub 2005 May 11.

    PMID: 15883651BACKGROUND

  • Carter FA, Carter JD, Luty SE, Wilson DA, Frampton CM, Joyce PR. Screening and treatment for depression during pregnancy: a cautionary note. Aust N Z J Psychiatry. 2005 Apr;39(4):255-61. doi: 10.1080/j.1440-1614.2005.01562.x.

    PMID: 15777362BACKGROUND

  • Kozhimannil KB, Adams AS, Soumerai SB, Busch AB, Huskamp HA. New Jersey's efforts to improve postpartum depression care did not change treatment patterns for women on medicaid. Health Aff (Millwood). 2011 Feb;30(2):293-301. doi: 10.1377/hlthaff.2009.1075.

    PMID: 21289351BACKGROUND

  • Gilbody S, Sheldon T, House A. Screening and case-finding instruments for depression: a meta-analysis. CMAJ. 2008 Apr 8;178(8):997-1003. doi: 10.1503/cmaj.070281.

    PMID: 18390942BACKGROUND

  • Yonkers KA, Smith MV, Lin H, Howell HB, Shao L, Rosenheck RA. Depression screening of perinatal women: an evaluation of the healthy start depression initiative. Psychiatr Serv. 2009 Mar;60(3):322-8. doi: 10.1176/appi.ps.60.3.322.

    PMID: 19252044BACKGROUND

  • Weissman MM, Pilowsky DJ, Wickramaratne PJ, Talati A, Wisniewski SR, Fava M, Hughes CW, Garber J, Malloy E, King CA, Cerda G, Sood AB, Alpert JE, Trivedi MH, Rush AJ; STAR*D-Child Team. Remissions in maternal depression and child psychopathology: a STAR*D-child report. JAMA. 2006 Mar 22;295(12):1389-98. doi: 10.1001/jama.295.12.1389.

    PMID: 16551710BACKGROUND

  • Smith MV, Shao L, Howell H, Wang H, Poschman K, Yonkers KA. Success of mental health referral among pregnant and postpartum women with psychiatric distress. Gen Hosp Psychiatry. 2009 Mar-Apr;31(2):155-62. doi: 10.1016/j.genhosppsych.2008.10.002. Epub 2008 Dec 3.

    PMID: 19269536BACKGROUND

  • Marcus SM, Flynn HA, Blow FC, Barry KL. Depressive symptoms among pregnant women screened in obstetrics settings. J Womens Health (Larchmt). 2003 May;12(4):373-80. doi: 10.1089/154099903765448880.

    PMID: 12804344BACKGROUND

  • Rowan P, Greisinger A, Brehm B, Smith F, McReynolds E. Outcomes from implementing systematic antepartum depression screening in obstetrics. Arch Womens Ment Health. 2012 Apr;15(2):115-20. doi: 10.1007/s00737-012-0262-6. Epub 2012 Mar 1.

    PMID: 22382279BACKGROUND

  • Byatt N, Levin LL, Ziedonis D, Moore Simas TA, Allison J. Enhancing Participation in Depression Care in Outpatient Perinatal Care Settings: A Systematic Review. Obstet Gynecol. 2015 Nov;126(5):1048-1058. doi: 10.1097/AOG.0000000000001067.

    PMID: 26444130BACKGROUND

  • McNicholas E, Boama-Nyarko E, Julce C, Nunes AP, Flahive J, Byatt N, Moore Simas TA. Understanding Perinatal Depression Care Gaps by Examining Care Access and Barriers in Perinatal Individuals With and Without Psychiatric History. J Womens Health (Larchmt). 2023 Oct;32(10):1111-1119. doi: 10.1089/jwh.2022.0306. Epub 2023 Aug 16.

    PMID: 37582274DERIVED

MeSH Terms

Conditions

Depression

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehavior

Study Officials

  • Nancy Byatt, DO, MS, MBA

    • UMass Memorial Medical Center/UMass Medical School

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor of Psychiatry and Obstetrics & Gynecology

Study Record Dates

First Submitted

October 4, 2016

First Posted

October 17, 2016

Study Start

March 1, 2014

Primary Completion

June 1, 2016

Study Completion

June 1, 2016

Last Updated

May 1, 2018

Record last verified: 2018-04

Data Sharing

IPD Sharing
Will not share