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

NCT02760004 | Completed Results DMC

• 2 other identifiers: H000091631U01DP006093
• Study Type: interventional
• Target: 312
• Locations: 1 country
• Sites: 1

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.

Conditions

Depression

Keywords

Depression

Outcome Measures

Primary Outcomes (1)

• Change in Edinburgh Postnatal Depression Scale Score (EPDS)

  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).

  Baseline up to 13 months postpartum

Secondary Outcomes (2)

• Participants Initiating Treatment

  Baseline to up to 13 months postpartum

• Participants Sustaining Mental Health Treatment

  Baseline to up to 13 months postpartum

Study Arms (2)

Prism Intervention

EXPERIMENTAL

PRogram In Support of Moms (PRISM)

Behavioral: PRogram In Support of Moms (PRISM)

MCPAP for Moms Intervention

EXPERIMENTAL

MCPAP for Moms (Massachusetts Child Psychiatry Access Program for Moms)

Behavioral: MCPAP for Moms

Interventions

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

Also known as: Rapid Access to Perinatal Psychiatric care in Depression

Prism Intervention

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

MCPAP for Moms Intervention

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Massachusetts, Worcester: lead
• Centers for Disease Control and Prevention: collaborator

Study Sites (1)

UMass Medical School/UMass Memorial Medical Center

Worcester, Massachusetts, 01655, United States

Location

Related Publications (26)

• Hirschfeld RM, Williams JB, Spitzer RL, Calabrese JR, Flynn L, Keck PE Jr, Lewis L, McElroy SL, Post RM, Rapport DJ, Russell JM, Sachs GS, Zajecka J. Development and validation of a screening instrument for bipolar spectrum disorder: the Mood Disorder Questionnaire. Am J Psychiatry. 2000 Nov;157(11):1873-5. doi: 10.1176/appi.ajp.157.11.1873.

  PMID: 11058490 BACKGROUND

• Cox JL, Holden JM, Sagovsky R. Detection of postnatal depression. Development of the 10-item Edinburgh Postnatal Depression Scale. Br J Psychiatry. 1987 Jun;150:782-6. doi: 10.1192/bjp.150.6.782.

  PMID: 3651732 BACKGROUND

• Chen H, Wang J, Ch'ng YC, Mingoo R, Lee T, Ong J. Identifying mothers with postpartum depression early: integrating perinatal mental health care into the obstetric setting. ISRN Obstet Gynecol. 2011;2011:309189. doi: 10.5402/2011/309189. Epub 2011 Sep 15.

  PMID: 21941662 BACKGROUND

• Flynn HA, O'Mahen HA, Massey L, Marcus S. The impact of a brief obstetrics clinic-based intervention on treatment use for perinatal depression. J Womens Health (Larchmt). 2006 Dec;15(10):1195-204. doi: 10.1089/jwh.2006.15.1195.

  PMID: 17199460 BACKGROUND

• Burton A, Patel S, Kaminsky L, Rosario GD, Young R, Fitzsimmons A, Canterino JC. Depression in pregnancy: time of screening and access to psychiatric care. J Matern Fetal Neonatal Med. 2011 Nov;24(11):1321-4. doi: 10.3109/14767058.2010.547234. Epub 2011 Jan 24.

  PMID: 21261444 BACKGROUND

• Goodman JH, Tyer-Viola L. Detection, treatment, and referral of perinatal depression and anxiety by obstetrical providers. J Womens Health (Larchmt). 2010 Mar;19(3):477-90. doi: 10.1089/jwh.2008.1352.

  PMID: 20156110 BACKGROUND

• Glavin K, Smith L, Sorum R, Ellefsen B. Redesigned community postpartum care to prevent and treat postpartum depression in women--a one-year follow-up study. J Clin Nurs. 2010 Nov;19(21-22):3051-62. doi: 10.1111/j.1365-2702.2010.03332.x. Epub 2010 Aug 19.

  PMID: 20726926 BACKGROUND

• Glavin K, Smith L, Sorum R. Prevalence of postpartum depression in two municipalities in Norway. Scand J Caring Sci. 2009 Dec;23(4):705-10. doi: 10.1111/j.1471-6712.2008.00667.x. Epub 2009 Aug 29.

  PMID: 19490523 BACKGROUND

• Chaudron LH, Kitzman HJ, Peifer KL, Morrow S, Perez LM, Newman MC. Prevalence of maternal depressive symptoms in low-income Hispanic women. J Clin Psychiatry. 2005 Apr;66(4):418-23. doi: 10.4088/jcp.v66n0402.

  PMID: 15816782 BACKGROUND

• Delucchi KL, Tajima B, Guydish J. Development of the Smoking Knowledge, Attitudes, and Practices (S-KAP) Instrument. J Drug Issues. 2009 Mar;39(2):347-364. doi: 10.1177/002204260903900207.

  PMID: 20717496 BACKGROUND

• McDonald SD, Calhoun PS. The diagnostic accuracy of the PTSD checklist: a critical review. Clin Psychol Rev. 2010 Dec;30(8):976-87. doi: 10.1016/j.cpr.2010.06.012. Epub 2010 Jul 6.

  PMID: 20705376 BACKGROUND

• Spitzer RL, Kroenke K, Williams JB, Lowe B. A brief measure for assessing generalized anxiety disorder: the GAD-7. Arch Intern Med. 2006 May 22;166(10):1092-7. doi: 10.1001/archinte.166.10.1092.

  PMID: 16717171 BACKGROUND

• Swanson LM, Flynn HA, Wilburn K, Marcus S, Armitage R. Maternal mood and sleep in children of women at risk for perinatal depression. Arch Womens Ment Health. 2010 Dec;13(6):531-4. doi: 10.1007/s00737-010-0177-z. Epub 2010 Jul 14.

  PMID: 20628772 BACKGROUND

• Clement S, Brohan E, Jeffery D, Henderson C, Hatch SL, Thornicroft G. Development and psychometric properties the Barriers to Access to Care Evaluation scale (BACE) related to people with mental ill health. BMC Psychiatry. 2012 Jun 20;12:36. doi: 10.1186/1471-244X-12-36.

  PMID: 22546012 BACKGROUND

• Cooper LA, Brown C, Vu HT, Palenchar DR, Gonzales JJ, Ford DE, Powe NR. Primary care patients' opinions regarding the importance of various aspects of care for depression. Gen Hosp Psychiatry. 2000 May-Jun;22(3):163-73. doi: 10.1016/s0163-8343(00)00073-6.

  PMID: 10880709 BACKGROUND

• Baron RM, Kenny DA. The moderator-mediator variable distinction in social psychological research: conceptual, strategic, and statistical considerations. J Pers Soc Psychol. 1986 Dec;51(6):1173-82. doi: 10.1037//0022-3514.51.6.1173.

  PMID: 3806354 BACKGROUND

• Heitjan DF. Annotation: what can be done about missing data? Approaches to imputation. Am J Public Health. 1997 Apr;87(4):548-50. doi: 10.2105/ajph.87.4.548. No abstract available.

  PMID: 9146428 BACKGROUND

• Myers ER, Aubuchon-Endsley N, Bastian LA, Gierisch JM, Kemper AR, Swamy GK, Wald MF, McBroom AJ, Lallinger KR, Gray RN, Green C, Sanders GD. Efficacy and Safety of Screening for Postpartum Depression [Internet]. Rockville (MD): Agency for Healthcare Research and Quality (US); 2013 Apr. Report No.: 13-EHC064-EF. Available from http://www.ncbi.nlm.nih.gov/books/NBK137724/

  PMID: 23678510 BACKGROUND

• Weathers F, Litz B, Huska J, Keane T. PTSD checklist-civilian version. In. Boston: Nation Center for PTSD. Behavioral Sciences Division. ; 1994

  BACKGROUND

• Little R. Statistical Analysis with Missing Data. New York: John Wiley and Sons; 1987

  BACKGROUND

• Karlson K, Holm A. Decomposing primary and secondary effects: A new decomposition method. Research in Social Stratification and Mobility 2011;29:221-37.

  BACKGROUND

• Julce C, Flahive J, Lightbourne T, Podila S, Mahanna A, Zimmermann M, Sheldrick RC, Moore Simas TA, Byatt N. Descriptive Characteristics of Psychiatric Medication Discontinuation Among Perinatal Women With Depressive Symptoms. Early Interv Psychiatry. 2025 Jun;19(6):e70070. doi: 10.1111/eip.70070.

  PMID: 40539750 DERIVED

• Byatt N, Brenckle L, Sankaran P, Flahive J, Ko JY, Robbins CL, Zimmermann M, Allison J, Person S, Moore Simas TA. Effectiveness of two systems-level interventions to address perinatal depression in obstetric settings (PRISM): an active-controlled cluster-randomised trial. Lancet Public Health. 2024 Jan;9(1):e35-e46. doi: 10.1016/S2468-2667(23)00268-2.

  PMID: 38176840 DERIVED

• Schipani Bailey E, Byatt N, Carroll S, Brenckle L, Sankaran P, Kroll-Desrosiers A, Smith NA, Allison J, Simas TAM. Results of a Statewide Survey of Obstetric Clinician Depression Practices. J Womens Health (Larchmt). 2022 May;31(5):675-681. doi: 10.1089/jwh.2021.0147. Epub 2021 Sep 2.

  PMID: 34491103 DERIVED

• Masters GA, Brenckle L, Sankaran P, Person SD, Allison J, Moore Simas TA, Ko JY, Robbins CL, Marsh W, Byatt N. Positive screening rates for bipolar disorder in pregnant and postpartum women and associated risk factors. Gen Hosp Psychiatry. 2019 Nov-Dec;61:53-59. doi: 10.1016/j.genhosppsych.2019.09.002. Epub 2019 Oct 22.

  PMID: 31710859 DERIVED

• Moore Simas TA, Brenckle L, Sankaran P, Masters GA, Person S, Weinreb L, Ko JY, Robbins CL, Allison J, Byatt N. The PRogram In Support of Moms (PRISM): study protocol for a cluster randomized controlled trial of two active interventions addressing perinatal depression in obstetric settings. BMC Pregnancy Childbirth. 2019 Jul 22;19(1):256. doi: 10.1186/s12884-019-2387-3.

  PMID: 31331292 DERIVED

Related Links

• Comparing regression coefficients between models using logit and probit: a new method. Available online at Social Science Research Network, 2010. (Accessed Accessed August, 2011)
• Total, direct, and indirect effects in logit models. 2010. (Accessed Accessed August, 2011

MeSH Terms

Conditions

Depression

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior

Results Point of Contact

• Title: Nancy Byatt, Tenured Professor of Psychiatry, ObGyn, and Population & Quantitative Health Sciences
• Organization: UMass Chan Medical School / UMass Memorial Health

Nancy.Byatt@umassmemorial.org

508.856.5812

Study Officials

• Nancy Byatt, DO, MS, MBA

  University of Massachusetts Medical School/UMass Memorial Health Care

  PRINCIPAL INVESTIGATOR

• Tiffany A Moore Simas, MD, MPH, MEd

  University of Massachusetts Medical School/UMass Memorial Health Care

  PRINCIPAL INVESTIGATOR

• Jeroan J Allison, MD, MS

  University of Massachusetts Medical School/UMass Memorial Health Care

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

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: April 27, 2016
• First Posted: May 3, 2016
• Study Start: October 11, 2017
• Primary Completion: March 16, 2022
• Study Completion: May 31, 2022
• Last Updated: June 10, 2024
• Results First Posted: June 10, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Starting 6 months after main publication up to a period of 3 years.
• Access Criteria: All researchers who work with the PRISM data will submit a proposal and sign a data-sharing agreement. Researchers will first submit a proposal which will be reviewed by the PRISM Publication Committee. If the proposal is approved, the researcher will sign a data-sharing agreement in which they commit to 1) using the data only for research purposes, 2) keeping the data secure using proper technological precautions, 3) destroying the data after analyses are completed, and 4) only conduct analyses described in the approved proposal. Our research team will create de-identified analytical datasets and share them with approved researchers as .CSV files that will be transferred by secure encrypted transfer using a secure managed data transfer server.

Locations

US (1)