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| ID | Type | Description | Link |
|---|---|---|---|
| 1U01DP006093 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| Centers for Disease Control and Prevention | FED |
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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.
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Prism Intervention | Experimental | PRogram In Support of Moms (PRISM) |
|
| MCPAP for Moms Intervention | Experimental | MCPAP for Moms (Massachusetts Child Psychiatry Access Program for Moms) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PRogram In Support of Moms (PRISM) | Behavioral |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Participants Initiating Treatment | 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. | Baseline to up to 13 months postpartum |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| 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 |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UMass Medical School/UMass Memorial Medical Center | Worcester | Massachusetts | 01655 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 11058490 | Background | 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. | |
| 3651732 | 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. |
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IPD sharing plan is as applicable with CDC requirements and policy. All IPD that underlie results in a publication will be shared. Analysis of the data by approved researchers will only be conducted as delineated in the approved proposal. Only the minimum amount of data necessary to accomplish the proposed analysis will be released and must be destroyed after the specified analysis has been completed. All analyses will be subjected to independent verification.
Starting 6 months after main publication up to a period of 3 years.
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.
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Of the 1265 screened, 312 met the inclusion criteria. The practices were randomized to the 2 intervention arms of the study.
Participants were enrolled from the 10 participating OB/Gyn practices from October 2017 to November 2020. The 10 obstetric practices were randomized to one of the two interventions (5 each) and patient participants from these practices provided data for evaluating the effectiveness of each intervention. Individual patient participant data were analyzed to assess effectiveness.
| ID | Title | Description |
|---|---|---|
| FG000 | PRISM Intervention | PRogram In Support of Moms (PRISM) PRogram In Support of Moms (PRISM): • Access to MCPAP for Moms
|
| FG001 | MCPAP for Moms | MCPAP for Moms Access to MCPAP for Moms: • 30-60 minute presentation on perinatal depression
|
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | PRISM Intervention | PRogram In Support of Moms (PRISM) PRogram In Support of Moms (PRISM): • Access to MCPAP for Moms
|
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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). | Out of the participants enrolled in the study, data was obtained and analyzed for 118 participants in the PRISM Intervention and 117 in the MCPAP for Moms for this outcome measure. These subgroups are based on the number of Participants who had both the baseline EPDS score and a final 11-13 months postpartum EPDS score. Participants can enter at [0 -20 weeks GA, 20-40 weeks GA or 0-12 weeks postpartum] and this serves as Baseline. Final measurement occurs at 11 to 13 months postpartum. | Posted | Mean | Standard Deviation | score on a scale | Baseline up to 13 months postpartum |
|
37 months - throughout the enrollment period
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | PRISM Intervention | PRogram In Support of Moms (PRISM) PRogram In Support of Moms (PRISM): • Access to MCPAP for Moms
|
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hospitalization for suicidal risk | Psychiatric disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Nancy Byatt, Tenured Professor of Psychiatry, ObGyn, and Population & Quantitative Health Sciences | UMass Chan Medical School / UMass Memorial Health | 508.856.5812 | Nancy.Byatt@umassmemorial.org |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | May 9, 2023 | Jul 18, 2023 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | May 9, 2023 | Jul 18, 2023 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D003863 | Depression |
| ID | Term |
|---|---|
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
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|
|
| MCPAP for Moms | Behavioral |
|
|
| Participants Sustaining Mental Health Treatment | 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. | Baseline to up to 13 months postpartum |
| 21941662 | 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. |
| 17199460 | 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. |
| 21261444 | 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. |
| 20156110 | 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. |
| 20726926 | 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. |
| 19490523 | 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. |
| 15816782 | 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. |
| 20717496 | 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. |
| 20705376 | 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. |
| 16717171 | 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. |
| 20628772 | 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. |
| 22546012 | 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. |
| 10880709 | 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. |
| 3806354 | 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. |
| 9146428 | 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. |
| 23678510 | 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/ |
| 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. |
| 40539750 | Derived | 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. |
| 38176840 | 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. |
| 34491103 | 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. |
| 31710859 | 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. |
| 31331292 | 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. |
| BG001 | MCPAP for Moms | MCPAP for Moms Access to MCPAP for Moms: • 30-60 minute presentation on perinatal depression
|
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Education | Count of Participants | Participants |
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| Primary source of payment for prenatal care | Count of Participants | Participants |
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| PRISM Intervention |
PRogram In Support of Moms (PRISM) PRogram In Support of Moms (PRISM): • PRogram In Support of Moms Toolkit with Stepped Care Algorithms
|
| OG001 | MCPAP for Moms | MCPAP for Moms
|
|
|
| Secondary | Participants Initiating Treatment | 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 can enter at [0 -20 weeks GA, 20-40 weeks GA or 0-12 weeks postpartum] and this serves as Baseline. Final measurement occurs at 11 to 13 months postpartum. | Posted | Count of Participants | Participants | Baseline to up to 13 months postpartum |
|
|
|
| Secondary | Participants Sustaining Mental Health Treatment | 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. | Participants can enter at [0 -20 weeks GA, 20-40 weeks GA or 0-12 weeks postpartum] and this serves as Baseline. Final measurement occurs at 11 to 13 months postpartum. | Posted | Count of Participants | Participants | Baseline to up to 13 months postpartum |
|
|
|
| 0 |
| 150 |
| 0 |
| 150 |
| 0 |
| 150 |
| EG001 | MCPAP for Moms | MCPAP for Moms Access to MCPAP for Moms: • 30-60 minute presentation on perinatal depression
| 0 | 162 | 0 | 162 | 1 | 162 |
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