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Perinatal DepressionPRISM-PilotNCT02935504

PRogram In Support of Moms (PRISM): A Pilot Study

A study testing PRogram In Support of Moms (PRISM) and MCPAP for Moms in people with Perinatal Depression, run by University of Massachusetts, Worcester.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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 Read more about this study

Who is it for?
Ages 18 to 55 years, women only
Conditions the study is for
Perinatal Depression
What is being tested?
PRogram In Support of Moms (PRISM) and MCPAP for Moms
Could I receive a placebo?
No, everyone receives an active treatment
How many people
33 participants
Where
No sites listed yet
Study dates
Mar 2014to Jun 2016
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 55 years
  • Women only
  • No healthy volunteers
  • Adult

Who may be able to join

  • Female
  • Age 18-55 years
  • English speaking
  • 4-36 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

Who cannot join

  • 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.

About this study

Official title: PRogram In Support of Moms (PRISM): A Pilot Group Randomized Controlled Trial

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

Read the detailed description

Major depressive disorder continues to be the leading cause of disability among women of reproductive age and major public health concern. 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, behavior and development. Maternal suicide causes 20% of postpartum deaths in depressed women. Although the majority of women are amenable to depression screening, screening alone does not improve treatment entry or outcome. Despite the availability of effective evidence-based treatments and frequent contact with obstetric providers, less than one-third of women who screen positive for depression receive treatment. Ob/Gyn practices need supports in place to adequately address depression in their patient populations. Thus, the Investigators developed a program called "PRogram In Support of Moms" (PRISM) that aims to leverage existing roles and resources to target patient, provider, and system level barriers to perinatal depression treatment. PRISM aims to improve perinatal depression treatment and treatment response rates through: (1) access to 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. Four practices were randomly assigned to PRISM versus an active comparison group called MCPAP for Moms which is a state-wide telephonic perinatal psychiatry program. The Investigators will compare the effectiveness of PRISM vs. MCPAP for Moms to improve depression severity and treatment participation in pregnancy through 3 months postpartum among patients.

Being tested
PRogram In Support of Moms (PRISM), MCPAP for Moms
Keywords
Depression, Pregnancy, Postpartum
Medical subject headings
Depression

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PRogram In Support of Moms (PRISM)Behavioural

    Also called Rapid Access to Perinatal Psychiatric care in Depression, RAPPID

    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

  • MCPAP for MomsBehavioural

    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

Study groups in NCT02935504
Study groupRoleWhat they receive
Program In Support of Moms PRISMExperimentalPRISM includes MCPAP for Moms and training, implementation support, and toolkits for Ob/Gyn practices on depression screening, assessment and treatment.
Receives: Behavioral: PRogram In Support of Moms (PRISM)
MCPAP for MomsActive comparatorConsists 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.
Receives: Behavioral: MCPAP for Moms

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: Baseline to 10-35 weeks follow-up

Secondary outcomes (1)

  1. Provider Fidelity

    To determine change in knowledge, attitudes, and practices as measured by S-KAP toward depression screening and treatment from baseline (pre implementation) to 1 year follow-up (post implementation) among providers in PRISM versus MCPAP for Moms practices.

    Measured: Baseline to 1 year follow-up (post intervention)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Oct 2016 (estimated)
  2. Study startMar 2014
  3. Primary completionJun 2016
  4. Study completionJun 2016

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Health services research
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Participant
Enrolment
33 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02935504
Sponsor's protocol ID
H00004195
Other IDs
UL1TR000161
Acronym
PRISM-Pilot
Status last verified
Apr 2018
First submitted
4 Oct 2016
Last updated
1 May 2018
Results posted
No
Data monitoring committee
No
Individual data sharing
No

Publications

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

  • 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.

    PubMed 20921117

  • 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.

    PubMed 19175819

  • 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.

    PubMed 18651886

  • 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.

    PubMed 15883651

  • 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.

    PubMed 15777362

  • 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.

    PubMed 21289351

  • 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.

    PubMed 18390942

  • 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.

    PubMed 19252044

  • 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.

    PubMed 16551710

  • 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.

    PubMed 19269536

  • 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.

    PubMed 12804344

  • 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.

    PubMed 22382279

  • 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.

    PubMed 26444130

  • 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.

    PubMed 37582274

Questions about this trial

What is this clinical trial studying?

A study testing PRogram In Support of Moms (PRISM) and MCPAP for Moms in people with Perinatal Depression, run by University of Massachusetts, Worcester.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 1 May 2018. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Depression Severity (time frame: Baseline to 10-35 weeks follow-up). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02935504, which also lists 15 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 May 2018.

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