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

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ClinicalTrials.gov Identifier: NCT02935504
Recruitment Status : Completed
First Posted : October 17, 2016
Last Update Posted : October 18, 2016
National Institutes of Health (NIH)
Information provided by (Responsible Party):
Nancy Byatt, University of Massachusetts, Worcester

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

Condition or disease Intervention/treatment
Perinatal Depression Behavioral: PRogram In Support of Moms (PRISM) Behavioral: MCPAP for Moms

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 33 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Health Services Research
Official Title: PRogram In Support of Moms (PRISM): A Pilot Group Randomized Controlled Trial
Study Start Date : March 2014
Primary Completion Date : June 2016
Study Completion Date : June 2016

Arm Intervention/treatment
Experimental: Program In Support of Moms PRISM
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)

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
Other Names:
  • Rapid Access to Perinatal Psychiatric care in Depression
Active Comparator: MCPAP for Moms
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
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

Primary Outcome Measures :
  1. Depression Severity [ Time Frame: Baseline to 10-35 weeks follow-up ]
    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.

Secondary Outcome Measures :
  1. Provider Fidelity [ Time Frame: Baseline to 1 year follow-up (post intervention) ]
    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.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  1. Female
  2. Age 18-55 years
  3. English speaking
  4. 4-36 weeks gestational age (GA) or 2-12 weeks postpartum
  5. Receiving care from one of the 4 participating clinics (2 clinics which will participate in PRISM and 2 with access to MCPAP for Moms)
  6. Edinburgh Postnatal Depression Scale score (EPDS) ≥10
  7. Able to communicate in written and spoken English; and
  8. Cognitively able to participate in informed consent

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02935504

Sponsors and Collaborators
University of Massachusetts, Worcester
National Institutes of Health (NIH)
Principal Investigator: Nancy Byatt, DO, MS, MBA • UMass Memorial Medical Center/UMass Medical School

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

Responsible Party: Nancy Byatt, Associate Professor of Psychiatry and Obstetrics & Gynecology, University of Massachusetts, Worcester
ClinicalTrials.gov Identifier: NCT02935504     History of Changes
Other Study ID Numbers: H00004195
UL1TR000161 ( U.S. NIH Grant/Contract )
First Posted: October 17, 2016    Key Record Dates
Last Update Posted: October 18, 2016
Last Verified: October 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by Nancy Byatt, University of Massachusetts, Worcester:

Additional relevant MeSH terms:
Behavioral Symptoms