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Completed

NCT Number: NCT02935504

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

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

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Key information

Age range

18 year–55 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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.

Treatment and study plan

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

  • Engage clinic leaders and staff
  • Identify leadership group and prepare for change
  • Assess readiness to implement PRISM
  • Identify steps to achieve goals
  • Implement PRISM components into the clinic
  • 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, RAPPID

MCPAP for Moms

Behavioral

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 outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

University of Massachusetts, Worcester

Other

Collaborators

  • National Institutes of Health (NIH)

Registry information

Official study title

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

Acronym: PRISM-Pilot

Important dates

Study start
2014
Primary completion
2016
Study completion
2016
First posted
Oct 17, 2016
Registry last updated
May 1, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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