PRogram In Support of Moms (PRISM): a pilot group randomized controlled trial of two approaches to improving depression among perinatal women

Abstract

Purpose: This pilot study was designed to inform a larger effectiveness trial by: (1) assessing the feasibility of the PRogram In Support of Moms (PRISM) and our study procedures; and, (2) determining the extent to which PRISM as compared to an active comparison group, the Massachusetts Child Access Psychiatry Program (MCPAP) for Moms alone, improves depression among perinatal women.

Methods: Four practices were randomized to either PRISM or MCPAP for Moms alone, a state-wide telephonic perinatal psychiatry program. PRISM includes MCPAP for Moms plus implementation assistance with local champions, training, and implementation of office prompts and procedures to enhance depression screening, assessment and treatment. Patients with Edinburgh Postnatal Depression Scales (EPDS) ≥ 10 were recruited during pregnancy, and completed the EPDS and a structured interview at baseline and 3–12 weeks’ postpartum.

Results: Among MCPAP for Moms alone practices, patients’ (n = 9) EPDS scores improved from 15.22 to 10.11 (p = 0.010), whereas in PRISM practices patients’ (n = 21) EPDS scores improved from 13.57 to 6.19 (p = 0.001); the between groups difference-of-differences was 2.27 (p = 0.341).

Conclusions: PRISM was beneficial for patients, clinicians, and support staff. Both PRISM and MCPAP for Moms alone improve depression symptom severity and the percentage of women with an EPDS >10. The improvement difference between groups was not statistically significant due to limited power associated with small sample size.

Keywords:

• Maternal depression
• obstetrics
• perinatal metal health
• post-natal depression
• mental health

Disclosure statement

The content is solely the responsibility of the authors and does not necessarily represent the official views of the NIH.

This work was presented as an oral presentation at the Academy of Psychosomatic Medicine Annual Meeting in Austin, TX November 11, 2016 and at the International Marcé Society for Perinatal Mental Health in Melbourne, Australia on September 25, 2016.

The first, second, third and sixth author have received salary and/or funding support from Massachusetts Department of Mental Health via the Massachusetts Child Psychiatry Access Program for Moms (MCPAP for Moms). The first author is also the statewide Medical Director of MCPAP for Moms. The first author serves on the American College of Ob/Gyn Maternal Mental Health Expert Work Group, the Perinatal Depression Advisory Board for the Janssen Disease Interception Accelerator Program, the Physician Advisory Board for Sage Therapeutics, and is a Council Member of the Gerson Lehrman Group. The second author is the Lead Obstetric Liaison for MCPAP for Moms and serves on the Physician Advisory Board for Sage Therapeutics, is Co-Chair of the American College of Ob/Gyn Maternal Mental Health Expert Work Group, and serves on the Council on Pt Safety in Women’s Health, Perinatal Mood and Anxiety Disorder Pt Safety Bundle. The third author has been the Program Director of MCPAP for Moms, and the sixth author has served as a Consultant for MCPAP for Moms. The fourth, fifth, seventh and eighth authors do not have any disclosures.

Current knowledge on this subject

• Perinatal depression screening alone does not translate into treatment participation because patient, program, and system level barriers exist.

• The majority of women who screen positive for depression do not initiate treatment and even less participate in a full treatment course.

• Obstetric providers need supports in place to be able to appropriately detect, assess and manage depression.

What this study adds

• Building the capacity of front line obstetric practices to detect, assess, and manage depression can improve depression outcomes among women.

• PRISM appears promising in that it provides a practical solution for obstetric practices that does not require large resources and empowers physicians to treat most patients with depression while providing the security of referral and clinical back up for the more complicated cases.

• MCPAP for Moms alone also appears promising as a less intensive approach that has the potential to serve a larger number of women.

Additional information

Funding

This work was supported by the National Institutes of Health (NIH), [Grant numbers KL2TR000160, UL1TR000161].