Skip to main content
OpenTrials
Completed

NCT Number: NCT01407783

Systems of Care for New Moms: Integrating Depression Treatment

NUMOMS involves collaboration between Nurses for Newborns Foundation and Washington University in St. Louis. This study explores the co-location of depression treatment within nurse home visitation and the organizational changes needed to maintain access to evidence-based treatment. Problem Solving Tools (PST) was chosen as the depression treatment because it is well suited for use by non-mental health specialists and for in-home treatment. It is also a brief treatment (4-8 sessions) takes a non-pathologizing approach.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Washington University and Nurses for Newborns Foundations

St Louis, Missouri, 63105, United States

About this study

NUMOMS involves collaboration between Nurses for Newborns Foundation and Washington University in St. Louis. This study explores the co-location of depression treatment within nurse home visitation and the organizational changes needed to maintain access to evidence-based treatment. Problem Solving Tools (PST) was chosen as the depression treatment because it is well suited for use by non-mental health specialists and for in-home treatment. It is also a brief treatment (4-8 sessions) takes a non-pathologizing approach.

In the first part of the study we will gather information from women and their providers to determine what system and treatment modifications are needed to effectively deliver acceptable depression treatment in home visitation programs. Based on this information, a panel of local and national experts will provide advice on decisions regarding the intervention adaptation. Once these adaptation decisions are made a small group of experts will adapt a PST manual for use in home visitation.

In the second phase of the NUMOMS study we will carry out a small two-arm randomized trial comparing the effectiveness, acceptability, and practicality of PST provided by home visitation RNs versus usual care (referral to mental health specialty care).

Significantly, NUMOMS has the potential to provide home visitation agencies with a viable means of access to effective and acceptable depression treatment for mothers in the face of policy mandates for depression screening.The specific aims are to:

  • Adapt PST for implementation in nurse home visitation programs.
  • Examine internal (organization and client level) and external (community and policy level) factors that may impact upon PST adaptation and delivery in nurse home visitation.
  • Build protocols for targeting depression treatment to the woman's symptom severity and patient preferences.
  • Develop and routinize protocols for supervision, clinical consultation, and risk assessment for PST provided by nurse home visitors.
  • Modify protocols and systems for client tracking and outcomes.
  • Implement a two-arm randomized pilot study comparing: PST provided by non-mental health home visitation nurses and referral for treatment (Care as Usual).
  • Compare outcomes on the Beck Depression Inventory, the Patient Health Questionnaire-9, and Parenting Stress Index for women treated with PST by non-specialty RNs and Care as Usual.
  • Track pathways and barriers to care for women referred to mental health specialty care or primary care for medications.
  • Develop an R01 for a full scale randomized controlled trial using data on effect sizes and addressing organizational issues, infrastructure needs, and treatment refinements.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Depressed as indicated by Edinburgh Postpartum Depression Scale or Clinical Checklist
  • NFNF client from a certain zip code
  • Either pregnant or have a child under the age of 12 months in the home

Exclusion criteria

  • Under the age of 18
  • Severe Mental Illness
  • Chemical Dependency

Treatment and study plan

Problem Solving Tools (PST)

Behavioral

The problem solving tools was chosen as the depression treatment because it is well suited for use by non-mental health professionals and for in-home treatment. It is also a brief treatment (4-8 sessions) that takes a non-pathologizing approach.

Other names: Problem Solving Therapy

Primary outcomes

  1. PHQ-9

    Time frame: baseline, 6months and 12 months post treatment

    Measure the reduction of post partum depression after intervention at 6 months and 12 months post treatment.

  2. BDI-II

    Time frame: baseline, 6months &12 months post treatment

    Measure the reduction of post partum depression after intervention at 6 months and 12 months post treatment.

Secondary outcomes

  1. Qualitative Interview

    Time frame: 1 month post treatment

    Questions asking the participants their feelings about the intervention.

Sponsors and collaborators

Lead sponsor

Washington University School of Medicine

Other

Collaborators

  • Nurses for Newborns Foundation

Registry information

Acronym: NUMOMS

Important dates

Study start
2008
Primary completion
2013
Study completion
2013
First posted
Aug 2, 2011
Registry last updated
May 11, 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.

Published trials that share one or more normalized conditions with this study.