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Systems of Care for New Moms: Integrating Depression Treatment (NUMOMS)

This study is enrolling participants by invitation only.
Sponsor:
Collaborator:
Nurses for Newborns Foundation
Information provided by:
Washington University School of Medicine
ClinicalTrials.gov Identifier:
NCT01407783
First received: July 28, 2011
Last updated: July 29, 2011
Last verified: July 2011

July 28, 2011
July 29, 2011
August 2008
April 2012   (final data collection date for primary outcome measure)
  • PHQ-9 [ Time Frame: baseline, 6months and 12 months post treatment ] [ Designated as safety issue: No ]
    Measure the reduction of post partum depression after intervention at 6 months and 12 months post treatment.
  • BDI-II [ Time Frame: baseline, 6months &12 months post treatment ] [ Designated as safety issue: No ]
    Measure the reduction of post partum depression after intervention at 6 months and 12 months post treatment.
Same as current
Complete list of historical versions of study NCT01407783 on ClinicalTrials.gov Archive Site
Qualitative Interview [ Time Frame: 1 month post treatment ] [ Designated as safety issue: No ]
Questions asking the participants their feelings about the intervention.
Same as current
Not Provided
Not Provided
 
Systems of Care for New Moms: Integrating Depression Treatment
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.

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:

  1. Adapt PST for implementation in nurse home visitation programs.

    1. 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.
    2. Build protocols for targeting depression treatment to the woman's symptom severity and patient preferences.
    3. Develop and routinize protocols for supervision, clinical consultation, and risk assessment for PST provided by nurse home visitors.
    4. Modify protocols and systems for client tracking and outcomes.
  2. Implement a two-arm randomized pilot study comparing: PST provided by non-mental health home visitation nurses and referral for treatment (Care as Usual).

    1. 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.
    2. Track pathways and barriers to care for women referred to mental health specialty care or primary care for medications.
    3. Develop an R01 for a full scale randomized controlled trial using data on effect sizes and addressing organizational issues, infrastructure needs, and treatment refinements.
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Post-partum Depression
Behavioral: Problem Solving Tools (PST)
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 Name: Problem Solving Therapy
  • Experimental: Problem Solving Tools
    The home visitation nurse will teach and utilize the problem solving tools to help low-income depressed mothers. It is a brief treatment with the a non-pathologizing intervention being done in 4-8 sessions.
    Intervention: Behavioral: Problem Solving Tools (PST)
  • No Intervention: Enhanced Referral
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Enrolling by invitation
30
June 2012
April 2012   (final data collection date for primary outcome measure)

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
Female
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01407783
5R34MH083085-02
Yes
Luis H. Zayas, PhD - Professor, Washington University in St Louis
Washington University School of Medicine
Nurses for Newborns Foundation
Principal Investigator: Luis H Zayas, Ph.D. Washington University School of Medicine
Washington University School of Medicine
July 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP