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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
  Purpose

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.


Condition Intervention
Post-partum Depression
Behavioral: Problem Solving Tools (PST)

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Systems of Care for New Moms: Integrating Depression Treatment

Resource links provided by NLM:


Further study details as provided by Washington University School of Medicine:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • Qualitative Interview [ Time Frame: 1 month post treatment ] [ Designated as safety issue: No ]
    Questions asking the participants their feelings about the intervention.


Estimated Enrollment: 30
Study Start Date: August 2008
Estimated Study Completion Date: June 2012
Estimated Primary Completion Date: April 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
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
No Intervention: Enhanced Referral

Detailed Description:

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.
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01407783

Locations
United States, Missouri
Washington University and Nurses for Newborns Foundations
St. Louis, Missouri, United States, 63105
Sponsors and Collaborators
Washington University School of Medicine
Nurses for Newborns Foundation
Investigators
Principal Investigator: Luis H Zayas, Ph.D. Washington University School of Medicine
  More Information

No publications provided

Responsible Party: Luis H. Zayas, PhD - Professor, Washington University in St Louis
ClinicalTrials.gov Identifier: NCT01407783     History of Changes
Other Study ID Numbers: 5R34MH083085-02
Study First Received: July 28, 2011
Last Updated: July 29, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by Washington University School of Medicine:
Post-partum depression
Low-income mothers
home nurse visitation

Additional relevant MeSH terms:
Depression
Depression, Postpartum
Depressive Disorder
Behavioral Symptoms
Mental Disorders
Mood Disorders
Pregnancy Complications
Puerperal Disorders

ClinicalTrials.gov processed this record on November 20, 2014