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

Primary Purpose

Post-partum Depression

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Problem Solving Tools (PST)
Sponsored by
Washington University School of Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Post-partum Depression focused on measuring Post-partum depression, Low-income mothers, home nurse visitation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Washington University and Nurses for Newborns Foundations

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Problem Solving Tools

Enhanced Referral

Arm Description

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.

Outcomes

Primary Outcome Measures

PHQ-9
Measure the reduction of post partum depression after intervention at 6 months and 12 months post treatment.
BDI-II
Measure the reduction of post partum depression after intervention at 6 months and 12 months post treatment.

Secondary Outcome Measures

Qualitative Interview
Questions asking the participants their feelings about the intervention.

Full Information

First Posted
July 28, 2011
Last Updated
May 4, 2018
Sponsor
Washington University School of Medicine
Collaborators
Nurses for Newborns Foundation
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1. Study Identification

Unique Protocol Identification Number
NCT01407783
Brief Title
Systems of Care for New Moms: Integrating Depression Treatment
Acronym
NUMOMS
Official Title
Systems of Care for New Moms: Integrating Depression Treatment
Study Type
Interventional

2. Study Status

Record Verification Date
May 2018
Overall Recruitment Status
Completed
Study Start Date
August 2008 (undefined)
Primary Completion Date
May 2013 (Actual)
Study Completion Date
May 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Washington University School of Medicine
Collaborators
Nurses for Newborns Foundation

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
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: 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Post-partum Depression
Keywords
Post-partum depression, Low-income mothers, home nurse visitation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
29 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Problem Solving Tools
Arm Type
Experimental
Arm Description
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.
Arm Title
Enhanced Referral
Arm Type
No Intervention
Intervention Type
Behavioral
Intervention Name(s)
Problem Solving Tools (PST)
Other Intervention Name(s)
Problem Solving Therapy
Intervention Description
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.
Primary Outcome Measure Information:
Title
PHQ-9
Description
Measure the reduction of post partum depression after intervention at 6 months and 12 months post treatment.
Time Frame
baseline, 6months and 12 months post treatment
Title
BDI-II
Description
Measure the reduction of post partum depression after intervention at 6 months and 12 months post treatment.
Time Frame
baseline, 6months &12 months post treatment
Secondary Outcome Measure Information:
Title
Qualitative Interview
Description
Questions asking the participants their feelings about the intervention.
Time Frame
1 month post treatment

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Luis H Zayas, Ph.D.
Organizational Affiliation
Washington University School of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Washington University and Nurses for Newborns Foundations
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63105
Country
United States

12. IPD Sharing Statement

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Systems of Care for New Moms: Integrating Depression Treatment

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