Systems of Care for New Moms: Integrating Depression Treatment (NUMOMS)
|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|
- 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.
- Qualitative Interview [ Time Frame: 1 month post treatment ] [ Designated as safety issue: No ]Questions asking the participants their feelings about the intervention.
|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)|
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|
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01407783
|United States, Missouri|
|Washington University and Nurses for Newborns Foundations|
|St. Louis, Missouri, United States, 63105|
|Principal Investigator:||Luis H Zayas, Ph.D.||Washington University School of Medicine|