Systems of Care for New Moms: Integrating Depression Treatment (NUMOMS)
Tracking Information | |||||
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First Received Date ICMJE | July 28, 2011 | ||||
Last Updated Date | July 29, 2011 | ||||
Start Date ICMJE | August 2008 | ||||
Estimated Primary Completion Date | April 2012 (final data collection date for primary outcome measure) | ||||
Current Primary Outcome Measures ICMJE |
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Original Primary Outcome Measures ICMJE | Same as current | ||||
Change History | Complete list of historical versions of study NCT01407783 on ClinicalTrials.gov Archive Site | ||||
Current Secondary Outcome Measures ICMJE |
Qualitative Interview [ Time Frame: 1 month post treatment ] [ Designated as safety issue: No ] Questions asking the participants their feelings about the intervention. |
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Original Secondary Outcome Measures ICMJE | Same as current | ||||
Current Other Outcome Measures ICMJE | |||||
Original Other Outcome Measures ICMJE | |||||
Descriptive Information | |||||
Brief Title ICMJE | Systems of Care for New Moms: Integrating Depression Treatment | ||||
Official Title ICMJE | Systems of Care for New Moms: Integrating Depression Treatment | ||||
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. |
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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:
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Study Type ICMJE | Interventional | ||||
Study Phase | |||||
Study Design ICMJE | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
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Condition ICMJE | Post-partum Depression | ||||
Intervention ICMJE | 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 |
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Study Arm (s) |
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Publications * | |||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||
Recruitment Status ICMJE | Enrolling by invitation | ||||
Estimated Enrollment ICMJE | 30 | ||||
Estimated Completion Date | June 2012 | ||||
Estimated Primary Completion Date | April 2012 (final data collection date for primary outcome measure) | ||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Gender | Female | ||||
Ages | 18 Years and older | ||||
Accepts Healthy Volunteers | No | ||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
Location Countries ICMJE | United States | ||||
Administrative Information | |||||
NCT Number ICMJE | NCT01407783 | ||||
Other Study ID Numbers ICMJE | 5R34MH083085-02 | ||||
Has Data Monitoring Committee | Yes | ||||
Responsible Party | Luis H. Zayas, PhD - Professor, Washington University in St Louis | ||||
Study Sponsor ICMJE | Washington University School of Medicine | ||||
Collaborators ICMJE | Nurses for Newborns Foundation | ||||
Investigators ICMJE |
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Information Provided By | Washington University School of Medicine | ||||
Verification Date | July 2011 | ||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |