- ICH GCP
- Registro de ensaios clínicos dos EUA
- Ensaio Clínico NCT01407783
Systems of Care for New Moms: Integrating Depression Treatment (NUMOMS)
Visão geral do estudo
Status
Condições
Intervenção / Tratamento
Descrição detalhada
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.
Tipo de estudo
Inscrição (Real)
Estágio
- Não aplicável
Contactos e Locais
Locais de estudo
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Missouri
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Saint Louis, Missouri, Estados Unidos, 63105
- Washington University and Nurses for Newborns Foundations
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Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Descrição
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
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Tratamento
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Nenhum (rótulo aberto)
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
|
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.
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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.
Outros nomes:
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Sem intervenção: Enhanced Referral
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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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PHQ-9
Prazo: baseline, 6months and 12 months post treatment
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Measure the reduction of post partum depression after intervention at 6 months and 12 months post treatment.
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baseline, 6months and 12 months post treatment
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BDI-II
Prazo: baseline, 6months &12 months post treatment
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Measure the reduction of post partum depression after intervention at 6 months and 12 months post treatment.
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baseline, 6months &12 months post treatment
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Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Qualitative Interview
Prazo: 1 month post treatment
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Questions asking the participants their feelings about the intervention.
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1 month post treatment
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Colaboradores e Investigadores
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Luis H Zayas, Ph.D., Washington University School of Medicine
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo
Conclusão Primária (Real)
Conclusão do estudo (Real)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Estimativa)
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- 5R34MH083085-02 (Concessão/Contrato do NIH dos EUA)
Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .
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