- ICH GCP
- Registro de ensaios clínicos dos EUA
- Ensaio Clínico NCT01913366
Senior Peer Alliance for Rural Research On Wellness (SPARROW)
Case Management and Problem Solving Therapy for Depressed Older Adults
Visão geral do estudo
Status
Condições
Intervenção / Tratamento
Descrição detalhada
If you are eligible to participate in the study after completing the screening assessment, and if you choose to continue on, we will randomize you (like a flip of a coin) to receive either 12 weeks of case management combined with problem solving therapy (CM-PST) with a social worker or 12 weeks of self-guided problem solving therapy (SG-PST) with support from a senior peer counselor.
As part of your participation in the study you will participate in three 1.5 hour assessment interviews of psychological and neuropsychological functioning (similar to your screening assessment) prior to your first week of treatment (baseline), two weeks after your final session (week 14), and three months after your final session (week 24). Additionally, you will participate in three shorter assessment interviews of psychological functioning, which will be conducted at weeks 3 and 6. These assessments will take approximately 30-45 minutes.
Tipo de estudo
Inscrição (Real)
Estágio
- Não aplicável
Contactos e Locais
Locais de estudo
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California
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Sonora, California, Estados Unidos, 95370
- Catholic Charities Motherlode Office- Sonora
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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:
- Residence in rural Tuolumne, Calaveras, San Joaquin or Stanislaus Counties;
- Diagnosis: Major depression, unipolar (by SCID ascertained DSM-IV criteria);
- Severity of depression: A PHQ-9>10 or a 24-Item HDRS>19;
- Need for social services: CANE score> 2, i.e. at least one unmet need;
Exclusion Criteria:
- Psychotic depression by SCID-IV, i.e., presence of delusions;
- High suicide risk, i.e. intent or plan to attempt suicide in near future;
- Presence of any Axis I psychiatric disorder or substance abuse other than unipolar major depression;
- Axis II diagnosis of antisocial personality (by SCID-P and DSM-IV);
- History of psychiatric disorders other than unipolar major depression or generalized anxiety disorder (including bipolar disorder, hypomania, and dysthymia);
- Dementia: MMSE below 24 or clinical diagnosis of dementia by DSM-IV;
- Acute/severe medical illness (delirium, metastatic cancer, de-compensated cardiac, liver or kidney failure, stroke or myocardial infarction) 3 months prior to entry; or use of drugs causing depression, (steroids, reserpine, alphamethyl-dopa, tamoxiphen, vincristine);
- Inability to perform any of the ADLs (MAI: ADL subscale) even with assistance (walking with a cane is not an exclusion criterion)
- Inability to speak English;
- Aphasia interfering with communication;
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: CM-PST
If you are assigned to CM-PST, you will be working with the same care manager from your introductory session.
The care manager will continue to work with you on your problem-solving plan.
Additionally, you will receive case management services.
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Experimental: SG-PST
If you are assigned to SG-PST, you will continue to work on your problem-solving plan, using the self-guided materials provided to you during the introductory session.
Additionally, you will be partnered with a senior peer counselor who will support you in your SG-PST efforts.
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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Hamilton Rating Scale for Depression (HRSD)
Prazo: Baseline
|
A multiple item questionnaire used to provide an indication of depression, and as a guide to evaluate recovery.
|
Baseline
|
|
Hamilton Rating Scale for Depression (HRSD)
Prazo: Week 3
|
A multiple item questionnaire used to provide an indication of depression, and as a guide to evaluate recovery.
|
Week 3
|
|
Hamilton Rating Scale for Depression (HRSD)
Prazo: Week 6
|
A multiple item questionnaire used to provide an indication of depression, and as a guide to evaluate recovery.
|
Week 6
|
|
Hamilton Rating Scale for Depression (HRSD)
Prazo: Week 12
|
A multiple item questionnaire used to provide an indication of depression, and as a guide to evaluate recovery.
|
Week 12
|
|
WHO Disability Assessment Schedule 2.0 (WHODAS-II)
Prazo: Week 0
|
Generic assessment instrument for health and disability
|
Week 0
|
|
WHO Disability Assessment Schedule 2.0 (WHODAS-II)
Prazo: Week 3
|
Generic assessment instrument for health and disability
|
Week 3
|
|
WHO Disability Assessment Schedule 2.0 (WHODAS-II)
Prazo: Week 6
|
Generic assessment instrument for health and disability
|
Week 6
|
|
WHO Disability Assessment Schedule 2.0 (WHODAS-II)
Prazo: Week 12
|
Generic assessment instrument for health and disability
|
Week 12
|
Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Brooke Hollister, Ph.D., University of California, San Francisco
- Investigador principal: Patricia Arean, Ph.D., University of California, San Francisco
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Real)
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
Outros números de identificação do estudo
- R01AG043584-01A1 (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 .