- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT01913366
Senior Peer Alliance for Rural Research On Wellness (SPARROW)
Case Management and Problem Solving Therapy for Depressed Older Adults
Descripción general del estudio
Descripción detallada
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 estudio
Inscripción (Actual)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
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California
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Sonora, California, Estados Unidos, 95370
- Catholic Charities Motherlode Office- Sonora
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
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;
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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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.
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Hamilton Rating Scale for Depression (HRSD)
Periodo de tiempo: 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)
Periodo de tiempo: 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)
Periodo de tiempo: 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)
Periodo de tiempo: 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)
Periodo de tiempo: Week 0
|
Generic assessment instrument for health and disability
|
Week 0
|
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WHO Disability Assessment Schedule 2.0 (WHODAS-II)
Periodo de tiempo: Week 3
|
Generic assessment instrument for health and disability
|
Week 3
|
|
WHO Disability Assessment Schedule 2.0 (WHODAS-II)
Periodo de tiempo: Week 6
|
Generic assessment instrument for health and disability
|
Week 6
|
|
WHO Disability Assessment Schedule 2.0 (WHODAS-II)
Periodo de tiempo: 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
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Actual)
Finalización del estudio (Actual)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Estimar)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Otros números de identificación del estudio
- R01AG043584-01A1 (Subvención/contrato del NIH de EE. UU.)
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .