- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT02371954
Exercise to Prevent Depression and Anxiety in Older Hispanics
6 de septiembre de 2018 actualizado por: Daniel Enrique Jimenez, University of Miami
The study is a randomized pilot trial of a health promotion intervention in the prevention of anxiety and depression in older Hispanics.
Descripción general del estudio
Estado
Terminado
Intervención / Tratamiento
Descripción detallada
Eligible participants will be randomized to either the Happy Older Latinos are Active (HOLA) intervention or a psychoeducation condition.
Participants randomized to HOLA will participate in a group exercise, 3 times a week, for 16 weeks.
The exercise is a moderate intensity walk at a centrally located park in Miami-Dade county and will last for an hour (10 minute warmup/stretching, 30 minute walk, 5 minute cool down).
Groups will consist of 6 participants and be led by a community health worker.
During the cool down phase, participants will plan a pleasant event to be done in between sessions.
Participants randomized to the psychoeducation component will receive a fotonovela and will meet once a month after they receive the fotonovela to discuss their thoughts on the materials they received.
These discussion groups will last one hour and will consist of 10 participants.
A total of 60 participants will be randomized (30 to HOLA, 30 to fotonovela).
Assessments will be conducted at baseline, post intervention, 6 months post-intervention, and 12 months post-intervention.
Tipo de estudio
Intervencionista
Inscripción (Actual)
60
Fase
- No aplica
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Ubicaciones de estudio
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Florida
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Miami, Florida, Estados Unidos, 33136
- Jackson Memorial Mental Health Hospital
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Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
60 años y mayores (Adulto, Adulto Mayor)
Acepta Voluntarios Saludables
Sí
Géneros elegibles para el estudio
Todos
Descripción
Inclusion Criteria:
- Hispanic (self-identified);
- Age 60+;
- Minor depression as defined by a primary DSM-IV Axis I diagnosis of minor depressive disorder or subthreshold depression defined as a score ≥ 3 on the Patient Health Questionnaire (PHQ-2), OR subthreshold anxiety as defined as a score ≥ 3 on the Generalized Anxiety Disorder-2 scale (GAD-2);
- Absence of episodes of major depression and anxiety disorders for past 12 months (as determined by the MINI);
- Voluntary informed consent for participation in the study by the participant or by the participant's legally designated guardian or conservator;
- Medical clearance for participation in an exercise program by a physician, physician's assistant, or nurse practitioner;
- Expect to be resident in Miami for the subsequent 12 months.
Exclusion Criteria:
- Currently residing in a nursing or group home;
- A terminal physical illness expected to result in the death within one year;
- A diagnosis of dementia, co-morbid diagnosis of dementia, or significant cognitive impairment as indicated by an MMSE score <24;
- Presence of any axis 1 psychiatric disorder or substance abuse during preceding 12 months;
- History of psychiatric disorders other than non-psychotic unipolar major depression or anxiety disorder;
- High suicide risk, i.e., intent or plan to attempt suicide in the near future (a response of "yes" to questions 3, 4, and/or 5 on the Paykel Questionnaire);
- Participants taking cognitive enhancing medication or psychotropic medications (e.g. antidepressants);
- unable to complete 400 m walk test in less than 15 min;
- if participant heart rate exceeded 170 beats per minute OR systolic blood pressure exceeds 180 during 400 m walk test;
- chest or leg pain, dyspnea, dizziness, feeling faint, or other significant symptoms while completing 400 m walk test;
(i) acute or severe medical illness that would prevent participants from walking at a moderate pace for 45 minutes, three times a week.
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Prevención
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Único
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
---|---|
Experimental: Health Promotion
Happy Older Latinos are Active (HOLA) is multicomponent health promotion intervention led by a community health worker (CHW).
First component is a social and physical activation session.
Participants meet individually with CHW for 30 minutes once at week 1, then again at week 8 (the midway point).
Second component is a moderate intensity group walk.
Groups will consist of 6 participants and will meet for one hour, 3 times a week, for 16 weeks.
Third component is pleasant events scheduling during cool down phase of the group walk.
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Health promotion intervention desgined to prevent anxiety and depression in at risk older Hispanics
Otros nombres:
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Comparador activo: Psychoeducation
Participants will be given a fotonovela and will meet once a month after they receive the fotonovela to discuss their thoughts on the materials they received.
These discussion groups will last one hour and will consist of 10 participants.
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Comic book style informational booklet designed for people with low literacy to educate them on mental illness.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Prevention of major depression, generalized anxiety, and social anxiety as measured the Mini International Neuropsychiatric Interview
Periodo de tiempo: change from baseline at 16 months
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I will be using the Mini International Neuropsychiatric Interview to test whether the HOLA intervention was successful in preventing participants from getting major depressive disorder, generalized anxiety disorder, and social anxiety disorder.
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change from baseline at 16 months
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Physical functioning as measured by the World Health Organization Disability Assessment Schedule 2.0 (WHO-DAS 2)
Periodo de tiempo: change from baseline at 16 months
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I will be measuring the effect the HOLA intervention has on the scores of the Getting Around, Life Activities, and Self-Care subscales of the WHO-DAS 2.0
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change from baseline at 16 months
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Social functioningas measured by the World Health Organization Disability Assessment Schedule 2.0 (WHO-DAS 2)
Periodo de tiempo: change from baseline at 16 months
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I will be measuring the effect the HOLA intervention has on the scores of the Getting Along with People and Participation in Life subscales of the WHO-DAS 2.0
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change from baseline at 16 months
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Self-efficacy as measured by the General Self-Efficacy Scale
Periodo de tiempo: change from baseline at 16 months
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I will be measuring the effect the HOLA intervention has on total scores of the General-Self Efficacy Scale.
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change from baseline at 16 months
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Sleep quality as measured by the Pittsburgh Sleep Quality Index
Periodo de tiempo: change from baseline at 16 months
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I will be measuring the effect the HOLA intervention has on the total scores of the Pittsburgh Sleep Quality Index
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change from baseline at 16 months
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Change in depression symptom severity as measured by the Quick Inventory of Depressive Symptomatology - Self Report (QIDS-SR).
Periodo de tiempo: change from baseline at 16 months
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I will be measuring the effect the HOLA intervention has on the total scores of the QIDS-SR
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change from baseline at 16 months
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Change in anxiety symptom severity as measured by the Beck Anxiety Inventory (BAI)
Periodo de tiempo: change from baseline at 16 months
|
I will be measuring the effect the HOLA intervention has on the total scores of the BAI
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change from baseline at 16 months
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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Investigadores
- Investigador principal: Daniel E Jimenez, Ph.D., University of Miami
Publicaciones y enlaces útiles
La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio (Actual)
1 de septiembre de 2013
Finalización primaria (Actual)
1 de agosto de 2018
Finalización del estudio (Actual)
1 de agosto de 2018
Fechas de registro del estudio
Enviado por primera vez
21 de enero de 2015
Primero enviado que cumplió con los criterios de control de calidad
20 de febrero de 2015
Publicado por primera vez (Estimar)
26 de febrero de 2015
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
7 de septiembre de 2018
Última actualización enviada que cumplió con los criterios de control de calidad
6 de septiembre de 2018
Última verificación
1 de septiembre de 2018
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- 20140607
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. .