- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT01263730
Tai Chi Training for Treating Depressed Chinese Americans
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
When a first line treatment for depression fails, clinicians often choose to increase the dosage, or augment with a second agent, prior to considering switching agents altogether (Rosenbaum et al, 1995). Combination of an SSRI/SNRI with other agents such as tricyclic antidepressants (TCAs) or lithium are examples of popular strategies (Fava et al, 1994). In many instances, augmentation with multiple psychotropic agents may not be desirable, because of risk of side effects or drug-drug interactions.
In view of their benign adverse effect profiles, non-pharmacological interventions such as psychotherapy and mind-body intervention have been used to augment treatment for treatment resistant depressed patients. Preliminary studies have shown that meditation is beneficial for the treatment of depression (Smith et al., 2007; Sephton et al., 2007; Finucane and Mercer, 2006; Astin et al., 2003; Speca et al., 2000).
Tai Chi training consists of a sequence of slow, soft, and graceful movements derived from the martial arts. It is considered as a moving form of yoga and meditation combined. Tai Chi has been considered as one form of oriental healing arts, like acupuncture, which fosters the circulation of this 'chi' or energy within the body. By doing so, the health and vitality of the person are enhanced. Tai Chi, with its slow movement synchronized to the person's breathing, has been known to lead to a calm and tranquil mind when the person is focused on the precise execution of these exercises.
Tipo de estudio
Inscripción (Actual)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
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Massachusetts
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Boston, Massachusetts, Estados Unidos
- South Cove
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
General Inclusion criteria
- Men and women between the ages of 18 and 65 years;
- Satisfy DSM-IV criteria for current Major Depressive Disorder (MDD), or have a history of MDD, prior to the initiation of Tai Chi treatment, as determined by the SCID interview;
- Have not had Tai Chi treatment training and have not started other forms of mind/body intervention in the past 3 months.
General Exclusion criteria
- Patients with primary diagnosis other than MDD and/or do not have a history of MDD;
- Conditions that may make it difficult to conclusively determine that depressive symptoms are the result of MDD or having a history of MDD and not some other condition, including any form of substance abuse or dependence within the last 6 months, relevant medical conditions that may be the medical basis of a depression including epilepsy, history of an abnormal EEG, severe head trauma, or stroke;
- Medical conditions that would preclude entry into a clinical trial, including serious uncontrolled medical conditions (e.g. poorly controlled diabetes, severe congestive heart failure), or other medical conditions that have not been stable for a minimum of 3 months);
- Confounding treatments, such as current ongoing treatment other than what is provided by South Cove for depression; plans to receive confounding treatments.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Cuidados de apoyo
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación de un solo grupo
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
---|---|
Comparador activo: Tai Chi Training
The active group will be given 12 weeks of tai chi training
|
Tai Chi training consists of a sequence of slow, soft, and graceful movements derived from the martial arts.
It is considered as a moving form of yoga and meditation combined.
Tai Chi has been considered as one form of oriental healing arts, like acupuncture, which fosters the circulation of this 'chi' or energy within the body.
|
Sin intervención: Waitlist control group
There is a waitlist control group that will receive the training following a 12 week no treatment period of time
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Depressive Symptoms
Periodo de tiempo: 12 weeks of Tai Chi Training
|
We will be looking for a decrease in depressive symptoms at the mid- (week 6) and post- (week 12) time point following Tai Chi training as compared to the baseline (week 0).
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12 weeks of Tai Chi Training
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Psychological questionnaires, specifically the Quality of Life Enjoyment questionnaire.
Periodo de tiempo: 12 weeks of Tai Chi Training
|
We will compare psychometric questionnaire results pre-(wk 0), mid- (wk 6), and post- (wk 12) Tai Chi training.
The questionnaires administered include the Hamilton Depression Rating Scale, Clinical Global Inventory, Patient Health Questionnaire, Beck Depression Inventory, Quality of Life Enjoyment and Satisfaction, Expectations Tai Chi training on depression, International Physical Activity, and Mimet's Multidimensional Scale of Perceived Social Support.
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12 weeks of Tai Chi Training
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Colaboradores e Investigadores
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Albert Yeung, MD, Massachusetts General Hospital
- Director de estudio: Herbert Benson, MD, Massachusetts General Hospital
- Director de estudio: Gregory Fricchione, MD, Massachusetts General Hospital
- Director de estudio: John W. Denninger, MD, Massachusetts General Hospital
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio
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 (Estimar)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- 2008P000262
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. .
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