Brain Connectivity and Response to Tai Chi in Geriatric Depression
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
The proposed randomized trial aims to investigate neural mechanisms of brain connectivity when comparing response to TCC to health and wellness education classes using fMRI biomarkers of emotional regulation and cognition. Control group will include health wellness education programs (HEW) that will help to control for the non-specific social support factors. Primary outcomes include measures of depressive symptom severity. Secondary outcomes include cognition, resilience, health functioning, quality of life. Maintenance of response and relapse of major depression will be determined during 6 month (and 12 month follow-up if MRI eligible). Functional magnetic resonance imaging (fMRI) correlates of emotional processing and connectivity in related functional networks. Neural correlates of working memory, and brain structure will be examined in ½ of the sample. The researchers will investigate whether variations in emotional regulation will moderate or predict emotional and functional improvement linked to TCC.
The investigators will recruit 220 older adults with depressive symptoms who have been on a stable form of treatment for at least 4 months, who will be randomly assigned to 12 weeks of: 1.Ta-Chi-Chih (TCC) class; or 2. Health/Wellness Education Program (HEW); all for 120 minutes per week. All subjects will receive comprehensive evaluations of mood, mental and physical health, and cognition at baseline, 12 weeks, and 6 months. Changes over time in measures of depressive symptoms, resilience, quality of life, and cognition will be assessed in random regression models. The investigators anticipate that greater clinical improvement in mood and cognition will in the TCC group compared to the HEW. The investigators also expect clinical improvement to correlate with the change in the activation in the right ventrolateral prefrontal cortex (VLPFC) and amygdala in an affect labeling task, and working memory-related activation of dorsolateral prefrontal cortex (DLPFC), and change in functional connectivity in brain network activity. This is the first randomized trial of response to TCC that integrates the use of fMRI biomarkers of response to guide the development of treatment and preventive approaches in geriatric depression.
Tipo de estudio
Inscripción (Actual)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
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California
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Los Angeles, California, Estados Unidos, 90095
- UCLA Semel Institute
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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:
- A 24-item Hamilton Rating Scale for Depression (HAMD) score greater than 14 consistent with moderate-severe depression.
- Mini-Mental State Exam (MMSE) score greater than 24.
- Sufficient English proficiency and 8th grade or higher reading level as determined by the word reading subtest of the Wide Range Achievement Test-IV.
- Capacity to provide informed consent.
- A stable form of treatment for at least 4 months.
Exclusion Criteria:
- Any current or past psychiatric disorders, or recent unstable medical or neurological disorders
- Any disabilities preventing their participation in Tai-Chi Chih exercise (e.g. severe visual or hearing impairment)
- Insufficient English proficiency
- Diagnosis of dementia
- Mini Mental Health Examination score of 24 and below
- Effective antidepressant, psychotropic medications, or effective therapy
- Participation in a psychotherapy that involves cognitive training
- Do not meet criteria for moderate-severe depression with a 24-item Hamilton Rating Scale for Depression (HAMD) score less than 14
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Cuidados de apoyo
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Doble
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
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Experimental: Tai-Chi Chih Classes
Participants will engage in 12 weekly 60 minute Tai-Chi-Chih classes.
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Otros nombres:
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Comparador activo: Health Education and Wellness Classes
Participants will engage in 12 weekly 60 minute Health Education and Wellness classes.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Change in Hamilton Depression Rating Scale (HDRS) Scores
Periodo de tiempo: Measured at baseline and 3 months
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Clinician administered scale measures severity of depressive symptoms.
This measure includes 24 items.
Response options vary item to item and include the following ranges: [0-2], [0-3], and [0-4].
A score of 0 suggests absence of symptoms and/or difficulties and higher scores represent more severe difficulties.
Possible overall score range [0-74], higher scores representing more severe difficulties.
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Measured at baseline and 3 months
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Change in Delayed Recall Cognitive Domain Scores
Periodo de tiempo: Measured at baseline and 3 months
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Neuropsychological battery of tests which included the following domains: Delayed Recall (CVLT-II [Long-Delay Free Recall], Rey-Osterrieth Complex Figure Test [30-minute Delayed Recall]) Raw scores were transformed to z-scores (with a mean of 0 and standard deviation of 1) for each test score of interest across all participants. Thus the sample mean (across both arms) is zero for each test score. These z-scores were then averaged within each neuropsychological domain to produce composite scores. Higher scores are indicative of better performance. |
Measured at baseline and 3 months
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Change in Attention/Executive Function Cognitive Domain Scores
Periodo de tiempo: Measured at baseline and 3 months
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Neuropsychological battery of tests which included the following domains: Attention/Executive Function (Trail Making Test A and B, Stroop Interference [Golden version]) Raw scores were transformed to z-scores (with a mean of 0 and standard deviation of 1) for each test score of interest across all participants. Thus the sample mean (across both arms) is zero for each test score. These z-scores were then averaged within each neuropsychological domain to produce composite scores. Higher scores are indicative of better performance. |
Measured at baseline and 3 months
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Change in Language Cognitive Domain Scores
Periodo de tiempo: Measured at baseline and 3 months
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Neuropsychological battery of tests which included the following domains: Language (Controlled Oral Word Association test [FAS], Animal Fluency, and Boston Naming Test) Raw scores were transformed to z-scores (with a mean of 0 and standard deviation of 1) for each test score of interest across all participants. Thus the sample mean (across both arms) is zero for each test score. These z-scores were then averaged within each neuropsychological domain to produce composite scores. Higher scores are indicative of better performance. |
Measured at baseline and 3 months
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Otras medidas de resultado
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Number of Participants With Adverse Events
Periodo de tiempo: Measured at 3 months
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The UKU (Udvalg for Kliniske Undersogelser) Side Effect Rating Scale organizes symptoms into 4 categories (i.e., Psychic, Neurologic, Autonomic, Other) containing 8-19 symptoms each.
Each symptom receives a score for degree and causal relationship.
Degree is scored between 0-3 with higher scores being more severe.
Causal relationship is scored as improbable, possible, or probable.
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Measured at 3 months
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Helen Lavretsky, M.D., University of California, Los Angeles
Publicaciones y enlaces útiles
Publicaciones Generales
- Irwin MR, Olmstead R, Carrillo C, Sadeghi N, Breen EC, Witarama T, Yokomizo M, Lavretsky H, Carroll JE, Motivala SJ, Bootzin R, Nicassio P. Cognitive behavioral therapy vs. Tai Chi for late life insomnia and inflammatory risk: a randomized controlled comparative efficacy trial. Sleep. 2014 Sep 1;37(9):1543-52. doi: 10.5665/sleep.4008.
- Siddarth D, Siddarth P, Lavretsky H. An observational study of the health benefits of yoga or tai chi compared with aerobic exercise in community-dwelling middle-aged and older adults. Am J Geriatr Psychiatry. 2014 Mar;22(3):272-3. doi: 10.1016/j.jagp.2013.01.065. Epub 2013 May 2. No abstract available.
- Lavretsky H, Alstein LL, Olmstead RE, Ercoli LM, Riparetti-Brown M, Cyr NS, Irwin MR. Complementary use of tai chi chih augments escitalopram treatment of geriatric depression: a randomized controlled trial. Am J Geriatr Psychiatry. 2011 Oct;19(10):839-50. doi: 10.1097/JGP.0b013e31820ee9ef.
- Schneider B, Ercoli L, Siddarth P, Lavretsky H. Vascular burden and cognitive functioning in depressed older adults. Am J Geriatr Psychiatry. 2012 Aug;20(8):673-81. doi: 10.1097/JGP.0b013e31822ccd64.
- Abbott R, Lavretsky H. Tai Chi and Qigong for the treatment and prevention of mental disorders. Psychiatr Clin North Am. 2013 Mar;36(1):109-19. doi: 10.1016/j.psc.2013.01.011.
- Lavretsky H, Milillo MM, Kilpatrick L, Grzenda A, Wu P, Nguyen SA, Ercoli LM, Siddarth P. A Randomized Controlled Trial of Tai Chi Chih or Health Education for Geriatric Depression. Am J Geriatr Psychiatry. 2022 Mar;30(3):392-403. doi: 10.1016/j.jagp.2021.07.008. Epub 2021 Jul 30.
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 (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- R01AT008383-01A1 (Subvención/contrato del NIH de EE. UU.)
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
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Ensayos clínicos sobre Trastorno depresivo mayor
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University of Maryland, College ParkTerminadoMajor evento cardíaco adverso (MACE)Estados Unidos
Ensayos clínicos sobre Tai-Chi-Chih (TCC)
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National Center for Complementary and Integrative...Terminado
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University of California, San FranciscoUniversity of California, Los Angeles; United States Department of Defense; San... y otros colaboradoresTerminadoDefecto cognitivo leve | Disminución de la memoria subjetivaEstados Unidos
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The University of Hong KongTerminadoInsomnio crónicoHong Kong
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The Hong Kong Polytechnic UniversityFood and Health Bureau, Hong KongReclutamientoDormir | Anciano | Atención plena | Tai Chi ChuanHong Kong
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Lidian ChenPeking University Third HospitalAún no reclutando
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Harvard University Faculty of MedicineBeth Israel Deaconess Medical Center; Brigham and Women's HospitalTerminado
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Jonsson Comprehensive Cancer CenterNational Center for Research Resources (NCRR)Activo, no reclutandoDesordenes mentales | Enfermedades del Sistema Nervioso | Disomnias | Trastornos de iniciación y mantenimiento del sueño | Trastornos del sueñoEstados Unidos
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Chengdu University of Traditional Chinese MedicineAún no reclutandoCalidad de vida | Diálisis; Complicaciones | Medicina china
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Sheba Medical CenterTel Aviv UniversityRetiradoCáncer de ovarios | Cáncer peritoneal primario | Otros cánceres ginecológicosIsrael
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University Hospital, Clermont-FerrandTerminado