Brain Connectivity and Response to Tai Chi in Geriatric Depression
NCT ID: NCT02460666
Last Updated: 2021-07-16
Study Results
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View full resultsBasic Information
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COMPLETED
NA
220 participants
INTERVENTIONAL
2016-01-31
2020-12-01
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
DOUBLE
Study Groups
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Tai-Chi Chih Classes
Participants will engage in 12 weekly 60 minute Tai-Chi-Chih classes.
Tai-Chi-Chih (TCC)
Health Education and Wellness Classes
Participants will engage in 12 weekly 60 minute Health Education and Wellness classes.
Health Education and Wellness Classes (HEW)
Interventions
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Tai-Chi-Chih (TCC)
Health Education and Wellness Classes (HEW)
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 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
60 Years
ALL
No
Sponsors
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University of California, Los Angeles
OTHER
Responsible Party
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Helen Lavretsky, MD
Professor
Principal Investigators
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Helen Lavretsky, M.D.
Role: PRINCIPAL_INVESTIGATOR
University of California, Los Angeles
Locations
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UCLA Semel Institute
Los Angeles, California, United States
Countries
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References
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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.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Document Type: Informed Consent Form
Other Identifiers
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