Brain Connectivity and Response to Tai Chi in Geriatric Depression
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|ClinicalTrials.gov Identifier: NCT02460666|
Recruitment Status : Completed
First Posted : June 2, 2015
Last Update Posted : January 22, 2021
|Condition or disease||Intervention/treatment||Phase|
|Major Depressive Disorder||Behavioral: Tai-Chi-Chih (TCC) Behavioral: Health Education and Wellness Classes (HEW)||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||220 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Investigator, Outcomes Assessor)|
|Primary Purpose:||Supportive Care|
|Official Title:||Brain Connectivity and Response to Tai Chi in Geriatric Depression|
|Study Start Date :||January 2016|
|Actual Primary Completion Date :||November 18, 2020|
|Actual Study Completion Date :||December 1, 2020|
Experimental: Tai-Chi Chih Classes
Participants will engage in 12 weekly 60 minute Tai-Chi-Chih classes.
Behavioral: Tai-Chi-Chih (TCC)
Other Name: Tai Chi
Active Comparator: Health Education and Wellness Classes
Participants will engage in 12 weekly 60 minute Health Education and Wellness classes.
Behavioral: Health Education and Wellness Classes (HEW)
- Change in Hamilton Depression Rating Scale (HDRS) scores [ Time Frame: Measured at baseline,12 weeks, and 6 months ]
- Change in cognitive domain scores [ Time Frame: Measured at baseline, 12 weeks, and 6 months ]
- Number of Participants with Adverse Events [ Time Frame: Measured at 12 weeks and 6 months ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02460666
|United States, California|
|UCLA Semel Institute|
|Los Angeles, California, United States, 90095|
|Principal Investigator:||Helen Lavretsky, M.D.||University of California, Los Angeles|