Brain Connectivity and Response to Tai Chi in Geriatric Depression



Status:Recruiting
Conditions:Depression, Depression, Major Depression Disorder (MDD)
Therapuetic Areas:Psychiatry / Psychology, Pulmonary / Respiratory Diseases
Healthy:No
Age Range:60 - Any
Updated:1/20/2019
Start Date:January 2016
End Date:April 2020
Contact:Helen Lavretsky, M.D.
Phone:310-794-4619

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The purpose of this study is to evaluate the effects after up to 1 year of supervised weekly
Tai-Chi-Chi versus Health Education and Wellness classes on reduction of depressive symptoms
and improvement in resilience, health functioning, quality of life, cognition, sleep, fMRI
neural correlates of working memory, and brain structure.

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.

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
We found this trial at
1
site
Los Angeles, California 90095
Principal Investigator: Helen Lavretsky, MD
Phone: 310-794-4619
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Los Angeles, CA
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