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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
Sponsor:
Information provided by (Responsible Party):
Helen Lavretsky, MD, University of California, Los Angeles

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Major Depressive Disorder Behavioral: Tai-Chi-Chih (TCC) Behavioral: Health Education and Wellness Classes (HEW) Not Applicable

Detailed Description:

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 220 participants
Allocation: Randomized
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

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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)



Primary Outcome Measures :
  1. Change in Hamilton Depression Rating Scale (HDRS) scores [ Time Frame: Measured at baseline,12 weeks, and 6 months ]

Secondary Outcome Measures :
  1. Change in cognitive domain scores [ Time Frame: Measured at baseline, 12 weeks, and 6 months ]

Other Outcome Measures:
  1. Number of Participants with Adverse Events [ Time Frame: Measured at 12 weeks and 6 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   60 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

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


Locations
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United States, California
UCLA Semel Institute
Los Angeles, California, United States, 90095
Sponsors and Collaborators
University of California, Los Angeles
Investigators
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Principal Investigator: Helen Lavretsky, M.D. University of California, Los Angeles
  Study Documents (Full-Text)

Documents provided by Helen Lavretsky, MD, University of California, Los Angeles:
Informed Consent Form  [PDF] August 13, 2020

Publications:
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Responsible Party: Helen Lavretsky, MD, Professor, University of California, Los Angeles
ClinicalTrials.gov Identifier: NCT02460666    
Other Study ID Numbers: R01AT008383-01A1 ( U.S. NIH Grant/Contract )
First Posted: June 2, 2015    Key Record Dates
Last Update Posted: January 22, 2021
Last Verified: January 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Helen Lavretsky, MD, University of California, Los Angeles:
depressed
older adults
Major Depressive Disorder
Tai-Chi
geriatric
Additional relevant MeSH terms:
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Depression
Depressive Disorder
Depressive Disorder, Major
Behavioral Symptoms
Mood Disorders
Mental Disorders