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Completed

NCT Number: NCT02460666

Brain Connectivity and Response to Tai Chi in Geriatric Depression

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.

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Key information

Conditions

Major Depressive Disorder Consciousness Disorders Depressive Disorder Depressive Disorder, Major Mental Disorders Mood Disorders Nervous System Diseases Neurobehavioral Manifestations Neurocognitive Disorders Neurologic Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

60 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

UCLA Semel Institute

Los Angeles, California, 90095, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Tai-Chi-Chih (TCC)

Behavioral

Other names: Tai Chi

Health Education and Wellness Classes (HEW)

Behavioral

Primary outcomes

  1. Change in Hamilton Depression Rating Scale (HDRS) Scores

    Time frame: Measured at baseline and 3 months

    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.

Secondary outcomes

  1. Change in Delayed Recall Cognitive Domain Scores

    Time frame: Measured at baseline and 3 months

    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.

  2. Change in Attention/Executive Function Cognitive Domain Scores

    Time frame: Measured at baseline and 3 months

    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.

  3. Change in Language Cognitive Domain Scores

    Time frame: Measured at baseline and 3 months

    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.

Other outcomes

  1. Number of Participants With Adverse Events

    Time frame: Measured at 3 months

    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.

Sponsors and collaborators

Lead sponsor

University of California, Los Angeles

Other

Registry information

Important dates

Study start
2016
Primary completion
2020
Study completion
2020
First posted
Jun 2, 2015
Registry last updated
Jul 16, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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