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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Tai-Chi Chih Classes | Experimental | Participants will engage in 12 weekly 60 minute Tai-Chi-Chih classes. |
|
| Health Education and Wellness Classes | Active Comparator | Participants will engage in 12 weekly 60 minute Health Education and Wellness classes. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tai-Chi-Chih (TCC) | Behavioral |
|
| |
| Health Education and Wellness Classes (HEW) |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Hamilton Depression Rating Scale (HDRS) Scores | 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. | Measured at baseline and 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Delayed Recall Cognitive Domain Scores | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Adverse Events | 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. |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Helen Lavretsky, M.D. | University of California, Los Angeles | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UCLA Semel Institute | Los Angeles | California | 90095 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25142571 | Background | 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. | |
| 23642461 | Background | 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. |
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220 participants were enrolled after providing consent and completing the screen visit. 178 participants completed baseline procedures and were randomized to either group.
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| ID | Title | Description |
|---|---|---|
| FG000 | Tai-Chi Chih Classes | Participants will engage in 12 weekly 60 minute Tai-Chi-Chih classes. Tai-Chi-Chih (TCC) |
| FG001 | Health Education and Wellness Classes | Participants will engage in 12 weekly 60 minute Health Education and Wellness classes. Health Education and Wellness Classes (HEW) |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Tai-Chi Chih Classes | Participants will engage in 12 weekly 60 minute Tai-Chi-Chih classes. Tai-Chi-Chih (TCC) |
| BG001 | Health Education and Wellness Classes | Participants will engage in 12 weekly 60 minute Health Education and Wellness classes. Health Education and Wellness Classes (HEW) |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change in Hamilton Depression Rating Scale (HDRS) Scores | 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. | Posted | Mean | Standard Deviation | units on a scale | Measured at baseline and 3 months |
|
Adverse event data was collected over the course of 6 months, from the time the participants began the intervention until the Week 24 follow-up.
Adverse events were obtained via the UKU Side Effect Rating Scale, where items were scored on a 0-3 scale for degree (0 = none, 1 = mild, 2 = moderate, 3 = severe) and on a scale of 1-3 of probability if an adverse event was present (1 = impossibly related, 2 = possibly related, 3 = probably related).
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Tai-Chi Chih Classes | Participants will engage in 12 weekly 60 minute Tai-Chi-Chih classes. Tai-Chi-Chih (TCC) |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Asthenia/Lassitude/Increased Fatigability | Musculoskeletal and connective tissue disorders | Systematic Assessment |
After March 18th, 2020, all assessments were completed remotely due to COVID-19 until restrictions were lifted for eligible participants to come in-person.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Helen Lavretsky, MD | University of California, Los Angeles | (310) 794-4619 | HLavretsky@mednet.ucla.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Apr 2, 2020 | May 25, 2021 | Prot_SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Aug 13, 2020 | Jan 19, 2021 | ICF_000.pdf |
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| ID | Term |
|---|---|
| D003865 | Depressive Disorder, Major |
| D003244 | Consciousness Disorders |
| ID | Term |
|---|---|
| D003866 | Depressive Disorder |
| D019964 | Mood Disorders |
| D001523 | Mental Disorders |
| D019954 | Neurobehavioral Manifestations |
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| ID | Term |
|---|---|
| D026302 | Tai Ji |
| ID | Term |
|---|---|
| D026441 | Mind-Body Therapies |
| D000529 | Complementary Therapies |
| D013812 | Therapeutics |
| D026241 | Exercise Movement Techniques |
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| Behavioral |
|
| Measured at baseline and 3 months |
| Change in Attention/Executive Function Cognitive Domain Scores | 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. | Measured at baseline and 3 months |
| Change in Language Cognitive Domain Scores | 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. | Measured at baseline and 3 months |
| Measured at 3 months |
| 21358389 | Background | 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. |
| 21857219 | Background | 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. |
| 23538081 | Background | 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. |
| 34404606 | Derived | 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. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Hamilton Depression Rating Scale | 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. | Mean | Standard Deviation | units on a scale |
|
Participants will engage in 12 weekly 60 minute Health Education and Wellness classes.
Health Education and Wellness Classes (HEW)
|
|
|
| Secondary | Change in Delayed Recall Cognitive Domain Scores | 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. | Posted | Mean | Standard Deviation | z-score | Measured at baseline and 3 months |
|
|
|
|
| Secondary | Change in Attention/Executive Function Cognitive Domain Scores | 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. | Posted | Mean | Standard Deviation | z-score | Measured at baseline and 3 months |
|
|
|
|
| Secondary | Change in Language Cognitive Domain Scores | 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. | Posted | Mean | Standard Deviation | z-score | Measured at baseline and 3 months |
|
|
|
|
| Other Pre-specified | Number of Participants With Adverse Events | 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. | Posted | Count of Participants | Participants | Measured at 3 months |
|
|
|
| 0 |
| 89 |
| 0 |
| 89 |
| 4 |
| 89 |
| EG001 | Health Education and Wellness Classes | Participants will engage in 12 weekly 60 minute Health Education and Wellness classes. Health Education and Wellness Classes (HEW) | 0 | 89 | 0 | 89 | 3 | 89 |
| Failing memory | Psychiatric disorders | Systematic Assessment |
|
| Tension/Inner Unrest | Psychiatric disorders | Systematic Assessment |
|
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| D009461 |
| Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D019965 | Neurocognitive Disorders |
| D026741 |
| Physical Therapy Modalities |