Brain Connectivity and Response to Tai Chi in Geriatric Depression
研究概览
详细说明
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.
研究类型
注册 (实际的)
阶段
- 不适用
联系人和位置
学习地点
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California
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Los Angeles、California、美国、90095
- UCLA Semel Institute
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
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
学习计划
研究是如何设计的？
设计细节
- 主要用途：支持治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：双倍的
武器和干预
参与者组/臂 |
干预/治疗 |
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实验性的：Tai-Chi Chih Classes
Participants will engage in 12 weekly 60 minute Tai-Chi-Chih classes.
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其他名称：
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有源比较器：Health Education and Wellness Classes
Participants will engage in 12 weekly 60 minute Health Education and Wellness classes.
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Change in Hamilton Depression Rating Scale (HDRS) Scores
大体时间：Measured at baseline and 3 months
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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.
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Measured at baseline and 3 months
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Change in Delayed Recall Cognitive Domain Scores
大体时间：Measured at baseline and 3 months
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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. |
Measured at baseline and 3 months
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Change in Attention/Executive Function Cognitive Domain Scores
大体时间：Measured at baseline and 3 months
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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
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Change in Language Cognitive Domain Scores
大体时间：Measured at baseline and 3 months
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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
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其他结果措施
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Number of Participants With Adverse Events
大体时间：Measured at 3 months
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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.
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Measured at 3 months
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合作者和调查者
调查人员
- 首席研究员：Helen Lavretsky, M.D.、University of California, Los Angeles
出版物和有用的链接
一般刊物
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
研究记录日期
研究主要日期
学习开始
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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