Brain Connectivity and Response to Tai Chi in Geriatric Depression
NCT02460666, Not applicable, Completed, University of California, Los Angeles; results first posted 2021-07-09
Trial 12
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
| Field | Value | Source |
|---|---|---|
| Title | Brain Connectivity and Response to Tai Chi in Geriatric Depression | ClinicalTrials.gov |
| NCT number | NCT02460666 | ClinicalTrials.gov |
| Status | Completed | ClinicalTrials.gov |
| Phases | Not applicable | ClinicalTrials.gov |
| Enrollment | 220 participants, actual | ClinicalTrials.gov |
| Lead sponsor | University of California, Los Angeles | ClinicalTrials.gov |
| Conditions | Major Depressive Disorder | ClinicalTrials.gov |
| Interventions | Tai-Chi-Chih (TCC), Health Education and Wellness Classes (HEW) | ClinicalTrials.gov |
| First posted | 2015-06-02 | ClinicalTrials.gov |
| Last updated | 2021-07-16 | ClinicalTrials.gov |
| Results first posted | 2021-07-09 | ClinicalTrials.gov |
| Limitations and caveats | After March 18th, 2020, all assessments were completed remotely due to COVID-19 until restrictions were lifted for eligible participants to come in-person. | ClinicalTrials.gov |
Registered outcomes 5
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description | Source |
|---|---|---|---|---|
| Primary | Change in Hamilton Depression Rating Scale (HDRS) Scores | 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. | ClinicalTrials.gov |
| Secondary | Change in Delayed Recall Cognitive Domain Scores | 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. | ClinicalTrials.gov |
| Secondary | Change in Attention/Executive Function Cognitive Domain Scores | 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. | ClinicalTrials.gov |
| Secondary | Change in Language Cognitive Domain Scores | 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. | ClinicalTrials.gov |
| Other | Number of Participants With Adverse Events | 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. | ClinicalTrials.gov |
Outcomes 5
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as | Source |
|---|---|---|---|---|---|---|
| PRIMARY | Change in Hamilton Depression Rating Scale (HDRS) Scores | Measured at baseline and 3 months | units on a scale | MEAN | ClinicalTrials.gov | |
| SECONDARY | Change in Delayed Recall Cognitive Domain Scores | Measured at baseline and 3 months | z-score | MEAN | ClinicalTrials.gov | |
| SECONDARY | Change in Attention/Executive Function Cognitive Domain Scores | Measured at baseline and 3 months | z-score | MEAN | ClinicalTrials.gov | |
| SECONDARY | Change in Language Cognitive Domain Scores | Measured at baseline and 3 months | z-score | MEAN | ClinicalTrials.gov | |
| OTHER_PRE_SPECIFIED | Number of Participants With Adverse Events | Measured at 3 months | Participants | COUNT_OF_PARTICIPANTS | ClinicalTrials.gov |
Results by group 10
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units | Source |
|---|---|---|---|---|---|---|
| Change in Hamilton Depression Rating Scale (HDRS) Scores | Tai-Chi Chih Classes | -9.27 | Standard Deviation 5.29 | units on a scale | ClinicalTrials.gov | |
| Change in Hamilton Depression Rating Scale (HDRS) Scores | Health Education and Wellness Classes | -9.40 | Standard Deviation 5.35 | units on a scale | ClinicalTrials.gov | |
| Change in Delayed Recall Cognitive Domain Scores | Tai-Chi Chih Classes | -0.15 | Standard Deviation 0.57 | z-score | ClinicalTrials.gov | |
| Change in Delayed Recall Cognitive Domain Scores | Health Education and Wellness Classes | -0.002 | Standard Deviation 0.61 | z-score | ClinicalTrials.gov | |
| Change in Attention/Executive Function Cognitive Domain Scores | Tai-Chi Chih Classes | -0.04 | Standard Deviation 0.61 | z-score | ClinicalTrials.gov | |
| Change in Attention/Executive Function Cognitive Domain Scores | Health Education and Wellness Classes | 0.03 | Standard Deviation 0.53 | z-score | ClinicalTrials.gov | |
| Change in Language Cognitive Domain Scores | Tai-Chi Chih Classes | 0.03 | Standard Deviation 0.40 | z-score | ClinicalTrials.gov | |
| Change in Language Cognitive Domain Scores | Health Education and Wellness Classes | -0.12 | Standard Deviation 0.46 | z-score | ClinicalTrials.gov | |
| Number of Participants With Adverse Events | Tai-Chi Chih Classes | 4 | Participants | ClinicalTrials.gov | ||
| Number of Participants With Adverse Events | Health Education and Wellness Classes | 3 | Participants | ClinicalTrials.gov |
Participant flow 6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted | Source |
|---|---|---|---|---|---|
| Overall Study | STARTED | Tai-Chi Chih Classes | 89 | ClinicalTrials.gov | |
| Overall Study | STARTED | Health Education and Wellness Classes | 89 | ClinicalTrials.gov | |
| Overall Study | COMPLETED | Tai-Chi Chih Classes | 62 | ClinicalTrials.gov | |
| Overall Study | COMPLETED | Health Education and Wellness Classes | 63 | ClinicalTrials.gov | |
| Overall Study | NOT COMPLETED | Tai-Chi Chih Classes | 27 | ClinicalTrials.gov | |
| Overall Study | NOT COMPLETED | Health Education and Wellness Classes | 26 | ClinicalTrials.gov |
Adverse events 6
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events | Source |
|---|---|---|---|---|---|---|---|
| other | Asthenia/Lassitude/Increased Fatigability | Musculoskeletal and connective tissue disorders | Tai-Chi Chih Classes | 4 | 89 | 4 | ClinicalTrials.gov |
| other | Asthenia/Lassitude/Increased Fatigability | Musculoskeletal and connective tissue disorders | Health Education and Wellness Classes | 0 | 89 | 0 | ClinicalTrials.gov |
| other | Failing memory | Psychiatric disorders | Tai-Chi Chih Classes | 0 | 89 | 0 | ClinicalTrials.gov |
| other | Failing memory | Psychiatric disorders | Health Education and Wellness Classes | 1 | 89 | 1 | ClinicalTrials.gov |
| other | Tension/Inner Unrest | Psychiatric disorders | Tai-Chi Chih Classes | 0 | 89 | 0 | ClinicalTrials.gov |
| other | Tension/Inner Unrest | Psychiatric disorders | Health Education and Wellness Classes | 2 | 89 | 2 | ClinicalTrials.gov |
Adverse event totals 6
The totals the trial posted for each group.
| Total | Group | Affected | At risk | Source |
|---|---|---|---|---|
| Total, all-cause mortality | Tai-Chi Chih Classes | 0 | 89 | ClinicalTrials.gov |
| Total, all-cause mortality | Health Education and Wellness Classes | 0 | 89 | ClinicalTrials.gov |
| Total, other adverse events | Tai-Chi Chih Classes | 4 | 89 | ClinicalTrials.gov |
| Total, other adverse events | Health Education and Wellness Classes | 3 | 89 | ClinicalTrials.gov |
| Total, serious adverse events | Tai-Chi Chih Classes | 0 | 89 | ClinicalTrials.gov |
| Total, serious adverse events | Health Education and Wellness Classes | 0 | 89 | ClinicalTrials.gov |
Papers 6
The papers the trial lists on ClinicalTrials.gov.
Grants 1
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years | Source |
|---|---|---|---|---|---|---|
| R01AT008383 | Brain connectivity and response to Tai Chi in geriatric depression | LAVRETSKY, HELEN | UNIVERSITY OF CALIFORNIA LOS ANGELES | NATIONAL CENTER FOR COMPLEMENTARY & INTEGRATIVE HEALTH | 2015 to 2019 | NIH RePORTER |
Trial comparisons 3
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Tai-Chi Chih Classes vs Health Education and Wellness Classes: Number of Participants With Adverse Events | Trial comparisons |
| Tai-Chi Chih Classes vs Health Education and Wellness Classes: deaths from any cause | Trial comparisons |
| Tai-Chi Chih Classes vs Health Education and Wellness Classes: serious adverse events | Trial comparisons |
Tests 7
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
| Test | Named as | Source |
|---|---|---|
| Category Fluency | Secondary outcome | ConductCognition |
| Complex Figure Copy and Recall | Secondary outcome | ConductCognition |
| Picture Naming Test | Secondary outcome | ConductCognition |
| Stroop Color-Word Test | Secondary outcome | ConductCognition |
| Trail Making Test A | Secondary outcome | ConductCognition |
| Trail Making Test B | Secondary outcome | ConductCognition |
| Verbal Fluency | Secondary outcome | ConductCognition |
Source 5
| Field | Value | Source |
|---|---|---|
| Release | trials-2026-11-12-0.4.0 | ClinicalTrials.gov |
| Release manifest SHA-256 | 0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4 | ClinicalTrials.gov |
| Registry capture | 2026-11-12 | ClinicalTrials.gov |
| Results copy, AACT | 2026-03-23 | ClinicalTrials.gov |
| NIH clinical studies file | 2026-11-13 | ClinicalTrials.gov |
Release trials-2026-11-12-0.4.0
ClinicalTrials.gov's posted results, through CTTI's AACT: ClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299 ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
ClinicalTrials.gov: none stated ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
NIH RePORTER's clinical studies and project files: Public domain (NIH RePORTER)