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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.

FieldValueSource
TitleBrain Connectivity and Response to Tai Chi in Geriatric DepressionClinicalTrials.gov
NCT numberNCT02460666ClinicalTrials.gov
StatusCompletedClinicalTrials.gov
PhasesNot applicableClinicalTrials.gov
Enrollment220 participants, actualClinicalTrials.gov
Lead sponsorUniversity of California, Los AngelesClinicalTrials.gov
ConditionsMajor Depressive DisorderClinicalTrials.gov
InterventionsTai-Chi-Chih (TCC), Health Education and Wellness Classes (HEW)ClinicalTrials.gov
First posted2015-06-02ClinicalTrials.gov
Last updated2021-07-16ClinicalTrials.gov
Results first posted2021-07-09ClinicalTrials.gov
Limitations and caveatsAfter 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.

ListOutcomeTime frameDescriptionSource
PrimaryChange in Hamilton Depression Rating Scale (HDRS) ScoresMeasured 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
SecondaryChange in Delayed Recall Cognitive Domain ScoresMeasured 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
SecondaryChange in Attention/Executive Function Cognitive Domain ScoresMeasured 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
SecondaryChange in Language Cognitive Domain ScoresMeasured 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
OtherNumber of Participants With Adverse EventsMeasured 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.

TypeOutcomeTime framePopulationUnitsMeasured asSource
PRIMARYChange in Hamilton Depression Rating Scale (HDRS) ScoresMeasured at baseline and 3 monthsunits on a scaleMEANClinicalTrials.gov
SECONDARYChange in Delayed Recall Cognitive Domain ScoresMeasured at baseline and 3 monthsz-scoreMEANClinicalTrials.gov
SECONDARYChange in Attention/Executive Function Cognitive Domain ScoresMeasured at baseline and 3 monthsz-scoreMEANClinicalTrials.gov
SECONDARYChange in Language Cognitive Domain ScoresMeasured at baseline and 3 monthsz-scoreMEANClinicalTrials.gov
OTHER_PRE_SPECIFIEDNumber of Participants With Adverse EventsMeasured at 3 monthsParticipantsCOUNT_OF_PARTICIPANTSClinicalTrials.gov

Results by group 10

Each measurement the trial posted, group by group, in the words and numbers it posted.

OutcomeGroupCategoryValueSpreadUnitsSource
Change in Hamilton Depression Rating Scale (HDRS) ScoresTai-Chi Chih Classes-9.27Standard Deviation 5.29units on a scaleClinicalTrials.gov
Change in Hamilton Depression Rating Scale (HDRS) ScoresHealth Education and Wellness Classes-9.40Standard Deviation 5.35units on a scaleClinicalTrials.gov
Change in Delayed Recall Cognitive Domain ScoresTai-Chi Chih Classes-0.15Standard Deviation 0.57z-scoreClinicalTrials.gov
Change in Delayed Recall Cognitive Domain ScoresHealth Education and Wellness Classes-0.002Standard Deviation 0.61z-scoreClinicalTrials.gov
Change in Attention/Executive Function Cognitive Domain ScoresTai-Chi Chih Classes-0.04Standard Deviation 0.61z-scoreClinicalTrials.gov
Change in Attention/Executive Function Cognitive Domain ScoresHealth Education and Wellness Classes0.03Standard Deviation 0.53z-scoreClinicalTrials.gov
Change in Language Cognitive Domain ScoresTai-Chi Chih Classes0.03Standard Deviation 0.40z-scoreClinicalTrials.gov
Change in Language Cognitive Domain ScoresHealth Education and Wellness Classes-0.12Standard Deviation 0.46z-scoreClinicalTrials.gov
Number of Participants With Adverse EventsTai-Chi Chih Classes4ParticipantsClinicalTrials.gov
Number of Participants With Adverse EventsHealth Education and Wellness Classes3ParticipantsClinicalTrials.gov

Participant flow 6

How many started, completed or left each group, period by period.

PeriodMilestoneGroupParticipantsUnits countedSource
Overall StudySTARTEDTai-Chi Chih Classes89ClinicalTrials.gov
Overall StudySTARTEDHealth Education and Wellness Classes89ClinicalTrials.gov
Overall StudyCOMPLETEDTai-Chi Chih Classes62ClinicalTrials.gov
Overall StudyCOMPLETEDHealth Education and Wellness Classes63ClinicalTrials.gov
Overall StudyNOT COMPLETEDTai-Chi Chih Classes27ClinicalTrials.gov
Overall StudyNOT COMPLETEDHealth Education and Wellness Classes26ClinicalTrials.gov

Adverse events 6

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

TypeEventOrgan systemGroupAffectedAt riskEventsSource
otherAsthenia/Lassitude/Increased FatigabilityMusculoskeletal and connective tissue disordersTai-Chi Chih Classes4894ClinicalTrials.gov
otherAsthenia/Lassitude/Increased FatigabilityMusculoskeletal and connective tissue disordersHealth Education and Wellness Classes0890ClinicalTrials.gov
otherFailing memoryPsychiatric disordersTai-Chi Chih Classes0890ClinicalTrials.gov
otherFailing memoryPsychiatric disordersHealth Education and Wellness Classes1891ClinicalTrials.gov
otherTension/Inner UnrestPsychiatric disordersTai-Chi Chih Classes0890ClinicalTrials.gov
otherTension/Inner UnrestPsychiatric disordersHealth Education and Wellness Classes2892ClinicalTrials.gov

Adverse event totals 6

The totals the trial posted for each group.

TotalGroupAffectedAt riskSource
Total, all-cause mortalityTai-Chi Chih Classes089ClinicalTrials.gov
Total, all-cause mortalityHealth Education and Wellness Classes089ClinicalTrials.gov
Total, other adverse eventsTai-Chi Chih Classes489ClinicalTrials.gov
Total, other adverse eventsHealth Education and Wellness Classes389ClinicalTrials.gov
Total, serious adverse eventsTai-Chi Chih Classes089ClinicalTrials.gov
Total, serious adverse eventsHealth Education and Wellness Classes089ClinicalTrials.gov

Papers 6

The papers the trial lists on ClinicalTrials.gov.

PMIDListed asSource
21358389BACKGROUNDPubMed
21857219BACKGROUNDPubMed
23538081BACKGROUNDPubMed
23642461BACKGROUNDPubMed
25142571BACKGROUNDPubMed
34404606DERIVEDPubMed

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.

ProjectTitlePrincipal investigatorsOrganizationFunderFiscal yearsSource
R01AT008383Brain connectivity and response to Tai Chi in geriatric depressionLAVRETSKY, HELENUNIVERSITY OF CALIFORNIA LOS ANGELESNATIONAL CENTER FOR COMPLEMENTARY & INTEGRATIVE HEALTH2015 to 2019NIH RePORTER

Trial comparisons 3

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

ComparisonSource
Tai-Chi Chih Classes vs Health Education and Wellness Classes: Number of Participants With Adverse EventsTrial comparisons
Tai-Chi Chih Classes vs Health Education and Wellness Classes: deaths from any causeTrial comparisons
Tai-Chi Chih Classes vs Health Education and Wellness Classes: serious adverse eventsTrial 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.

TestNamed asSource
Category FluencySecondary outcomeConductCognition
Complex Figure Copy and RecallSecondary outcomeConductCognition
Picture Naming TestSecondary outcomeConductCognition
Stroop Color-Word TestSecondary outcomeConductCognition
Trail Making Test ASecondary outcomeConductCognition
Trail Making Test BSecondary outcomeConductCognition
Verbal FluencySecondary outcomeConductCognition

Source 5

FieldValueSource
Releasetrials-2026-11-12-0.4.0ClinicalTrials.gov
Release manifest SHA-2560f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4ClinicalTrials.gov
Registry capture2026-11-12ClinicalTrials.gov
Results copy, AACT2026-03-23ClinicalTrials.gov
NIH clinical studies file2026-11-13ClinicalTrials.gov

The same record as JSON

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)