Major Depressive DisorderNCT02460666

Brain Connectivity and Response to Tai Chi in Geriatric Depression

A study testing Tai-Chi-Chih (TCC) and Health Education and Wellness Classes (HEW) in people with Major Depressive Disorder, run by University of California, Los Angeles at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

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… Read more about this study

Who is it for?: Ages 60 years and older
Conditions the study is for: Major Depressive Disorder
What is being tested?: Tai-Chi-Chih (TCC) and Health Education and Wellness Classes (HEW)
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 220 participants
Where: 1 siteUnited States
Study dates: Jan 2016to 1 Dec 2020
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 60 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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.

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

United States1 site

UCLA Semel Institute
Los Angeles, California, 90095

Other trials in United States

About this study

Read the detailed description

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.

Conditions: Major Depressive Disorder
Being tested: Tai-Chi-Chih (TCC), Health Education and Wellness Classes (HEW)
Keywords: depressed, older adults, Major Depressive Disorder, Tai-Chi, geriatric
Medical subject headings: Depressive Disorder, Major, Consciousness Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Tai-Chi-Chih (TCC)Behavioural
Also called Tai Chi
Health Education and Wellness Classes (HEW)Behavioural

Study groups in NCT02460666
Study group	Role	What they receive
Tai-Chi Chih Classes	Experimental	Participants will engage in 12 weekly 60 minute Tai-Chi-Chih classes. Receives: Behavioral: Tai-Chi-Chih (TCC)
Health Education and Wellness Classes	Active comparator	Participants will engage in 12 weekly 60 minute Health Education and Wellness classes. Receives: Behavioral: Health Education and Wellness Classes (HEW)

What is being measured

The primary outcome is the main question the study is designed to answer.

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: Measured at baseline and 3 months

Secondary outcomes (3)

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.
Measured: 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: 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: Measured at baseline and 3 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jan 20161 Dec 2020

First posted2 Jun 2015 (estimated)
Study startJan 2016
Primary completion18 Nov 2020
Study completion1 Dec 2020

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (6)Papers the sponsor has linked to this study.
Other trials for Major Depressive DisorderStudies of the same condition, open and under way.
More trials run by University of California, Los AngelesThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Supportive care
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Investigator, Outcomes assessor
Enrolment: 220 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02460666
Sponsor's protocol ID: R01AT008383-01A1
Status last verified: Jul 2021
First submitted: 16 Mar 2015
Last updated: 16 Jul 2021
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
Individual data sharing: No

Publications

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.
PubMed 25142571
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.
PubMed 23642461
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.
PubMed 21358389
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.
PubMed 21857219
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.
PubMed 23538081
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.
PubMed 34404606

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 16 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Brain Connectivity and Response to Tai Chi in Geriatric Depression
ClinicalTrials.gov ID: NCT02460666
Acronym / sponsor ID: R01AT008383-01A1
Conditions: Major Depressive Disorder
Keywords: depressed, older adults, Major Depressive Disorder, Tai-Chi, geriatric
Study type: Interventional
Recruitment status: Completed
Enrolment: 220 participants (actual)
Lead sponsor: University of California, Los AngelesUniversity, hospital or other
Study start: Jan 2016
Primary completion: 18 Nov 2020 (actual)
Study completion: 1 Dec 2020 (actual)
First posted: 2 Jun 2015 (estimated)
Results: Posted 9 Jul 2021

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Supportive care
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Tai-Chi Chih Classes	Experimental	Behavioral: Tai-Chi-Chih (TCC)Participants will engage in 12 weekly 60 minute Tai-Chi-Chih classes.
Health Education and Wellness Classes	Active comparator	Behavioral: Health Education and Wellness Classes (HEW)Participants will engage in 12 weekly 60 minute Health Education and Wellness classes.

Who may qualify

Ages: 60 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

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.

Key exclusion criteria (8 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Tai-Chi-Chih (TCC)Also: Tai Chi	Behavioural	Tai-Chi Chih Classes
Health Education and Wellness Classes (HEW)	Behavioural	Health Education and Wellness Classes

Primary outcome

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.

3 secondary outcomes

Change in Delayed Recall Cognitive Domain Scores
Time frame: Measured at baseline and 3 months
Change in Attention/Executive Function Cognitive Domain Scores
Time frame: Measured at baseline and 3 months
Change in Language Cognitive Domain Scores
Time frame: Measured at baseline and 3 months

Results and safety

Results posted to the registry on 9 Jul 2021, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Tai-Chi Chih Classes	89	62
Health Education and Wellness Classes	89	63

Primary outcome: Change in Hamilton Depression Rating Scale (HDRS) Scores

Time frame: Measured at baseline and 3 months. Mean (Standard Deviation). Unit: units on a scale

Measure	Tai-Chi Chih Classes n = 62	Health Education and Wellness Classes n = 63
Value	-9.27 (5.29)	-9.40 (5.35)

Tai-Chi Chih Classes vs Health Education and Wellness Classes: p = 0.3, Mixed Models Analysis

3 secondary outcomes are reported in the full results.

Adverse events

Time frame: 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.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Tai-Chi Chih Classes	0 of 89 (0%)	4 of 89 (4.5%)	0 of 89
Health Education and Wellness Classes	0 of 89 (0%)	3 of 89 (3.4%)	0 of 89

Limitations and caveats (from the sponsor): After March 18th, 2020, all assessments were completed remotely due to COVID-19 until restrictions were lifted for eligible participants to come in-person.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 16 Jul 2021.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 25142571Irwin 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.
Background: PubMed 23642461Siddarth 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.
Background: PubMed 21358389Lavretsky 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.
Background: PubMed 21857219Schneider 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.
Background: PubMed 23538081Abbott 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.
Derived from this study: PubMed 34404606Lavretsky 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.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Helen Lavretsky, M.D. principal investigator

University of California, Los Angeles

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Tai-Chi-Chih (TCC) and Health Education and Wellness Classes (HEW) in people with Major Depressive Disorder, run by University of California, Los Angeles at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 16 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 9 Jul 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Hamilton Depression Rating Scale (HDRS) Scores (time frame: Measured at baseline and 3 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02460666, which also lists 6 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jul 2021; AzTrials last refreshed its copy on 6 Nov 2026.