Brain Connectivity and Response to Tai Chi in Geriatric Depression

NCT02460666 | Completed Results DMC

• 1 other identifier: R01AT008383-01A1
• Study Type: interventional
• Target: 220
• Locations: 1 country
• Sites: 1

Brief 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 brain structure.

Conditions

Major Depressive Disorder

Keywords

depressed; older adults; Major Depressive Disorder; Tai-Chi; geriatric

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (3)

• Change in Delayed Recall Cognitive Domain Scores

  Measured at baseline and 3 months

• Change in Attention/Executive Function Cognitive Domain Scores

  Measured at baseline and 3 months

• Change in Language Cognitive Domain Scores

  Measured at baseline and 3 months

Other Outcomes (1)

• Number of Participants With Adverse Events

  Measured at 3 months

Study Arms (2)

Tai-Chi Chih Classes

EXPERIMENTAL

Participants will engage in 12 weekly 60 minute Tai-Chi-Chih classes.

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.

Behavioral: Health Education and Wellness Classes (HEW)

Interventions

Tai-Chi-Chih (TCC) BEHAVIORAL

Also known as: Tai Chi

Tai-Chi Chih Classes

Health Education and Wellness Classes (HEW) BEHAVIORAL

Health Education and Wellness Classes

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of California, Los Angeles: lead

Study Sites (1)

UCLA Semel Institute

Los Angeles, California, 90095, United States

Location

Related Publications (6)

• 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.

  PMID: 25142571 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.

  PMID: 23642461 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.

  PMID: 21358389 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.

  PMID: 21857219 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.

  PMID: 23538081 BACKGROUND

• 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.

  PMID: 34404606 DERIVED

MeSH Terms

Conditions

Depressive Disorder, Major; Consciousness Disorders

Interventions

Tai Ji

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neurocognitive Disorders

Intervention Hierarchy (Ancestors)

Mind-Body Therapies; Complementary Therapies; Therapeutics; Exercise Movement Techniques; Physical Therapy Modalities

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.

Results Point of Contact

• Title: Helen Lavretsky, MD
• Organization: University of California, Los Angeles

HLavretsky@mednet.ucla.edu

(310) 794-4619

Study Officials

• Helen Lavretsky, M.D.

  University of California, Los Angeles

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: March 16, 2015
• First Posted: June 2, 2015
• Study Start: January 1, 2016
• Primary Completion: November 18, 2020
• Study Completion: December 1, 2020
• Last Updated: July 16, 2021
• Results First Posted: July 9, 2021

Record last verified: 2021-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)