Clinical trial NCT02460666: Brain Connectivity and Response to Tai Chi in Geriatric Depression
Official title: Brain Connectivity and Response to Tai Chi in Geriatric Depression
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Major Depressive Disorder
Keywords: depressed
older adults
Major Depressive Disorder
Tai-Chi
geriatric
Lead sponsor: University of California, Los Angeles
Sponsor class: OTHER
First posted: 2015-06-02
Enrollment: 220
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in Hamilton Depression Rating Scale (HDRS) Scores
timeFrame: Measured at baseline and 3 months
Secondary outcomes:
measure: Change in Delayed Recall Cognitive Domain Scores
timeFrame: Measured at baseline and 3 months
measure: Change in Attention/Executive Function Cognitive Domain Scores
timeFrame: Measured at baseline and 3 months
measure: Change in Language Cognitive Domain Scores
timeFrame: Measured at baseline and 3 months
Other outcomes:
measure: Number of Participants With Adverse Events
timeFrame: Measured at 3 months
Locations:
city: Los Angeles
country: United States
facility: UCLA Semel Institute
state: California
Study officials:
affiliation: University of California, Los Angeles
name: Helen Lavretsky, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.