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| ID | Type | Description | Link |
|---|---|---|---|
| R01AG026364 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute on Aging (NIA) | NIH |
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The purpose of this study is to evaluate whether Tai Chi Chih vs. cognitive behavioral therapy vs. sleep education reduces insomnia in older adults. The secondary goal of the study is to determine whether the behavioral treatment of insomnia alters proinflammatory cytokine activity.
Insomnia is a prominent complaint in late-life. However, little scientific effort has been directed toward identifying the biological mechanisms that are related to abnormal sleep or to evaluating the efficacy of behavioral treatments for insomnia in older adults. Basic observations demonstrate that proinflammatory cytokines play a key role in the regulation of sleep. Previous research shows that cytokines are reciprocally linked with abnormal sleep. This trial builds upon these findings and extends a program of study that has examined the efficacy of behavioral interventions on health outcomes in the elderly.
Preliminary studies found that Tai Chi Chih (TCC), a slow moving meditation, contributes to improvements in subjective sleep quality, sleep amounts and sleep efficiency, alterations in sympathetic activity, decreases in proinflammatory cytokines, and improvements in health functioning in community-dwelling older adults. Additionally, cognitive behavior therapy (CBT) confers benefits on sleep outcomes.
In this randomized, controlled trial, 150 older adults will be randomly assigned to CBT, TCC, or sleep hygiene/education control (EC) over 16 weeks and followed for one year. The aims of this project are to: 1) evaluate the effects of CBT vs TCC vs. EC on objective and subjective measures of sleep and on fatigue, mood, and health functioning in older adults with insomnia; 2) determine the effects of CBT vs.TCC vs. EC on measures of proinflammatory cytokine activity and sympathovagal balance, and whether these two biological mechanisms are related to changes of disordered sleep over the course of the treatment trial; and 3) evaluate whether circulating levels of proinflammatory cytokines are associated with measures of sleep continuity in older adults with insomnia over the treatment trial. This study will advance psychobiological models of disordered sleep and the potential benefits of two readily exportable behavioral interventions for promoting improvements in sleep outcomes in the elderly.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CBT | Experimental |
| |
| TCC | Experimental |
| |
| SS | Active Comparator |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tai Chi Chih (TCC) | Behavioral | Participants will learn and practice 20 movements in 1 hour sessions twice per week for 16 weeks |
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| Measure | Description | Time Frame |
|---|---|---|
| Changes in insomnia symptoms as measured by subjective report and objective polysomnography | Subjective report: Baseline, 8, 12, 16 weeks, 3 months 1 year; PSG: Baseline, 16 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in measures of proinflammatory cytokine activity. | Baseline, 8, 12, 16 weeks, 3 months 1 year (single samples); repeated blood sampling during PSG nights for circadian cytokine activity: Baseline, 16 weeks | |
| Change in daytime impairment secondary to insomnia |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Michael R. Irwin, MD | Cousins Center for Psychoneuroimmunology, UCLA Neuropsychiatric Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cousins Center for Psychoneuroimmunology, UCLA Neuropsychiatric Institute | Los Angeles | California | 90095 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 15841255 | Background | Irwin M, Pike J, Oxman M. Shingles Immunity and Health Functioning in the Elderly: Tai Chi Chih as a Behavioral Treatment. Evid Based Complement Alternat Med. 2004 Dec;1(3):223-232. doi: 10.1093/ecam/neh048. Epub 2004 Dec 1. | |
| 14508027 | Background | Irwin MR, Pike JL, Cole JC, Oxman MN. Effects of a behavioral intervention, Tai Chi Chih, on varicella-zoster virus specific immunity and health functioning in older adults. Psychosom Med. 2003 Sep-Oct;65(5):824-30. doi: 10.1097/01.psy.0000088591.86103.8f. |
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| ID | Term |
|---|---|
| D007319 | Sleep Initiation and Maintenance Disorders |
| D012893 | Sleep Wake Disorders |
| ID | Term |
|---|---|
| D020919 | Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D009422 | Nervous System Diseases |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D015928 | Cognitive Behavioral Therapy |
| ID | Term |
|---|---|
| D001521 | Behavior Therapy |
| D011613 | Psychotherapy |
| D004191 | Behavioral Disciplines and Activities |
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| Cognitive Behavior Therapy (CBT) | Behavioral | For each 2-hour session held once a week for 16 weeks, the CBT treatment manual will outline objectives, patient skills, and treatment activities. Therapists will direct role-playing and other skill-development exercises that will be designed to increase patients' self-efficacy in managing their insomnia. Homework assignments will be planned weekly to ensure practice and skill application. |
|
| Sleep Seminar (SS) | Behavioral | Each 2-hour session, held once a week for 16 weeks, consists of a 60-minute video presentation followed by a 60-minute question-and-answer discussion. |
|
| Baseline, 8, 12, 16 weeks, 3 months 1 year |
| Changes in fatigue, depression and mood, and health function | Baseline, 8, 12, 16 weeks, 3 months 1 year |
| Changes in sympathovagal function and energy balance | Baseline, 8, 12, 16 weeks, 3 months 1 year |
| Changes in measures of interpersonal resilience and social | Baseline, 8, 12, 16 weeks, 3 months 1 year |
| Allostatic load | CBC, glucose, HbA1c, lipids, fibrinogen, measures of inflammation | baseline, post-treatment, and one year follow-up |
| 15784782 | Background | Motivala SJ, Sarfatti A, Olmos L, Irwin MR. Inflammatory markers and sleep disturbance in major depression. Psychosom Med. 2005 Mar-Apr;67(2):187-94. doi: 10.1097/01.psy.0000149259.72488.09. |
| 31552779 | Derived | Lee SM, Te S, Breen EC, Olmstead R, Irwin MR, Cho JH. Circulating versus lipopolysaccharide-induced inflammatory markers as correlates of subthreshold depressive symptoms in older adults. World J Biol Psychiatry. 2020 Oct;21(8):634-641. doi: 10.1080/15622975.2019.1671608. Epub 2019 Oct 9. |
| 25770704 | Derived | Carroll JE, Seeman TE, Olmstead R, Melendez G, Sadakane R, Bootzin R, Nicassio P, Irwin MR. Improved sleep quality in older adults with insomnia reduces biomarkers of disease risk: pilot results from a randomized controlled comparative efficacy trial. Psychoneuroendocrinology. 2015 May;55:184-92. doi: 10.1016/j.psyneuen.2015.02.010. Epub 2015 Feb 25. |
| 25748580 | Derived | Irwin MR, Olmstead R, Breen EC, Witarama T, Carrillo C, Sadeghi N, Arevalo JM, Ma J, Nicassio P, Bootzin R, Cole S. Cognitive behavioral therapy and tai chi reverse cellular and genomic markers of inflammation in late-life insomnia: a randomized controlled trial. Biol Psychiatry. 2015 Nov 15;78(10):721-9. doi: 10.1016/j.biopsych.2015.01.010. Epub 2015 Feb 4. |
| 25142571 | Derived | 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. |
| D009461 |
| Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |