Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
123 participants
INTERVENTIONAL
2006-04-30
2011-08-31
Brief Summary
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Detailed Description
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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.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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CBT
Cognitive Behavior Therapy (CBT)
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.
TCC
Tai Chi Chih (TCC)
Participants will learn and practice 20 movements in 1 hour sessions twice per week for 16 weeks
SS
Sleep Seminar (SS)
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.
Interventions
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Tai Chi Chih (TCC)
Participants will learn and practice 20 movements in 1 hour sessions twice per week for 16 weeks
Cognitive Behavior Therapy (CBT)
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)
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.
Eligibility Criteria
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Inclusion Criteria
* Sleep-onset delay, maintenance insomnia, or terminal insomnia
* Difficulties with sleep for a minimum of 3 nights per week
* Insomnia duration of at least 6 months
* Complaint of at least 1 negative effect during waking hours (e.g., fatigue, impaired functioning, mood disturbances) attributed to insomnia
* Habitual sleep-wake schedule reporting "lights-out" between 9:00 PM and midnight
* Accessible geographically
Exclusion Criteria
* Presence of sleep apnea or periodic limb movements during sleep
* Presence of another sleep disorder (e.g., Advanced or Delay Sleep Phase Syndrome)
* Regular use of a hypnotic or psychotropic medication (sleeping pills) and/or current psychotherapy or other behavioral therapy that would confound CBT or TCC
* Current history of a major psychiatric disorder (e.g. current major depression, alcohol or substance dependence, anxiety disorder)
* Cognitive impairment as suggested by a score lower than 23 on the Mini-Mental State examination
* Abnormal screening laboratory tests (e.g., abnormal thyroid hormone, elevated TSH, positive screening for HIV or hepatitis C)
* Smokers will also be excluded because of potential confounding effects on markers of inflammation
* Body mass index that is greater than 30 kg/m2 as obesity is associated with excessive levels of inflammatory markers
* Women must be post-menopausal
* Unable to commit to intervention schedule
55 Years
90 Years
ALL
No
Sponsors
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National Institute on Aging (NIA)
NIH
University of California, Los Angeles
OTHER
Responsible Party
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Michael Irwin, M.D.
Professor in Residence
Principal Investigators
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Michael R. Irwin, MD
Role: PRINCIPAL_INVESTIGATOR
Cousins Center for Psychoneuroimmunology, UCLA Neuropsychiatric Institute
Locations
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Cousins Center for Psychoneuroimmunology, UCLA Neuropsychiatric Institute
Los Angeles, California, United States
Countries
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References
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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.
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.
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.
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.
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.
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.
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.
Other Identifiers
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AG0061
Identifier Type: -
Identifier Source: org_study_id