Tai Chi Effects on Chronic Insomnia in Breast Cancer Survivors: Immune Mechanism
This investigation is a randomized controlled trial that will evaluate the effects of
cognitive-behavioral therapy (CBT) and Tai Chi Chih (TCC) on objective and subjective
measures of sleep, on mood and fatigue, on health functioning and on two biological
parameters, sympathovagal tone and proinflammatory cytokine activity in older adults with
insomnia. One hundred breast cancer survivors will be randomly assigned to CBT, or TCC.
Patients will be assessed at pre-treatment, during midtreatment, post-treatment, 3-month
follow-up and 12-month follow-up. At all 5 assessment periods, indices of sleep quality as
measured by sleep diaries and clinical ratings will be obtained along with measures of mood,
health functioning, proinflammatory cytokine activity and heart rate variability (HRV). The
pre-treatment and post-treatment assessment periods will also include all-night
polysomnography along with nocturnal sampling of proinflammatory cytokine activity and HRV
tone. Hence, polysomnographic measures of sleep which are coupled with nocturnal measures
of cytokines by serial blood sampling will occur at the baseline assessment and again at the
post-treatment assessment. During midtreatment and at 3 month follow-up and 12 month
follow-up, we will obtain questionnaire ratings of sleep quality along with a single morning
sample of cytokine levels.
Interventional
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment
Changes in insomnia symptoms as measured by subjective report and objective polysomnography; Changes in daytime impairment secondary to insomnia; Changes in fatigue, depression and mood, and health function
5 years
No
Michael Irwin, MD
Principal Investigator
University of California, Los Angeles
United States: Institutional Review Board
R01 CA119 159
NCT00690196
March 2008
July 2012
Name | Location |
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UCLA Cousins Center for Psychoneuroimmunology | Los Angeles, California 91744 |