Behavioral Treatment of Insomnia in Aging

Completed · Not applicable

Conditions studied: Aging, Insomnia

In brief

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.

Key facts

Study ID

NCT00280020

Run by

University of California, Los Angeles

People needed

123

Starts

2006-04-01

Expected to finish

2011-08-01

Last updated by the study team

2012-07-11

Who can join

Age: 55 and older, up to 90. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Older than 55 years of age at time of entry
• 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

You may not qualify if…

• Evidence that insomnia is directly related to a medical disorder (e.g., hyperthyroidism) or effects of a medication that affects sleep structure and/or immune functioning
• 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

Where it is running

• Cousins Center for Psychoneuroimmunology, UCLA Neuropsychiatric Institute — Los Angeles, California, United States

Full record on ClinicalTrials.gov

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