Status:
COMPLETED
Behavioral Treatment of Insomnia in Aging
Lead Sponsor:
University of California, Los Angeles
Collaborating Sponsors:
National Institute on Aging (NIA)
Conditions:
Aging
Insomnia
Eligibility:
All Genders
55-90 years
Phase:
NA
Brief Summary
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 whe...
Detailed Description
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...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
April 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2011
Estimated Enrollment :
123 Patients enrolled
Trial Details
Trial ID
NCT00280020
Start Date
April 1 2006
End Date
August 1 2011
Last Update
July 11 2012
Active Locations (1)
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1
Cousins Center for Psychoneuroimmunology, UCLA Neuropsychiatric Institute
Los Angeles, California, United States, 90095