Behavioral Treatment of Insomnia in Aging

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Michael Irwin, M.D., University of California, Los Angeles
ClinicalTrials.gov Identifier:
NCT00280020
First received: January 18, 2006
Last updated: July 9, 2012
Last verified: July 2012

January 18, 2006
July 9, 2012
April 2006
August 2011   (final data collection date for primary outcome measure)
Changes in insomnia symptoms as measured by subjective report and objective polysomnography [ Time Frame: Subjective report: Baseline, 8, 12, 16 weeks, 3 months 1 year; PSG: Baseline, 16 weeks ] [ Designated as safety issue: No ]
Changes in insomnia symptoms.
Complete list of historical versions of study NCT00280020 on ClinicalTrials.gov Archive Site
  • Changes in measures of proinflammatory cytokine activity. [ Time Frame: Baseline, 8, 12, 16 weeks, 3 months 1 year (single samples); repeated blood sampling during PSG nights for circadian cytokine activity: Baseline, 16 weeks ] [ Designated as safety issue: No ]
  • Change in daytime impairment secondary to insomnia [ Time Frame: Baseline, 8, 12, 16 weeks, 3 months 1 year ] [ Designated as safety issue: No ]
  • Changes in fatigue, depression and mood, and health function [ Time Frame: Baseline, 8, 12, 16 weeks, 3 months 1 year ] [ Designated as safety issue: No ]
  • Changes in sympathovagal function and energy balance [ Time Frame: Baseline, 8, 12, 16 weeks, 3 months 1 year ] [ Designated as safety issue: No ]
  • Changes in measures of interpersonal resilience and social [ Time Frame: Baseline, 8, 12, 16 weeks, 3 months 1 year ] [ Designated as safety issue: No ]
  • Allostatic load [ Time Frame: baseline, post-treatment, and one year follow-up ] [ Designated as safety issue: No ]
    CBC, glucose, HbA1c, lipids, fibrinogen, measures of inflammation
Changes in measures of proinflammatory cytokine activity.
Not Provided
Not Provided
 
Behavioral Treatment of Insomnia in Aging
Aging: Cytokine Mechanisms and Treatment of Insomnia

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Aging
  • Insomnia
  • Behavioral: Tai Chi Chih (TCC)
    Participants will learn and practice 20 movements in 1 hour sessions twice per week for 16 weeks
  • Behavioral: 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.
  • Behavioral: 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.
  • Experimental: CBT
    Intervention: Behavioral: Cognitive Behavior Therapy (CBT)
  • Experimental: TCC
    Intervention: Behavioral: Tai Chi Chih (TCC)
  • Active Comparator: SS
    Intervention: Behavioral: Sleep Seminar (SS)

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
123
August 2011
August 2011   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • 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 Criteria:

  • 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
Both
55 Years to 90 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00280020
AG0061, R01AG026364
Yes
Michael Irwin, M.D., University of California, Los Angeles
University of California, Los Angeles
National Institute on Aging (NIA)
Principal Investigator: Michael R. Irwin, MD Cousins Center for Psychoneuroimmunology, UCLA Neuropsychiatric Institute
University of California, Los Angeles
July 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP