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Completed

NCT Number: NCT00280020

Behavioral Treatment of Insomnia in Aging

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.

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Key information

Age range

55 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Cousins Center for Psychoneuroimmunology, UCLA Neuropsychiatric Institute

Los Angeles, California, 90095, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Tai Chi Chih (TCC)

Behavioral

Participants will learn and practice 20 movements in 1 hour sessions twice per week for 16 weeks

Cognitive behavior therapy (CBT)

Behavioral

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)

Behavioral

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.

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

  2. Change in daytime impairment secondary to insomnia

    Time frame: Baseline, 8, 12, 16 weeks, 3 months 1 year

  3. Changes in fatigue, depression and mood, and health function

    Time frame: Baseline, 8, 12, 16 weeks, 3 months 1 year

  4. Changes in sympathovagal function and energy balance

    Time frame: Baseline, 8, 12, 16 weeks, 3 months 1 year

  5. Changes in measures of interpersonal resilience and social

    Time frame: Baseline, 8, 12, 16 weeks, 3 months 1 year

  6. Allostatic load

    Time frame: baseline, post-treatment, and one year follow-up

    CBC, glucose, HbA1c, lipids, fibrinogen, measures of inflammation

Sponsors and collaborators

Lead sponsor

University of California, Los Angeles

Other

Collaborators

  • National Institute on Aging (NIA)

Registry information

Official study title

Aging: Cytokine Mechanisms and Treatment of Insomnia

Important dates

Study start
2006
Primary completion
2011
Study completion
2011
First posted
Jan 20, 2006
Registry last updated
Jul 11, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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