Behavioral Treatment of Insomnia in Aging

July 9, 2012 updated by: Michael Irwin, M.D., University of California, Los Angeles

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 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.

Study Type

Interventional

Enrollment (Actual)

123

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Los Angeles, California, United States, 90095
        • Cousins Center for Psychoneuroimmunology, UCLA Neuropsychiatric Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

55 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: CBT
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.
Experimental: TCC
Behavioral: Tai Chi Chih (TCC)
Participants will learn and practice 20 movements in 1 hour sessions twice per week for 16 weeks
Active Comparator: SS
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
Subjective report: Baseline, 8, 12, 16 weeks, 3 months 1 year; PSG: Baseline, 16 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Baseline, 8, 12, 16 weeks, 3 months 1 year (single samples); repeated blood sampling during PSG nights for circadian cytokine activity: Baseline, 16 weeks
Change in daytime impairment secondary to insomnia
Time Frame: Baseline, 8, 12, 16 weeks, 3 months 1 year
Baseline, 8, 12, 16 weeks, 3 months 1 year
Changes in fatigue, depression and mood, and health function
Time Frame: Baseline, 8, 12, 16 weeks, 3 months 1 year
Baseline, 8, 12, 16 weeks, 3 months 1 year
Changes in sympathovagal function and energy balance
Time Frame: Baseline, 8, 12, 16 weeks, 3 months 1 year
Baseline, 8, 12, 16 weeks, 3 months 1 year
Changes in measures of interpersonal resilience and social
Time Frame: Baseline, 8, 12, 16 weeks, 3 months 1 year
Baseline, 8, 12, 16 weeks, 3 months 1 year
Allostatic load
Time Frame: baseline, post-treatment, and one year follow-up
CBC, glucose, HbA1c, lipids, fibrinogen, measures of inflammation
baseline, post-treatment, and one year follow-up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of California, Los Angeles

Collaborators

National Institute on Aging (NIA)

Investigators

  • Principal Investigator: Michael R. Irwin, MD, Cousins Center for Psychoneuroimmunology, UCLA Neuropsychiatric Institute

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2006

Primary Completion (Actual)

August 1, 2011

Study Completion (Actual)

August 1, 2011

Study Registration Dates

First Submitted

January 18, 2006

First Submitted That Met QC Criteria

January 18, 2006

First Posted (Estimate)

January 20, 2006

Study Record Updates

Last Update Posted (Estimate)

July 11, 2012

Last Update Submitted That Met QC Criteria

July 9, 2012

Last Verified

July 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AG0061
  • R01AG026364 (U.S. NIH Grant/Contract)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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