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Insomnia: Behavioral Treatments
This study is currently recruiting participants.
Verified by National Institute on Aging (NIA), October 2008
First Received: January 18, 2006   Last Updated: October 2, 2008   History of Changes
Sponsored by: National Institute on Aging (NIA)
Information provided by: National Institute on Aging (NIA)
ClinicalTrials.gov Identifier: NCT00280020
  Purpose

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.


Condition Intervention Phase
Aging
Insomnia
 Behavioral: Tai Chi Chih (TCC)
Behavioral: Cognitive Behavior Therapy (CBT)
Behavioral: Sleep Seminar (SS)
 Phase II

MedlinePlus related topics: Sleep Disorders
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study
Official Title: Aging: Cytokine Mechanisms and Treatment of Insomnia

Further study details as provided by National Institute on Aging (NIA):

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 150
Study Start Date: February 2006
Estimated Study Completion Date: March 2011
Estimated Primary Completion Date: March 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
CBT: Experimental 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.
TCC: Experimental Behavioral: Tai Chi Chih (TCC)
Participants will learn and practice 20 movements in 1 hour sessions twice per week for 16 weeks
SS: Active Comparator 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.

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.

  Eligibility

Ages Eligible for Study:   55 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00280020

Contacts
Contact: Michael R. Irwin, MD 310-825-8281 mirwin1@ucla.edu

Locations
United States, California
Cousins Center for Psychoneuroimmunology, UCLA Neuropsychiatric Institute Recruiting
Los Angeles, California, United States, 90095
Contact: Michael Irwin, MD     310-825-8281     mirwin1@ucla.edu    
Contact: Sarosh Motivala, PhD     310-260-7492     smotivala@mednet.ucla.edu    
Principal Investigator: Michael R. Irwin, MD            
Sponsors and Collaborators
National Institute on Aging (NIA)
Investigators
Principal Investigator: Michael R. Irwin, MD Cousins Center for Psychoneuroimmunology, UCLA Neuropsychiatric Institute
  More Information

Publications:
Irwin M, Pike J, Oxman M. Shingles Immunity and Health Functioning in the Elderly: Tai Chi Chih as a Behavioral Treatment. Evid Based Complement Alternat Med. 2004 Dec;1(3):223-232. Epub 2004 Dec 1.
Irwin MR, Pike JL, Cole JC, Oxman MN. Effects of a behavioral intervention, Tai Chi Chih, on varicella-zoster virus specific immunity and health functioning in older adults. Psychosom Med. 2003 Sep-Oct;65(5):824-30.
Motivala SJ, Sarfatti A, Olmos L, Irwin MR. Inflammatory markers and sleep disturbance in major depression. Psychosom Med. 2005 Mar-Apr;67(2):187-94.

Responsible Party: Department of Psychiatry and Biobehavioral Science, UCLA Cousins Center ( Michael Irwin, MD, Professor in Residence )
Study ID Numbers: AG0061, R01AG026364
Study First Received: January 18, 2006
Last Updated: October 2, 2008
ClinicalTrials.gov Identifier: NCT00280020     History of Changes
Health Authority: United States: Federal Government

Keywords provided by National Institute on Aging (NIA):
sleep disorders
meditation
cognitive behavior therapy

Study placed in the following topic categories:
Sleep Initiation and Maintenance Disorders
Mental Disorders
Dyssomnias
Sleep Disorders
Sleep Disorders, Intrinsic

Additional relevant MeSH terms:
Sleep Initiation and Maintenance Disorders
Mental Disorders
Nervous System Diseases
 Sleep Disorders
Dyssomnias
Sleep Disorders, Intrinsic

ClinicalTrials.gov processed this record on May 07, 2009



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