Behavioral Treatment of Insomnia in Aging

Aging Clinical Trial

Official title:

Aging: Cytokine Mechanisms and Treatment of Insomnia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00280020
• Other study ID #: AG0061
• Secondary ID: R01AG026364
• Status: Completed
• Phase: N/A
• First received: January 18, 2006
• Last updated: July 9, 2012
• Start date: April 2006
• Est. completion date: August 2011

Study information

• Verified date: July 2012
• Source: University of California, Los Angeles
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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 whether the behavioral treatment of insomnia alters proinflammatory cytokine activity.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 123
• Est. completion date: August 2011
• Est. primary completion date: August 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 55 Years to 90 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Aging
• Insomnia

Intervention

Behavioral:
• Tai Chi Chih (TCC)
Participants will learn and practice 20 movements in 1 hour sessions twice per week for 16 weeks
• 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.
• 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.

Locations

Country	Name	City	State
United States	Cousins Center for Psychoneuroimmunology, UCLA Neuropsychiatric Institute	Los Angeles	California

Sponsors (2)

Lead Sponsor	Collaborator
University of California, Los Angeles	National Institute on Aging (NIA)

Country where clinical trial is conducted

United States, 

References & Publications (3)

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in insomnia symptoms as measured by subjective report and objective polysomnography		Subjective report: Baseline, 8, 12, 16 weeks, 3 months 1 year; PSG: Baseline, 16 weeks	No
Secondary	Changes in measures of proinflammatory cytokine activity.		Baseline, 8, 12, 16 weeks, 3 months 1 year (single samples); repeated blood sampling during PSG nights for circadian cytokine activity: Baseline, 16 weeks	No
Secondary	Change in daytime impairment secondary to insomnia		Baseline, 8, 12, 16 weeks, 3 months 1 year	No
Secondary	Changes in fatigue, depression and mood, and health function		Baseline, 8, 12, 16 weeks, 3 months 1 year	No
Secondary	Changes in sympathovagal function and energy balance		Baseline, 8, 12, 16 weeks, 3 months 1 year	No
Secondary	Changes in measures of interpersonal resilience and social		Baseline, 8, 12, 16 weeks, 3 months 1 year	No
Secondary	Allostatic load	CBC, glucose, HbA1c, lipids, fibrinogen, measures of inflammation	baseline, post-treatment, and one year follow-up	No