Behavioral Treatment of Insomnia in Aging
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00280020|
Recruitment Status : Completed
First Posted : January 20, 2006
Last Update Posted : July 11, 2012
|Condition or disease||Intervention/treatment||Phase|
|Aging Insomnia||Behavioral: Tai Chi Chih (TCC) Behavioral: Cognitive Behavior Therapy (CBT) Behavioral: Sleep Seminar (SS)||Not Applicable|
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 (Clinical Trial)|
|Actual Enrollment :||123 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Aging: Cytokine Mechanisms and Treatment of Insomnia|
|Study Start Date :||April 2006|
|Actual Primary Completion Date :||August 2011|
|Actual Study Completion Date :||August 2011|
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: 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.
- 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 ]
- 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 ]
- Change in daytime impairment secondary to insomnia [ Time Frame: 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 ]
- Changes in sympathovagal function and energy balance [ Time Frame: 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 ]
- Allostatic load [ Time Frame: baseline, post-treatment, and one year follow-up ]CBC, glucose, HbA1c, lipids, fibrinogen, measures of inflammation
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00280020
|United States, California|
|Cousins Center for Psychoneuroimmunology, UCLA Neuropsychiatric Institute|
|Los Angeles, California, United States, 90095|
|Principal Investigator:||Michael R. Irwin, MD||Cousins Center for Psychoneuroimmunology, UCLA Neuropsychiatric Institute|