Behavioral Treatment of Insomnia in Aging
Condition: Aging; Insomnia
MeSH terms: Sleep Initiation and Maintenance Disorders
Study type: Interventional

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.
    

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.
    

Intervention name(s): Tai Chi Chih (TCC); Cognitive Behavior Therapy (CBT); Sleep Seminar (SS)
Intervention type(s): Behavioral; Behavioral; Behavioral
Intervention description(s): Participants will learn and practice 20 movements in 1 hour sessions twice per week for 16 weeks; 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.; 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.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: sleep disorders; meditation; cognitive behavior therapy