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Behavioral Intervention for Insomnia in Older Adults

Not Applicable
Completed
Conditions
Sleep Initiation and Maintenance Disorders
Interventions
Behavioral: stimulus control therapy, sleep restriction therapy, multi-component treatment (stimulus control therapy, sleep restriction therapy)
Registration Number
NCT01154023
Lead Sponsor
Carl T. Hayden VA Medical Center
Brief Summary

The purpose of the study was to evaluate and compare the efficacy of single interventions (stimulus control instructions, sleep restriction therapy) and multi-component intervention (stimulus control instructions and sleep restriction therapy) for chronic insomnia in community dwelling older adults. The subjects were randomly assigned to one of four conditions: stimulus control instructions, sleep restriction therapy, multi-component treatment (stimulus control instructions and sleep restriction therapy), or measurement control.

Detailed Description

Not available

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
179
Inclusion Criteria
  • 55 years or older
  • Sleep onset or maintenance insomnia of 45 minutes or more per night for at least 3 nights per week as ascertained through 14 days of sleep diaries
  • Insomnia duration of at least 6 months
  • Impaired daytime functioning as a consequence of insomnia
Exclusion Criteria
  • Psychopathology evidenced by the Brief Symptom Inventory Global Severity Index T score >60
  • Cognitive impairment as ascertained by the Mini-Mental State Exam score < 27
  • Current psychotherapy or medical treatment for major depression or other psychopathology
  • Current and regular use of over-the-counter medication or prescription medication for sleep (verified through urinalysis), or any medication affecting sleep
  • Major physical or mental illness directly related to the onset and course of insomnia
  • Substance abuse problem ascertained per interview
  • Suspicion of sleep apnea as determined by an Epworth Sleepiness Scale score of 11 or greater, a respiratory disturbance index of > 15 as established through in-home overnight use of the EdenTec Model 3711 Digital Recorder, and interview with a significant other, if available
  • Restless leg syndrome, periodic limb movement disorder, or circadian rhythm sleep disorders as determined through the participant interview and an interview with a significant other, if available.

Study & Design

Study Type
INTERVENTIONAL
Study Design
FACTORIAL
Arm && Interventions
GroupInterventionDescription
stimulus control therapystimulus control therapy, sleep restriction therapy, multi-component treatment (stimulus control therapy, sleep restriction therapy)Focuses on strengthening the bed and bedroom as cues for sleepiness and sleep, weaken them as cues for arousal, and developing a consistent sleep-wake pattern
multi-component interventionstimulus control therapy, sleep restriction therapy, multi-component treatment (stimulus control therapy, sleep restriction therapy)Combines stimulus control and sleep restriction: strengthen the bed and bedroom as cues for sleepiness and sleep, weaken them as cues for arousal, develop a consistent sleep-wake pattern, consolidate sleep by restricting the amount of time spent in bed and limit sleep to a specific time period
sleep restriction therapystimulus control therapy, sleep restriction therapy, multi-component treatment (stimulus control therapy, sleep restriction therapy)Sleep restriction therapy consolidates sleep by restricting the amount of time spent in bed and limiting sleep to a specific time period .
Primary Outcome Measures
NameTimeMethod
subjective sleep1 year

daily sleep diaries were used for 2 weeks at each of the four measurement points, pre-treatment, post-treatment, 3 months and 1 year - called daily to voice mail service to avoid retrospective estimates of sleep

Secondary Outcome Measures
NameTimeMethod
insomnia severity1 year

Insomnia Severity Index was used at the four measurement points (pre-treatment, post-treatment, 3 months, and 1 year) and also included the significant other version of the instrument

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