Behavioral Intervention for Insomnia in Older Adults

This study has been completed.
Sponsor:
Information provided by:
Carl T. Hayden VA Medical Center
ClinicalTrials.gov Identifier:
NCT01154023
First received: June 28, 2010
Last updated: June 29, 2010
Last verified: June 2010

June 28, 2010
June 29, 2010
September 2000
August 2004   (final data collection date for primary outcome measure)
subjective sleep [ Time Frame: 1 year ] [ Designated as safety issue: No ]
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
Same as current
Complete list of historical versions of study NCT01154023 on ClinicalTrials.gov Archive Site
insomnia severity [ Time Frame: 1 year ] [ Designated as safety issue: No ]
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
Same as current
Not Provided
Not Provided
 
Behavioral Intervention for Insomnia in Older Adults
Behavioral Intervention for Insomnia in Older Adults

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.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Open Label
Primary Purpose: Treatment
Sleep Initiation and Maintenance Disorders
Behavioral: stimulus control therapy, sleep restriction therapy, multi-component treatment (stimulus control therapy, sleep restriction therapy)
Treatment was given weekly for 6 weeks. Sessions 1 - 4 were in a group format. Session 5 & 6 were delivered individually by phone.
  • Experimental: stimulus control 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
    Intervention: Behavioral: stimulus control therapy, sleep restriction therapy, multi-component treatment (stimulus control therapy, sleep restriction therapy)
  • Experimental: 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 .
    Intervention: Behavioral: stimulus control therapy, sleep restriction therapy, multi-component treatment (stimulus control therapy, sleep restriction therapy)
  • Experimental: multi-component intervention
    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
    Intervention: Behavioral: stimulus control therapy, sleep restriction therapy, multi-component treatment (stimulus control therapy, sleep restriction therapy)
Epstein DR, Sidani S, Bootzin RR, Belyea MJ. Dismantling multicomponent behavioral treatment for insomnia in older adults: a randomized controlled trial. Sleep. 2012 Jun 1;35(6):797-805. doi: 10.5665/sleep.1878.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
179
August 2004
August 2004   (final data collection date for primary outcome measure)

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.
Both
55 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT01154023
R29NR04951
No
Dana R. Epstein, Carl T. Hayden Veterans Affairs Medical Center
Carl T. Hayden VA Medical Center
Not Provided
Principal Investigator: Dana R Epstein, PhD, RN Carl T. Hayden VA
Carl T. Hayden VA Medical Center
June 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP