Status:
COMPLETED
Behavioral Intervention for Insomnia in Older Adults
Lead Sponsor:
Carl T. Hayden VA Medical Center
Conditions:
Sleep Initiation and Maintenance Disorders
Eligibility:
All Genders
55+ years
Phase:
NA
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 ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
September 1 2000
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2004
Estimated Enrollment :
179 Patients enrolled
Trial Details
Trial ID
NCT01154023
Start Date
September 1 2000
End Date
August 1 2004
Last Update
June 30 2010
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