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Behavioral Intervention for Insomnia in Older Adults

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ClinicalTrials.gov Identifier: NCT01154023
Recruitment Status : Completed
First Posted : June 30, 2010
Last Update Posted : June 30, 2010
Sponsor:
Information provided by:
Carl T. Hayden VA Medical Center

Study Description
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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.

Condition or disease Intervention/treatment Phase
Sleep Initiation and Maintenance Disorders Behavioral: stimulus control therapy, sleep restriction therapy, multi-component treatment (stimulus control therapy, sleep restriction therapy) Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 179 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Behavioral Intervention for Insomnia in Older Adults
Study Start Date : September 2000
Actual Primary Completion Date : August 2004
Actual Study Completion Date : August 2004
Arms and Interventions
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Arm Intervention/treatment
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
 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: 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 .
 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: 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
 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.


Outcome Measures
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Primary Outcome Measures :
  1. subjective sleep [ Time Frame: 1 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 :
  1. insomnia severity [ Time Frame: 1 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


Eligibility Criteria
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Ages Eligible for Study:   55 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

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): NCT01154023


Sponsors and Collaborators
Carl T. Hayden VA Medical Center
Investigators
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Principal Investigator: Dana R Epstein, PhD, RN Carl T. Hayden VA
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Dana R. Epstein, Carl T. Hayden Veterans Affairs Medical Center
ClinicalTrials.gov Identifier: NCT01154023    
Other Study ID Numbers: R29NR004951 ( U.S. NIH Grant/Contract )
First Posted: June 30, 2010    Key Record Dates
Last Update Posted: June 30, 2010
Last Verified: June 2010
Keywords provided by Carl T. Hayden VA Medical Center:
Sleep Initiation and Maintenance Disorders
Behavior Therapy
Additional relevant MeSH terms:
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Sleep Initiation and Maintenance Disorders
Sleep Disorders, Intrinsic
Dyssomnias
 Sleep Wake Disorders
Nervous System Diseases
Mental Disorders