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Behavioral Intervention for Insomnia in Older Adults

Primary Purpose

Sleep Initiation and Maintenance Disorders

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
stimulus control therapy, sleep restriction therapy, multi-component treatment (stimulus control therapy, sleep restriction therapy)
Sponsored by
Carl T. Hayden VA Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Sleep Initiation and Maintenance Disorders focused on measuring Sleep Initiation and Maintenance Disorders, Behavior Therapy

Eligibility Criteria

55 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Experimental

    Experimental

    Experimental

    Arm Label

    stimulus control therapy

    sleep restriction therapy

    multi-component intervention

    Arm Description

    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

    Sleep restriction therapy consolidates sleep by restricting the amount of time spent in bed and limiting sleep to a specific time period .

    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

    Outcomes

    Primary Outcome Measures

    subjective sleep
    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

    insomnia severity
    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

    Full Information

    First Posted
    June 28, 2010
    Last Updated
    June 29, 2010
    Sponsor
    Carl T. Hayden VA Medical Center
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    1. Study Identification

    Unique Protocol Identification Number
    NCT01154023
    Brief Title
    Behavioral Intervention for Insomnia in Older Adults
    Official Title
    Behavioral Intervention for Insomnia in Older Adults
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    June 2010
    Overall Recruitment Status
    Completed
    Study Start Date
    September 2000 (undefined)
    Primary Completion Date
    August 2004 (Actual)
    Study Completion Date
    August 2004 (Actual)

    3. Sponsor/Collaborators

    Name of the Sponsor
    Carl T. Hayden VA Medical Center

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Sleep Initiation and Maintenance Disorders
    Keywords
    Sleep Initiation and Maintenance Disorders, Behavior Therapy

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Factorial Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    179 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    stimulus control therapy
    Arm Type
    Experimental
    Arm Description
    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
    Arm Title
    sleep restriction therapy
    Arm Type
    Experimental
    Arm Description
    Sleep restriction therapy consolidates sleep by restricting the amount of time spent in bed and limiting sleep to a specific time period .
    Arm Title
    multi-component intervention
    Arm Type
    Experimental
    Arm Description
    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 Type
    Behavioral
    Intervention Name(s)
    stimulus control therapy, sleep restriction therapy, multi-component treatment (stimulus control therapy, sleep restriction therapy)
    Intervention Description
    Treatment was given weekly for 6 weeks. Sessions 1 - 4 were in a group format. Session 5 & 6 were delivered individually by phone.
    Primary Outcome Measure Information:
    Title
    subjective sleep
    Description
    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
    Time Frame
    1 year
    Secondary Outcome Measure Information:
    Title
    insomnia severity
    Description
    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
    Time Frame
    1 year

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    55 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility 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.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Dana R Epstein, PhD, RN
    Organizational Affiliation
    Carl T. Hayden VA
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    22654199
    Citation
    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.
    Results Reference
    derived

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    Behavioral Intervention for Insomnia in Older Adults

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