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
  Purpose

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 Intervention
Sleep Initiation and Maintenance Disorders
Behavioral: stimulus control therapy, sleep restriction therapy, multi-component treatment (stimulus control therapy, sleep restriction therapy)

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Behavioral Intervention for Insomnia in Older Adults

Further study details as provided by Carl T. Hayden VA Medical Center:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • 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


Enrollment: 179
Study Start Date: September 2000
Study Completion Date: August 2004
Primary Completion Date: August 2004 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   55 Years and older
Genders Eligible for Study:   Both
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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Please refer to this study by its ClinicalTrials.gov identifier: NCT01154023

Sponsors and Collaborators
Carl T. Hayden VA Medical Center
Investigators
Principal Investigator: Dana R Epstein, PhD, RN Carl T. Hayden VA
  More Information

No publications provided by Carl T. Hayden VA Medical Center

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Dana R. Epstein, Carl T. Hayden Veterans Affairs Medical Center
ClinicalTrials.gov Identifier: NCT01154023     History of Changes
Other Study ID Numbers: R29NR04951
Study First Received: June 28, 2010
Last Updated: June 29, 2010
Health Authority: United States: Federal Government

Keywords provided by Carl T. Hayden VA Medical Center:
Sleep Initiation and Maintenance Disorders
Behavior Therapy

ClinicalTrials.gov processed this record on October 20, 2014