Behavioral Intervention for Insomnia in Older Adults

NCT01154023 | Completed

• 1 other identifier: R29NR004951
• Study Type: interventional
• Target: 179
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Sleep Initiation and Maintenance Disorders

Keywords

Sleep Initiation and Maintenance Disorders; Behavior Therapy

Outcome Measures

Primary Outcomes (1)

• 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

  1 year

Secondary Outcomes (1)

• insomnia severity

  1 year

Study Arms (3)

stimulus control therapy

EXPERIMENTAL

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)

sleep restriction therapy

EXPERIMENTAL

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)

multi-component intervention

EXPERIMENTAL

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)

Interventions

stimulus control therapy, sleep restriction therapy, multi-component treatment (stimulus control therapy, sleep restriction therapy) BEHAVIORAL

Treatment was given weekly for 6 weeks. Sessions 1 - 4 were in a group format. Session 5 \& 6 were delivered individually by phone.

multi-component intervention; sleep restriction therapy; stimulus control therapy

Eligibility Criteria

• Age: 55 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Carl T. Hayden VA Medical Center: lead

Related Publications (1)

• 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.

  PMID: 22654199 DERIVED

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders

Condition Hierarchy (Ancestors)

Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Study Officials

• Dana R Epstein, PhD, RN

  Carl T. Hayden VA

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: FED

Study Record Dates

• First Submitted: June 28, 2010
• First Posted: June 30, 2010
• Study Start: September 1, 2000
• Primary Completion: August 1, 2004
• Study Completion: August 1, 2004
• Last Updated: June 30, 2010

Record last verified: 2010-06